JMIR Research Protocols

Ongoing Trials, Grant Proposals, Formative Research, Methods, Early Results

A framework to assess the role of adoption and usage of mHealth technology on quality and experience of care provided by frontline workers: observations from rural Bihar

Background: mHealth applications are deployed with the aim of improveing access, quality and experience of health care. It is possible that any mHealth intervention can yield differential impacts for different types of users. Mediating and determining factors, including personal and socio-economic factors affect technology adoption, the way the health workers leverage and use the technology, and subsequently the quality and experience of care they provide. Objective: To develop a framework to assess whether mHealth platforms affect the quality and experience care provided by frontline workers, and whether these effects on quality and experience are different depending on the level of technology adoption and individual characteristics of the health worker. Literacy, education, age, and previous mobile experience are identified as individual factors that affect technology adoption and use, as well as factors that affect the quality and experience of care directly and via the technology. Methods: Formative research with 14 community health workers (CHW) using CommCare, a mHealth application for maternal and new born care, in Bihar, India. CHWs are first classified on level of CommCare adoption using data from CommCareHQ and then shadowed on home visits to evaluate their levels of technology proficiency, and the quality and experience of care provided. Regression techniques are employed to test the relationships. Results: Level of technology adoption is important for both quality and experience of care. The quality score for high users of CommCare is higher by 33.4% (P=.036) on average compared to low users of CommCare. Those who score higher on CommCare proficiency, also provide significantly higher quality and experience of care, where an additional point in CommCare proficiency score, increases quality score by around half a point (.541, P=.069), and experience score by around a third of a point (.308, P=.032). Compared to low-literate CHWs, illiterate CHWs have lower CommCare proficiency and usage scores, with illiteracy decreasing the CommCare proficiency score by 41% compared to lower literacy (P=0.087). Compared to literate ASHAS, illiterate ASHAs have a CommCare proficiency score that is lower by 51% (P=0.072). Age affects CommCare user-type negatively, with increasing in age increasing the likelihood of belonging to a lower category of CommCare adoption (-.105, P=.076). Predicted values estimating the relationship between CommCare proficiency and quality of care are negatively affected for those that are illiterate compared to those that are lower literate (-4.95, P=.087). Similarly, predicted values estimating the relationship between CommCare proficiency and experience of care are negatively affected, for those that are illiterate compared to those that are lower literate (-2.815, P=.087). Conclusions: mHealth technology adoption by frontline workers can positively impact the quality and experience of care they provide. Individual characteristics, especially literacy and age can be an important element affecting technology adoption, and the way users leverage the technology for their work. Our formative study provides informed hypothesis and methods for further research. Clinical Trial: None

2014-11-06

The year 2014 comes to an end - have you published enough in 2014 to keep your career moving ahead?

Add another paper to your 2014 publication list by publishing a grant proposal or protocol of your ongoing or planned research in our PubMed-indexed journal JMIR Res Protoc:

  • submit your protocol/proposal of your ongoing study to JMIR Res Protoc before Nov 15th, 2014, and if it is already reviewed/approved by your granting agency (attach review reports), WE GUARANTEE ACCEPTANCE/PUBLICATION BEFORE DEC 31, 2014, with FAST-TRACK FEES WAIVED (APF for already peer-reviewed proposals/protocols is $950)
  • NO SUBMISSION FEES for articles submitted to JMIR Res Protoc between Nov 6th-15th, 2014 (UPDATE: We now decided to permanently suspend submission fees for JMIR Res Protoc!)
  • for all studies published in JMIR Res Protoc, we offer a 20% discount on the APF if the subsequent full study results are published in a JMIR journal (this is a $490 value)
  • while many JMIR Res Protoc papers are from the field of ehealth, we publish protocols from all areas of medicine and health research, including wet lab science, systematic review protocols, clinical randomized trial protocols, qualitative study protocols, formative research such as usability studies etc.

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Journal Description

 

JMIR Research Protocols (ISSN 1929-0748) publishes peer-reviewed, openly accessible research ideas and grant proposals, study and trial protocols, reports of ongoing research, current methods and approaches, and preliminary results from pilot studies or formative research informing the design of medical and health-related research and technology innovations.

  • JMIR Res Protoc is a new journal spin-off of JMIR, the worlds' leading medical journal in health sciences / health services research and health informatics (Impact Factor: 4.7)
  • JMIR Res Protoc publishes protocols and grant proposals in all areas of medicine (and their peer-review reports, if available), as well as feasibility studies, early reports and formative/process evaluations of ongoing studies and descriptions of the development and pilot evaluations of innovations and software applications or other interventions
  • JMIR Res Protoc is fully open access, with full text articles deposited in PubMed Central
  • Publishing research protocols, grant proposals, pilot/feasibility studies and early reports of ongoing and planned work encourages collaboration and early feedback, and reduces duplication of effort 
  • JMIR Res Protoc will be a valuable ressource for researchers who want to learn about current research methodologies and how to write a winning grant proposal
  • JMIR Res Protoc creates an early scientific record for researchers who have developed novel methodologies, software, innovations or elaborate protocols
  • JMIR Res Protoc faciliates subsequent publication of results demonstrating that the methodology has already been reviewed, and reduces the effort of writing up the results, as the protocol can be easily referenced
  • JMIR Res Protoc demonstrates to reviewers of subsequent results papers that authors followed and adhered to carefully developed and described a-priori methods
  • Studies whose protocols or grant proposal have been accepted in JMIR Res Protoc are "in principle accepted" for subsequent publication of results in other JMIR journals as long as authors adhere to their original protocol - regardless of study results (even if they are negative), reducing publication bias in medicine
  • Authors publishing their protocols in JMIR Res Protoc will receive a 20% discount on the article processing fee if they publish their results in another journal of the JMIR journal family (for example, JMIR for ehealth studies, i-JMR for others)
 
 

Recent Articles:

  • This is a royalty free image by Praisaeng (http://www.freedigitalphotos.net/images/disabled-woman-using-a-laptop-in-her-wheelchair-photo-p182055).

    Tying eHealth Tools to Patient Needs: Exploring the Use of eHealth for Community-Dwelling Patients With Complex Chronic Disease and Disability

    Abstract:

    Background: Health policy makers have recently shifted attention towards examining high users of health care, in particular patients with complex chronic disease and disability (CCDD) characterized as having multimorbidities and care needs that require ongoing use of services. The adoption of eHealth technologies may be a key strategy in supporting and providing care for these patients; however, these technologies need to address the specific needs of patients with CCDD. This paper describes the first phase of a multiphased patient-centered research project aimed at developing eHealth technology for patients with CCDD. Objective: As part of the development of new eHealth technologies to support patients with CCDD in primary care settings, we sought to determine the perceived needs of these patients with respect to (1) the kinds of health and health service issues that are important to them, (2) the information that should be collected and how it could be collected in order to help meet their needs, and (3) their views on the challenges/barriers to using eHealth mobile apps to collect the information. Methods: Focus groups were conducted with community-dwelling patients with CCDD and caregivers. An interpretive description research design was used to identify the perceived needs of participants and the information sharing and eHealth technologies that could support those needs. Analysis was conducted concurrently with data collection. Coding of transcripts from four focus groups was conducted by 3 authors. QSR NVivo 10 software was used to manage coding. Results: There were 14 total participants in the focus groups. The average age of participants was 64.4 years; 9 participants were female, and 11 were born in Canada. Participants identified a need for open two-way communication and dialogue between themselves and their providers, and better information sharing between providers in order to support continuity and coordination of care. Access issues were mainly around wait times for appointments, challenges with transportation, and costs. A visual depiction of these perceived needs and their relation to each other is included as part of the discussion, which will be used to guide development of our eHealth technologies. Participants recognized the potential for eHealth technologies to support and improve their care but also expressed common concerns regarding their adoption. Specifically, they mentioned privacy and data security, accessibility, the loss of necessary visits, increased social isolation, provider burden, downloading responsibility onto patients for care management, entry errors, training requirements, and potentially confusing interfaces. Conclusions: From the perspective of our participants, there is a significant potential for eHealth tools to support patients with CCDD in community and primary care settings, but we need to be wary of the potential downfalls of adopting eHealth technologies and pay special attention to patient-identified needs and concerns. eHealth tools that support ongoing patient-provider interaction, patient self-management (such as telemonitoring), and provider-provider interactions (through electronic health record integration) could be of most benefit to patients similar to those in our study.
  • MyDecisionQuality screenshot.

    Increasing User Involvement in Health Care and Health Research Simultaneously: A Proto-Protocol for "Person-as-Researcher" and Online Decision Support Tools

    Abstract:

    Background: User involvement is appearing increasingly on policy agendas in many countries, with a variety of proposals for facilitating it. The belief is that it will produce better health for individuals and community, as well as demonstrate greater respect for the basic principles of autonomy and democracy. Objective: Our Web-based project aims to increase involvement in health care and health research and is presented in the form of an umbrella protocol for a set of project-specific protocols. We conceptualize the person as a researcher engaged in a continual, living, informal “n-of-1”-type study of the effects of different actions and interventions on their health, including those implying contact with health care services. We see their research as primarily carried out in order to make better decisions for themselves, but they can offer to contribute the results to the wider population. We see the efforts of the "person-as-researcher" as contributing to the total amount of research undertaken in the community, with research not being confined to that undertaken by professional researchers and institutions. This view is fundamentally compatible with both the emancipatory and conventional approaches to increased user involvement, though somewhat more aligned with the former. Methods: Our online decision support tools, delivered directly to the person in the community and openly accessible, are to be seen as research resources. They will take the form of interactive decision aids for a variety of specific health conditions, as well as a generic one that supports all health and health care decisions through its focus on key aspects of decision quality. We present a high-level protocol for the condition-specific studies that will implement our approach, organized within the Populations, Interventions, Comparators, Outcomes, Timings, and Settings (PICOTS) framework. Results: Our underlying hypothesis concerns the person-as-researcher who is equipped with a prescriptive, transparent, expected value-based opinion—an opinion that combines their criterion importance weights with the Best Estimates Available Now for how well each of the available options performs on each of those outcomes. The hypothesis is that this person-as-researcher is more likely to be able to position themselves as an active participant in a clinical encounter, if they wish, than someone who has engaged with a descriptive decision aid that attempts to work with their existing cognitive processes and stresses the importance of information. The precise way this is hypothesis tested will be setting-specific and condition-specific and will be spelled out in the individual project protocols. Conclusions: Decision resources that provide fast access to the results of slower thinking can provide the stimulus that many individuals need to take a more involved role in their own health. Our project, advanced simply as one approach to increased user involvement, is designed to make progress in the short term with minimal resources and to do so at the point of decision need, when motivation is highest. Some basic distinctions, such as those between science and non-science, research and practice, community and individual, and lay and professional become somewhat blurred and may need to be rethought in light of this approach.
  • Developing Community-Based Rehabilitation Programs for Musculoskeletal Diseases in Low-Income Areas of Mexico: The Community-Based Rehabilitation for...

    Abstract:

    Background: The negative impact of musculoskeletal diseases on the physical function and quality of life of people living in developing countries is considerable. This disabling effect is even more marked in low-socioeconomic communities within developing countries. In Mexico, there is a need to create community-based rehabilitation programs for people living with musculoskeletal diseases in low-socioeconomic areas. These programs should be directed to prevent and decrease disability, accommodating the specific local culture of communities. Objective: The objective of this paper is to describe a research protocol designed to develop, implement, and evaluate culturally sensitive community-based rehabilitation programs aiming to decrease disability of people living with musculoskeletal diseases in two low-income Mexican communities. Methods: A community-based participatory research approach is proposed, including multi and transdisciplinary efforts among the community, medical anthropology, and the health sciences. The project is structured in 4 main stages: (1) situation analysis, (2) program development, (3) program implementation, and (4) program evaluation. Each stage includes the use of quantitative and qualitative methods (mixed method program). Results: So far, we obtained resources from a Mexican federal agency and completed stage one of the project at Chankom, Yucatán. We are currently receiving funding from an international agency to complete stage two at this same location. We expect that the project at Chankom will be concluded by December of 2017. On the other hand, we just started the execution of stage one at Nuevo León with funding from a Mexican federal agency. We expect to conclude the project at this site by September of 2018. Conclusions: Using a community-based participatory research approach and a mixed method program could result in the creation of culturally sensitive community-based rehabilitation programs that promote community development and decrease the disabling effects of musculoskeletal diseases within two low-income Mexican communities.
  • Homepage of the SOULAGE-TAVIE website showing functions to determine patient profile and to start the intervention.

    Acceptability of a Web-Based and Tailored Intervention for the Self-Management of Pain After Cardiac Surgery: The Perception of Women and Men

    Abstract:

    Background: Approximately two thirds of adults undergoing cardiac surgery suffer from moderate to severe postoperative pain. Assisting patients with pain management is therefore critical to prevent its negative consequences. Information technologies have become part of our lifestyle and can facilitate the implementation of interventions to manage pain in a busy care setting. A computer-tailored and Web-based intervention—referred to as SOUtien à L’AutoGEstion-Traitement-Assistance Virtuelle Infirmière-Enseignement (SOULAGE-TAVIE)—for the self-management of pain was developed. Findings from a previous pilot randomized controlled trial (RCT) provided some evidence of the feasibility and preliminary effectiveness of this intervention in decreasing pain interference with a few postoperative activities and by modulating pain beliefs and analgesic intake. However, its acceptability from the patient’s perspective remains unclear. Moreover, the proportion of women is much lower in the cardiac surgical population, making it difficult to detect differences in experiences between men and women. Objective: The objectives were (1) to describe SOULAGE-TAVIE’s acceptability from the perspective of adults experiencing pain after cardiac surgery and (2) to compare the perceptions of men and women. Methods: A mixed-method approach was used to capture the various attributes of patients’ perceptions of the intervention’s acceptability and to compare the perceptions of men and women. Quota samples of men (n=10; mean age 62.5 years, SD 7.3) and women (n=10; mean age 64.3 years, SD 10.7) who had cardiac surgery in the past month were invited to view the intervention, complete a brief questionnaire rating its acceptability, and then to discuss each component in a 60-minute, semistructured interview. Mann-Whitney U tests were used to compare groups. The transcripts were content analyzed to generate themes based on patients’ experiences with the intervention and reports of acceptability. The content of each category and subcategory were compared between men and women. Frequency counts were also done to validate the emergence of a difference between the 2 subgroups. Results: Participants perceived the intervention to be very acceptable in terms of content and format, and tended to describe awareness-raising and convenient support experiences. Women scored higher than men in terms of the intervention’s appropriateness (U=13.5, P=.008). They were willing to adhere to the intervention based on the importance and relevance of the advice provided, whereas men were more focused on the delivery mode and its flexibility. Conclusions: This study underlined the acceptability of computer tailoring and persuasive communication to modulate pain beliefs and attitudes in an acute care context. Both men and women appreciated the Web-based interface and general self-guided approach of the intervention. The delivery of SOULAGE-TAVIE across the continuum of care seems to be an interesting avenue to influence the transition from acute to chronic postoperative pain.
  • The Library frontpage translated into English by Google Translate.

    Examining the Use of an Open Digital Health Library for Professionals

    Abstract:

    Background: The Norwegian Electronic Health Library (The Library) is a website for health personnel. Most of the content is also open to the public. Usage statistics have risen sharply in the years 2010-2013. Objective: We wanted to find out whether the rise was caused by health personnel, the general public, or other factors. Methods: Since we lacked direct information, we had to use proxy data to shed light on our questions. We applied mixed methods (database of registered users, user survey, usage statistics, and statistics from suppliers), and triangulated between them. Results: Health personnel were our largest user group, but The Library was also accessed by students, patients, and other groups. Content in Norwegian was preferred to English language content. Concise, practical information was preferred to more comprehensive information. Patient leaflets were the most popular information type. Mobile phone visits differed from personal computer visits both in terms of time of day and what kind of information was viewed. Conclusions: The Library was used mostly by health personnel, as intended, but our data are inconclusive regarding a possible change in user groups. There was a large degree of consistency in results when using different investigation methods. The survey points toward health personnel being the largest user group, and the usage statistics show that patient leaflets are the most popular content, being viewed by both health personnel and patients.
  • Screenshot of MijnSAB.

    An Online Health Community for Aneurysmal Subarachnoid Hemorrhage Patients: A Pilot Study

    Abstract:

    Background: Aneurysmal subarachnoid hemorrhage (aSAH) is a condition affecting relatively young patients and has high rates of morbidity and mortality. Online health communities have emerged to fill the void for patient advocacy and information, allowing individuals with shared experiences and chronic disorders to connect. Objective: We have developed an online health community for aSAH patients, and this pilot study was conducted to evaluate it from a patient’s perspective. Methods: We implemented an online, members-only, health community (MijnSAB, translation: MySAH) in addition to the usual aSAH care at Radboudumc, Nijmegen, the Netherlands. A questionnaire that was sent to consecutive aSAH patients was used to evaluate the usability and utility of MySAH. Answers were provided using a 5-point Likert scale. There was also one open-ended question asking about what was missing from the MySAH tool. Results: In total, 66 consecutive patients with aneurysmal subarachnoid hemorrhage were informed about the online health community. Of 64 potential MySAH users, 26 patients gained access to MySAH, 20 of whom were willing to participate in the evaluation. Those who used the community were younger (P=.03) and in a better condition at discharge (P=.03). The patients were positive about MySAH’s contribution to the quality of their care, but not to their quality of life. Most patients (18/20, 90%) reported that they would recommend the community to others in their position. Open suggestions on how to improve the tool included more frequent blogs, including by a rehabilitation specialist. Conclusions: This pilot study showed that the online health community, MySAH, has a beneficial effect on the aftercare of patients suffering from aSAH because it gives easy access to relevant information provided by peers or caregivers. Due to the variable clinical outcomes after aSAH, the tool will mainly be useful for a select group of patients (with a better clinical outcome).
  • Cropped Figure 2.

    A Formative Evaluation of a Social Media Campaign to Reduce Adolescent Dating Violence

    Abstract:

    Background: The Emory Jane Fonda Center implemented the Start Strong Atlanta social marketing campaign, “Keep It Strong ATL”, in 2007 to promote the development of healthy adolescent relationships and to foster the prevention of adolescent dating abuse among 11-14 year olds. Objective: A formative evaluation was conducted to understand whether messages directed at the target audience were relevant to the program’s relationship promotion and violence prevention goals, and whether the “Web 2.0” social media channels of communication (Facebook, Twitter, YouTube, Flickr, Tumblr, and Pinterest) were reaching the intended audience. Methods: Mixed methodologies included qualitative interviews and a key informant focus group, a cross-sectional survey, and web analytics. Qualitative data were analyzed using constant comparative methodology informed by grounded theory. Descriptive statistics were generated from survey data, and web analytics provided user information and traffic patterns. Results: Results indicated that the Keep It Strong ATL social marketing campaign was a valuable community resource that had potential for broader scope and greater reach. The evaluation team learned the importance of reaching adolescents through Web 2.0 platforms, and the need for message dissemination via peers. Survey results indicated that Facebook (ranked 6.5 out of 8) was the highest rated social media outlet overall, and exhibited greatest appeal and most frequent visits, yet analytics revealed that only 3.5% of “likes” were from the target audience. These results indicate that the social media campaign is reaching predominantly women (76.5% of viewership) who are outside of the target age range of 11-14 years. Conclusions: While the social media campaign was successfully launched, the findings indicate the need for a more focused selection of communication channels, timing of media updates to maximize visibility, balancing message tone and delivery, and incorporating differentiated messaging for the target audiences. Collaboration with parents and community partners is also emphasized in order to expand the campaign’s reach and create more channels to disseminate relationship promotion and dating violence prevention messaging to the intended audience.
  • By Kamnuan, published on 07 August 2014 Stock Photo - image ID: 100279614; http://www.freedigitalphotos.net/images/surreal-fruit-concept-photo-p279614.

    Comparison of Two Theory-Based, Fully Automated Telephone Interventions Designed to Maintain Dietary Change in Healthy Adults: Study Protocol of a Three-Arm...

    Abstract:

    Background: Health behavior change interventions have focused on obtaining short-term intervention effects; few studies have evaluated mid-term and long-term outcomes, and even fewer have evaluated interventions that are designed to maintain and enhance initial intervention effects. Moreover, behavior theory has not been developed for maintenance or applied to maintenance intervention design to the degree that it has for behavior change initiation. Objective: The objective of this paper is to describe a study that compared two theory-based interventions (social cognitive theory [SCT] vs goal systems theory [GST]) designed to maintain previously achieved improvements in fruit and vegetable (F&V) consumption. Methods: The interventions used tailored, interactive conversations delivered by a fully automated telephony system (Telephone-Linked Care [TLC]) over a 6-month period. TLC maintenance intervention based on SCT used a skills-based approach to build self-efficacy. It assessed confidence in and barriers to eating F&V, provided feedback on how to overcome barriers, plan ahead, and set goals. The TLC maintenance intervention based on GST used a cognitive-based approach. Conversations trained participants in goal management to help them integrate their newly acquired dietary behavior into their hierarchical system of goals. Content included goal facilitation, conflict, shielding, and redundancy, and reflection on personal goals and priorities. To evaluate and compare the two approaches, a sample of adults whose F&V consumption was below public health goal levels were recruited from a large urban area to participate in a fully automated telephony intervention (TLC-EAT) for 3-6 months. Participants who increase their daily intake of F&V by ≥1 serving/day will be eligible for the three-arm randomized controlled trial. A sample of 405 participants will be randomized to one of three arms: (1) an assessment-only control, (2) TLC-SCT, and (3) TLC-GST. The maintenance interventions are 6 months. All 405 participants who qualify for the trial will complete surveys administered by blinded interviewers at baseline (randomization), 6, 12, 18, and 24 months. Results: Data analysis is not yet complete, but we hypothesize that (1) TLC-GST > TLC-SCT > control at all follow-up time points for F&V consumption, and (2) intervention effects will be mediated by the theoretical constructs (eg, self-efficacy, goal pursuit, conflict, shielding, and facilitation). Conclusions: This study used a novel study design to initiate and then promote the maintenance of dietary behavior change through the use of an evidence-based fully automated telephony intervention. After the first 6 months (the acquisition phase), we will examine whether two telephony interventions built using different underlying behavioral theories were more successful than an assessment-only control group in helping participants maintain their newly acquired health behavior change. Clinical Trial: Clinicaltrials.gov NCT00148525; http://clinicaltrials.gov/ct2/show/NCT00148525 (Archived by Webcite at http://www.webcitation.org/6TiRriJOs).
  • Screenshot of a patient account from https://patienttime.nivel.nl/.

    Active Patient Participation in the Development of an Online Intervention

    Abstract:

    Background: An important and challenging part of living with cancer relates to the repeated visits to the hospital. Since how patients cope between these post-diagnostic visits depends partly on the information and support received from their physician during the visits, it is important to make the most of them. Recent findings reinforce the importance of training not only the health care professionals in communication skills, but providing patients with support in communication as well. Delivering such supportive interventions online can have potential benefits in terms of accessibility, cost-effectiveness, and ability to tailor information to personal needs. However, problems with attrition (dropout, non-usage) during the test phase and poor uptake after implementation are frequently reported. The marginal level of engagement of the patient as end user seems to play a role in this. Therefore, recent research suggests integrating theory-based development methods with methods that promote involvement of the patient at an early stage. This paper describes a participatory protocol, used to let patients guide a theory-informed development process. Objective: The objective of this project was to apply a bottom-up inspired procedure to develop a patient-centered intervention with corresponding evaluation and implementation plan. Methods: The applied development protocol was based on the intervention mapping framework, combined with patient participatory methods that were inspired by the participation ladder and user-centred design methods. Results: The applied protocol led to a self-directed online communication intervention aimed at helping patients gain control during their communications with health care professionals. It also led to an evaluation plan and an implementation plan. The protocol enabled the continuous involvement of patient research partners and the partial involvement of patient service users, which led to valuable insights and improvements. Conclusions: The applied protocol realized patient participation on different levels throughout the entire project. Early involvement, involvement on different levels, and flexibility in terms of planning and setup seem to be preconditions to creating a bottom-up inspired development procedure with (seriously ill) patients. Further research is necessary to find out if a more patient-centered approach improves the implementation and uptake of eHealth interventions. Clinical Trial: Netherlands National Trial Register ID number: NTR3779; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=3779 (Archived by WebCite at http://www.webcitation.org/6TdfALKxV).
  • Thumbnail screenshot.

    Treatment of Infantile Hemangioma in Regional Hospitals With eHealth Support: Evaluation of Feasibility and Acceptance by Parents and Doctors

    Abstract:

    Background: Since beta blockers became the preferred treatment for infantile hemangiomas (IH), the number of patients eligible for treatment is increasing. Currently treatment of IH with beta blockers is mainly reserved for expert centers, where wait times are lengthening. This demonstrated the need for development of a more efficient and accessible way of providing care for children needing treatment for IH. An eHealth intervention, Hemangioma Treatment Plan (HTP), was developed to treat IH in regional hospitals with online support from an academic doctor. Objective: Our goal was to evaluate the feasibility of the eHealth intervention by determining its use, acceptance, and usability. By evaluating the feasibility, usage can be predicted and points for improvement can be defined, thereby facilitating implementation of the intervention. Methods: Parents of children with an IH, presenting between October 2012 and November 2013 at the tertiary expert Center for Congenital Vascular Anomalies Utrecht, requiring treatment with a beta blocker, were asked to participate in the digital HTP. Both parents and regional doctors were sent a study questionnaire. Acceptance and usability of the HTP were evaluated by using the modified Technology Acceptance Model. Results: A total of 31 parents and 22 regional doctors participated in the eHealth intervention and received the questionnaire, and 25 parents and 15 doctors responded (response rates respectively 81% and 68%). A majority of the parents (96%, 24/25) and the regional doctors (87%, 13/15) considered the eHealth intervention useful in the care for IH. Most parents (76%, 19/25) and over half of the regional doctors (53%, 8/15) found the HTP easy to use. Technical problems using the HTP were reported by 28% (7/25) of the parents and 73% (11/15) of the doctors. The majority of parents (92%, 23/25) felt positive about usage of the HTP during treatment of their child. All regional doctors (100%, 15/15) felt positive about transition of treatment from the tertiary expert center to them, and 93% (14/15) felt positive about using the HTP. Conclusions: Our eHealth intervention shows good feasibility, especially among parents. Improvement with respect to technical problems, training of regional doctors, and achieving organizational support might be needed for successful implementation in the future.
  • Zoom from Figure 1.

    The Evolution of a Professional Practice Forum: Balancing Peer-to-Peer Learning With Course Objectives

    Abstract:

    Background: The Opioid Treatment Accreditation Course (OTAC) is a mandatory accreditation requirement in New South Wales, Australia, and aims to prepare medical practitioners for the provision of safe and effective Opioid Substitution Treatment to people with opioid dependence. The course has a strong focus on safe prescribing practices and the course design includes a Professional Practice Forum that is engaging for participants and effective at imparting complex ideas and concepts that do not place additional time constraints on already time-poor health professionals. Objective: The study aimed to use participatory action research methods to develop and evaluate an online Professional Practice Forum that is a key component of the OTAC teaching and learning experience. Methods: Three evaluation cycles were implemented with three cohorts of participants (N=40) to inform the design and review of the updated OTAC course. Overall, the study relied on participatory action research methods to enhance a sense of online community and to revise the Professional Practice Forum component of the course. Findings from survey feedback and an examination of Web metrics were used to monitor participant learning and were subsequently subject to thematic analysis in order to identify key themes. Results: The use of participatory action techniques in the redesign of the OTAC course was a successful means of engaging with participants and resulted in four revisions based on feedback from facilitators and participants. The Professional Practice Forum was rated highly and received positive feedback from both moderators and participants. Conclusions: The use of interactive forums in online learning in an educational module for adult learners can prove extremely valuable as a means for participants to share their expertise and improve their learning outcomes. In particular, the use of sticky and welcome threads were significant features that enhanced interactions between participants and facilitators and resulted in increased quantity and quality of postings. These findings can help inform future researchers on how to develop peer engagement modules that are amenable to assessment and that build an online sense of community.
  • TOC image created for trial by TRW.

    Promoting Physical Activity in Low-Active Adolescents via Facebook: A Pilot Randomized Controlled Trial to Test Feasibility

    Abstract:

    Background: The World Wide Web is an effective method for delivering health behavior programs, yet major limitations remain (eg, cost of development, time and resource requirements, limited interactivity). Social media, however, has the potential to deliver highly customizable and socially interactive behavioral interventions with fewer constraints. Thus, the evaluation of social media as a means to influence health behaviors is warranted. Objective: The objective of this trial was to examine and demonstrate the feasibility of using an established social networking platform (ie, Facebook) to deliver an 8 week physical activity intervention to a sample of low-active adolescents (N=21; estimated marginal mean age 13.48 years). Methods: Participants were randomized to either an experimental (ie, Behavioral) or attentional control (ie, Informational) condition. Both conditions received access to a restricted-access, study-specific Facebook group where the group’s administrator made two daily wall posts containing youth-based physical activity information and resources. Primary outcomes included physical activity as assessed by accelerometry and self-report. Interactions and main effects were examined, as well as mean differences in effect sizes. Results: Analyses revealed significant improvements over time on subjectively reported weekly leisure-time physical activity (F1,18=8.426, P=.009, η2 = .319). However, there was no interaction between time and condition (F1,18=0.002, P=.968, η2 = .000). There were no significant time or interaction effects among the objectively measured physical activity variables. Examination of effect sizes revealed moderate-to-large changes in physical activity outcomes. Conclusions: Results provide initial support for the feasibility of delivery of a physical activity intervention to low-active adolescents via social media. Whether by employing behavioral interventions via social media can result in statistically meaningful changes in health-related behaviors and outcomes remains to be determined. Clinical Trial: ClinicalTrials.gov NCT01870323; http://clinicaltrials.gov/show/NCT01870323 (Archived by WebCite at http://www.webcitation.org/6SUTmSeZZ).

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  • A framework to assess the role of adoption and usage of mHealth technology on quality and experience of care provided by frontline workers: observations from rural Bihar

    Date Submitted: Nov 15, 2014

    Open Peer Review Period: Nov 18, 2014 - Dec 2, 2014

    Background: mHealth applications are deployed with the aim of improveing access, quality and experience of health care. It is possible that any mHealth intervention can yield differential impacts for...

    Background: mHealth applications are deployed with the aim of improveing access, quality and experience of health care. It is possible that any mHealth intervention can yield differential impacts for different types of users. Mediating and determining factors, including personal and socio-economic factors affect technology adoption, the way the health workers leverage and use the technology, and subsequently the quality and experience of care they provide. Objective: To develop a framework to assess whether mHealth platforms affect the quality and experience care provided by frontline workers, and whether these effects on quality and experience are different depending on the level of technology adoption and individual characteristics of the health worker. Literacy, education, age, and previous mobile experience are identified as individual factors that affect technology adoption and use, as well as factors that affect the quality and experience of care directly and via the technology. Methods: Formative research with 14 community health workers (CHW) using CommCare, a mHealth application for maternal and new born care, in Bihar, India. CHWs are first classified on level of CommCare adoption using data from CommCareHQ and then shadowed on home visits to evaluate their levels of technology proficiency, and the quality and experience of care provided. Regression techniques are employed to test the relationships. Results: Level of technology adoption is important for both quality and experience of care. The quality score for high users of CommCare is higher by 33.4% (P=.036) on average compared to low users of CommCare. Those who score higher on CommCare proficiency, also provide significantly higher quality and experience of care, where an additional point in CommCare proficiency score, increases quality score by around half a point (.541, P=.069), and experience score by around a third of a point (.308, P=.032). Compared to low-literate CHWs, illiterate CHWs have lower CommCare proficiency and usage scores, with illiteracy decreasing the CommCare proficiency score by 41% compared to lower literacy (P=0.087). Compared to literate ASHAS, illiterate ASHAs have a CommCare proficiency score that is lower by 51% (P=0.072). Age affects CommCare user-type negatively, with increasing in age increasing the likelihood of belonging to a lower category of CommCare adoption (-.105, P=.076). Predicted values estimating the relationship between CommCare proficiency and quality of care are negatively affected for those that are illiterate compared to those that are lower literate (-4.95, P=.087). Similarly, predicted values estimating the relationship between CommCare proficiency and experience of care are negatively affected, for those that are illiterate compared to those that are lower literate (-2.815, P=.087). Conclusions: mHealth technology adoption by frontline workers can positively impact the quality and experience of care they provide. Individual characteristics, especially literacy and age can be an important element affecting technology adoption, and the way users leverage the technology for their work. Our formative study provides informed hypothesis and methods for further research. Clinical Trial: None

  • A shared mealtime approach to improving social and nutritional functioning among older adults living alone (RelAte): study protocol for a randomised controlled trial

    Date Submitted: Nov 17, 2014

    Open Peer Review Period: Nov 18, 2014 - Dec 2, 2014

    Background: Background: Older adults living alone are at increased risk of malnutrition as well as social isolation. Previous research has evaluated psychosocial interventions aimed at improving socia...

    Background: Background: Older adults living alone are at increased risk of malnutrition as well as social isolation. Previous research has evaluated psychosocial interventions aimed at improving social support for older adults living alone. One meta-analysis in particular has suggested that multimodal psychosocial interventions are more effective than unimodal interventions. As such it may be more effective to deliver an intervention which combines nutritional and social support together. Consequently, we designed the RelAte intervention, which focuses on shared mealtimes as a source of combined social and nutritional support for older adults living alone who are at risk of social isolation. Objective: Objective: The RelAte Trial was designed to evaluate the impact of such an intervention on energy intake, anthropometric measurements, and nutritional social cognitive variables among older adults living alone in the community. Methods: Methods/Design: 100 participants will be recruited and randomised to either the treatment (n = 50) or the control group. The treatment group will receive a visit from a trained peer volunteer once weekly for a period of 8 weeks. Outcomes of interest include: energy intake, social cognitive factors related to diet, abdominal circumference, body mass index, psychosocial wellbeing, frailty, nutritional status, and health utilities. Outcomes will be obtained at baseline, immediately post-intervention (8 weeks after baseline), 12-week follow-up, and 26-week follow-up, by assessors blinded to participants’ randomised assignment. Conclusions: Discussion: Results from this study will primarily describe the effectiveness of a shared mealtime intervention for older adults living alone in terms of their dietary wellbeing, physical health, and psychosocial wellbeing. Clinical Trial: Trial Registration: Clinical Trials (clinicaltrials.gov) NCT02007551

  • Simulation Of Direct Exchange Of Monitoring Information Between A Personalized Mobile App And The Ehr For Patients With Congestive Heart Failure: A Research Project Proposal

    Date Submitted: Nov 15, 2014

    Open Peer Review Period: Nov 18, 2014 - Dec 2, 2014

    Background: Mobile health applications (mHealth apps) for consumer health informatics are opening the way to patients’ responsible and active contribution to their healthcare management. However, ap...

    Background: Mobile health applications (mHealth apps) for consumer health informatics are opening the way to patients’ responsible and active contribution to their healthcare management. However, apart from Apps allowing patient’s access to their electronic health records (EHRs), mHealth apps are currently developed as dedicated “island systems” relying on ad-hoc repositories, specific access policies that require information duplicated in the patient’s EHR. Conversely, the clinician’s daily practice is based on EHR systems with minimal or no patient interaction from home. Objective: This project aims to test the feasibility of the integration between an mHealth App for congestive heart failure patient’s monitoring and the patient’s EHR by simulating the integration environment using an open-access EHR system. Methods: As a first step, we will review the current literature and standards to define the conceptual framework for the integration of requirements of the mHealth app/EHR exchange. From these, we will design the preliminary architecture of the EHR/mHealth app integrated system. To do so, we will first model through the Unified Modeling Language (UML) the process of home monitoring for patients with congestive heart failure, and then we will identify the building blocks for the system architecture responding to the requirements. The development of the EHR side prototype will be based on OpenMRS, an open source initiative that implements a longitudinal EHR. OpenMRS allows the development of customized forms and modules to support the simulated integration environment. The mHealth app for the patients and their caregiver will be developed for the iOS platform, with the contribution of domain experts in the interface design phase. The testing phase will be devoted to assess the feasibility of the approach. Results: We defined the main requirements for mHealth Apps/EHR exchange process as: (1) accurate information representation - ensuring the proper concept mapping from the patient/family domain to the healthcare domain; (2) data protection - considering the patient’s mobile device as an “unsafe” environment; (3) patient education - increasing the degree of trust of information generated by Apps; (4) information tracking - prompt evidence-based research on mHealth Apps adoption. From these, we designed an integration architecture based on the exchange of standard clinical documents, to ensure data accuracy, and implementing only the exchange of de-identified data. The interface of the system prototype was also developed. Conclusions: This project, if successful, will represent a step forward in the integration of personal mHealth apps into the larger health-IT ecosystem envisaged by HIE thus supporting the patient’s engagement in self-management and self-care and, ultimately, allowing better care and preventing frequent re-admissions.

  • A Pragmatic randomized controlled trial to evaluate the impact of mobile HealthPROMISE Platform on the quality of care and quality of life in patients with inflammatory Bowel Disease.

    Date Submitted: Nov 15, 2014

    Open Peer Review Period: Nov 17, 2014 - Dec 1, 2014

    Background: Inflammatory Bowel Disease (IBD) is a chronic condition of the bowel that affects over 1 million people in the United States. The recurring nature of disease makes IBD patients’ ideal ca...

    Background: Inflammatory Bowel Disease (IBD) is a chronic condition of the bowel that affects over 1 million people in the United States. The recurring nature of disease makes IBD patients’ ideal candidates for patient-engaged care that is centered on enhanced self-management and improved doctor-patient communication. In IBD, optimal approaches to management vary for patients with different phenotypes and extent of disease and past surgical history. Hence, a single quality metric cannot define a heterogeneous disease such as IBD, unlike hypertension and diabetes. A more comprehensive assessment may be provided by complementing traditional quality metrics with measures of the patient’s quality of life (QOL) through an application like HealthPROMISE. Objective: The objective of this pragmatic randomized controlled trial is to determine the impact of HealthPROMISE app in improving outcomes (quality of care, QOL, patient adherence, disease control and resource utilization) as compared to patient education app. Our hypothesis is that a patient-centric self-monitoring and collaborative decision support platform will lead to sustainable improvement in overall quality of IBD patients. Methods: Participants will be recruited during face-face visits and randomized to either an interventional (i.e., HealthPROMISE) or control (i.e., education app). Patients in the HealthPROMISE arm will be able to update their information and receive disease summary, quality metrics and a graph showing the trend of quality of life (SIBDQ )scores and resource utilization over time. Providers will utilize the data for collaborative decision making and QI interventions at the point of care. Patients in control arm will enter data at baseline, during office visits and at the end of the study, but will not receive any decision support (trend of quality of life, alert or dashboard views). Results: Enrollment in trial will be starting in first quarter of 2015. It is intended that up to 300 patients with IBD will be recruited into the study (with 1:1 allocation ratio). The primary endpoint is number of quality indicators met in HealthPROMISE vs. control arm. Secondary endpoints include decrease in number of emergency visits due to IBD, Decrease in number of hospitalization due to IBD , change in generic QOL score from baseline, proportion of patients in each group who meet all eligible outpatient quality metrics and proportion of patients in disease control in each group. In addition, we plan to conduct protocol analysis of intervention patients with adequate HealthPROMISE utilization (> 6 logins from week 0- week 52) achieving above mentioned primary and secondary endpoints. Conclusions: HealthPROMISE is a unique cloud based PRO (patient reported outcome) and decision support tool that empowers both patients and providers. Patients track their quality of life as well as symptoms and providers can use the visual data in real time (integrated with EHRs) to provide better care to entire patient population.Utilizing pragmatic trial design, we hope to show that. IBD patients who participate in their own care and share in decision-making have appreciably improved outcomes when compared to patients who do not. Clinical Trial: In-process

  • Proposal of new medication for chronic wound in type 1 diabetic patient

    Date Submitted: Nov 14, 2014

    Open Peer Review Period: Nov 17, 2014 - Dec 1, 2014

    Background It is estimated there are 2.9 million diabetic patients in UK and around 5-7% patients have diabetic ulcers. This number will be continued to increase globally. Diabetic ulcers are major...

    Background It is estimated there are 2.9 million diabetic patients in UK and around 5-7% patients have diabetic ulcers. This number will be continued to increase globally. Diabetic ulcers are major economic burden in healthcare system. £650 million is spent on foot ulcers or amputations each year, and up to 100 people a week have a limb amputated due to diabetes. Objective Understand the pathophysiology in type 1 diabetes (T1DM) and investigate possible future treatment based on its clinical feature. An experiment protocol is designed in mouse model for others to conduct the experiment. The discussion is purely based on diabetic conditions, other life style influences like smoking and drinking are not considered. Finding T1DM patient has decreased number of Treg cells and IL-2. These are the key of disease progression and delay in wound healing. Diabetic ulcer is a chronic wound and characterised by prolonged inflammatory phase. Experimental hypothesis IL-2 topical cream can shorten the healing process in T1DM patients. This experiment has never been done on animal models or humans. Methods Skin incisions will be created on 20 NOD mice and apply IL-2 topical cream in 10-week-study to prove the hypothesis. Mice will be randomly and equally divide into two groups and one group will be the control group. Significant of the experiment If the experiment is successful, T1DM patients will have an alternative, non-invasive treatment. In theory, some other autoimmune patients could also use IL-2 topical cream for treatment. Key words: Type 1 diabetes, T1DM, chronic wound healing, immunotherapy, IL-2

  • Evaluating a mobile telehealth intervention for adults with insulin-requiring diabetes: Protocol and early results for a mixed methods randomized controlled trial

    Date Submitted: Nov 14, 2014

    Open Peer Review Period: Nov 17, 2014 - Dec 1, 2014

    Background: The role of technology in health care delivery has grown rapidly in the last decade. The potential of mobile telehealth (MTH) to support patient self-management is a key area of research....

    Background: The role of technology in health care delivery has grown rapidly in the last decade. The potential of mobile telehealth (MTH) to support patient self-management is a key area of research. Providing patients with technological tools that allow for the recording and transmission of health parameters to health care professionals (HCPs) may promote behaviour changes that result in improved health outcomes. Although for some conditions the evidence on the effectiveness of MTH is clear, to date the findings on the effects of MTH on diabetes management remain inconsistent. Objective: this study aims to evaluate a MTH intervention in insulin-requiring adults with diabetes to establish whether supplementing standard care with MTH results in improved health outcomes (hemoglobin glycated (HbA1c), blood pressure (BP), health-related quality of life (HRQoL), diabetes self-management behaviours, diabetes health care utilization, and diabetes self-efficacy and illness beliefs. An additional objective was to explore the acceptability of MTH and patients’ perceptions of and experience using it. Methods: A mixed-method design consisting of a 9 month two-arm parallel randomized controlled trial (RCT) was used in combination with exit qualitative interviews. Quantitative data was collected at baseline, 3 months and 9 months. Additional intervention fidelity data such as participants’ MTH transmissions and contacts with the MTH nurse during the study were also recorded. Results: Data analysis is ongoing and we expect to publish study results in 2015. Preliminary data on MTH training sessions and MTH usage by intervention participants are presented in this paper. Conclusions: The range of data collected in the current study will allow for a comprehensive evaluation of processes and outcomes. The early results presented suggest that MTH usage decreases over time and that MTH participants would benefit from receiving more than one training session. Clinical Trial: ClinicalTrials.gov (NCT00922376)