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JMIR Research Protocols

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

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Journal Description

 

JMIR Research Protocols (ISSN 1929-0748) is a unique Pubmed-indexed journal, publishing 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 journal spin-off of JMIR, the worlds' leading medical journal in health sciences / health services research and health informatics (JMIR Impact Factor 2016: 5.175).

While the original focus was on eHealth studies, JMIR Res Protoc now 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.

JRP is compatible with the concept of "Registered Reports" and since May 2018, published protocols receive a Registered Report Identifier (What is a Registered Report Identifier?) and acceptance of the subsequent results paper is "in principle" guaranteed in any JMIR journal and partner journals - see What is a Registered Report?

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 provides a "dry-run" for peer-review of the final results paper, and allows feedback/critique of the methods, often while they still can be fixed.

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).

JMIR Res Protoc is also a unique crowdfunding platform, allowing backers to crowdfund carefully peer-reviewed projects that are not junk-science, and giving researchers additional small funding to conduct and publish their research results. Each article is published with a crowdfunding widget, allowing readers to make nominal donations to the project, which benefit the authors (currently in beta).

Need more reasons? Read the Knowledge Base article on "Why should I publish my protocol/grant proposal"!

 
 

Recent Articles:

  • Source: Defense Visual Information Distribution Service; Copyright: US Marine Corps (Gregory Moore); URL: https://www.dvidshub.net/image/770423/2012-marine-corps-marathon-helmand; License: Public Domain (CC0).

    Recruitment and Participation of Recreational Runners in a Large Epidemiological and Genetic Research Study: Retrospective Data Analysis

    Abstract:

    Background: With the increasing capacity for remote collection of both data and samples for medical research, a thorough assessment is needed to determine the association of population characteristics and recruitment methodologies with response rates. Objective: The aim of this research was to assess population representativeness in a two-stage study of health and injury in recreational runners, which consisted of an epidemiological arm and genetic analysis. Methods: The cost and success of various classical and internet-based methods were analyzed, and demographic representativeness was assessed for recruitment to the epidemiological survey, reported willingness to participate in the genetic arm of the study, actual participation, sample return, and approval for biobank storage. Results: A total of 4965 valid responses were received, of which 1664 were deemed eligible for genetic analysis. Younger age showed a negative association with initial recruitment rate, expressed willingness to participate in genetic analysis, and actual participation. Additionally, female sex was associated with higher initial recruitment rates, and ethnic origin impacted willingness to participate in the genetic analysis (all P<.001). Conclusions: The sharp decline in retention through the different stages of the study in young respondents suggests the necessity to develop specific recruitment and retention strategies when investigating a young, physically active population.

  • Source: Image created by the Authors; Copyright: The Authors; URL: http://www.researchprotocols.org/2018/5/e106/; License: Licensed by JMIR.

    Applicability of a Web-Based, Individualized Exercise Intervention in Patients With Liver Disease, Cystic Fibrosis, Esophageal Cancer, and Psychiatric...

    Abstract:

    Background: In the primary and secondary prevention of civilization diseases, regular physical activity is recommended in international guidelines to improve disease-related symptoms, delay the progression of the disease, or to enhance postoperative outcomes. In the preoperative context, there has been a paradigm shift in favor of using preconditioning concepts before surgery. Web-based interventions seem an innovative and effective tool for delivering general information, individualized exercise recommendations, and peer support. Objective: Our first objective was to assess feasibility of our Web-based interventional concept and analyze similarities and differences in a sustained exercise implementation in different diseases. The second objective was to investigate the overall participants’ satisfaction with our Web-based concept. Methods: A total of 4 clinical trials are still being carried out, including patients with esophageal carcinoma scheduled for oncologic esophagectomy (internet-based perioperative exercise program, iPEP, study), nonalcoholic fatty liver disease (hepatic inflammation and physical performance in patients with nonalcoholic steatohepatitis, HELP, study), depression (exercise for depression, EXDEP, study), and cystic fibrosis (cystic fibrosis online mentoring for microbiome, exercise, and diet, COMMED, study). During the intervention period, the study population had access to the website with disease-specific content and a disease-specific discussion forum. All participants received weekly, individual tailored exercise recommendations from the sports therapist. The main outcome was the using behavior, which was obtained by investigating the log-in rate and duration. Results: A total of 20 participants (5 from each trial) were analyzed. During the intervention period, a regular contact and a consequent implementation of exercise prescription were easily achieved in all substudies. Across the 4 substudies, there was a significant decrease in log-in rates (P<.001) and log-in durations (P<.001) over time. A detailed view of the different studies shows a significant decrease in log-in rates and log-in durations in the HELP study (P=.004; P=.002) and iPEP study (P=.02; P=.001), whereas the EXDEP study (P=.58; P=.38) and COMMED study (P=.87; P=.56) showed no significant change over the 8-week intervention period. There was no significant change in physical activity within all studies (P=.31). Only in the HELP study, the physical activity level increased steadily over the period analyzed (P=.045). Overall, 17 participants (85%, 17/20) felt secure and were not scared of injury, with no major differences in the subtrials. Conclusions: The universal use of the Web-based intervention appears to be applicable across the heterogonous collectives of our study patients with regard to age and disease. Although the development of physical activity shows only moderate improvements, flexible communication and tailored support could be easily integrated into patients’ daily routine. Trial Registration: iPEP study: ClinicalTrials.gov NCT02478996; https://clinicaltrials.gov/ct2/show/NCT02478996 (Archived by WebCite at http://www.webcitation.org/6zL1UmHaW); HELP study: ClinicalTrials.gov NCT02526732; http://www.webcitation.org/6zJjX7d6K (Archived by WebCite at http://www.webcitation.org/6Nch4ldcL); EXDEP study: ClinicalTrials.gov NCT02874833; https://clinicaltrials.gov/ct2/show/NCT02874833 (Archived by WebCite at http://www.webcitation.org/6zJjj7FuA)

  • Source: Image created by the authors; Copyright: The Authors; URL: http://www.researchprotocols.org/2018/5/e132/; License: Creative Commons Attribution (CC-BY).

    Confocal Laser Endomicroscopy and Optical Coherence Tomography for the Diagnosis of Prostate Cancer: A Needle-Based, In Vivo Feasibility Study Protocol...

    Abstract:

    Background: Focal therapy for prostate cancer has been proposed as an alternative treatment to whole-gland therapies in selected men to diminish side effects in localized prostate cancer. As nowadays imaging cannot offer complete prostate cancer disease characterization, multicore systematic biopsies are recommended (transrectal or transperineal). Optical imaging techniques such as confocal laser endomicroscopy and optical coherence tomography allow in vivo, high-resolution imaging. Moreover, they can provide real-time visualization and analysis of tissue and have the potential to offer additive diagnostic information. Objective: This study has 2 separate primary objectives. The first is to assess the technical feasibility and safety of in vivo focal imaging with confocal laser endomicroscopy and optical coherence tomography. The second is to identify and define characteristics of prostate cancer and normal prostate tissue in confocal laser endomicroscopy and optical coherence tomography imaging by comparing these images with the corresponding histopathology. Methods: In this prospective, in vivo feasibility study, needle-based confocal laser endomicroscopy and optical coherence tomography imaging will be performed before transperineal template mapping biopsy or radical prostatectomy. First, confocal laser endomicroscopy and optical coherence tomography will be performed in 4 patients (2 for each imaging modality) undergoing transperineal template mapping biopsy to assess the feasibility and safety of confocal laser endomicroscopy and optical coherence tomography. If proven to be safe and feasible, confocal laser endomicroscopy and optical coherence tomography will be performed in 10 patients (5 for each imaging modality) undergoing radical prostatectomy. Confocal laser endomicroscopy and optical coherence tomography images will be analyzed by independent, blinded observers. Confocal laser endomicroscopy– and optical coherence tomography–based qualitative and quantitative characteristics and histopathology will be compared. The study complies with the IDEAL (Idea, Development, Exploration, Assessment, Long-term study) stage 2a recommendations. Results: At present, the study is enrolling patients and results and outcomes are expected in 2019. Conclusions: Confocal laser endomicroscopy and optical coherence tomography are promising optical imaging techniques that can visualize and analyze tissue structure, possible tumor grade, and architecture in real time. They can potentially provide real-time, high-resolution microscopic imaging and tissue characteristics of prostate cancer in conjunction with magnetic resonance imaging or transrectal ultrasound fusion-guided biopsy procedures. This study will provide insight into the feasibility and tissue-specific characteristics of confocal laser endomicroscopy and optical coherence tomography for real-time optical analysis of prostate cancer. Trial Registration: ClinicalTrials.gov NCT03253458; https://clinicaltrials.gov/ct2/show/NCT03253458 (Archived by WebCite at http://www.webcitation.org/6z9owM66B) Registered Report Identifier: RR1-10.2196/9813

  • Dimmand. Source: Image created by Samuel Walter, Designer for Synergation Limited; Copyright: Synergation Limited; URL: http://www.researchprotocols.org/2018/5/e135/; License: Licensed by JMIR.

    A Digital App to Aid Detection, Monitoring, and Management of Dyslexia in Young Children (DIMMAND): Protocol for a Digital Health and Education Solution

    Abstract:

    Background: Dyslexia, a specific learning difficulty and a disability as defined in the Equality Act 2010, is a lifelong condition that affects a child from the start of education. Dyslexia is characterized by difficulties in language processing (reading, spelling, and writing) which do not correspond with the child’s general intellectual abilities. Although dyslexia cannot be cured, there is a consensus that interventions are more effective and have greater impact the earlier they are administered. Effective interventions start with diagnosis. Currently, formal diagnosis requires an assessment by a dyslexia specialist or educational psychologist. These assessments are expensive and are not easy for a non-specialist teacher or parent to interpret. Consequently, formal assessments are normally performed at a much later age, when interventions are less likely to be effective. Combining the latest in scientific research, expertise of dyslexia practitioners and real-time interactivity facilitated by digital technologies, we aim to provide a cost-effective and convenient solution that focuses on early dyslexia detection and management. Objective: We discuss the rationale and protocol for the design and development of a digital health solution aimed at improving the early detection, monitoring and management of dyslexia (DIMMAND) in young children (4-8 years). The primary objective is to create a game-based digital solution aimed at children, parents, and teachers that firstly assesses, then monitors and manages progress in a convenient, cost-effective and private environment. Methods: The proposed solution will be designed and developed in phases. In the initial phase, the full functional specification of the games that constitute the app will be designed, together with the overall architecture of the solution. Prototype proof-of-concept implementation for few of these games, and commercialization strategies will also be developed. The follow-on phases will see the design implemented into a validated solution. Results: In the initial phase, we worked closely with dyslexia specialists, adult dyslexics, teachers of special-needs children, parents of dyslexic children, and senior dyslexia representatives for large organizations. These interactions provided insights into the range of language difficulties faced by dyslexics, which solutions are used by teachers and professionals, and an overall understanding of the market. We comprehensively defined the ethical, privacy, and data security issues. The detailed design spec of the games, the methodology to be followed to interpret the results, and flow diagrams illustrating how the game screens will be presented was completed. As proof of concept, a few reading, visual, and auditory games were developed and successfully tested by stakeholders on different digital devices. The stakeholders provided regular feedback and confirmed the viability of our game-based solution. Conclusions: DIMMAND has the potential to provide significant positive health care and economic impact. It is expected to reduce intervention costs, improve dyslexia detection at an early age and aid self-management. Registered Report Identifier: RR1-10.2196/9583

  • Study logo. Source: Image created by the Authors; Copyright: Lauren M Touyz; URL: http://www.researchprotocols.org/2018/5/e129/; License: Creative Commons Attribution (CC-BY).

    Design and Rationale for a Parent-Led Intervention to Increase Fruit and Vegetable Intake in Young Childhood Cancer Survivors (Reboot): Protocol for a Pilot...

    Abstract:

    Background: Poor dietary habits are common among childhood cancer survivors, despite increasing their risk of cardio metabolic complications after cancer treatment. Here, we describe the design and rationale for a pilot telephone-based, parent-led intervention aimed at increasing fruit and vegetable intake in young cancer survivors (Reboot). Objective: This pilot study aims to assess the feasibility and acceptability of delivering evidence-based telephone support to parents of childhood cancer survivors. A secondary aim includes assessing the effect of Reboot on improving childhood cancer survivors’ dietary quality by increasing child fruit and vegetable intake and variety and its contribution to overall nutrient intake. Methods: We aim to recruit parents of 15 young cancer survivors aged 2 to 12 years who have completed cancer treatment less than five years ago. The intervention comprises of 4 weekly 45-minute telephone sessions led by a health professional and one booster session 6 weeks later. Sessions address the effects of cancer treatment on children’s diets, recommended fruit and vegetable intake for children, and evidence-based strategies to promote the consumption of fruit and vegetables as well as to manage fussy eating. Results: Reboot is based on an existing, evidence-based parent nutrition intervention and modified for childhood cancer survivors following extensive collaboration with experts in the field. Primary outcomes of feasibility and acceptability will be measured by the number of participants who complete all five sessions, average session length (minutes), length between sessions (days) and parent Likert ratings of the usefulness and impact of the intervention collected after the booster session. Of the 15 participants we aim to recruit, 3 have completed the intervention, 1 declined to participate, 11 are actively completing the intervention and 2 participants are providing written consent. The remaining 3 participants will be recruited via telephone follow-up calls. The intervention is due to be completed by July 2018. Conclusions: Reboot aims to support healthy dietary behaviors in childhood cancer survivors who are at increased risk of developing serious cardiometabolic complications after their cancer treatment. Results will inform the development and implementation of future evidence-based dietary interventions delivered to childhood cancer survivors, particularly those living in rural and remote areas. Registered Report Identifier: RR1-10.2196/9252

  • WaznApp research study logo. Source: Image created by the Authors; Copyright: The Authors; URL: http://www.researchprotocols.org/2018/5/e133/; License: Creative Commons Attribution + NoDerivatives (CC-BY-ND).

    A Self-Directed Mobile Intervention (WaznApp) to Promote Weight Control Among Employees at a Lebanese University: Protocol for a Feasibility Pilot Randomized...

    Abstract:

    Background: Overweight and obesity have become major health problems globally with more than 1.9 billion overweight adults. In Lebanon, the prevalence of obesity and overweight is 65.4% combined. Risk factors of obesity and overweight are preventable and can be addressed by modifications in the environment and in an individual’s lifestyle. Mobile technologies are increasingly used in behavioral, self-directed weight management interventions, providing users with additional opportunities to attain weight control (weight loss, weight gain prevention, etc). Mobile apps may allow for the delivery of Just-in-Time Adaptive Interventions (JITAIs), which provide support through skill building, emotional support, and instrumental support, following the participants’ progress. A few commercially available apps offer JITAI features, but no studies have tested their efficacy. Objective: The primary objective of this study is to examine the feasibility of a self-directed weight loss intervention, targeting employees of an academic institution, using a virtual coaching app with JITAI features (Lark) and a self-help calorie-counting app (MyFitnessPal). The secondary objective is to estimate the effects of the intervention on main study outcomes. Methods: This study is a single-center, parallel, randomized controlled trial with 2 study arms (intervention and control). Participants will be randomly allocated in equal proportions to the intervention (Lark) and control groups (MyFitnessPal). To be eligible for this study, participants must be employed full- or part-time at the university or its medical center, able to read English, have a smartphone, and be interested in controlling their weight. Recruitment strategies entail email invitations, printed posters, and social media postings. We will assess quantitative rates of recruitment, adherence, and retention, self-reported app quality using the user version of the Mobile App Rating Scale. We will also assess changes in weight-related outcomes (absolute weight and waist circumference), behavioral outcomes (physical activity and diet), and cognitive factors (motivation to participate in the trial and to manage weight). Results: WaznApp was funded in June 2017, and recruitment started in March 2018. Conclusions: This study will provide information as to whether the selected mobile apps offer a feasible solution for promoting weight management in an academic workplace. The results will inform a larger trial whose results might be replicated in similar workplaces in Lebanon and the Middle East and North Africa region, and will be used as a benchmark for further investigations in other settings and similar target groups. Trial Registration: ClinicalTrials.gov NCT03321331; https://clinicaltrials.gov/ct2/show/NCT03321331 (Archived by WebCite at http://www.webcitation.org/6ys9NOLo5) Registered Report Identifier: RR1-10.2196/9793

  • Ecological Momentary Intervention messages will be delivered by text message. Source: Pixabay; Copyright: rawpixel; URL: https://pixabay.com/en/cup-technology-holding-relax-2218405/; License: Public Domain (CC0).

    Effectiveness of a Combined Web-Based and Ecological Momentary Intervention for Incoming First-Year University Students: Protocol for a 3-Arm Randomized...

    Abstract:

    Background: Alcohol use among university students is common, and those who drink often choose to drink heavily (ie, 4 or more drinks per session for women or 5 or more for men). Web-based interventions (WBIs), in which students complete assessments and receive personalized feedback about their alcohol use, and ecological momentary interventions (EMIs), which use mobile devices as a method of delivering intervention information, are 2 methods that have had some success in reducing alcohol use among university students. Objective: The aim of this study was to investigate the effectiveness of a combined WBI and EMI intervention to reduce alcohol use among university students. Methods: The study is a 3-arm randomized controlled trial. Participants will be randomized into either a WBI+EMI condition, a WBI-only condition, or an assessment-only control. Our sample will consist of first-year university students, recruited through 5 residential colleges at the University of Otago, New Zealand. All participants will complete an online survey at baseline (ie, before Orientation Week); those in the WBI-only and WBI+EMI conditions will immediately receive personalized feedback (ie, the WBI), whereas participants in the assessment-only condition will receive no feedback. In addition, participants randomized into the WBI+EMI, but not those in the WBI-only or assessment-only groups, will receive 8 Orientation Week (2 per day on nights with large social events) and 6 academic year EMIs (delivered fortnightly). Participants in all conditions will complete brief surveys at the end of the first and second semester and report their weekend alcohol use fortnightly throughout each semester via ecological momentary assessments. Results: The primary hypothesis is that participants in the WBI+EMI group will consume significantly fewer drinks during weekends in their first semester at university compared with WBI-only and assessment-only groups. Secondary hypotheses are that, when compared with the WBI-only and assessment-only groups, the WBI+EMI group will report consuming fewer drinks during Orientation Week, report experiencing fewer negative alcohol-related consequences after first semester, and report lower Alcohol Use Disorder Identification Test-Consumption scores following their first semester. Conclusions: This study adds to a growing body of work investigating the utility of WBIs and EMIs in curbing alcohol consumption. In addition, the study will help to inform policy approaches aimed at curbing alcohol consumption and alcohol-related harm in university students. Trial Registration: Australian New Zealand Clinical Trials Registry ACTRN12618000015246; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=374104&isReview=true (Archived by WebCite at http://www.webcitation.org/6z9jRLTz6) Registered Report Identifier: RR1-10.2196/10164

  • A patient-facing Web portal home page (montage). Source: The Authors / Smartmockups.com; Copyright: JMIR Publications; URL: http://www.researchprotocols.org/2018/5/e136/; License: Creative Commons Attribution (CC-BY).

    Development of a Web Portal for Physical Activity and Symptom Tracking in Oncology Patients: Protocol for a Prospective Cohort Study

    Abstract:

    Background: Significant benefits accrue from increasing physical activity levels in people with a history of cancer. Physical activity levels can be increased using behavioral change interventions in this population. Access to Web portals and provision of activity monitors to provide feedback may support behavior change by encouraging patient engagement in physical therapy. The Web portal evaluated in this study will provide a system to monitor physical activity and sleep, for use by both clinician and patient, along with symptom and health-related quality of life tracking capabilities. Objective: The aim of this study was to outline a protocol for a feasibility study focused on a Web-based portal that provides activity monitoring and personalized messaging to increase physical activity in people with cancer. Methods: Using a longitudinal cohort design, people with cancer will be serially allocated to 3 intervention cohorts of 20 participants each and followed for 10 weeks. Cohort 1 will be provided a wearable activity monitor and access to a Web-based portal. Cohort 2 will receive the same content as Cohort 1 and in addition will receive a weekly activity summary message. Cohort 3 will receive the same content as Cohorts 1 and 2 and in addition will receive a personalized weekly coaching message. Feasibility of the use of the portal is the primary outcome. Results: Results are expected in early 2018. Outcome measures will include goal attainment and completion rate. Conclusions: This study will provide information about the feasibility of investigating eHealth initiatives to promote physical activity in people with cancer. Registered Report Identifier: RR1-10.2196/9586

  • Older adult preparing for a walk. Source: Pixabay; Copyright: Steve Buissinne; URL: https://pixabay.com/en/hand-walking-stick-arm-elderly-588982/; License: Public Domain (CC0).

    A Mobile Health Intervention to Reduce Pain and Improve Health (MORPH) in Older Adults With Obesity: Protocol for the MORPH Trial

    Abstract:

    Background: Chronic pain is a complex, age-related health issue that affects both physical functioning and quality of life. Because the impact of chronic pain is worsened by obesity and inactivity, nonpharmacological interventions that promote movement, reduce sitting, and aid in weight loss are needed to help manage pain symptoms among older adults with chronic pain. Objective: The Mobile Intervention to Reduce Pain and Improve Health (MORPH) pilot trial aims to develop and test the feasibility and acceptability of a novel, patient-centered intervention to reduce chronic pain and improve physical functioning in older adults, leveraging the combination of telecoaching and individually adaptive mHealth tools to decrease both body mass and sedentary behavior. Methods: MORPH comprises 2 phases, including a 1-year iterative development phase, and a 1-year pilot randomized controlled trial (RCT). During the development phase, representative participants will engage in one-on-one structured interviews and a 1-week field test. The resulting feedback will be used to guide the development of the finalized MORPH intervention package. During the second phase, the finalized intervention will be tested in a pilot RCT (N=30) in which older adult participants with chronic pain and obesity will be assigned to receive the 12-week MORPH intervention or to a waitlist control. Primary outcomes include self-reported pain symptoms and physical function. Results: Phase 1 recruitment is ongoing as of December 2017. Conclusions: The MORPH intervention brings together a strong body of evidence using group-based behavioral intervention designs with contemporary mHealth principles, allowing for intervention when and where it matters the most. Given the ubiquity of smartphone devices and the popularity of consumer activity and weight monitors, the results of this study may serve to inform the development of scalable, socially driven behavioral pain management interventions. Trial Registration: ClinicalTrials.gov NCT03377634; https://clinicaltrials.gov/ct2/show/NCT03377634 (Archived by WebCite at http://www.webcitation.org/6yj0J5Pan) Registered Report Identifier: RR1-10.2196/9712

  • Doctor using laptop with ZIPSE start-up page. Source: Placeit/Central Information Portal on Rare Diseases (ZIPSE)/start-up page; Copyright: JMIR publications; URL: http://www.researchprotocols.org/2018/4/e112/; License: Licensed by JMIR.

    Conceptualization and Implementation of the Central Information Portal on Rare Diseases: Protocol for a Qualitative Study

    Abstract:

    Background: Recently, public and political interest has focused on people living with rare diseases and their health concerns. Due to the large number of different types of rare diseases and the sizable number of patients, taking action to improve the life of those affected is gaining importance. In 2013, the federal government of Germany adopted a national action plan for rare diseases, including the call to establish a central information portal on rare diseases (Zentrales Informationsportal über seltene Erkrankungen, ZIPSE). Objective: The objective of this study, therefore, was to conduct scientific research on how such a portal must be designed to meet the needs of patients, their families, and medical professionals, and to provide high-quality information for information seekers. Methods: We chose a 3-step procedure to develop a needs-based prototype of a central information portal. In the first step, we determined the information needs of patients with rare diseases, their relatives, and health care professionals by means of qualitative interviews and their content-analytical evaluation. On the basis of this, we developed the basic structure of the portal. In the second step, we identified quality criteria for websites on rare diseases to ensure that the information linked with ZIPSE meets the quality demands. Therefore, we gathered existing criteria catalogs and discussed them in an expert workshop. In the third step, we implemented and tested the developed prototypical information portal. Results: A portal page was configured and made accessible on the Web. The structure of ZIPSE was based on the findings from 108 qualitative interviews with patients, their relatives, and health care professionals, through which numerous information needs were identified. We placed particularly important areas of information, such as symptoms, therapy, research, and advisory services, on the start page. Moreover, we defined 13 quality criteria, referring to factors such as author information, creation date, and privacy, enabling links with high-quality information. Moreover, 19 users tested all the developed routines based on usability and comprehensibility. Subsequently, we improved the visual presentation of search results and other important search functions. Conclusions: The implemented information portal, ZIPSE, provides high-quality information on rare diseases from a central point of access. By integrating the targeted groups as well as different experts on medical information during the construction, the website can assure an improved search for information for users. ZIPSE can also serve as a model for other Web-based information systems in the field of rare diseases. Registered Report Identifier: RR1-10.2196/7425

  • Source: Daman; Copyright: Daman; URL: http://www.researchprotocols.org/2018/5/e10098/; License: Licensed by JMIR.

    Cocreated Smartphone App to Improve the Quality of Life of Adolescents and Young Adults with Cancer (Kræftværket): Protocol for a Quantitative and...

    Abstract:

    Background: Adolescents and young adults with cancer face significant challenges during the course of their medical treatment and recovery from illness. Many adolescents and young adults struggle with long-term complications in the physical, psychosocial, economic, and academic domains. Mobile health (mHealth) interventions provide an innovative platform for delivering supportive care, particularly through the utilization of apps on smartphones and tablets. To create a successful mHealth intervention for adolescents and young adults, youth input and feedback is essential. The process of cocreation, in which the target app user has a direct role in dictating design and function, was utilized to create the prototype smartphone app for adolescents and young adults with cancer, “Kræftværket.” Objective: The objective of this paper is to describe the protocol for the evaluation of the Kræftværket app, a prototype app designed via cocreation, to support and improve health-related quality of life for adolescents and young adults with cancer. Methods: The Kræftværket app has three primary features, (1) a symptom and activity diary, (2) a supportive communication network between app users, and (3) a “one-stop shop” information bank with practical information as well as links to patient organizations and other resources. The app will be evaluated in two phases, a pilot test and an implementation test. In the pilot test, the app will be launched to a test group of 20 adolescents and young adults aged 15 to 29 years, selected for equal representation amongst age group and treatment status. Patients will be allowed to utilize the app over the course of six weeks and will complete a baseline and follow-up European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) health-related quality of life inventory. In addition, participant focus group interviews will be conducted according to a semistructured interview guide. Resulting data will be analyzed using thematic analysis. Results and appropriate analysis from both the qualitative and quantitative branches of the pilot test will be discussed amongst the research group, and appropriate changes based on user feedback will be made to the app before the final project phase. In the implementation test, the app will be provided and utilized by a sample of 50 adolescents and young adults aged 15-29 years selected for equal representation amongst gender, age group, diagnosis, and treatment status over the course of 3 months. Participants will be asked to complete a baseline and follow-up EORTC QLQ-C30 HRQoL inventory. Results: Pilot testing is expected to take place in February 2018, and implementation testing is expected to begin May 2018. Conclusions: It is the hope that Kræftværket app will serve as a beneficial and easily utilized product. The process of evaluating the app and its effect on quality of life will address the absence of evidence-based mHealth interventions, and attempt to validate new approaches to benefitting adolescents and young adult oncology patients in the digital world. Registered Report Identifier: RR1-10.2196/10098

  • Source: Max Pixel; Copyright: Max Pixel; URL: https://www.maxpixel.net/Woman-Text-Hands-Technology-People-Phone-2586977; License: Public Domain (CC0).

    Engagement Strategies for Self-Monitoring Symptoms of Bipolar Disorder With Mobile and Wearable Technology: Protocol for a Randomized Controlled Trial

    Abstract:

    Background: Monitoring signs and symptoms in bipolar disorder (BP) is typically based on regular assessments from patient-clinician interactions. Mobile and wearable technology promises to make monitoring symptoms in BP easier, but little is known about how best to engage individuals with BP in monitoring symptoms. Objective: The objective of this study was to provide the rationale and protocol for a randomized controlled trial that investigates engagement strategies for monitoring symptoms of BP, including the strategies of using activity trackers compared with self-reports and reviewing recorded symptoms weekly with an interviewer. Methods: A total of 50 individuals with BP will be recruited from the Prechter Longitudinal Study of Bipolar Disorder at the University of Michigan to participate in a 6-week study. Participants will monitor their symptoms through an activity tracker (Fitbit Alta HR) and a mobile phone app designed for this study. In addition to monitoring symptoms, participants have a 50-50 chance of being assigned to an arm that reviews self-reports and activity information weekly. Statistical tests will be performed to test hypotheses that participants adhere to activity tracking significantly more than self-reporting, prefer activity tracking significantly more than self-reporting, and better adhere to both activity tracking and self-reporting when reviewing collected information weekly. Results: Recruitment commenced in November 2017. The first group of participants began the study in January 2018. Conclusions: This study aims to establish strategies to engage individuals with BP in monitoring their symptoms with mobile and wearable technology. Better engagement strategies are expected to aid current efforts in bipolar research and clinical care, from the development of new mobile phone apps to providing the right intervention to the right individual at the right moment. Trial Registration: ClinicalTrials.gov NCT03358238; https://clinicaltrials.gov/ct2/show/NCT03358238 (Archived by WebCite at http://www.webcitation.org/6yebuNfz5) Registered Report Identifier: RR1-10.2196/9899

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  • Rationale and Design of the Hispanic Secondary Stroke Prevention Initiative: A Community Health Worker Intervention among Latino Patients at Risk of Recurrent Stroke

    Date Submitted: May 17, 2018

    Open Peer Review Period: May 22, 2018 - Jun 5, 2018

    Background: Hispanic-Latino populations face a disproportionate stroke burden, and are less likely to have sufficient control over stroke risk factors in comparison to other ethnic populations. A prom...

    Background: Hispanic-Latino populations face a disproportionate stroke burden, and are less likely to have sufficient control over stroke risk factors in comparison to other ethnic populations. A promising approach to improving chronic health outcomes has been the use of Community Health Workers (CHWs) Objective: This study aims to evaluate their effectiveness in a randomized controlled trial setting Methods: The Hispanic Secondary Stroke Prevention Initiative is an Randomized Clinical Trial of 300 Latinos from South Florida whom have experienced a stroke within the last 5 years. Participants randomized into the CHW intervention arm receive health education and assistance with healthcare navigation and social services through home visits and phone calls. Results: Outcomes at 12 months include changes in systolic blood pressure, LDL, HbA1c, and medication adherence. Conclusions: HiSSPI is one of the first RTCs to examine CHW-facilitated stroke prevention and will provide rigorous evidence on the impact of CHWs on secondary stroke risk factors among Latinos having had a stroke. Clinical Trial: ClinicalTrials.gov: NCT02251834

  • Multi-center, observational, prospective study of endotracheal intubation among the critically ill: HEModynamic and AIRway (HEMAIR) management protocol

    Date Submitted: May 21, 2018

    Open Peer Review Period: May 21, 2018 - Jun 4, 2018

    Background: Endotracheal intubation can occur in up to 60% of critically ill patients. Despite the frequency with which endotracheal intubation may occur, the current practice is largely unknown. Th...

    Background: Endotracheal intubation can occur in up to 60% of critically ill patients. Despite the frequency with which endotracheal intubation may occur, the current practice is largely unknown. This is relevant as advances in airway equipment, i.e., video laryngoscopes, have become more prevalent leading to possible improvement of care delivered during this process. In addition to new devices, a greater emphasis on airway plans and choices in sedation have evolved, although the influence on patient morbidity and mortality is largely unknown. Thus, through a multi-center prospective study, our aim was to derive and validate prediction models for immediate airway and hemodynamic complications of intensive care unit intubations. Objective: The overall goal of this multi-center prospective study is to arrive at a prediction model for both immediate airway and hemodynamic complications thus allowing critical care physicians to be better prepared to address these occurrences and improve the quality of care delivered to the critically ill. Methods: A multi-center, observational, prospective study of adult critically ill patients admitted to both medical and surgical intensive care units at participating sites throughout 8 health and human services regions of the country for which endotracheal intubation was needed was conducted. A steering committee composed of both anesthesia and pulmonary critical care physicians proposed a core set of data variables as a data collection form to be used within the multiple intensive care units across the country during the time of intubation. The data collection form consisted of two basic components, focusing 1- on airway management and 2- on hemodynamic management. The form was generated using RedCap and distributed to the participating centers. Quality checks on the dataset was performed several times from each center to arrive at less than 10% missing values for each data variable and subsequently entered into a database. The primary outcomes will focus on both derivation and validation of airway and hemodynamic models to predict immediate airway and hemodynamic complications of intensive care unit intubations. Results: With these procedures and requirements in place, the rights and welfare of subjects were not adversely affected by study participation or the waiver of consent/authorization. This multi-center, prospective trial will be among the first to include a large diverse patient population from across the United States with a large sample size. The potential benefits would include deriving and validating prediction models for immediate severe complications regarding airway and hemodynamic management surrounding intubations among the critically ill. Conclusions: With this information, it is our hope that the clinician will have a tool to predict which patients will become unstable during this procedure so as to adjust treatment plans allowing improved quality of care delivered during this procedure. This prospective observational trial is even more important as post-intubation hypotension/hemodynamic derangement is noted by some to occur at a fairly high rate leading to possibly increased risk of mortality. Clinical Trial: Clinicaltrials.gov identifier NCT02508948 (07/21/2015)

  • Creating, implementing and evaluating an app that uses sports, videogames, and gamification to improve young men’s mental health and wellbeing

    Date Submitted: May 17, 2018

    Open Peer Review Period: May 19, 2018 - Jun 2, 2018

    Background: Young men have different mental health needs to young women, who make up the primary audience of digital mental health interventions. An app (MindMax) incorporating sport (Australian Footb...

    Background: Young men have different mental health needs to young women, who make up the primary audience of digital mental health interventions. An app (MindMax) incorporating sport (Australian Football League; AFL), videogames, and gamification was developed in an effort to address this issue. Objective: This protocol outlines the research and development process of MindMax. Methods: These include: 1) six participatory design workshops with young people aged 16 to 35 years; 2) 15 user experience testing interviews at three separate time points to iteratively assess and improve the app; and 3) a naturalistic trial, tracking users across multiple time points to evaluate the app. Results: Preliminary results suggest a preference for an action-based approach and a strong preference for a personalised experience. A naturalistic longitudinal trial (baseline N=441) concluded in May 2018. Conclusions: In basing itself strongly within the AFL and videogaming subcultures, MindMax aims to tackle mental health help-seeking barriers for men, and to provide psychoeducation on strategies to increase mental wellbeing. A successful implementation would indicate that generalising this approach to other traditional sporting codes and even competitive videogaming leagues (esports) would be fruitful.

  • The use of augmented reality in a serious game to motivate oral hygiene practices among children and toddlers: a research protocol

    Date Submitted: May 10, 2018

    Open Peer Review Period: May 14, 2018 - May 28, 2018

    Background: New technologies invariably open up possibilities towards new forms of action, of interaction, and of knowledge acquirement, something extremely relevant in the health education field. How...

    Background: New technologies invariably open up possibilities towards new forms of action, of interaction, and of knowledge acquirement, something extremely relevant in the health education field. However, a protocol is needed for new digital means towards the use of an immersive interactive interface, both ludic and educational, regarding oral health with a preventive focus on health maintenance and a healthy development of the child, by means of Augmented Reality, activated by the user interaction with the projection. Objective: Development of an immersive virtual environment protocol using Augmented Reality for the improvement of the quality of teaching, in the fields of science and youth odontological health, making available modern content and interfaces, in order to point out paths for the evolution of technological resources in teaching and learning; i.e., a concrete tool for the universalization of knowledge and digital inclusion. Methods: A qualitative study will be conducted in order to define a research protocol for the development of a serious game that uses augmented reality techniques in order to disseminate oral health knowledge among children at school age, and its training as to the correct execution of teeth brushing techniques. During the first phase of the study, a template analysis will be conducted to identify barriers and facilitators in each scenario. Then, during the second phase, the computational process, the gestural, graphic elements and cognitive processes involved in the development of the research protocol of the interactive panel will be analyzed and delineated. In a posterior phase, after the implementation of the system, an analysis of the product efficacy will be conducted, by means of usability tests conducted with the target audience. Results: This article presents the development protocol of the instructional immersive interactive environment, using projection and computational resources. Conclusions: It is hoped that these protocols contribute to the prevention of buccal problems afflicting the population, by means of the diffusion of scientific knowledge of the aforementioned fields in the school environment, and that its replication is done by the students themselves, assuming the role of multipliers of this knowledge with the community.

  • Access to Resources in the Community (ARC) through Navigation – A Feasibility Study Protocol

    Date Submitted: May 11, 2018

    Open Peer Review Period: May 14, 2018 - May 28, 2018

    Background: Community based health and social resources can help individuals with complex health and social needs. However, there is often a discontinuation of patient care between primary care practi...

    Background: Community based health and social resources can help individuals with complex health and social needs. However, there is often a discontinuation of patient care between primary care practices and community resources due to: a lack of physician or patient awareness of available resources; the presence of social barriers; the paucity of means to facilitate patients’ trajectory along the continuum of care; and more broadly, to the difficulties implementing organizational changes in primary care practices already busy providing health care services. Navigation services – where a person is tasked with helping connect patients to community resources – can strengthen continuity of care for patients. The implementation and study of the navigators’ impact is complex and warrants further investigation. Objective: Assess whether the ARC Model is feasible, including its potential to achieve its intended outcomes, and the viability of the evaluation approach. Methods: Describe the protocol of a single arm, prospective, explanatory mixed methods, pre-post design feasibility study, focusing on primary care practice settings with vulnerable populations. Participants include primary care providers, and patients. Results: Enrollment is closed with 82 patients. Navigation services have ended for 69 patients. Conclusions: Multilayered complex issues contribute to a high risk of failing to sustainably implement navigation services, thwarting randomized control trials’ effectiveness at assessing their impact. Undertaking a feasibility study from a conceptually clear and methodologically solid protocol will inform on the acceptability, ease of implementation, quality of integration, practicality and adaptation needs prior to initiating a randomized control trial. Clinical Trial: ClinicalTrials.gov, NCT03105635. Registered 10 April 2017

  • Australian Collaboration for Coordinated Enhanced Sentinel Surveillance (ACCESS): A Protocol for Monitoring the Control of Sexually Transmissible Infections and Blood Borne Viruses

    Date Submitted: May 11, 2018

    Open Peer Review Period: May 14, 2018 - May 28, 2018

    Background: New biomedical prevention interventions make the control or elimination of some blood -borne viruses (BBVs) and sexually transmissible infections (STIs) increasingly feasible. In response,...

    Background: New biomedical prevention interventions make the control or elimination of some blood -borne viruses (BBVs) and sexually transmissible infections (STIs) increasingly feasible. In response, the World Health Organization and governments around the world have established elimination targets and associated timelines. Objective: This paper describes ACCESS (Australian Collaboration for Coordinated Enhanced Sentinel Surveillance), a national surveillance network designed to monitor public health and evaluate the impact of strategies aimed at controlling BBVs and STIs in Australia. Methods: ACCESS is a sentinel surveillance system comprising health services and pathology laboratories in each of the eight Australian jurisdictions. Sites that provide significant testing or management of BBVs and/or STIs or see populations with particular risks for these infections (‘priority populations’) are included in the network. ACCESS is based on regular and automated extraction of de-identified patient data using specialised software called GRHANITE™, which creates a unique and anonymous identifier from individual patient details. This identifier allows anonymous linkage between and within participating sites, creating a national cohort that allows the evaluation of clinical and public health interventions and related research. Results: As of March 2018, 104 health services (sexual health clinics, general practice clinics, drug and alcohol services, community-led testing services, and hospital outpatient clinics) and 17 pathology laboratories (private and public) were participating in ACCESS. Between 2009 and 2017, ACCESS captured data from 1,171,658 individual patients who attended a participating health service at least once, comprising a total of 7,992,241 consultations. Conclusions: ACCESS is a unique system with the ability to track efforts to control STIs and BBVs – including through the calculation of powerful epidemiological indicators – by identifying response gaps and facilitating the evaluation of programs and interventions. By anonymously linking patients between and within services and over time, ACCESS has exciting potential as a research and evaluation platform.

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