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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.

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).

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

 
 

Recent Articles:

  • Source: Pixabay; Copyright: maxlkt; URL: https://pixabay.com/en/hospice-care-elderly-old-1750928/; License: Public Domain (CC0).

    Evaluating the CARE4Carer Blended Care Intervention for Partners of Patients With Acquired Brain Injury: Protocol for a Randomized Controlled Trial

    Abstract:

    Background: Support programs for partners of patients with acquired brain injury are necessary since these partners experience several unfavorable consequences of caregiving, such as a high burden, emotional distress, and poor quality of life. Evidence-based support strategies that can be included in these support programs are psychoeducation, skill building, problem solving, and improving feelings of mastery. A promising approach would seem to be to combine web-based support with face-to-face consultations, creating a blended care intervention. Objective: This paper outlines the protocol of a randomized controlled trial to evaluate the CARE4Carer blended care intervention for partners of patients with acquired brain injury. Methods: A multicenter two-arm randomized controlled trial will be conducted. A total of 120 partners of patients with acquired brain injury will be recruited from five rehabilitation centers in the Netherlands. The blended care intervention consists of a nine-session web-based support program and two face-to-face consultations with a social worker. Themes that will be addressed are: giving partners insight into their own situation, including possible pitfalls and strengths, learning how to cope with the situation, getting a grip on thoughts and feelings, finding a better balance in the care for the patient with acquired brain injury, thinking about other possible care options, taking care of oneself, and communication. The intervention lasts 20 weeks and the control group will receive usual care. The outcome measures will be assessed at baseline and at 24- and 40-week follow-up. The primary outcome is caregiver mastery. Secondary outcome measures are strain, burden, family functioning, emotional functioning, coping, quality of life, participation, and social network. Results: The effect of the intervention on the primary and secondary outcome measures will be determined. Additional a process evaluation will be conducted. Conclusions: The findings of this study will be used to improve the care for partners of patients with acquired brain injury. Barriers and facilitators that emerge from the process evaluation will be used in the nationwide implementation of the intervention. Trial Registration: Dutch Trial Register NTR6197; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=6197 (Archived by WebCite at http://www.webcitation.org/6xHBAxx0y)

  • Email intervention (montage). Source: Cancer Care Ontario / Mockdrop.io; Copyright: JMIR Publications; URL: http://www.researchprotocols.org/2018/1/e11/; License: Creative Commons Attribution (CC-BY).

    Testing Behavior Change Techniques to Encourage Primary Care Physicians to Access Cancer Screening Audit and Feedback Reports: Protocol for a Factorial...

    Abstract:

    Background: Cancer Care Ontario’s Screening Activity Report (SAR) is an online audit and feedback tool designed to help primary care physicians in Ontario, Canada, identify patients who are overdue for cancer screening or have abnormal results requiring follow-up. Use of the SAR is associated with increased screening rates. To encourage SAR use, Cancer Care Ontario sends monthly emails to registered primary care physicians announcing that updated data are available. However, analytics reveal that 50% of email recipients do not open the email and less than 7% click the embedded link to log in to their report. Objective: The goal of the study is to determine whether rewritten emails result in increased log-ins. This manuscript describes how different user- and theory-informed messages intended to improve the impact of the monthly emails will be experimentally tested and how a process evaluation will explore why and how any effects observed were (or were not) achieved. Methods: A user-centered approach was used to rewrite the content of the monthly email, including messages operationalizing 3 behavior change techniques: anticipated regret, material incentive (behavior), and problem solving. A pragmatic, 2x2x2 factorial experiment within a multiphase optimization strategy will test the redesigned emails with an embedded qualitative process evaluation to understand how and why the emails may or may not have worked. Trial outcomes will be ascertained using routinely collected administrative data. Physicians will be recruited for semistructured interviews using convenience and snowball sampling. Results: As of April 2017, 5576 primary care physicians across the province of Ontario, Canada, had voluntarily registered for the SAR, and in so doing, signed up to receive the monthly email updates. From May to August 2017 participants received the redesigned monthly emails with content specific to their allocated experimental condition prompting use of the SAR. We have not yet begun analyses. Conclusions: This study will inform how to communicate effectively with primary care providers by email and identify which behavior change techniques tested are most effective at encouraging engagement with an audit and feedback report. Trial Registration: ClinicalTrials.gov NCT03124316; https://clinicaltrials.gov/ct2/show/NCT03124316 (Archived by WebCite at http://www.webcitation.org/6w2MqDWGu)

  • Source: The Authors / Unsplash; Copyright: The Authors / Simon Hattinga Verschure; URL: https://unsplash.com/photos/WNevBlZWCKA; License: Creative Commons Attribution (CC-BY).

    National Food, Nutrition, and Physical Activity Survey of the Portuguese General Population (2015-2016): Protocol for Design and Development

    Abstract:

    Background: The assessment of food consumption data using harmonized methodologies at the European level is fundamental to support the development of public policies. Portugal is one of the countries with the most outdated information on individual food consumption. Objective: The objective of this study was to describe the design and methodology of the National Food, Nutrition and Physical Activity Survey, 2015-2016, developed to collect national and regional data on dietary habits, physical activity (PA), and nutritional status, in a representative sample of the Portuguese general population (3 months-84 years). Methods: Participants were selected by multistage sampling, using the National Heath Registry as the sampling frame. Data collection, during 12 months, was harmonized according to European guidelines (EU-MENU, European Food Safety Authority [EFSA]). Computer-assisted personal interviewing (CAPI) was performed on a specific electronic platform synchronized with nutritional composition data and considering the FoodEx2 classification system. Dietary assessment was performed using 24-hour recalls (two nonconsecutive, 8-15 days apart) or food diaries in the case of children aged <10 years, complemented with a food propensity questionnaire; PA data (International Physical Activity Questionnaire [IPAQ], the Activity Choice Index [ACI], and 4-days PA diaries); sociodemographic data, and other health-related data were also collected. Results: A sample of 6553 individuals completed the first interview, and 5811 participants completed two dietary assessments. The participation rate among eligible individuals was 33.38% (6553/19,635), considering the first interview, and 29.60% (5811/19,635) for the participants with two completed interviews (about 40% in children and adolescents and 20% in elderly individuals). Results of the survey will be disseminated in national and international scientific journals during 2018-2019. Conclusions: The survey will assist policy planning and management of national and European health programs on the improvement of nutritional status and risk assessment related to food hazards, and the enhancement of PA. The infrastructures and data driven from this Survey are a solid basis to the development of a future national surveillance system on diet, PA, and other health behaviors reproducible over time.

  • Source: Freepik; Copyright: bearfotos; URL: https://www.freepik.com/free-photo/happy-mature-man-speaks-by-phone_1238559.htm; License: Creative Commons Attribution (CC-BY).

    mHealth Technology and Nurse Health Coaching to Improve Health in Diabetes: Protocol for a Randomized Controlled Trial

    Abstract:

    Background: Chronic diseases, including diabetes mellitus, are the leading cause of mortality and disability in the United States. Current solutions focus primarily on diagnosis and pharmacological treatment, yet there is increasing evidence that patient-centered models of care are more successful in improving and addressing chronic disease outcomes. Objective: The objective of this clinical trial is to evaluate the impact of a mobile health (mHealth) enabled nurse health coaching intervention on self-efficacy among adults with type-2 diabetes mellitus. Methods: A randomized controlled trial was conducted at an academic health system in Northern California. A total of 300 participants with type-2 diabetes were scheduled to be enrolled through three primary care clinics. Participants were randomized to either usual care or intervention. All participants received training on use of the health system patient portal. Participants in the intervention arm received six scheduled health-coaching telephone calls with a registered nurse and were provided with an activity tracker and mobile application that integrated data into the electronic health record (EHR) to track their daily activity and health behavior decisions. All participants completed a baseline survey and follow-up surveys at 3 and 9 months. Primary and secondary outcomes include diabetes self-efficacy, hemoglobin A1c (HbA1c), and quality of life measures. Results: Data collection for this trial, funded by the Patient-Centered Outcomes Research Institute, will be completed by December 2017. Results from the trial will be available mid-2018. Conclusions: This protocol details a patient-centered intervention using nurse health coaching, mHealth technologies, and integration of patient-generated data into the EHR. The aim of the intervention is to enhance self-efficacy and health outcomes by providing participants with a mechanism to track daily activity by offering coaching support to set reasonable and attainable health goals, and by creating a complete feedback loop by bringing patient-generated data into the EHR. Trial Registration: ClinicalTrials.gov NCT02672176; https://clinicaltrials.gov/ct2/show/NCT02672176 (Archived by WebCite at http://www.webcitation.org/6xEQXe1M5)

  • Source: Pixabay; Copyright: Daniel Reche; URL: https://pixabay.com/de/spaziergang-pfad-f%C3%BC%C3%9Fe-trail-tennis-2635038/; License: Public Domain (CC0).

    Reducing Sedentary Time for Obese Older Adults: Protocol for a Randomized Controlled Trial

    Abstract:

    Background: Older adults have high rates of obesity and are prone to chronic health conditions. These conditions are in part due to high rates of sedentary time (ST). As such, reducing ST could be an innovative strategy for improving health outcomes among obese older adults. To test this theory, we developed a novel, technology-enhanced intervention to reduce sitting time (I-STAND) and pilot tested it to assess the feasibility, acceptability, and preliminary effects of the intervention on ST and biometric outcomes. Objective: The current paper aims to describe the rationale, design, and methods of the I-STAND sitting reduction pilot trial. Methods: Older adults with obesity (n=60) were recruited from a large health care system and randomized to receive I-STAND or a healthy living intervention. I-STAND combined personal coaching with a technology-enhanced intervention (Jawbone UP band) to cue breaks from sitting. Participants completed self-report and biometric assessments at baseline and 3 months. Additional qualitative results were collected from a subset of I-STAND participants (n=22) to further inform the feasibility and acceptability of the interventions. The primary outcome was total hours of daily sitting time measured by the activPAL device. Secondary outcomes included sit-to-stand transitions, bouts of sitting longer than 30 minutes, physical function, blood pressure, fasting glucose, cholesterol, and depressive symptoms. Results: Study enrollment has ended and data processing is underway. Conclusions: Data from randomized trials on sitting reduction are needed to inform novel approaches to health promotion among older adults with obesity. Our trial will help fill this gap. The methods used in our study can guide future research on using technology-based devices to assess or prompt sedentary behavior reduction, or those interested in behavioral interventions targeting obese older adults with novel approaches Trial Registration: ClinicalTrials.gov: NCT02692560; https://clinicaltrials.gov/ct2/show/NCT02692560 (Archived by WebCite at http://www.webcitation.org/6wppLTWAl)

  • Digital voice technology with real time updates. Source: Image created by the Authors; Copyright: The Authors; URL: https://www.researchprotocols.org/2018/2/e27/; License: Creative Commons Attribution (CC-BY).

    Increasing Physical Activity Amongst Overweight and Obese Cancer Survivors Using an Alexa-Based Intelligent Agent for Patient Coaching: Protocol for the...

    Abstract:

    Background: Physical activity has established health benefits, but motivation and adherence remain challenging. Objective: We designed and launched a three-arm randomized trial to test artificial intelligence technology solutions to increase daily physical activity in cancer survivors. Methods: A single-center, three-arm randomized clinical trial with an allocation ration of 1:1:1: (A) control, in which participants are provided written materials about the benefits of physical activity; (B) text intervention, where participants receive daily motivation from a fully automated, data-driven algorithmic text message via mobile phone (Coachtext); and (C) Voice Assist intervention, where participants are provided with an in-home on demand autonomous Intelligent Agent using data driven Interactive Digital Voice Assist on the Amazon Alexa/Echo (MyCoach). Results: The study runs for 5 weeks: a one-week run-in to establish baseline, followed by 4 weeks of intervention. Data for study outcomes is collected automatically through a wearable sensor, and data are transferred in real-time to the study server. The recruitment goal is 42 participants, 14 in each arm. Electronic health records are used to prescreen candidates, with 39 participants recruited to date. Discussion: This study aims to investigate the effects of different types of intelligent technology solutions on promoting physical activity in cancer survivors. This innovative approach can easily be expanded and customized to other interventions. Early lessons from our initial participants are helping us develop additional advanced solutions to improve health outcomes. Trial Registration: Retrospectively registered on July 10, 2017 at ClinicalTrials.gov: NCT03212079; https://clinicaltrials.gov/ct2/show/NCT03212079 (Archived by WebCite at http://www.webcitation.org/6wgvqjTji)

  • Visual Probe Task for attention bias assessment and modification (montage). Source: The Authors / Mockdrop.io; Copyright: JMIR Publications; URL: http://www.researchprotocols.org/2018/2/e41/; License: Creative Commons Attribution (CC-BY).

    Attention Bias in Individuals with Addictive Disorders: Systematic Review Protocol

    Abstract:

    Background: Globally, substance disorders, particularly that of opiate use, cannabis use, and stimulant use disorders, are highly prevalent. Psychological treatments are an integral aspect of intervention, but a proportion of individuals still relapse despite having received such an intervention. Recently, the dual-process theory proposed that the unconscious processes of attention biases are responsible for these relapses. Prior meta-analyses have reported the presence of attention bias in alcohol and tobacco use disorders. More recent research has examined attention bias and its effectiveness in opiate use, cannabis use, and stimulant use disorder. The evidence syntheses to date have not examined whether attention bias is present in these disorders and could be subjected to manipulation. This is important information and would support the introduction of psychological interventions for attention bias for such patients. Such psychological interventions would help individuals maintain their abstinence and minimize the risk of relapse. Objective: This paper aims to undertake a systematic review to synthesize the existing evidence for the presence of attention bias in all the disorders mentioned above, and to determine the clinical efficacy of attention bias modification. Methods: A systematic review will be conducted. A search will be conducted on the respective databases up till 2017. Selection of the studies will be determined by the Preferred Reporting Items for Systematic Review and Meta-Analysis guidelines. Quality assessment of the included studies will be assessed using the Cochrane Risk of Bias tool. A narrative synthesis will be conducted, with a meta-analysis considered only if there are sufficient studies for statistical analysis. Results: The results of the systematic review will be available 12 months after the publication of this protocol. Conclusions: This review is important as it will support the introduction of psychological interventions for attention bias for such patients. Such psychological interventions would help individuals maintain their abstinence and minimize the risk of relapse.

  • Source: Flickr; Copyright: Raelene Gutierrez; URL: https://www.flickr.com/photos/raes_antics/5447101634; License: Creative Commons Attribution (CC-BY).

    Influence of Radiofrequency Electromagnetic Fields on the Fertility System: Protocol for a Systematic Review and Meta-Analysis

    Abstract:

    Background: Due to the increased number of users of mobile phones, tablets, and other devices over the past few years, concerns about the potential impact of mobile phones on health are growing. The influence of mobile phone exposure on male fertility has been studied in recent years. Other research has shown that electromagnetic fields (EMFs) increase macrophages in the corpus luteum and growing follicles. Due to conflicting results among studies and since no systematic review has been performed to analyze the effects of radiofrequency EMF exposure from electronic devices on the fertility system in recent years, this evidence-based study is necessary. Objective: The main objectives of this study are to determine the best evidence associated with the influence of radiofrequency EMFs on the fertility system and to provide insight into a potential mechanism using our observations. Methods: In this systematic review, the databases and gray literature will be searched with no language and date limitation. The following databases will be searched: Cochrane Library, MEDLINE, PubMed, EMBASE, CINAHL, ProQuest, Scopus, Science Direct, Google Scholar, and other Persian databases. The combination of the Medical Subject Heading terms “radiofrequency electromagnetic” and “male reproductive system” or “female reproductive system” will be searched. Observational study designs will be included but case reports, case series, reviews, and letters to the editor will be excluded. Papers selected for retrieval will be evaluated by two independent referees for methodological validation before entering a review using the Newcastle-Ottawa Scale for nonrandomized studies and cohort studies. Results: The results of this study will be submitted to a peer-reviewed journal for publication and also presented at PROSPERO. Conclusions: This systematic review will provide evidence-based data on the effect of radiofrequency EMFs on the fertility system. This article will also classify the harmful effect of radiofrequency waves on primary and secondary infertility. This study could be useful for decreasing infertility. This is important because the rate of infertility is growing, leading to negative outcomes for couples and the health care system. Trial Registration: PROSPERO CRD42017072462; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=72462 (Archived by WebCite at http://www.webcitation.org/6wjiE9R2q)

  • The Do CHANGE webpage (montage). Source: do-change.eu / Mockdrop.io; Copyright: JMIR Publications; URL: http://www.researchprotocols.org/2018/2/e40/; License: Creative Commons Attribution (CC-BY).

    Enhancing Lifestyle Change in Cardiac Patients Through the Do CHANGE System (“Do Cardiac Health: Advanced New Generation Ecosystem”): Randomized...

    Abstract:

    Background: Promoting a healthy lifestyle (eg, physical activity, healthy diet) is crucial for the primary and secondary prevention of cardiac disease in order to decrease disease burden and mortality. Objective: The current trial aims to evaluate the effectiveness of the Do Cardiac Health: Advanced New Generation Ecosystem (Do CHANGE) service, which is developed to assist cardiac patients in adopting a healthy lifestyle and improving their quality of life. Methods: Cardiac patients (ie, people who have been diagnosed with heart failure, coronary artery disease, and/or hypertension) will be recruited at three pilot sites (Badalona Serveis Assistencials, Badalona, Spain [N=75]; Buddhist Tzu Chi Dalin General Hospital, Dalin, Taiwan [N=100] and Elisabeth-TweeSteden Hospital, Tilburg, The Netherlands [N=75]). Patients will be assisted by the Do Something Different (DSD) program to change their unhealthy habits and/or lifestyle. DSD has been developed to increase behavioral flexibility and subsequently adopt new (healthier) habits. In addition, patients’ progress will be monitored with a number of (newly developed) devices (eg, Fitbit, Beddit, COOKiT, FLUiT), which will be integrated in one application. Results: The Do CHANGE trial will provide us with new insights regarding the effectiveness of the proposed intervention in different cultural settings. In addition, it will give insight into what works for whom and why. Conclusions: The Do CHANGE service integrates new technologies into a behavior change intervention in order to change the unhealthy lifestyles of cardiac patients. The program is expected to facilitate long-term, sustainable behavioral change. Trial Registration: Clinicaltrials.gov NCT03178305; https://clinicaltrials.gov/ct2/show/NCT03178305 (Archived by WebCite at http://www.webcitation.org/6wfWHvuyU).

  • Telehealth session. Source: Image created by the Authors; Copyright: Megan O'Connell; URL: http://www.researchprotocols.org/2018/2/e43/; License: Creative Commons Attribution (CC-BY).

    Telehealth Rehabilitation for Cognitive Impairment: Randomized Controlled Feasibility Trial

    Abstract:

    Background: Nonpharmacological interventions are needed to support the function of older adults struggling with subjective cognitive impairment (SCI), mild cognitive impairment (MCI), and dementia due to Alzheimer disease (AD). Telerehabilitation aims to provide rehabilitation at a distance, but cognitive rehabilitation by videoconferencing has not been explored. Objective: The objective of this study was to compare goal-oriented cognitive rehabilitation delivered in-person with videoconferencing to determine whether telehealth cognitive rehabilitation appears feasible. Methods: Random assignment to in-person or telehealth videoconferencing cognitive rehabilitation with a combined between-subjects, multiple baseline single-case experimental design, cognitive rehabilitation was delivered by a therapist to 6 participants with SCI (n=4), MCI (n=1), or dementia due to AD (n=1). Results: Two of the 6 participants randomly assigned to the telehealth condition withdrew before beginning the intervention. For those who participated in the intervention, 6 out of 6 goals measured with the Canadian Occupational Performance Measure improved for those in the in-person group, and 7 out of 9 goals improved for those in the telehealth group. Conclusions: Delivery of cognitive rehabilitation by telehealth appeared feasible but required modifications such as greater reliance on caregivers and clients for manipulating materials.

  • Bladder tumor with confocal laser endomicroscope (CLE) probe and CLE image. Source: Image created by the Authors; Copyright: The Authors; URL: http://www.researchprotocols.org/2018/2/e34/; License: Creative Commons Attribution (CC-BY).

    Confocal Laser Endomicroscopy for the Diagnosis of Urothelial Carcinoma in the Bladder and the Upper Urinary Tract: Protocols for Two Prospective Explorative...

    Abstract:

    Background: Visual confirmation of a suspicious lesion in the urinary tract is a major corner stone in diagnosing urothelial carcinoma. However, during cystoscopy (for bladder tumors) and ureterorenoscopy (for tumors of the upper urinary tract) no real-time histopathologic information can be obtained. Confocal laser endomicroscopy (CLE) is an optical imaging technique that allows for in vivo high-resolution imaging and may allow real-time tumor grading of urothelial lesions. Objective: The primary objective of both studies is to develop descriptive criteria for in vivo CLE images of urothelial carcinoma (low-grade, high-grade, carcinoma in situ) and normal urothelium by comparing CLE images with corresponding histopathology. Methods: In these two prospective clinical trials, CLE imaging will be performed of suspicious lesions and normal tissue in the urinary tract during surgery, prior to resection or biopsy. In the bladder study, CLE will be performed in 60 patients using the Cystoflex UHD-R probe. In the upper urinary tract study, CLE will be performed in 25 patients during ureterorenoscopy, who will undergo radical treatment (nephroureterectomy or segmental ureter resection) thereafter. All CLE images will be analyzed frame by frame by three independent, blinded observers. Histopathology and CLE-based diagnosis of the lesions will be evaluated. Both studies comply with the IDEAL stage 2b recommendations. Results: Presently, recruitment of patients is ongoing in both studies. Results and outcomes are expected in 2018. Conclusions: For development of CLE-based diagnosis of urothelial carcinoma in the bladder and the upper urinary tract, a structured conduct of research is required. This study will provide more insight in tissue-specific CLE criteria for real-time tumor grading of urothelial carcinoma. Trial Registration: Confocal Laser Endomicroscopy: ClinicalTrials.gov NCT03013894; https://clinicaltrials.gov /ct2/show/NCT03013894?term=NCT03013894&rank=1 (Archived by WebCite at http://www.webcitation.org/6wiPZ378I); and Dutch Central Committee on Research Involving Human Subjects NL55537.018.15; https://www.toetsingonline.nl /to/ccmo_search.nsf/fABRpop?readform&unids=6B72AE6EB0FC3C2FC125821F001B45C6 (Archived by WebCite at http://www.webcitation.org/6wwJQvqWh). Confocal Laser Endomicroscopy in the upper urinary tract: ClinicalTrials.gov NCT03013920; https://clinicaltrials.gov/ct2/show/NCT03013920? term=NCT03013920&rank=1 (Archived by WebCite at http://www.webcitation.org/6wiPkjyt0); and Dutch Central Committee on Research Involving Human Subjects NL52989.018.16; https://www.toetsingonline.nl/to/ccmo_search.nsf/fABRpop?readform&unids=D27C9C3E5755CFECC12581690016779F (Archived by WebCite at http://www.webcitation.org/6wvy8R44C).

  • Source: Flickr; Copyright: Psoriasis-Netz; URL: https://www.flickr.com/photos/psoriasis-netz/24905965693/sizes/o/; License: Creative Commons Attribution (CC-BY).

    Psychosocial Distress of Patients with Psoriasis: Protocol for an Assessment of Care Needs and the Development of a Supportive Intervention

    Abstract:

    Background: Psoriasis is a chronic inflammatory disease that is often associated with a number of somatic and mental comorbidity. Patients with psoriasis show an increased risk of depression and (social) anxiety. Objective: The aims of this study are 1) to explore the psychosocial distress of patients with psoriasis and to assess their care needs; and 2) to develop a supportive intervention based on the prior results. Methods: A multi-stage design with four phases combining quantitative and qualitative methodology will be used and conducted in two centers. 1) A scoping review and focus groups will be used to design a questionnaire to assess the psychosocial distress and care needs of the patients. 2) The questionnaire developed in phase 1 will be used in a cross-sectional survey to assess the extent of psychosocial distress and supportive care needs in 400 patients with psoriasis. 3) A systematic review and meta-analysis will be conducted to identify psychosocial and psychoeducational interventions for patients with psoriasis and to describe their effectiveness. 4) Based on the results of the phases 2 and 3 a manualized supportive intervention will be developed and the feasibility and acceptance of the intervention will be assessed. Results: Currently, phase 1 of the project has been completed and the recruitment for phase 2 has been started. The systematic review and meta-analysis of phase 3 are conducted simultaneously to phase 2 and results are expected soon. Phase 4 has not been started yet. Conclusions: The expected results of this study will show the extent of psychosocial distress of patients with psoriasis in Germany and supplement previous research with findings about the supportive care needs of this patient group. Moreover, the developed intervention will help to address the psychosocial support needs of patients with psoriasis. Research shows that psychosocial support is strongly needed.

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  • Effectiveness of a combined Web Based and Ecological Momentary Intervention for incoming first-year university students: Protocol for a three-arm randomised controlled trial.

    Date Submitted: Feb 16, 2018

    Open Peer Review Period: Feb 17, 2018 - Mar 3, 2018

    Background: Alcohol use among university students is common and those who drink often choose to drink heavily (i.e., 4 or more drinks per session for women or 5 or more for men). Web-Based Interventio...

    Background: Alcohol use among university students is common and those who drink often choose to drink heavily (i.e., 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 two methods that have had some success in reducing alcohol use among university students. Objective: The aim of the current study is to investigate the efficacy of a combined WBI and EMI intervention to reduce alcohol use among university students. Methods: The study is a three-arm RCT. Participants will be randomised 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 five residential colleges at the University of Otago, New Zealand. All participants will complete an online questionnaire at baseline (i.e., before Orientation Week); those in the WBI and WBI + EMI conditions will immediately receive feedback (i.e., the WBI) based on their answers, whereas participants in the control group will receive no feedback. In addition, participants randomised in the WBI + EMI, but not those in the WBI-only or control groups, will receive eight Orientation Week (two per-day on nights with orientation events) and six academic year EMIs (fortnightly). Participants in all conditions will complete brief surveys at the send of the first and second semester and report their weekend alcohol use fortnightly throughout each semester via Ecological Momentary Assessments (EMAs). Results: The primary hypothesis is that participants in the WBI + EMI condition will consume significantly fewer drinks during weekends in their first year at university compared to a WBI only and control group. Secondary hypotheses are that, when compared with the WBI alone and control group, the WBI + EMI condition will report consuming fewer drinks during Orientation Week, report experiencing fewer negative alcohol-related consequences after first semester, and report lower AUDIT-C scores following their first semester. Conclusions: N/A Clinical Trial: Australian New Zealand Clinical Trials Registry (ANZCTR) ACTRN12618000015246.

  • Protocol for a Systematic Review of Gamified Attention Bias Interventions for Psychiatric Disorders

    Date Submitted: Feb 16, 2018

    Open Peer Review Period: Feb 17, 2018 - Mar 3, 2018

    Background Attention biases are subconscious processes that tend to result in individuals having increased attention for threatening or stimuli with high salience. These biases have been posited to b...

    Background Attention biases are subconscious processes that tend to result in individuals having increased attention for threatening or stimuli with high salience. These biases have been posited to be involved in the psychopathologies of several psychiatric disorders. Technological advances have transformed how such interventions are being delivered. Gamification technologies are increasingly being used for bias modification, as it could help increase motivation to train and make these tasks more engaging. While there are published research on gamification and attention bias, there remains several gaps in knowledge. Objectives The primary objective of the review is thus to identify attention bias modification games that have been published in the literature and to synthesise the current evidence for such interventions and to identify, if possible, the rationale for gamification. The secondary objective is to determine if gamified attention or cognitive bias modification influences secondary outcomes measures, as such anxiety levels or severity of depressive symptoms. Methods To achieve the objective of this review, a systematic review will be undertaken. For the studies that are identified, they will be reviewed by independent assessors and screened against our predefined inclusion and exclusion criteria. The Cochrane risk of bias tool will be used for assessment of the risk of biases in randomised trials that have been identified. The evidence will be synthesized by means of a qualitative synthesis. Results We expect that the review will be completed 12 months from the publication of this protocol. Conclusions This review is pertinent as it helps to provide an overview of the evidence base for gamified attention bias interventions. The findings from the current review will help in the future conceptualisation of gamified attention bias interventions.

  • Protocol for qualitative and quantitative evaluation of ‘Kræftværket’ - a smartphone application designed via co-creation to improve quality of life in adolescents and young adults with cancer.

    Date Submitted: Feb 12, 2018

    Open Peer Review Period: Feb 16, 2018 - Mar 2, 2018

    Background: Adolescents and young adults (AYA) with cancer face significant challenges during the course of medical treatment and recovery from illness. Many struggle with long-term complications in p...

    Background: Adolescents and young adults (AYA) with cancer face significant challenges during the course of medical treatment and recovery from illness. Many struggle with long-term complications in physical, psychosocial, economic and academic domains. Mobile health (mHealth) interventions provide an innovative platform for delivering supportive care, particularly through the utilization of applications (apps) on smartphones and tablets. In order to create a successful mHealth intervention for AYAs, youth input and feedback is essential. The process of co-creation, in which the target app user has a direct role in dictating design and function, was utilized to create the prototype smartphone app for AYA with cancer, TeleKræftværket. Objective: The objective of this article is to describe the protocol for the qualitative and quantitative testing and analysis of the Kræftværket app, a prototype app designed via co-creation for AYAs with cancer to support and improve health-related quality of life (HRQoL). Methods: 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 AYAs age 15-29 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 EORTC QLQ-C30 HRQoL inventory. In addition, participant focus group interviews will be conducted according to a semi-structured 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 size of 50 AYAs age 15-29 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 AYA oncology patients in the digital world.

  • Development of a smartphone application for inpatient assessment and post discharge follow-up in child and adolescent psychiatry: a research protocol

    Date Submitted: Feb 15, 2018

    Open Peer Review Period: Feb 15, 2018 - Mar 1, 2018

    Background: New methods for in- and outpatient data collection and for improvning outpatient compliance after discharge are called for. Interactive and mobile technologies i.e. smartphone applications...

    Background: New methods for in- and outpatient data collection and for improvning outpatient compliance after discharge are called for. Interactive and mobile technologies i.e. smartphone applications (apps) have shown promising results, e.g. helping unwell people by offering support and resources. Screening the current condition, including comorbidity, is a vital part of psychiatric care. Comorbid conditions, especially in emergency evaluation, are often missed leading to inaccurate diagnosis and treatment. Also in child and adolescent psychiatric emergency settings, little is known regarding treatment satisfaction. One way of improving diagnostic accuracy and to increase knowledge regarding treatment satisfaction is to use a structured diagnostic process as well as adding a tool to assess consumer satisfaction. Digitalized screening and follow-up has the advantage of making the administration and scoring easier and less time consuming leading to higher response rate. To address the described problems we decided to create a smartphone application: Blå Appen. Objective: The aim of this paper is to describe the development of Blå Appen and to describe the two planned research studies to evaluate the application. Methods: : Blå Appen was developed through 7 different steps: (1) Identifying the need for quick and easy information gathering; (2) identifying desired information and choosing adequate screening questionnaires (3) examining the feasibility in acute psychiatric environment – pilot study; (4) getting organizational acceptance – feasibility study; (5) App construction; (6) Workshop with adolescents - what do the patients think; (7) evaluation - research study 1 & 2. Results: (1) We decided to create a smartphone application based on our previous work on interactive voice response. (2) Eleven validated screening questionnaires were chosen with regard to frequent comorbid states in child & adolescent psychiatry. (3) A pilot study was performed (n=16) indicating good acceptability. In the next step (4) we performed a feasibility study concluding that the method we planned adds value for our patients and no existing solutions were found on the market. The IT department gave their final approval for funding in May 2015. (5) The work resulted in a public procurement. (6) We performed a workshop indicating good feasibility. (7) Two studies will be performed, one in inpatients identifying comorbid conditions and the other to assess outpatient compliance and treatment outcome. Conclusions: A technically advanced and easy-to-use web based mobile phone application corresponding to the unit’s needs was developed and two studies to evaluate its usefulness were planned.

  • Study Protocol of Cost Effectiveness Analysis on Randomised Control Trial of Dental Home Visits (DHVs) in Caries Prevention among Preschool Children

    Date Submitted: Feb 6, 2018

    Open Peer Review Period: Feb 15, 2018 - Mar 1, 2018

    Background: In 2012, nearly 4,000 children in Malaysia were referred for hospital paediatric dental services because of dental caries. Recent research has reported on the effectiveness of dental home...

    Background: In 2012, nearly 4,000 children in Malaysia were referred for hospital paediatric dental services because of dental caries. Recent research has reported on the effectiveness of dental home visits (DHVs) in preventing caries development of caries in young children. DHVs is described as an ongoing relationship between the dentist and his/her patients, providing all aspects of preventive oral health care programme in the presence of the parents at home. The aim of this study is to evaluate the cost effectiveness of DHVs and oral health information in the form of educational leaflets (ELs) in preventing new caries development in young children compared to those receiving only ELs over a period of two years. The cost-effectiveness analysis (CEA) is widely used to inform decision makers about the value of new health programme and interventions. Study methods: This is a collaborative project with the Oral Health Division (OHD) of the Ministry of Health Malaysia. The OHD will provide access to a sub-sample from the National Oral Health of Preschoolers Survey (NOHPS) which was carried out in year 2015. The population of interest is children aged 5 and 6 year-olds from kindergartens in the Selangor state in Malaysia. The study adopted a societal perspective for CEA, all types of resources that are of value to society will be included in analyzing the costs; such as cost to the patient, cost to the provider/institution and indirect costs because of the loss of productivity. Discussion: The amount of young children in Malaysia who have been referred to the hospital children’s dentistry service for severe caries is disturbing. The cost of dental treatment in young children is high due to the severity of the caries which require an aggressive treatment, and the need for general anaesthesia or sedation. This study will provide information on the cost and effectiveness of DHVs in caries prevention of young children in Malaysia.

  • Community Volunteer Support for Families with Young Children: The Volunteer Family Connect Randomised Controlled Trial Research Protocol

    Date Submitted: Feb 14, 2018

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

    Background: Use of community volunteers to support vulnerable families is a widely employed strategy with a long history. However, there has been minimal formal scientific investigation into the effec...

    Background: Use of community volunteers to support vulnerable families is a widely employed strategy with a long history. However, there has been minimal formal scientific investigation into the effectiveness of volunteer home visiting programs for families. There is also a need for research examining whether this form of community participation leads to improved outcomes for volunteers. This paper describes the research protocol for a pragmatic randomised controlled trial (RCT) of the Volunteer Family Connect intervention, a volunteer home visiting program designed to support families of young children who experience social isolation and/or a lack of parenting confidence and skills. The project is being conducted in partnership with three leading not-for-profit organisations, designed to contribute to the body of evidence that informs decisions about appropriate family support services according to level of need. It is the first study to examine both outcomes for the families and for the volunteers who deliver the service. Methods: The RCT is being conducted in seven sites across Australia. We aim to recruit 300 families to the study, 150 control (services as usual), and 150 intervention (services as usual + volunteer home visiting) families. Intervention families receive the service for between 3 and 12 months according to need, and all participants complete six data collection points over 15 months. A minimum of 80 volunteers will also be recruited, along with a matched community comparison group. Volunteers will complete three data collection points over 12 months. Primary outcomes include community connectedness and parenting competence. Secondary outcomes include parent physical and mental health, general parent wellbeing, parent empowerment, child-parent relationship, sustainability of family routines, child immunization, child nutrition/breastfeeding, number of accidental injury reports, and volunteer health, well-being and community connectedness. Discussion: There is a need to rigorously assess volunteer home visiting and whether it has a unique and important role on the service landscape, complementary to professional services. This research is the first trial of a volunteer home visiting program to be conducted in Australia and one of the largest of its kind worldwide. Trial Registration: Australian New Zealand Clinical Trial Registry (Trial ID: ACTRN12616000396426).

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