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Journal Description

 

JMIR Research Protocols (ISSN 1929-0748) is a unique Pubmed- and (new!) Scopus-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.

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 (preliminary results from pilot studies, early results, and formative research should now be published in JMIR Formative Research).

While the original focus was on the design of medical and health-related research and technology innovations, JRP publishes research protocols, proposals, feasibility studies, methods and early results in all areas of medical and health research.

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 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 proposals 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: Image created by the Authors; Copyright: The Authors; URL: http://www.researchprotocols.org/2020/4/e16474/; License: Fair use/fair dealings.
    Non-randomized Protocols and Methods...

    Apr 3, 2020

    Promoting Wellness Through Mobile Health Technology in a College Student Population: Protocol Development and Pilot Study

    Authors List:

    Abstract:

    Background: The health and well-being of college students has garnered widespread attention and concern in recent years. At the same time, the expansion and evaluation of digital technologies has grown in recent years for different target populations. Objective: This protocol aims to describe a pilot feasibility study on wearables to assess student interest and to gather baseline data from college freshmen, for the academic year 2019 to 2020. Methods: All full-time college freshmen residing in a single residence hall were eligible to participate. Study invitations were sent by post and email 5 weeks prior to move-in. Web-based enrollment and in-person attendance at study orientation sessions were mandatory. We provided the incoming freshmen with a wearable and study app. Wearable data and weekly survey data will be collected through the study app and analyzed. We have collected demographic, enrollment, and attrition data and the number and type of support requests from students. Results: The planning phase of the WearDuke initiative was completed in 2018 to 2019, and the pilot study was launched in July 2019. Of the 175 students invited, 120 enrolled and 114 started the study; 107 students remained active participants till the end of the fall semester. For Apple Watch participants (the majority of study population), weekly survey completion rates ranged from 70% (74/106) to 96% (95/99). Conclusions: Halfway through the pilot, we noticed that the initiative has been received positively by the students with minimal attrition. The short- and long-term benefits may be substantial for students, the campus, the utilization of health services, and long-term health.

  • Source: Image created by the Authors; Copyright: The Authors; URL: http://www.researchprotocols.org/2020/4/e16641/; License: Creative Commons Attribution (CC-BY).
    Non-randomized Protocols and Methods...

    Apr 3, 2020

    User Experience and Potential Health Effects of a Conversational Agent-Based Electronic Health Intervention: Protocol for an Observational Cohort Study

    Authors List:

    Abstract:

    Background: While the average human life expectancy has increased remarkably, the length of life with chronic conditions has also increased. To limit the occurrence of chronic conditions and comorbidities, it is important to adopt a healthy lifestyle. Within the European project “Council of Coaches,” a personalized coaching platform was developed that supports developing and maintaining a healthy lifestyle. Objective: The primary aim of this study is to assess the user experience with and the use and potential health effects of a fully working Council of Coaches system implemented in a real-world setting among the target population, specifically older adults or adults with type 2 diabetes mellitus or chronic pain. Methods: An observational cohort study with a pretest-posttest design will be conducted. The study population will be a dynamic cohort consisting of older adults, aged ≥55 years, as well as adults aged ≥18 years with type 2 diabetes mellitus or chronic pain. Each participant will interact in a fully automated manner with Council of Coaches for 5 to 9 weeks. The primary outcomes are user experience, use of the program, and potential effects (health-related factors). Secondary outcomes include demographics, applicability of the virtual coaches, and user interaction with the virtual coaches. Results: Recruitment started in December 2019 and is conducted through mass mailing, snowball sampling, and advertisements in newspapers and social media. This study is expected to conclude in August 2020. Conclusions: The results of this study will either confirm or reject the hypothesis that a group of virtual embodied conversational coaches can keep users engaged over several weeks of interaction and contribute to positive health outcomes. Trial Registration: The Netherlands Trial Register: NL7911; https://www.trialregister.nl/trial/7911

  • Source: Freepik; Copyright: katemangostar; URL: https://www.freepik.com/free-photo/serious-young-businessman-opening-letter-cafe_1473452.htm#page=1&query=opening%20a%20letter&position=14; License: Licensed by JMIR.
    RCTs - Protocols/Proposals (non-eHealth)

    Apr 3, 2020

    Effect of Various Invitation Schemes on the Use of Fecal Immunochemical Tests for Colorectal Cancer Screening: Protocol for a Randomized Controlled Trial

    Authors List:

    Abstract:

    Background: Fecal occult blood testing has been offered for many years in the German health care system, but participation rates have been notoriously low. Objective: The aim of this study is to evaluate the effect of various personal invitation schemes on the use of fecal immunochemical tests (FITs) in persons aged 50-54 years. Methods: This study consists of a three-armed randomized controlled trial: (1) arm A: an invitation letter from a health insurance plan including a FIT test kit, (2) arm B: an invitation letter from a health insurance plan including an offer to receive a free FIT test kit by mail upon easy-to-handle request (ie, by internet, fax, or reply mail), and (3) arm C: an information letter on an existing colonoscopy offer (ie, control). Within arms A and B, a random selection of 50% of the study population will receive reminder letters, the effects of which are to be evaluated in a substudy. Results: A total of 17,532 persons aged 50-54 years in a statutory health insurance plan in the southwest of Germany—AOK Baden-Wuerttemberg—were sent an initial invitation, and 5825 reminder letters were sent out. The primary end point is FIT usage within 1 year from receipt of invitation or information letter. The main secondary end points include gender-specific FIT usage within 1 year, rates of positive test results, rates of colonoscopies following a positive test result, and detection rates of advanced neoplasms. The study was launched in September 2017. Data collection and workup were completed in fall 2019. Conclusions: This randomized controlled trial will provide important empirical evidence for enhancing colorectal cancer screening offers in the German health care system. Trial Registration: German Clinical Trials Register (DRKS) DRKS00011858; https://bit.ly/2UBTIdt

  • Mother completing information giving and consent process with her child. Source: Image created by the Authors; Copyright: The Authors; URL: http://www.researchprotocols.org/2020/4/e16531/; License: Creative Commons Attribution (CC-BY).
    Non-Randomized Study Protocols and...

    Apr 2, 2020

    Determining the Agreement Between an Automated Respiratory Rate Counter and a Reference Standard for Detecting Symptoms of Pneumonia in Children: Protocol...

    Authors List:

    Abstract:

    Background: Acute respiratory infections (ARIs), primarily pneumonia, are the leading infectious cause of under-5 mortality worldwide. Manually counting respiratory rate (RR) for 60 seconds using an ARI timer is commonly practiced by community health workers to detect fast breathing, an important sign of pneumonia. However, correctly counting breaths manually and classifying the RR is challenging, often leading to inappropriate treatment. A potential solution is to introduce RR counters, which count and classify RR automatically. Objective: This study aims to determine how the RR count of an Automated Respiratory Infection Diagnostic Aid (ARIDA) agrees with the count of an expert panel of pediatricians counting RR by reviewing a video of the child’s chest for 60 seconds (reference standard), for children aged younger than 5 years with cough and/or difficult breathing. Methods: A cross-sectional study aiming to enroll 290 children aged 0 to 59 months presenting to pediatric in- and outpatient departments at a teaching hospital in Addis Ababa, Ethiopia, was conducted. Enrollment occurred between April and May 2017. Once enrolled, children participated in at least one of three types of RR evaluations: (1) agreement—measure the RR count of an ARIDA in comparison with the reference standard, (2) consistency—measure the agreement between two ARIDA devices strapped to one child, and (3) RR fluctuation—measure RR count variability over time after ARIDA attachment as measured by a manual count. The agreement and consistency of expert clinicians (ECs) counting RR for the same child with the Mark 2 ARI timer for 60 seconds was also measured in comparison with the reference standard. Results: Primary outcomes were (1) mean difference between the ARIDA and reference standard RR count (agreement) and (2) mean difference between RR counts obtained by two ARIDA devices started simultaneously (consistency). Conclusions: Study strengths included the design allowing for comparison between both ARIDA and the EC with the reference standard RR count. A limitation is that exactly the same set of breaths were not compared between ARIDA and the reference standard since ARIDA can take longer than 60 seconds to count RR. Also, manual RR counting, even when aided by a video of the child’s chest movements, is subject to human error and can result in low interrater reliability. Further work is needed to reach global consensus on the most appropriate reference standard and an acceptable level of agreement to provide ministries of health with evidence to make an informed decision on whether to scale up new automated RR counters. Trial Registration: ClinicalTrials.gov NCT03067558; https://clinicaltrials.gov/ct2/show/NCT03067558

  • Source: Freepik; Copyright: Freepik; URL: https://www.freepik.com/free-photo/close-up-old-couple-with-smartphone_5125304.htm; License: Licensed by JMIR.
    RCTs - Pilots/Feasibility Studies...

    Apr 2, 2020

    A Smartphone App (mDASHNa-CC) to Support Healthy Diet and Hypertension Control for Chinese Canadian Seniors: Protocol for Design, Usability and Feasibility...

    Authors List:

    Abstract:

    Background: This proposed study aims to translate the Dietary Approach to Stop Hypertension with Sodium (Na) Reduction for Chinese Canadians (DASHNa-CC), a classroom-based, antihypertensive, dietary educational intervention, to an innovative smartphone app (mDASHNa-CC). This study will enable Chinese Canadian seniors to access antihypertensive dietary interventions anytime, regardless of where they are. It is hypothesized that senior Chinese Canadians will be satisfied with their experiences using the mDASHNa-CC app and that the use of this app could lead to a decrease in their blood pressure and improvement in their health-related quality of life. Objective: The goal of this study is to design and test the usability and feasibility of a smartphone-based dietary educational app to support a healthy diet and hypertension control for Chinese Canadian seniors. Methods: A mixed-method two-phase design will be used. The study will be conducted in a Chinese immigrant community in Toronto, Ontario, Canada. Chinese Canadian seniors, who are at least 65 years old, self-identified as Chinese, living in Canada, and with elevated blood pressure, will be recruited. In Phase I, we will design and test the usability of the app using a user-centered approach. In Phase II, we will test the feasibility of the app, including implementation (primary outcomes of accrual and attrition rates, technical issues, acceptability of the app, and adherence to the intervention) and preliminary effectiveness (secondary outcomes of systolic and diastolic blood pressure, weight, waist circumference, health-related quality of life, and health service utilization), using a pilot, two-group, randomized controlled trial with a sample size of 60 participants in a Chinese Canadian community. Results: The study is supported by the Startup Research Grant from Nipissing University, Canada. The research ethics application is under review by a university research ethics review board. Conclusions: The study results will make several contributions to the existing literature, including illustrating the rigorous design and testing of smartphone app technology for hypertension self-management in the community, exploring an approach to incorporating traditional medicine into chronic illness management in minority communities and promoting equal access to current technology among minority immigrant senior groups. Trial Registration: Clinicaltrials.gov NCT03988894; https://clinicaltrials.gov/ct2/show/NCT03988894

  • Urine tenofovir point-of-care test. Source: Image created by the Authors; Copyright: The Authors; URL: https://www.researchprotocols.org/2020/4/e15029; License: Creative Commons Attribution (CC-BY).
    RCTs - Pilots/Feasibility Studies...

    Apr 2, 2020

    Testing a Real-Time Tenofovir Urine Adherence Assay for Monitoring and Providing Feedback to Preexposure Prophylaxis in Kenya (PUMA): Protocol for a Pilot...

    Authors List:

    Abstract:

    Background: The worldwide expansion of preexposure prophylaxis (PrEP) with oral tenofovir-disoproxil-fumarate/emtricitabine will be critical to ending the HIV epidemic. However, maintaining daily adherence to PrEP can be difficult, and the accuracy of self-reported adherence is often limited by social desirability bias. Pharmacologic adherence monitoring (measuring drug levels in a biomatrix) has been critical to interpreting PrEP trials, but testing usually requires expensive equipment and skilled personnel. We have recently developed a point-of-care (POC) immunoassay to measure tenofovir in urine, allowing real-time adherence monitoring for the first time. Objective: The goal of this study is to examine a point-of-care adherence metric in PrEP to support and increase adherence via a randomized controlled trial. Methods: The paper describes the protocol for a pilot randomized controlled trial to test the acceptability, feasibility, and impact on long-term adherence of implementing a POC urine test to provide real-time adherence feedback among women on PrEP. Eligible women (n=100) will be HIV-negative, ≥18 years old, and recruited from a clinic in Kenya that provides PrEP. Participants will be randomized 1:1 to the intervention of providing real-time feedback via the assay versus standard of care adherence counseling. Acceptability by participants will be assessed by a quantitative survey, as well as by qualitative data collected via in-depth interviews (n=20) and focus group discussions (n=4 groups, 5-10 women each). Feasibility will be assessed by the proportion of women retained in the study, the mean number of missed visits, the proportion of planned urine assessments completed, and messages delivered, while in-depth interviews with providers (n=8) will explore the ease of administering the urine test. Tenofovir levels in hair will serve as long-term adherence metrics. A linear mixed-effects model will estimate the effect of the intervention versus standard of care on logarithmically transformed levels of tenofovir in hair. Results: This study has been funded by the National Institute of Health, approved by the Kenya Medical Research Institute Institutional Review Board, and will commence in June 2020. Conclusions: A novel urine assay to measure and deliver information on adherence to PrEP in real-time will be tested for the first time in this trial planned among women on PrEP in Kenya. Study findings will inform a larger-scale trial assessing the impact of real-time adherence monitoring/feedback on HIV prevention. Improving adherence to PrEP will have long-term implications for efforts to end the HIV epidemic worldwide. Trial Registration: ClinicalTrials.gov NCT03935464; https://clinicaltrials.gov/ct2/show/NCT03935464

  • Source: Iijima M; Copyright: The Authors; URL: http://www.researchprotocols.org/2020/4/e17117/; License: Creative Commons Attribution (CC-BY).
    RCTs - Protocols/Proposals (funded,...

    Apr 1, 2020

    Efficacy and Safety of Rituximab in Refractory CIDP With or Without IgG4 Autoantibodies (RECIPE): Protocol for a Double-Blind, Randomized, Placebo-Controlled...

    Authors List:

    Abstract:

    Background: Chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) is an immune-mediated peripheral neuropathy that is currently classified into several clinical subtypes, which are presumed to have different pathogenic mechanisms. Recently, studies identified a subgroup of patients with CIDP who were positive for IgG4 autoantibodies against paranodal proteins, such as neurofascin-155 and contactin-1, who respond poorly to first-line therapies for typical CIDP, including intravenous immunoglobulin therapy. Objective: This study aims to evaluate the efficacy and safety of intravenous rituximab according to IgG4 autoantibody status in patients with refractory CIDP. Methods: The Evaluation of the Efficacy and Safety of Rituximab in Refractory CIDP Patients with IgG4 Autoantibodies in the Exploratory Clinical (RECIPE) trial consists of 2 cohorts: a multicenter, placebo-controlled, randomized study cohort of 15 patients with IgG4 autoantibody-positive CIDP (rituximab:placebo = 2:1) and an open-label trial cohort of 10 patients with antibody-negative CIDP. The primary endpoint is improvement in functional outcome assessed using the adjusted Inflammatory Neuropathy Cause and Treatment Disability Scale score at 26, 38, or 52 weeks after the start of treatment with rituximab in patients with CIDP and anti-paranodal protein antibodies. Secondary outcome measures include grip strength, manual muscle testing sum scores, results of nerve conduction studies, and other functional scales. Results: We plan to enroll 25 cases for the full analysis set. Recruitment is ongoing, with 14 patients enrolled as of January 2020. Enrollment will close in September 2020, and the study is planned to end in December 2021. Conclusions: This randomized controlled trial will determine if rituximab is safe and effective in patients with anti-paranodal antibodies. An open-label study will provide additional data on the effects of rituximab in patients with antibody-negative CIDP. The results of the RECIPE trial are expected to provide evidence for the positioning of rituximab as a pathogenesis-based therapeutic for refractory CIDP. Trial Registration: ClinicalTrials.gov NCT03864185, https://clinicaltrials.gov/ct2/show/NCT03864185 ; The Japan Registry of Clinical Trials jRCT2041180037, https://jrct.niph.go.jp/en-latest-detail/jRCT2041180037

  • Administration of ADRCs to liver via hepatic artery by using a catheter. Source: Image created by the Authors; Copyright: The Authors; URL: http://www.researchprotocols.org/2020/3/e17904/; License: Creative Commons Attribution (CC-BY).
    Non-Randomized Study Protocols and...

    Mar 31, 2020

    Regenerative Therapy for Liver Cirrhosis Based on Intrahepatic Arterial Infusion of Autologous Subcutaneous Adipose Tissue-Derived Regenerative (Stem) Cells:...

    Authors List:

    Abstract:

    Background: Liver cirrhosis results from chronic hepatitis, and is characterized by advanced fibrosis due to long-term hepatic inflammation. Cirrhosis ultimately leads to manifestations of jaundice, ascites, and encephalopathy, and increases the risk of hepatocellular carcinoma. Once cirrhosis is established, resulting in hepatic failure, no effective treatment is available. Therefore, novel therapies to inhibit disease progression of cirrhosis are needed. Objective: The objective of this investigator-initiated clinical trial is to assess the safety and efficacy of autologous adipose tissue-derived regenerative (stem) cell therapy delivered to the liver via the hepatic artery in patients with liver cirrhosis. Methods: Through consultation with the Japan Pharmaceuticals and Medical Devices Agency, we designed a clinical trial to assess a therapy for liver cirrhosis based on autologous adipose tissue-derived regenerative (stem) cells, which are extracted using an adipose tissue dissociation device. The primary endpoints of the trial are the serum albumin concentration, prothrombin activity, harmful events, and device malfunction. Results: Enrollment and registration were initiated in November 2017, and the follow-up period ended in November 2019. Data analysis and the clinical study report will be completed by the end of March 2020. Conclusions: Completion of this clinical trial, including data analysis, will provide data on the safety and efficacy of this novel liver repair therapy based on autologous adipose tissue-derived regenerative (stem) cells using an adipose tissue dissociation device. Trial Registration: UMIN Clinical Trials Registry UMIN000022601; https://tinyurl.com/w9uqw3q

  • Source: freepik; Copyright: freepik; URL: https://www.freepik.com/free-photo/doctors-looking-laptop-while-sitting_5480800.htm#page=2&query=doctor+with+laptop&position=42; License: Licensed by JMIR.
    Systematic Review Protocols

    Mar 31, 2020

    Application of Internet of Things in Cell-Based Therapy Delivery: Protocol for a Systematic Review

    Authors List:

    Abstract:

    Background: Internet of Things (IoT), or Industry 4.0, represents a smart shift to more interconnected manufacturing processes where individual entities within the supply chain communicate with each other to achieve greater flexibility and responsiveness in general manufacturing and leaner manufacturing to reduce the cost of production. IoT has become instrumental in driving leaner manufacturing and more efficient systems in other industries such as transportation and logistics. Cell-based therapeutic products could potentially transform various diseases; however, the delivery of these products is complex and challenging. Objective: This study aims to understand the applicability of IoT in cell-based product supply chains and delivery. Methods: We will search Medline, EMBASE (OvidSP), Web of Science, Cochrane Library & HEED, Scopus, ACM digital library, INSPEC, ScienceDirect, and the IEEE Xplore Digital Library for studies published after 2008 using a combination of keywords and subject headings related to IoT used in cell therapies. Additionally, a Google search to identify gray literature will be conducted. Two authors will independently screen the titles and abstracts identified from the search and accept or reject the studies according to the study inclusion criteria. Any discrepancies will then be discussed and resolved. The quality of the selected literature will be assessed using the Critical Appraisal Skills Programme systematic review checklist. Results: Data from eligible publications will be abstracted into a predesigned form to map the current and future directions of the technologies, applications, benefits, and challenges in the implementation of IoT in regenerative medicine. This study will be published in a peer-reviewed journal in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. This systematic review will be executed by June 2020, and the completed review will be published in a peer-reviewed journal to inform future developments in IoT application for the delivery of cell-based therapies. Conclusions: This review paper will provide an overview of all technologies available in the area and inspect the current IoT applications in cell-based therapies to identify the benefits, challenges, and future directions of using IoT to allow safe and cost-effective delivery of cell-based therapies.

  • Source: freepik; Copyright: freepik; URL: https://www.freepik.com/free-photo/girl-boy-s-foot-soccer-ball_4807053.htm#page=8&query=child+sport&position=5; License: Licensed by JMIR.
    Systematic Review Protocols

    Mar 31, 2020

    Internet of Things–Enabled Technologies for Weight Management in Children and Adolescents: Protocol for a Systematic Review

    Authors List:

    Abstract:

    Background: Childhood obesity is a serious global issue, leading to increased medical spending on obesity-related diseases such as cardiovascular diseases and diabetes. There is a need for health care services that link health behavior to risk factors, such as diet and physical activity, and that provide better advice and feedback to users, which Internet of Things–enabled technologies could facilitate. Objective: The objective of the systematic review will be to identify available Internet of Things–enabled technologies for weight management of children and adolescents (users younger than 18 years). It will also aim to understand the use, effectiveness, and feasibility of these technologies. Methods: We will search the Medline, PubMed, Web of Science, Scopus, ProQuest Central, and IEEE Xplore Digital Library databases for studies published after 2010, using a combination of keywords and subject headings related to health activity tracking, youth, and Internet of Things. In addition, a Google search to identify grey literature will be conducted. Two authors will independently screen the titles and abstracts identified from the search and accept or reject the studies according to the study inclusion criteria. Any discrepancies will then be discussed and resolved. The quality of the included studies will be assessed using the Critical Appraisal Skills Programme (CASP) checklists. Data from included studies will be extracted into a predesigned form to identify the types of devices or apps, Internet of Things applications, and health outcomes related to weight management. Results: A preliminary search on Medline returned 484 results. The publication of the final systematic review is expected in mid-2020. Conclusions: The effectiveness and feasibility of physical activity trackers and consumer wearables for different patient groups have been well reviewed, but there are currently no published reviews that look into these technologies in the wider Internet of Things context. This review aims to address this gap by examining Internet of Things–enabled technologies that are designed for youth weight management and thus inform further research and clinical studies to reduce childhood obesity.

  • Source: Freepik; Copyright: rawpixel.com; URL: https://www.freepik.com/free-photo/patient-is-meeting-doctor_2765291.htm; License: Licensed by JMIR.
    RCTs - Pilots/Feasibility Studies...

    Mar 31, 2020

    Impact of Motivational Interviewing on Self-Management in Patients With Type 2 Diabetes: Protocol for a Pilot Randomized Controlled Trial

    Authors List:

    Abstract:

    Background: The nonpharmacological approach to diabetic control in patients with diabetes focuses on a healthy diet, physical activity, and self-management. Therefore, to help patients change their habits, it is essential to identify the most effective approach. Many efforts have been devoted to explain changes in or adherence to specific health behaviors. Such efforts have resulted in the development of theories that have been applied in prevention campaigns and include brief advice and counseling services. Within this context, motivational interviewing (MI) has proven to be effective in changing health behaviors for specific cases. However, stronger evidence is needed on the effectiveness of MI in treating chronic pathologies such as diabetes. Objective: This study will obtain preliminary data on the impact of a nurse-led MI intervention in improving glycemic control, as well as clinical, psychosocial, and self-care outcomes for individuals with type 2 diabetes mellitus when compared with usual care, with the aim of improving diabetic control in patients with diabetes. Methods: An open, two-arm, parallel, randomized controlled, pilot exploratory trial will be performed. Two government outpatient clinics in the New Territories West Cluster in Hong Kong will be involved. In total, 20 to 25 participants will be invited in each arm. Intervention participants will receive face-to-face MI interventions in addition to their usual care from the clinic. Control participants will only receive usual care. Outcomes are assessed at baseline, 6 months, and 12 months. The primary outcome measure is glycated hemoglobin levels. Secondary outcomes include blood pressure, BMI, hip and waist circumference, fasting blood, and psychosocial and self-care measures. Results: This study is currently underway with funding support from the Hong Kong College of Family Physician Research Seed Fund 2017. Conclusions: MI skills constitute the main strategies primary care nurses use on their patients. Having economical, simple, effective, and applicable techniques is essential for primary care professionals to help their patients change their lifestyle and improve their health. This study will provide scientific evidence on the effectiveness of MI. It will be performed with strict control over the data collection, ensuring the maintenance of therapeutic integrity. Clinical Trial: Centre for Clinical Research and Biostatistics CUHK_CCRB00614; https://tinyurl.com/v9awzk6

  • Source: iStock; Copyright: Sergey Peterman; URL: https://www.istockphoto.com/ca/photo/time-for-beer-concept-gm1151972917-312362208; License: Licensed by the authors.
    RCTs - Protocols/Proposals (eHealth)

    Mar 31, 2020

    Effectiveness of an Ecological Momentary Intervention for Reducing Risky Alcohol Consumption Among Young Adults: Protocol for a Three-Arm Randomized...

    Authors List:

    Abstract:

    Background: Recent research has investigated the utility of mobile phone–delivered interventions for reducing risky single-occasion drinking, also known as binge drinking. In the past five years, focus has been placed on ecological momentary interventions (EMIs), which aim to deliver intervention content in correspondence to real-time assessments of behavior, also known as ecological momentary assessments (EMAs). Objective: This study aims to assess the effect of a fully automated, tailored, mobile phone–delivered EMI termed Mobile Intervention for Drinking in Young people (MIDY) on young people's risky single-occasion drinking behavior. Methods: We will use a three-armed randomized controlled trial design to determine the impact of MIDY on peak consumption of alcohol among young people. A list of mobile telephone numbers for random digit dialing will be generated, and researchers will telephone potential participants to screen for eligibility. Participants will be randomized into one of three intervention groups. For 6 weeks, EMI, EMA, and attention control groups will complete hourly EMA surveys on their mobile phones on Friday and Saturday nights. EMI participants will receive personalized feedback in the form of text messages corresponding to their EMA survey responses, which focus on alcohol consumption, spending, and mood. EMA participants will not receive feedback. A third group will also complete EMA and receive feedback text messages at the same time intervals, but these will be focused on sedentary behavior and technology use. All groups will also complete a short survey on Saturday and Sunday mornings, with the primary outcome measure taken on Sunday mornings. A more detailed survey will be sent on the final Sunday of the 6-week period, and then again 1 year after recruitment. Results: The primary outcome measure will be an observed change (ie, reduction) in the mean peak number of drinks consumed in a single night over the 6-week intervention period between the EMI and attention control groups as measured in the weekly EMA. We expect to see a greater reduction in mean peak drinking in the EMI group compared to that in the attention control group. As a secondary aim, we will assess whether mean peak drinking is reduced in the EMA group compared to the attention control group. We will use a random-effects mixed-modeling approach using maximum-likelihood estimation to provide estimates of differences in peak drinking across time periods between those receiving the intervention (EMI) and attention control participants. An intention-to-treat approach will be taken for the analysis. Individuals and study groups will be modeled as random and fixed factors, respectively. Conclusions: This study extends our previous work investigating the efficacy of a mobile EMI (MIDY) for reducing risky drinking among young adults in Australia, and will add to the expanding literature on the use of mobile interventions for reducing risky alcohol consumption. Trial Registration: Australian New Zealand Clinical Trials Registration (ANZCTR): ACTRN12617001509358p; http://www.anzctr.org.au/ACTRN12617001509358p.aspx

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  • Mapping Evidence of Neonatal Resuscitation Training on Practice of Unskilled Birth Attendants in Low- Resource Countries: a scoping review protocol

    Date Submitted: Mar 27, 2020

    Open Peer Review Period: Mar 27, 2020 - May 22, 2020

    Background: Competence in neonatal resuscitation of the newborn is very critical to ensure the safety and health of the newborn infants. Effects of acquisition of neonatal resuscitation skills improve...

    Background: Competence in neonatal resuscitation of the newborn is very critical to ensure the safety and health of the newborn infants. Effects of acquisition of neonatal resuscitation skills improve self-efficacy, thereby reducing neonatal mortality as a result of asphyxia. About one-quarter of all neonatal deaths globally are caused by birth asphyxia. The need for neonatal resuscitation is most imperative in a resource-constrained setting, where access to intrapartum obstetric care is inadequate and poor. Objective: The protocol describes the methodology of a scoping review on evidence of training in neonatal resuscitation and its association with practice in low-resources countries. The aim of the review is to map available evidence of neonatal resuscitation training proficient on unskilled birth attendants practice. Methods: This scoping review protocol uses the framework proposed by Arksey & O’Malley and refined by Levac et al, published by Joanna Briggs Institute while following the Preferred Reporting Items for Systematic Review and Meta-Analysis Extension for Scoping Review Protocols guidelines. The search strategy was developed with the assistance of the college librarian. Five peer-reviewed data-bases (EBSCOhost (PsychINFO, Wiley online), PubMed, MEDLINE with full-text, Google Scholar (Science Direct), CINAHL Plus with full text EBSCOhost), databases committed to grey literature sources, and reference extraction will be used. Two independent reviewers will screen and extract data. Discrepancies will be resolved by the third reviewer. The extracted data will undergo a descriptive analysis of contextual data and a quantitative analysis using appropriate statistical methods. Results: NULL Conclusions: NULL

  • Active Brains: Protocol for a Feasibility Randomised Control Trial of a Digital Intervention to Reduce Cognitive Decline in Older Adults

    Date Submitted: Mar 27, 2020

    Open Peer Review Period: Mar 27, 2020 - May 22, 2020

    Background: Increasing physical activity, improving diet and doing 'brain training' exercises are associated with reduced cognitive decline in older adults. Here we describe a feasibility trial of the...

    Background: Increasing physical activity, improving diet and doing 'brain training' exercises are associated with reduced cognitive decline in older adults. Here we describe a feasibility trial of the Active Brains intervention, an online digital intervention developed to support older adults to make these three healthy behaviour changes associated with cognitive health. Objective: The Active Brains trial is a randomised feasibility trial that will test how accessible, acceptable and feasible the Active Brains intervention is and the effectiveness of the study procedures that we plan to use in our larger main trial. Methods: We will be trialling the intervention with two populations: 1) older adults with signs of cognitive decline, 2) older adults without any cognitive decline. Trial participants will be randomly allocated to one of three study groups: 1) usual care or 2) the Active Brains intervention, or 3) the Active Brains website plus brief support from a trained coach (over the phone or by email). The main outcomes are performance on cognitive tasks, Quality of Life (using EQ-5D-5L), Instrumental Activities of Daily Living and diagnoses of dementia. Secondary outcomes (including depression, enablement and healthcare costs) and process measures (including qualitative interviews with participants and supporters) will also be collected. Results: Results will be published in peer-reviewed journals, presented at conferences and shared at public engagement events. Conclusions: The findings of this study will help us to identify and make important changes to the website, the support received or the study procedures before we progress to our main randomized phase III trial. Clinical Trial: Trial registration number: ISRCTN 23758980

  • Effectiveness of a Theory-Based, Adaptive E-Learning Program on Acute Care Nurses’ Intentions to Provide Brief Counseling: Multicenter Randomized Controlled Trial Protocol

    Date Submitted: Mar 26, 2020

    Open Peer Review Period: Mar 26, 2020 - May 21, 2020

    Background: Brief counseling can motivate patients to initiate health behavior change. However, increasing the provision of brief counseling by acute care nurses is difficult due to contextual and pra...

    Background: Brief counseling can motivate patients to initiate health behavior change. However, increasing the provision of brief counseling by acute care nurses is difficult due to contextual and practitioner-level factors impeding nurses’ motivation and intentions to provide brief counseling (e.g., unfavorable attitude toward brief counseling, lack of perceived control linked to barriers). Moreover, most brief counseling training programs lack accessibility and personalization. Theory-based, adaptive e-learning programs could provide accessible and personalized brief counseling training. Objective: This paper presents a study protocol for evaluating the effectiveness of a theory-based, adaptive e-learning program on acute care nurses’ intentions to provide brief counseling for smoking, an unbalanced diet and medication nonadherence. Methods: A two-group, multicenter RCT will be conducted with acute care nurses (N=186). Nurses will be randomized to a theory-based, adaptive e-learning program (E_MOTIVA; experimental group) or knowledge-based, standardized e-learning program (E_MOTIVB; active control group). The E_MOTIVA program was designed to influence the constructs of the Theory of Planned Behavior (e.g., attitude, subjective norm and perceived behavioral control) in relation to brief counseling. The Cognitive Load Index and User Engagement Scale will be used to assess nurses’ cognitive load and engagement related to e-learning. Nurses will complete the Brief Counseling Nursing Practices Questionnaire at baseline and between 41- and 50-day post-randomization. Results: The study is ongoing (ISRCTN32603572). Conclusions: This study will be amongst the first in evaluating a theory-based, adaptive e-learning program in nurses. These programs have the potential to support evidence-based practice through accessible, personalized training in wide-ranging domains in nursing. Clinical Trial: ISRCTN Registry; ISRCTN32603572; https://www.isrctn.com/ISRCTN32603572

  • Comparison of Two Management Strategies, "Endoscopy First" and "Laparoscopic Cholecystectomy First", for Patients with Gallbladder Stones and Intermediate Risk for Choledocholithiasis: Study Protocol for a Diagnostic Randomized Trial

    Date Submitted: Mar 22, 2020

    Open Peer Review Period: Mar 22, 2020 - May 17, 2020

    Background: The optimal approach for patients with gallbladder stones and intermediate risk for choledocholithiasis still remains undetermined. Use of diagnostic endoscopic retrograde cholangiopancrea...

    Background: The optimal approach for patients with gallbladder stones and intermediate risk for choledocholithiasis still remains undetermined. Use of diagnostic endoscopic retrograde cholangiopancreatography should be minimized as it carries considerable risk of post-procedural complications. Objective: This study compares two different management strategies: intraoperative cholangiography and endoscopic ultrasound before laparoscopic cholecystectomy for patients with symptomatic cholecystolithiasis and intermediate risk for choledocholithiasis. Methods: It is a diagnostic randomized active-controlled single-center clinical trial enrolling adult patients undergoing laparoscopic cholecystectomy due to symptomatic gallbladder stones with intermediate risk for choledocholithiasis. The risk for choledocholithiasis is calculated using an original prognostic score – Vilnius University Hospital Index. A total of 106 participants will be included and randomized into two groups. Evaluation of bile ducts using endoscopic ultrasound and endoscopic retrograde cholangiography on demand will be performed before laparoscopic cholecystectomy for one arm (“Endoscopy first”). Intraoperative cholangiography during laparoscopic cholecystectomy and postoperative endoscopic retrograde cholangiopancreatography on demand will be administered in another arm (“Cholecystectomy first”). Postoperative follow-up is 6 months. Results: The primary endpoint is the length of hospital stay. Secondary endpoints will include accuracy of the different management strategies, adverse events of interventions, duct clearance and technical success of interventions (intraoperative cholangiography, endoscopic ultrasound, endoscopic retrograde cholangiography), costs of treatment. Conclusions: This trial is planned determine which strategy is better approach for a patient with intermediate common bile duct stones risk and to define a simple to calculate and safe algorithm on managing choledocholithiasis. Clinical Trial: The trial is registered at ClinicalTrials.gov, identification number NCT03658863.

  • Closing the Gap Between Mammalian and Invertebrate Peripheral Nerve Injury: A Novel Nerve Repair Protocol

    Date Submitted: Mar 13, 2020

    Open Peer Review Period: Mar 12, 2020 - May 7, 2020

    Background: Outcomes after peripheral nerve injuries are poor despite current nerve repair techniques. Currently, there is no conclusive evidence that mammalian axons are capable of spontaneous fusion...

    Background: Outcomes after peripheral nerve injuries are poor despite current nerve repair techniques. Currently, there is no conclusive evidence that mammalian axons are capable of spontaneous fusion after transection. Notably, certain invertebrate species have the ability to auto-fuse after transection. Although mammalian axonal auto-fusion has not been observed experimentally, no mammalian study to date has demonstrated regenerating axolemmal membranes contacting intact distal segment axolemmal membranes to determine whether mammalian peripheral nerve axons have the intrinsic mechanisms necessary to auto-fuse after transection. Objective: This study aims to assess fusion competence between regenerating axons and intact distal segment axons by enhancing axon regeneration, delaying Wallerian Degeneration, limiting the immune response, and preventing myelin obstruction. Methods: This study will use a rat sciatic nerve model to evaluate the effects of a novel peripheral nerve repair protocol on behavioral, electrophysiologic, and morphologic parameters. This protocol consists of a variety of pre-, intra-, and post- operative interventions. Fusion will be assessed with electrophysiological conduction of action potentials across the repaired transection site. Axon-axon contact will be assessed with transmission electron microscopy. Behavioral recovery will be analyzed with the sciatic functional index. A total of 36 rats will be used for this study. The experimental group will use 24 rats and the negative control group will use 12 rats. For both the experimental and negative control groups, there will be a behavior group and another group that will undergo electrophysiological and morphological analysis. The primary endpoint will be the presence or absence of action potentials across the lesion site. Secondary endpoints will include behavioral recovery with the sciatic functional index and morphological analysis of axon-axon contact between regenerating axons and intact distal segment axons. Results: We are in the process of grant funding and IRB approval as of March 2020. The final follow-up will be completed by December 2021. Conclusions: In this study, the efficacy of the proposed novel peripheral nerve repair protocol will be evaluated using behavioral and electrophysiologic parameters. The author believes this study will provide information regarding whether spontaneous axon fusion is possible in mammals under the proper conditions. This information could potentially be translated to clinical trials if successful in an effort to improve outcomes after peripheral nerve injury.

  • NOtifications To improve Engagement (NOTE) with an alcohol reduction app: protocol for a micro-randomised trial

    Date Submitted: Mar 12, 2020

    Open Peer Review Period: Mar 12, 2020 - May 7, 2020

    Background: Drink Less is a behaviour change app which aims to help users in the general adult population reduce hazardous and harmful alcohol consumption. The app includes a daily push notification,...

    Background: Drink Less is a behaviour change app which aims to help users in the general adult population reduce hazardous and harmful alcohol consumption. The app includes a daily push notification, delivered at 11am, asking users to “Please complete your mood and drinking diaries”. Previous analysis with Drink Less engagement data suggests the current notification strongly influences how users engage with the app in the subsequent hour of delivery, and patterns of engagement fluctuate over the course of the day, with an increase in frequency and duration of use observed between 8pm to 10pm. We aim to improve engagement by exploring the content and sequence of notifications delivered at 8pm, where we will test a bank of 30 new evidence-informed notifications which intend to increase the user’s perceived usefulness of the app. Objective: The primary objective is to assess if sending a notification at 8pm increases behavioural engagement in the subsequent hour. Secondary objectives include comparing the effect of the new bank of messages with the standard message and effect moderation over time. We also aim to more generally understand the role notifications have on the overall duration, depth and frequency of engagement with Drink Less over 30 days since download. Methods: This is a protocol for a micro-randomised trial with two parallel arms. The parallel arms include receiving no notifications (Secondary Arm A), and users receiving the standard notification “Please complete your mood and drinking diaries”, delivered daily at 11am (Secondary Arm B) over 30 days. Inclusion criteria include: users who i) consent to participate in the trial; ii) self-report a baseline Alcohol Use Disorders Identification Test (AUDIT) score of 8 or above; iii) reside in the UK; iv) are aged 18+ years and; v) report being interested in drinking less alcohol. The primary outcome is the time-varying, binary outcome of “Did the user login in to the app in the hour from 8pm to 9pm?”. The primary analysis will measure the marginal effect of the notifications, quantified as a relative risk with a 95% confidence interval, using an estimator developed for micro-randomised trials with binary outcomes. The parallel arms will allow us to compare the effect of different notification delivery strategies on overall engagement. Results: Ethical approval was granted by UCL’s Departmental Research Ethics Committee (CEHP/2016/556) on 11th October 2019 and LSHTM’s Interventions Research Ethics Committee (17929) on 27th November 2019. Recruitment began on the 2nd January 2020 and is currently ongoing. Conclusions: Understanding how push notifications may impact engagement with a behaviour change app can lead to further improvements in engagement, and ultimately help users reduce their alcohol consumption. This understanding may also be generalisable to other apps that target a variety of behaviour changes.

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