JMIR Publications

JMIR Research Protocols

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

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Journal Description

 

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

JMIR Res Protoc is a new journal spin-off of JMIR, the worlds' leading medical journal in health sciences / health services research and health informatics (Impact Factor 2015: 4.532)

JMIR Res Protoc publishes protocols and grant proposals in all areas of medicine (and their peer-review reports, if available), as well as feasibility studies, early reports and formative/process evaluations of ongoing studies and descriptions of the development and pilot evaluations of innovations and software applications or other interventions

JMIR Res Protoc is fully open access, with full text articles deposited in PubMed Central

Publishing research protocols, grant proposals, pilot/feasibility studies and early reports of ongoing and planned work encourages collaboration and early feedback, and reduces duplication of effort 

JMIR Res Protoc will be a valuable ressource for researchers who want to learn about current research methodologies and how to write a winning grant proposal

JMIR Res Protoc creates an early scientific record for researchers who have developed novel methodologies, software, innovations or elaborate protocols

JMIR Res Protoc faciliates subsequent publication of results demonstrating that the methodology has already been reviewed, and reduces the effort of writing up the results, as the protocol can be easily referenced

JMIR Res Protoc demonstrates to reviewers of subsequent results papers that authors followed and adhered to carefully developed and described a-priori methods

Studies whose protocols or grant proposal have been accepted in JMIR Res Protoc are "in principle accepted" for subsequent publication of results in other JMIR journals as long as authors adhere to their original protocol - regardless of study results (even if they are negative), reducing publication bias in medicine

Authors publishing their protocols in JMIR Res Protoc will receive a 20% discount on the article processing fee if they publish their results in another journal of the JMIR journal family (for example, JMIR for ehealth studies, i-JMR for others)

 
 

Recent Articles:

  • Copyright by Sirtex Medical. Copyright: Sirtex Medical; License: Permission acquired by the authors..

    Protocol for Combined Analysis of FOXFIRE, SIRFLOX, and FOXFIRE-Global Randomized Phase III Trials of Chemotherapy +/- Selective Internal Radiation Therapy...

    Abstract:

    Background: In colorectal cancer (CRC), unresectable liver metastases are associated with a poor prognosis. The FOXFIRE (an open-label randomized phase III trial of 5-fluorouracil, oxaliplatin, and folinic acid +/- interventional radioembolization as first-line treatment for patients with unresectable liver-only or liver-predominant metastatic colorectal cancer), SIRFLOX (randomized comparative study of FOLFOX6m plus SIR-Spheres microspheres versus FOLFOX6m alone as first-line treatment in patients with nonresectable liver metastases from primary colorectal carcinoma), and FOXFIRE-Global (assessment of overall survival of FOLFOX6m plus SIR-Spheres microspheres versus FOLFOX6m alone as first-line treatment in patients with nonresectable liver metastases from primary colorectal carcinoma in a randomized clinical study) clinical trials were designed to evaluate the efficacy and safety of combining first-line chemotherapy with selective internal radiation therapy (SIRT) using yttrium-90 resin microspheres, also called transarterial radioembolization. Objective: The aim of this analysis is to prospectively combine clinical data from 3 trials to allow adequate power to evaluate the impact of chemotherapy with SIRT on overall survival. Methods: Eligible patients are adults with histologically confirmed CRC and unequivocal evidence of liver metastases which are not treatable by surgical resection or local ablation with curative intent at the time of study entry. Patients may also have limited extrahepatic metastases. Final analysis will take place when all participants have been followed up for a minimum of 2 years. Results: Efficacy and safety estimates derived using individual participant data (IPD) from SIRFLOX, FOXFIRE, and FOXFIRE-Global will be pooled using 2-stage prospective meta-analysis. Secondary outcome measures include progression-free survival (PFS), liver-specific PFS, health-related quality of life, response rate, resection rate, and adverse event profile. The large study population will facilitate comparisons of low frequency adverse events and allow for more robust safety analyses. The potential treatment benefit in those patients who present with disease confined to the liver will be investigated using 1-stage IPD meta-analysis. Efficacy will be analyzed on an intention-to-treat basis. Conclusions: This analysis will assess the impact of SIRT combined with chemotherapy on overall survival in the first-line treatment of metastatic CRC. If positive, the results will change the standard of care for this disease. Trial Registration: FOXFIRE ISRCTN Registry ISRCTN83867919; http://www.isrctn.com/ISRCTN83867919 (Archived by WebCite at http://www.webcitation.org/6oN7axrvA). SIRFLOX ClinicalTrials.gov NCT00724503; https://clinicaltrials.gov/ ct2/show/NCT00724503 (Archived by WebCite at http://www.webcitation.org/6oN7lEGbD). FOXFIRE-Global ClinicalTrials.gov NCT01721954; https://clinicaltrials.gov/ct2/show/NCT01721954 (Archived by WebCite at http://www.webcitation.org/ 6oN7vvQvG).

  • Source: Pixabay; URL: https://pixabay.com/en/woman-middle-aged-swing-serious-797390/; License: Public Domain (CC0).

    Innovations in the Management of Musculoskeletal Pain With Alpha-Lipoic Acid (IMPALA Trial): Study protocol for a Double-Blind, Randomized,...

    Abstract:

    Background: Fibromyalgia is a common disorder characterized by chronic widespread pain, sleep disturbance, fatigue, depression, and cognitive dysfunction, resulting in substantial disability. As current analgesics provide incomplete relief and disabling side effects that aggravate fatigue and cognitive dysfunction, there is a need for new pain treatments with better efficacy and tolerability. Alpha-lipoic acid (ALA) is an antioxidant proven effective in painful diabetic neuropathy with minimal side effects. Objective: We hypothesize that this agent will provide benefits in fibromyalgia because of several similarities with neuropathic pain and also because it does not cause sedation, fatigue, or mental-slowing. To test this, we have designed a clinical trial that will assess pain, side effects, and other outcomes in participants with fibromyalgia. Methods: Using a crossover design, 24 adults with fibromyalgia will be randomly allocated to 1 of the 2 sequences of ALA and placebo. Participants will take capsules containing ALA or placebo for 4 weeks followed by a 1-week washout followed by a second 4-week treatment and 1-week washout period. ALA (or matching placebo) capsules will be titrated to 1800 mg/day over each 4-week period. The primary outcome will be mean daily pain intensity (0-10) during week 4 of each period. Secondary outcomes, assessed during week 4 of each period, will include global improvement, adverse events, mood, and quality of life. Results: This trial was registered in the International Standard Randomized Controlled Trial registry March 15, 2016 (Number ISRCTN58259979), and it attained ethics approval on December 3, 2016 (Queen’s University Health Sciences & Affiliated Teaching Hospitals Research Ethics Board protocol number ANAE-287-15). The recruitment started in February 2017. Conclusions: This trial will provide evidence for the efficacy of ALA in fibromyalgia. Trial Registration: International Standard Randomized Controlled Trial Number (ISRCTN): 58259979; www.isrctn.com/ISRCTN58259979 (Archived by WebCite at http://www.webcitation.org/6og9JdiyZ)

  • Propeller Health electronic sensor. Source: Propeller; Copyright: Propeller; License: Licensed by the authors.

    Automated Adherence Reminders for High Risk Children With Asthma: A Research Protocol

    Abstract:

    Background: The use of inhaled corticosteroid (ICS) medications has been shown to improve asthma control and reduce asthma-related morbidity and mortality. Two recent randomized trials demonstrated dramatic improvements in ICS adherence by monitoring adherence with electronic sensors and providing automated reminders to participants to take their ICS medications. Given their lower levels of adherence and higher levels of asthma-related emergency department (ED) visits, hospitalizations, and death, urban minority populations could potentially benefit greatly from these types of interventions. Objective: The principal objective of this study will be to evaluate the feasibility, acceptability, and limited efficacy of a text message (short message service, SMS) reminder intervention to enhance ICS adherence in an urban minority population of children with asthma. We will also assess trajectories of ICS adherence in the 2 months following asthma hospitalization. Methods: Participants will include 40 children aged 2-13 years, who are currently admitted to the Children’s Hospital of Philadelphia (CHOP) for asthma, and their parent or legal guardian. Participants will be assigned to intervention and control arms using a 1:1 randomization scheme. The intervention arm will receive daily text message reminders for a 30-day intervention phase following hospitalization. This will be followed by a 30-day follow-up phase, in which all participants may choose whether or not to receive the text messages. Feasibility will be assessed by measuring (1) retention of the participants through the study phases and (2) perceived usefulness, acceptability, and preferences regarding the intervention components. Limited efficacy outcomes will include percent adherence to prescribed ICS regimen measured using Propeller Health sensors and change in parent-reported asthma control. We will perform an exploratory analysis to assess for discrete trajectories of adherence using group-based trajectory modeling (GBTM). Results: Study enrollment began in December 2015 and the intervention and follow-up phases are ongoing. Results of the data analysis are expected to be available by December 2016. Conclusions: This study will add to the literature by providing foundational feasibility data on which elements of a mobile health text-message reminder intervention may need to be modified to suit the needs and constraints of high-risk urban minority populations. Trial Registration: Clinicaltrials.gov NCT02615743; https://www.clinicaltrials.gov/ct2/show/study/NCT02615743 (Archived with WebCite at http://www.webcitation.org/6ji59rAXN)

  • Source: Free Digital Photos.net; Copyright: Markuso; URL: http://www.freedigitalphotos.net/images/Medical_equipment_g280-Digital_Blood_Pressure_Monitor_p52116.html; License: Image courtesy of Markuso.

    Internet-based Self-Management Support for Patients With Well-Controlled Type 2 Diabetes: A Real-Life Study

    Abstract:

    Background: Little attention has been paid to self-management support of patients with well-controlled type 2 diabetes mellitus (T2DM). Most studies evaluated the addition of self-management support to regular diabetes care, but self-management as an alternative for part of regular diabetes care has hardly been studied. In this study, we offered patients with well-controlled T2DM the opportunity to perform the 3 quarterly monitoring sessions at home using an Internet-based self-management program, resulting in online personalized advice. Objective: The aim of our study was to assess the reach and feasibility of an Internet-based diabetes self-management support program for patients with well-controlled T2DM, addressing both primary care providers’ (PCPs) opinions and patients’ willingness to participate in such a support program. Methods: PCPs assessed patients’ eligibility for Internet-based self-management, and patients were offered the opportunity to participate. Characteristics of eligible and ineligible patients were compared, as well as those of participants and nonparticipants, also with regard to quality of life, treatment satisfaction, and illness perceptions. Multivariate logistic regression models were performed and odds ratios (ORs) calculated with 95% CIs. Results: Almost half (128/282, 45.4%) of the patients with well-controlled T2DM were considered ineligible by their PCPs mainly because of cognitive impairment and language barriers (8.2% and 8.9%). Older patients (OR for each year 1.06, 95% CI 1.03-1.09, P<.001), non–Western European patients (OR 3.64, 95% CI 1.67-7.92, P=.001), and patients with a longer diabetes duration (OR for each year 1.56, 95% CI 1.04-2.34, P=.03) were more often regarded as ineligible. Of the 154 patients considered eligible, 57 (37.0%) consented to participate and 30 (10.6%) started the program. Of 57 participants, 45 returned the 3 questionnaires; 21 of 97 nonparticipants returned the questionnaires. Nonparticipants less often thought that their disease would last their entire life (median 8.0 vs 10.0, P=.03) and they were more satisfied with their current treatment than participants (DTSQ total score 44.0 vs 40.0, P=.05). There was no significant difference in quality of life between the 2 groups. Conclusions: PCPs considered half of their patients with well-controlled T2DM incapable of Internet-based self-management mainly because of cognitive impairment and language barriers; of the selected patients, about 1 out of 3 was willing to participate. Older patients, non–Western European patients, and patients with a higher BMI were less likely to participate. Predominantly, practical issues (such as Internet problems) hindered implementation of the Internet-based self-management program.

  • Medical professional. Source: Alachua County; Copyright: via flickr; URL: https://www.flickr.com/photos/alachuacounty/23982227052/in/photostream/; License: Creative Commons Attribution (CC-BY).

    Use of the Total Cancer Care System to Enrich Screening for CD30-Positive Solid Tumors for Patient Enrollment Into a Brentuximab Vedotin Clinical Trial: A...

    Abstract:

    Background: One approach to identify patients who meet specific eligibility criteria for target-based clinical trials is to use patient and tumor registries to prescreen patient populations. Objective: Here we demonstrate that the Total Cancer Care (TCC) Protocol, an ongoing, observational study, may provide a solution for rapidly identifying patients with CD30-positive tumors eligible for CD30-targeted therapies such as brentuximab vedotin. Methods: The TCC patient gene expression profiling database was retrospectively screened for CD30 gene expression determined using HuRSTA-2a520709 Affymetrix arrays (GPL15048). Banked tumor tissue samples were used to determine CD30 protein expression by semiquantitative immunohistochemistry. Statistical comparisons of Z- and H-scores were performed using R statistical software (The R Foundation), and the predictive value, accuracy, sensitivity, and specificity of CD30 gene expression versus protein expression was estimated. Results: As of March 2015, 120,887 patients have consented to the institutional review board–approved TCC Protocol. A total of 39,157 fresh frozen tumor specimens have been collected, from which over 14,000 samples have gene expression data available. CD30 RNA was expressed in a number of solid tumors; the highest median CD30 RNA expression was observed in primary tumors from lymph node, soft tissue (many sarcomas), lung, skin, and esophagus (median Z-scores 1.011, 0.399, 0.202, 0.152, and 1.011, respectively). High level CD30 gene expression significantly enriches for CD30-positive protein expression in breast, lung, skin, and ovarian cancer; accuracy ranged from 72% to 79%, sensitivity from 75% to 100%, specificity from 70% to 76%, positive predictive value from 20% to 40%, and negative predictive value from 95% to 100%. Conclusions: The TCC gene expression profiling database guided tissue selection that enriched for CD30 protein expression in a number of solid tumor types. Such an approach may improve screening efficiency for enrolling patients into biomarker-based clinical trials.

  • Happy Patient. Copyright: iStock by Getty Images; URL: http://media.gettyimages.com/photos/loving-father-and-daughter-together-on-sofa-picture-id466144313; License: Licensed by the authors.

    Implementation of a Home Monitoring System for Heart Failure Patients: A Feasibility Study

    Abstract:

    Background: Improving the management of patients with complex chronic disease is a substantial undertaking with the simultaneous goals of improving patient outcomes and controlling costs. Reducing avoidable hospitalization for such patients is a step toward both objectives. Some of the deterioration experienced in chronic disease patients occurs outside the view of their clinicians, and before the patient becomes overtly symptomatic. Home monitoring has been used for more than 20 years to detect deterioration earlier so that the patients could be treated before they became ill enough to require hospitalization. Patient participation is an important requirement for successful home monitoring. There has been some concern that patients would be unwilling or unable to engage in a program that collected multiple measurements. The Cedars-Sinai Cardiology Center provides a high-touch, intense management program for patients with congestive heart failure (CHF). A group of their patients were chosen to join a complex, multidevice home monitoring system to see whether such patients would find value in the additional effort. Objective: The objective of our study was to determine whether patients already actively engaged in a high-touch intensive management program for CHF would take on the additional burden of a complex home monitoring effort. Methods: A total of 20 patients from the Cedars-Sinai group were enrolled in a monitoring program utilizing 5 different devices. Anonymous surveys were collected from the patients to assess their satisfaction with the program. Results: In total, 90% (18/20) completed the program, and 61% (11/20) submitted the survey. Among the 18 patients, overall compliance with the requested measurements was 70%. It was found that 73% (8/11) felt better about their health as a result of the program, whereas another 73% (8/11) believed that the care team now had a better picture of their health. Conclusions: Substantial patient compliance and satisfaction can be achieved in a sophisticated home monitoring program.

  • Police on the day before the 2013 Inauguration. Image source: Copyright Victoria Pickering via Flickr https://flic.kr/p/dYGBiS. Licensed by authors under Creative Commons Attribution 2.0.

    Biometrics and Policing: A Protocol for Multichannel Sensor Data Collection and Exploratory Analysis of Contextualized Psychophysiological Response During...

    Abstract:

    Background: Stress experienced by law enforcement officers is often extreme and is in many ways unique among professions. Although past research on officer stress is informative, it is limited, and most studies measure stress using self-report questionnaires or observational studies that have limited generalizability. We know of no research studies that have attempted to track direct physiological stress responses in high fidelity, especially within an operational police setting. The outcome of this project will have an impact on both practitioners and policing researchers. To do so, we will establish a capacity to obtain complex, multisensor data; process complex datasets; and establish the methods needed to conduct idiopathic clinical trials on behavioral interventions in similar contexts. Objective: The objective of this pilot study is to demonstrate the practicality and utility of wrist-worn biometric sensor-based research in a law enforcement agency. Methods: We will use nonprobability convenience-based sampling to recruit 2-3 participants from the police department in Durham, North Carolina, USA. Results: Data collection was conducted in 2016. We will analyze data in early 2017 and disseminate our results via peer reviewed publications in late 2017. Conclusions: We developed the Biometrics & Policing Demonstration project to provide a proof of concept on collecting biometric data in a law enforcement setting. This effort will enable us to (1) address the regulatory approvals needed to collect data, including human participant considerations, (2) demonstrate the ability to use biometric tracking technology in a policing setting, (3) link biometric data to law enforcement data, and (4) explore project results for law enforcement policy and training.

  • Person typing on computer. Image source: https://pixabay.com/en/hands-laptop-computer-typing-2069206. Copyright: CCO Public Domain.

    Writing for Health: Rationale and Protocol for a Randomized Controlled Trial of Internet-Based Benefit-Finding Writing for Adults With Type 1 or Type 2 Diabetes

    Abstract:

    Background: Diabetes mellitus is Australia’s fastest growing chronic disease, and has high comorbidity with depression. Both subthreshold depression and diabetes distress are common amongst people with type 1 or type 2 diabetes, and are associated with poorer diabetes self-care. A need exists for low-intensity self-help interventions for large numbers of people with diabetes and diabetes distress or subthreshold depression, as part of a stepped-care approach to meeting the psychological needs of people with diabetes. Benefit-finding writing is a very brief intervention that involves writing about any positive thoughts and feelings about a stressful experience, such as an illness. Benefit-finding writing has been associated with increases in positive affect and positive growth, and has demonstrated promising results in trials amongst other clinical populations. However, benefit-finding writing has not yet been examined in people with diabetes. Objective: The aim of this randomized controlled trial (RCT) is to evaluate the efficacy of an Internet-based benefit-finding writing (iBFW) intervention for adults with type 1 or type 2 diabetes (compared to a control writing condition) for reducing diabetes distress and increasing benefit-finding in diabetes, and also improving a range of secondary outcomes. Methods: A two-arm RCT will be conducted, using the online program Writing for Health. Adults with type 1 or type 2 diabetes living in Australia will be recruited using diabetes-related publications and websites, and through advertisements in diabetes services and general practitioners’ offices. Potential participants will be referred to the study-specific website for participant information and screening. All data will be collected online. Participants will be randomized to either iBFW about diabetes, or a control writing condition of writing about use-of-time. Both conditions involve three daily sessions (once per day for three consecutive days) of 15-minute online writing exercises. Outcome measures will be administered online at baseline, one-month, and three-month follow-ups. Results: This trial is currently underway. The primary outcomes will be diabetes distress and benefit-finding in diabetes. Secondary outcomes will be depression, anxiety, diabetes self-care, perceived health, and health care utilization. We aim to recruit 104 participants. All stages of the study will be conducted online using the Writing for Health program. Group differences will be analyzed on an intention-to-treat basis using mixed models repeated measures. Linguistic analyses of the writing exercise scripts, and examinations of the immediate emotional responses to the writing exercises, will also be undertaken. Conclusions: This RCT will be the first study to examine iBFW for adults with type 1 or type 2 diabetes. If iBFW is found to be efficacious in reducing diabetes distress and improving diabetes self-care and other outcomes, iBFW may offer the potential to be a low-cost, easily accessible self-help intervention to improve the wellbeing of adults with diabetes. Trial Registration: Australia and New Zealand Clinical Trials Registry (ACTRN12615000241538)

  • Image source: Created by the authors via Unsplash http://bit.ly/2nkinQk. Licensed under Creative Commons Zero.

    Home-Based Intervention Program to Reduce Food Insecurity in Elderly Populations Using a TV App: Study Protocol of the Randomized Controlled Trial...

    Abstract:

    Background: The limited or uncertain access to adequate food in elderly people includes not only economic restrictions but also inability of food utilization due to functional or cognitive impairment, health problems, and illiteracy. Objective: The aim of this work is to present the protocol of the randomized controlled trial Saúde.Come Senior, an educational and motivational television (TV)-based intervention to promote healthy lifestyles and decrease food insecurity in elderly people. Methods: A randomized controlled study will be conducted in subjects aged 60 years and older with food insecurity, identified at 17 primary care centers in the Lisboa e Vale do Tejo health region in Lisbon, Portugal. The primary outcome will be the changes in participants’ food insecurity score (evaluated by the Household Food Insecurity Scale) at 3 months. Change in other outcomes will be assessed (dietary habits, nutritional status, physical activity, health status, and clinical outcomes). Subjects will be followed over 6 months; the intervention will last 3 months. Data collection will be performed at 3 different time points (baseline, end of intervention at 3 months, and follow-up at 6 months). The intervention is based on an interactive TV app with an educational and motivational program specifically developed for the elderly that has weekly themes and includes daily content in video format: (1) nutrition and diet tips for healthy eating, (2) healthy, easy to cook and low-cost recipes, and (3) physical exercise programs. Furthermore, brief reminders on health behaviors will also be broadcasted through the TV app. The total duration of the study will be 6 months. The intervention is considered to be effective and meaningful if 50% of the individuals in the experimental group have a decrease of 1 point in the food insecurity score, all the remaining being unchanged. We expect to include and randomize 282 (141 experimental and 141 control) elderly with food insecurity. We will recruit a total of 1,128 subjects considering that 50% of the target individuals are food insecure (based on INFOFAMÍLIA Survey) (567) and about 50% of those will adhere to the study (282). Results: The randomized controlled trial with the 12-week home-based intervention with a comprehensive program on healthy eating and physical activity delivery is planned to start recruiting participants at the end of 2017. Conclusions: This study will assess the efficacy of this innovative tool (Saúde.Come Senior) for disseminating relevant health information, modifying behaviors, and decreasing food insecurity in an easy, low-cost, and massive way.

  • MP3 Youth study logo. Image created by the authors. Licensed under Creative Commons Attribution 2.0.".

    Gender-Specific Combination HIV Prevention for Youth in High-Burden Settings: The MP3 Youth Observational Pilot Study Protocol

    Abstract:

    Background: Nearly three decades into the epidemic, sub-Saharan Africa (SSA) remains the region most heavily affected by human immunodeficiency virus (HIV), with nearly 70% of the 34 million people living with HIV globally residing in the region. In SSA, female and male youth (15 to 24 years) are at a disproportionately high risk of HIV infection compared to adults. As such, there is a need to target HIV prevention strategies to youth and to tailor them to a gender-specific context. This protocol describes the process for the multi-staged approach in the design of the MP3 Youth pilot study, a gender-specific, combination, HIV prevention intervention for youth in Kenya. Objective: The objective of this multi-method protocol is to outline a rigorous and replicable methodology for a gender-specific combination HIV prevention pilot study for youth in high-burden settings, illustrating the triangulated methods undertaken to ensure that age, sex, and context are integral in the design of the intervention. Methods: The mixed-methods, cross-sectional, longitudinal cohort pilot study protocol was developed by first conducting a systematic review of the literature, which shaped focus group discussions around prevention package and delivery options, and that also informed age- and sex- stratified mathematical modeling. The review, qualitative data, and mathematical modeling created a triangulated evidence base of interventions to be included in the pilot study protocol. To design the pilot study protocol, we convened an expert panel to select HIV prevention interventions effective for youth in SSA, which will be offered in a mobile health setting. The goal of the pilot study implementation and evaluation is to apply lessons learned to more effective HIV prevention evidence and programming. Results: The combination HIV prevention package in this protocol includes (1) offering HIV testing and counseling for all youth; (2) voluntary medical circumcision and condoms for males; (3) pre-exposure prophylaxis (PrEP), conditional cash transfer (CCT), and contraceptives for females; and (4) referrals for HIV care among those identified as HIV-positive. The combination package platform selected is mobile health teams in an integrated services delivery model. A cross-sectional analysis will be conducted to determine the uptake of the interventions. To determine long-term impact, the protocol outlines enrolling selected participants in mutually exclusive longitudinal cohorts (HIV-positive, PrEP, CCT, and HIV-negative) followed by using mobile phone text messages (short message service, SMS) and in-person surveys to prospectively assess prevention method uptake, adherence, and risk compensation behaviors. Cross-sectional and sub-cohort analyses will be conducted to determine intervention packages uptake. Conclusions: The literature review, focus groups, and modeling indicate that offering age- and gender- specific combination HIV prevention interventions that include biomedical, behavioral, and structural interventions can have an impact on HIV risk reduction. Implementing this protocol will show the feasibility of delivering these services at scale. The MP3 Youth study is one of the few combination HIV prevention intervention protocols incorporating youth- and gender-specific interventions in one delivery setting. Lessons learned from the design of the protocol can be incorporated into the national guidance for combination HIV prevention for youth in Kenya and other high-burden SSA settings. Trial Registration: ClinicalTrials.gov NCT01571128; http://clinicaltrials.gov/ct2/show/NCT01571128?term=MP3+youth&rank=1 (Archived by WebCite at http://www.webcitation.org/6nmioPd54)

  • Image Source: https://static.pexels.com/photos/161641/pills-medicine-tablets-depending-161641.jpeg 
licensed under Creative Commons 2.0.

    Patterns and Predictors of Adherence to Statin Therapy Among Older Patients: Protocol for a Systematic Review

    Abstract:

    Background: The benefits of statin therapy are significantly compromised by noncompliance. Although elderly patients may have particular challenges with medication adherence and persistence, previous reviews on statin adherence have not focused on this population. Additionally, comparisons of adherence and persistence specific to statin indication (primary or secondary prevention) have not been thoroughly explored. Objective: We aim to assess the extent of, and factors associated with, adherence and persistence to statin therapy among older populations (aged ≥65 years). Methods: A systematic review will be undertaken according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses recommendations. Searches will be performed using multiple electronic databases (Ovid MEDLINE, EMBASE, PsycINFO, CINAHL, Cochrane Central Register of Controlled Trials, Database of Abstracts of Reviews of Effects, and the National Health Service Economic Evaluation Database) to identify relevant randomized trials and observational studies that evaluated statin adherence and/or persistence as an outcome. Eligible studies will include those involving community-living or outpatient elderly individuals. The methodological quality of randomized controlled trials (RCTs) will be assessed via the Joanna Briggs Institute’s critical appraisal checklist for RCTs, and the quality assessment of observational studies will be undertaken using a set of questions formulated with resort to the National Institute of Health Quality Assessment Tool for Observational Cohort and Cross-Sectional Studies. When possible, meta-analyses will be conducted using random-effect modeling and generic inverse variance analyses for adjusted-effect estimates. Heterogeneity across studies will be quantified using the I2 statistic. The presence of publication bias will be assessed using funnel plots and Egger’s regression tests. A leave-one-out sensitivity analysis will also be conducted to assess the impact of individual study results on pooled estimates. To explore possible sources of heterogeneity across studies, subgroup analyses will be performed based on covariates such as study design, statin indication, country of study, and length of patient follow-up. Results: The electronic database searches were completed in December 2016. Retrieved articles are currently being screened and the entire study is expected to be completed by June 2017. Conclusions: This systematic review will provide further understanding of the patterns of, and barriers to, statin adherence and persistence among older patients. The findings will inform clinical practice and the design of appropriate interventions. Trial Registration: PROSPERO CRD42016053191

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    Enhancing mHealth Technology in the Patient-Centered Medical Home Environment to Activate Patients With Type 2 Diabetes: A Multisite Feasibility Study Protocol

    Abstract:

    Background: The potential of mHealth technologies in the care of patients with diabetes and other chronic conditions has captured the attention of clinicians and researchers. Efforts to date have incorporated a variety of tools and techniques, including Web-based portals, short message service (SMS) text messaging, remote collection of biometric data, electronic coaching, electronic-based health education, secure email communication between visits, and electronic collection of lifestyle and quality-of-life surveys. Each of these tools, used alone or in combination, have demonstrated varying degrees of effectiveness. Some of the more promising results have been demonstrated using regular collection of biometric devices, SMS text messaging, secure email communication with clinical teams, and regular reporting of quality-of-life variables. In this study, we seek to incorporate several of the most promising mHealth capabilities in a patient-centered medical home (PCMH) workflow. Objective: We aim to address underlying technology needs and gaps related to the use of mHealth technology and the activation of patients living with type 2 diabetes. Stated differently, we enable supporting technologies while seeking to influence patient activation and self-care activities. Methods: This is a multisite phased study, conducted within the US Military Health System, that includes a user-centered design phase and a PCMH-based feasibility trial. In phase 1, we will assess both patient and provider preferences regarding the enhancement of the enabling technology capabilities for type 2 diabetes chronic care management. Phase 2 research will be a single-blinded 12-month feasibility study that incorporates randomization principles. Phase 2 research will seek to improve patient activation and self-care activities through the use of the Mobile Health Care Environment with tailored behavioral messaging. The primary outcome measure is the Patient Activation Measure scores. Secondary outcome measures are Summary of Diabetes Self-care Activities Measure scores, clinical measures, comorbid conditions, health services resource consumption, and technology system usage statistics. Results: We have completed phase 1 data collection. Formal analysis of phase 1 data has not been completed. We have obtained institutional review board approval and began phase 1 research in late fall 2016. Conclusions: The study hypotheses suggest that patients can, and will, improve their activation in chronic care management. Improved activation should translate into improved diabetes self-care. Expected benefits of this research to the scientific community and health care services include improved understanding of how to leverage mHealth technology to activate patients living with type 2 diabetes in self-management behaviors. The research will shed light on implementation strategies in integrating mHealth into the clinical workflow of the PCMH setting. Clinical Trial: ClinicalTrials.gov NCT02949037. https://clinicaltrials.gov/ct2/show/NCT02949037. (Archived by WebCite at http://www.webcitation.org/6oRyDzqei)

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    Open Peer Review Period: Mar 30, 2017 - Apr 13, 2017

    Background: The need to develop effective and accessible interventions for suicidal individuals engaging in heavy episodic drinking (HED) cannot be understated. While the link between alcohol use and...

    Background: The need to develop effective and accessible interventions for suicidal individuals engaging in heavy episodic drinking (HED) cannot be understated. While the link between alcohol use and suicidality is a complex one that remains to be elucidated, emotion dysregulation may play a key role in alcohol-related suicide risk in these individuals. . Objective: In the current study, an 8-week Internet-delivered Dialectical Behavior Therapy (DBT) skills training intervention was developed and preliminarily evaluated for suicidal individuals who engage in HED to regulate emotions. The aim of the study is to evaluate the feasibility and effectiveness of the intervention, and to inform the design of a subsequent full-scale study Methods: The study is a pilot randomized control trial comparing participants receiving immediate treatment (n=30) to waitlist controls (n=29) over a period of 16 weeks. Intervention effects will be assessed longitudinally using generalized estimating equations, along with analyses of effect sizes and clinically significant change. The primary outcomes are suicidal ideation, alcohol problems, and emotion dysregulation. Secondary outcomes include alcohol-related consequences, reasons for living, skills use, and depression. Results: The trial is ongoing. A total of 60 individuals returned their informed consent and were randomized, of which 59 individuals were intended to treat. A total of 50 participants in the study were retained through the 16-week enrollment. Conclusions: There is a dearth of evidence-based treatment for those presenting with high risk and complex behaviors. Furthermore, computerized interventions may provide a beneficial alternative to traditional therapy. The particular clinical features and treatment needs of suicidal individuals who also engage in HED constitute key domains for further investigation needed to consolidate the design of appropriate interventions for this high-risk population. Clinical Trial: Clinical.gov identifier: NCT02932241; Date of registration: 10-Oct-2016

  • Study protocol for a randomised waiting list control trial, with embedded process evaluation, to investigate the impact of health promotion information on the wellbeing of people living with and beyond cancer.

    Date Submitted: Mar 25, 2017

    Open Peer Review Period: Mar 29, 2017 - Apr 12, 2017

    Background: Evidence suggests physical activity can improve many of the common side-effects of cancer treatments, such as cancer related fatigue, psychological distress, and body composition, as well...

    Background: Evidence suggests physical activity can improve many of the common side-effects of cancer treatments, such as cancer related fatigue, psychological distress, and body composition, as well as improving physical function and quality of life. Increased levels of physical activity have been shown to have a positive relationship with improved survival from cancer, and reduced recurrence of cancer. Despite the benefits, only 23% of UK cancer patients are active to recommended levels. Cancer patients are interested in lifestyle behaviour change, and home-based interventions offer a promising means for changing physical activity behaviours. Objective: This study protocol outlines the aims, methodology, study design, timelines for completion, and a brief discussion, of a waiting list randomised control trial into the impact of printed health promotion information, supported by online tools, on the physical activity behaviour, quality of life and self-efficacy of cancer patients. Method: This is a two arm, waiting list control study, with embedded process evaluation to understand the mechanisms for any change reported. The primary aim of this study is to test the effectiveness of a specifically designed printed health promotion resource, supported with access to online experts, e-newsletters, digital apps, online case studies, an online exercise to music video, and an online forum, in increasing physical activity in cancer patients. Baseline measures include physical activity, including pre-diagnosis levels of physical activity, self-efficacy, and quality of life. A sample of 82 participants per arm will be recruited through the channels of Macmillan Cancer Support. Participants will be randomised to receive very brief physical activity information, and the UK guidelines for physical activity, or very brief physical activity information, and the printed health promotion resource, supported by the online tools. The intervention and control groups will be followed up at 12 weeks to identify any changes in physical activity, self-efficacy, and quality of life. Sub group analysis will be carried out on the pre-diagnosis levels of physical activity and baseline self-efficacy, as possible predictors of successful behaviour change. The control group will receive the health promotion resources and online tools at 12 weeks, and followed up again at 24 weeks to monitor any change. The intervention group will be followed up at 24 weeks to see if changes are maintained. Results: Recruitment to this trail starts in March 2017 for one month. The planned completion of this 24 week study is October 2017. Conclusion: This study will investigate the effectiveness of an evidenced based printed health promotion resource, supported by online tools, in bringing about a change in the physical activity behaviour of cancer patients. It will identify the mechanisms for change, and in whom this intervention is most effective, in the context of self-efficacy and pre-diagnosis levels of physical activity.

  • Real-World Treatment Sequences and Outcomes among Patients with NSCLC the US: The RESOUNDS Study Protocol

    Date Submitted: Mar 24, 2017

    Open Peer Review Period: Mar 25, 2017 - Apr 8, 2017

    Background: Survival outcomes are related to treatment choices in a line of therapy and treatment sequences across all lines of therapy. Objective: This study is designed to evaluate treatment sequenc...

    Background: Survival outcomes are related to treatment choices in a line of therapy and treatment sequences across all lines of therapy. Objective: This study is designed to evaluate treatment sequences used for patients who receive at least two lines of therapy for non-small cell lung cancer (NSCLC) in the US, and to evaluate patient outcomes in terms of progression-free and overall survival related to treatment sequencing. Additional objectives include the evaluation of symptoms, comorbidities, health care resource utilization and costs. Methods: Eligible patients are those diagnosed with NSCLC who initiate second line therapy between November 2015 and December 2017, insured by Anthem, Inc. and are captured in the HealthCore database. All data are de-identified and then retrospectively reviewed in a longitudinal manner from the enrollment date until death, disenrollment from their health plan, or end of the study period. Data collected from each patient include cost and resource utilization from administrative claims, clinical data collected through a Clinical Cancer Quality Program, death dates from national mortality databases, supplemented with detailed clinical reports from patient medical records. Descriptive analyses will be reported; survival times will be estimated using Kaplan-Meier methods. Patients will be censored at loss to follow-up due to leaving the health plan or reaching the end of the study period. Results: - Conclusions: The RESOUNDS cohort study is a novel approach to build a comprehensive dataset that mimics a prospective observational study using linked patient-level data from four real-world data sources. This study will provide timely information as to the sequencing of treatments for patients with NSCLC.

  • The development of the ORALS (Open Recording Automated Logging System). Sharing annotated audio recordings of clinic visits with patients: A Study Protocol

    Date Submitted: Mar 24, 2017

    Open Peer Review Period: Mar 25, 2017 - Apr 8, 2017

    Background: Providing patients with recordings of their clinic visits enhances patient and family engagement, yet few organizations routinely offer recordings. Challenges exist for organizations and p...

    Background: Providing patients with recordings of their clinic visits enhances patient and family engagement, yet few organizations routinely offer recordings. Challenges exist for organizations and patients, including data safety and navigating lengthy recordings. A secure system that allows patients to easily navigate recordings may be a solution. Objective: The aim of the current project is to develop and test an interoperable system to facilitate routine recording - the Open Recording Automated Logging System (ORALS) - with the aim of increasing patient and family engagement. ORALS will consist of 1) technically proficient software using automated machine learning technology to enable accurate and automatic tagging of in-clinic audio recordings. Tagging involves identifying elements of the clinic visit most important to patients (e.g. treatment plan) on the recording; and 2) a secure, easy to use web interface, enabling the upload and accurate linkage of recordings to patients, which can be accessed at home. Methods: We will use a mixed methods approach to develop and formatively test ORALS in four iterative stages: a case study of pioneer clinics where recordings are currently offered to patients; ORALS design and user experience testing; ORALS software and user interface development; and rapid cycle testing of ORALS in a primary care clinic, assessing impact on patient and family engagement. The Dartmouth’s Informatics Collaboratory for design, development and dissemination (ic3d) team, patients, patient partners, caregivers and clinicians will assist in developing ORALS. Conclusions: Upon the completion of this project we will have developed a novel recording system (ORALS) that will be ready for large scale testing. Our long term goal is for ORALS to seamlessly fit into a clinic’s and patient’s daily routine, increasing levels of patient engagement and transparency of care.

  • Study protocol for a randomized control trial of an in-person vs eHealth mindfulness-based intervention for adolescents with chronic illness

    Date Submitted: Mar 24, 2017

    Open Peer Review Period: Mar 25, 2017 - Apr 8, 2017

    Background: Eight-week mindfulness meditation programs have been shown to have a positive impact on mental health and well-being in adolescents with chronic health conditions. Usually delivered in per...

    Background: Eight-week mindfulness meditation programs have been shown to have a positive impact on mental health and well-being in adolescents with chronic health conditions. Usually delivered in person in a group setting, these programs are difficult to access for teens with disabilities or who live in remote areas. Objective: To compare the impact of an adapted mindfulness-based intervention (MBI) delivered either in person or via eHealth on mindfulness skills acquisition in adolescents with a chronic health conditions. This study will also gather quantitative data on the effects of the MBI related to mood, anxiety, self-esteem, illness perception and stress (via salivary cortisol) as well as qualitative data on individual practice, participant appreciation and adaptation of the MBI for eHealth. Methods: This is a longitudinal, randomized non-inferiority study comparing two arms: in-person and eHealth. Participants are eligible to participate if they are 13-18 years old, have a diagnosis of chronic medical condition, live close enough to the recruitment hospital to participate in the in-person arm of the study and are currently followed by a healthcare provider. Each participant will receive an adapted eight-week MBI delivered either in person at a tertiary pediatric hospital or via a secure eHealth audio-visual platform allowing group interactions in real time. Groups will be facilitated by two experienced mindfulness providers. Quantitative and qualitative data will be collected through standardized research questionnaires administered via a secure, youth-friendly online platform, through semi-structured interviews, participant log books, facilitator log books and salivary cortisol analysis. Qualitative data will be analyzed using a grounded theory model. Results: Study recruitment is currently underway. The intervention and data collection will take place during the winter and spring of 2017. Conclusions: Based on previous results from in-person trials conducted in adolescents and eHealth trials conducted in adults, we anticipate that both modes of delivery will significantly improve mindfulness skills acquisition, mood, anxiety, self-esteem, illness perception and stress and that the magnitude of the effects will be correlated to the level of home practice. We predict that participants in both arms will show similar levels of home practice and that both modes of delivery will have high levels of feasibility and acceptability. If successful, this study could provide evidence for the use of eHealth in the delivery of eight-week MBIs in clinical adolescent populations, potentially increasing availability to MBIs for a large group of youth with mobility issues or living away from large urban centers. Clinical Trial: Trial registry: Clinicaltrials.org Trial number: NCT03067207 URL: https://clinicaltrials.gov/ct2/show/NCT03067207

  • Feasibility, Acceptability and Usability of an mHealth Framework to Improve Birth Outcomes: Study Protocol

    Date Submitted: Mar 22, 2017

    Open Peer Review Period: Mar 24, 2017 - Apr 7, 2017

    Background: The unprecedented coverage of mobile technology across the globe have led to an increase in the use of mobile health applications and related strategies to make health information availabl...

    Background: The unprecedented coverage of mobile technology across the globe have led to an increase in the use of mobile health applications and related strategies to make health information available at the point-of-care. These strategies have the potential to improve birth outcomes but are limited by the availability of internet services especially in resource-limited settings. Objective: Our primary objective is to determine the feasibility of developing an integrated mobile health platform that is able to collect data from community-based programs, embed collected data into a smart card and read the smart card using a cell phone based application without the need for internet access. Our secondary objective is to determine (i) the acceptability of the smart card among pregnant women and (ii) usability of the smart cards by pregnant women and health facilities. Methods: We will leverage existing technology to develop a platform that integrates a database, smart card technology, and a cell phone-based application to read the smart cards. We will recruit 300 pregnant women with one of the three conditions (HIV, hepatitis B virus infection and sickle cell trait or disease) and four health facilities in their community. We will use the Glasgow’s RE-AIM framework as a guide to assess the implementation, acceptability, and usability of the mHealth platform. Results: We have recruited four health facilities and 300 pregnant women with at least one of the eligible conditions. Over the course of 3 months, we will complete the development of the mobile health platform and each participant will be offered a smart card and staff in each health facility will receive training on the use of the mobile health platform. Conclusions: Findings from this study could offer a new approach to making health data from pregnant women available at point of delivery without the need for an internet connection. This would allow clinicians to implement evidence-based interventions in real time to improve health outcomes. Clinical Trial: ClinicalTrials.gov NCT03027258; https://clinicaltrials.gov/ct2/show/NCT03027258 (Archived by WebCite at http://www.webcitation.org/6owR2D0kE)

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