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

Recent Articles:

  • Image Source: New sit-stand workstation for my office, copyright John M,
http://tinyurl.com/gsnfh9n,
Licensed under Creative Commons Attribution cc-by 2.0 https://creativecommons.org/licenses/by/2.0/.

    Organizational-Level Strategies With or Without an Activity Tracker to Reduce Office Workers’ Sitting Time: Rationale and Study Design of a Pilot...

    Abstract:

    Background: The office workplace is a key setting in which to address excessive sitting time and inadequate physical activity. One major influence on workplace sitting is the organizational environment. However, the impact of organizational-level strategies on individual level activity change is unknown. Further, the emergence of sophisticated, consumer-targeted wearable activity trackers that facilitate real-time self-monitoring of activity, may be a useful adjunct to support organizational-level strategies, but to date have received little evaluation in this workplace setting. Objective: The aim of this study is to evaluate the feasibility, acceptability, and effectiveness of organizational-level strategies with or without an activity tracker on sitting, standing, and stepping in office workers in the short (3 months, primary aim) and long-term (12 months, secondary aim). Methods: This study is a pilot, cluster-randomized trial (with work teams as the unit of clustering) of two interventions in office workers: organizational-level support strategies (eg, visible management support, emails) or organizational-level strategies plus the use of a waist-worn activity tracker (the LUMOback) that enables self-monitoring of sitting, standing, and stepping time and enables users to set sitting and posture alerts. The key intervention message is to ‘Stand Up, Sit Less, and Move More.’ Intervention elements will be implemented from within the organization by the Head of Workplace Wellbeing. Participants will be recruited via email and enrolled face-to-face. Assessments will occur at baseline, 3, and 12 months. Time spent sitting, sitting in prolonged (≥30 minute) bouts, standing, and stepping during work hours and across the day will be measured with activPAL3 activity monitors (7 days, 24 hours/day protocol), with total sitting time and sitting time during work hours the primary outcomes. Web-based questionnaires, LUMOback recorded data, telephone interviews, and focus groups will measure the feasibility and acceptability of both interventions and potential predictors of behavior change. Results: Baseline and follow-up data collection has finished. Results are expected in 2016. Conclusions: This pilot, cluster-randomized trial will evaluate the feasibility, acceptability, and effectiveness of two interventions targeting reductions in sitting and increases in standing and stepping in office workers. Few studies have evaluated these intervention strategies and this study has the potential to contribute both short and long-term findings.

  • Source: https://pixabay.com/en/bullying-hands-face-curl-up-her-679274, CC0 Public Domain.

    Prevalence, Motivations, and Social, Mental Health and Health Consequences of Cyberbullying Among School-Aged Children and Youth: Protocol of a Longitudinal...

    Abstract:

    Background: While the online environment may promote important developmental and social benefits, it also enables the serious and rapidly growing issue of cyberbullying. Cyberbullying constitutes an increasing public health problem – victimized children and youth experience a range of health and mental health concerns, including emotional and psychosomatic problems, maladaptive behaviors, and increased suicidality. Perpetrators demonstrate a lack of empathy, and may also struggle with health and mental health issues. Objective: This paper describes the protocols applied in a longitudinal and multi-perspective mixed-methods study with five objectives: (1) to explore children/youth’s experiences, and children/youth’s, parents’, and teachers’ conceptions, definitions, and understanding of cyberbullying; (2) to explore how children/youth view the underlying motivations for cyberbullying; (3) to document the shifting prevalence rates of cyberbullying victimization, witnessing, and perpetration; (4) to identify risk and protective factors for cyberbullying involvement; and (5) to explore social, mental health, and health consequences of cyberbullying. Methods: Quantitative survey data were collected over three years (2012-2014) from a stratified random baseline sample of fourth (n=160), seventh (n=243), and tenth (n=267) grade children/youth, their parents (n=246), and their teachers (n=103). Quantitative data were collected from students and teachers during in-person school visits, and from parents via mail-in surveys. Student, parent, and teacher surveys included questions regarding: student experiences with bullying/cyberbullying; student health, mental health, and social and behavioral issues; socio-demographics; and information and communication technology use. In-depth semi-structured qualitative interviews were conducted twice with a sub-sample of students (n=57), purposively selected based on socio-demographics and cyberbullying experience, twice with their parents (n=50), and once with their teachers (n=30). Results: Data collection for this study is complete. Planned analyses include transition probabilities and repeated measures analyses to determine involvement in cyberbullying. Repeated measures analyses, including between-subject factors (eg, socio-demographics), will be utilized to determine factors that protect or increase risk of involvement in cyberbullying. Qualitative analysis utilizing grounded theory is planned, to permit rich understanding of participant experiences and perspectives. Results will be reported in 2016 and 2017. Conclusions: This study will offer insight into the contemporary phenomenon of cyberbullying while also informing interventions to curb cyberbullying and address its pervasive social, mental health, and health consequences. Knowledge mobilization strategies and implications for research and practice are discussed.

  • Image source and copyright: the authors.

    A Decision Aid for Women Considering Neoadjuvant Systemic Therapy for Operable Invasive Breast Cancer: Development and Protocol of a Phase II Evaluation...

    Abstract:

    Background: Neoadjuvant systemic therapy is offered to selected women with large and/or highly proliferative operable breast cancers. This option adds further complexity to an already complex breast cancer treatment decision tree. Patient decision aids are an established method of increasing patient involvement and knowledge while decreasing decisional conflict. There is currently no decision aid available for women considering neoadjuvant systemic therapy. Objective: We aimed to develop a decision aid for women diagnosed with operable breast cancer and considered suitable for neoadjuvant systemic therapy, and the protocol for a multicenter pre-post study evaluating the acceptability and feasibility of the decision aid. Methods: The decision aid was developed through literature review, expert advisory panel, adherence to the International Patient Decision Aid Standards, and iterative review. The protocol for evaluation of the decision aid consists of the following: eligible women will undertake a series of questionnaires prior to and after using the decision aid. The primary endpoint is decision aid acceptability to patients and investigators and the feasibility of use. Secondary endpoints include change in decisional conflict, participant knowledge, and information involvement preference. Feasibility is defined as the proportion of eligible participants who use the decision aid to help inform their treatment decision. Results: This study has recruited 29 out of a planned 50 participants at four Australian sites. A 12-month recruitment period is expected with a further 12-months follow-up. Conclusions: The decision aid has the potential to allow patients with operable breast cancer, who have been offered neoadjuvant systemic therapy, decreased decisional conflict, and greater involvement in the decision. If this study finds that an online decision aid is feasible and acceptable, it will be made widely available for routine clinical practice. Trial Registration: Australian and New Zealand Clinical Trials Registry ACTRN12614001267640; http://www.anzctr.org.au/TrialSearch.aspx?searchTxt=ACTRN12614001267640&isBasic=True (Archived by WebCite at http://www.webcitation.org/6gh7BPZdG)

  • Source: https://www.pexels.com/photo/apple-desk-laptop-macbook-6568; CC0 Public Domain, modified using image from authors.

    Developing a Web-Based Version of An Exercise-Based Rehabilitation Program for People With Chronic Knee and Hip Pain: A Mixed Methods Study

    Abstract:

    Background: Osteoarthritis is highly prevalent and has enormous personal and socioeconomic impact. Enabling Self-management and Coping with Arthritic Pain through Exercise (ESCAPE-pain) is an integrated rehabilitation program that helps people understand how exercise can improve physical and psychosocial well-being. Unfortunately, its availability is limited. A Web-based version of the program could increase access for more people. Many Web-based resources are developed without end-user input and result in over-complex, unwanted, ineffective products with limited uptake. Objective: The objective of this study was to codesign a Web-based version of ESCAPE-pain that people with chronic joint pain find engaging, informative, and useful. Methods: To establish older persons' Internet use we conducted a postal survey of 200 people. To establish their opinions, likes or dislikes, and requirements for a Web-based version of the ESCAPE-pain program, we conducted two focus groups with 11 people who had participated in a program based on ESCAPE-pain and two with 13 people who had not. Information from the postal survey and focus groups was used to develop an online prototype website. People's opinions of the prototype website were gauged from thematic analysis of eight semistructured “think aloud” interviews. Results: The survey response rate was 42% (83/200), of whom 67% (56/83) were female and mean age was 67 years. Eighty-three percent of the people had used the Internet, 69% described themselves as either very confident or confident Internet users, and 77% had looked online for health information. With regard to participating online, 34% had read a commentary or watched a video of someone else’s experience of a health problem and 23% had tracked a health issue. Key qualitative themes emerged that included engagement, acceptability and usability, and structure and content of the program. Conclusions: Older people use the Internet as a source of health information but have concerns about safe use and quality of information. Users require a credible website that provides personalized information, support, monitoring, and feedback.

  • LHIV logo.  Source and Copyright Shabnam et al. Retrieved from http://www.lhiv.ca/.

    Perspectives of People Living with HIV on Access to Health Care: Protocol for a Scoping Review

    Abstract:

    Background: Strategies to improve access to health care for people living with human immunodeficiency virus (PLHIV) have demonstrated limited success. Whereas previous approaches have been informed by the views of health providers and decision-makers, it is believed that incorporating patient perspectives into the design and evaluations of health care programs will lead to improved access to health care services. Objective: We aim to map the literature on the perspectives of PLHIV concerning access to health care services, to identify gaps in evidence, and to produce an evidence-informed research action plan to guide the Living with HIV program of research. Methods: This scoping review includes peer-reviewed and grey literature from 1946 to May 2014 using double data extraction. Variations of the search terms “HIV”, “patient satisfaction”, and “health services accessibility” are used to identify relevant literature. The search strategy is being developed in consultation with content experts, review methodologists, and a librarian, and validated using gold standard studies identified by those stakeholders. The inclusion criteria are (1) the study includes the perspectives of PLHIV, (2) study design includes qualitative, quantitative, or mixed methods, and (3) outcome measures are limited to patient satisfaction, their implied needs, beliefs, and desires in relation to access to health care. The papers are extracted by two independent reviewers, including quality assessment. Data is then collated, summarized, and thematically analyzed. Results: A total of 12,857 references were retrieved, of which 326 documents were identified as eligible in pre-screening, and 64 articles met the inclusion criteria (56% qualitative studies, 38% quantitative studies and 6% mixed-method studies). Only four studies were conducted in Canada. Data synthesis is in progress and full results are expected in June, 2016. Conclusions: This scoping review will record and characterize the extensive body of literature on perspectives of PLHIV regarding access to health care. A literature repository will be developed to assist stakeholders, decision-makers, and PLHIV in developing and implementing patient-oriented health care programs.

  • Image Credit: from https://pixabay.com/photo-89810/  under CC0 (public domain).

    The Mobile Solutions for Immunization (M-SIMU) Trial: A Protocol for a Cluster Randomized Controlled Trial That Assesses the Impact of Mobile Phone Delivered...

    Abstract:

    Background: Text message (short message service, SMS) reminders and incentives are two demand-side interventions that have been shown to improve health care–seeking behaviors by targeting participant characteristics such as forgetfulness, lack of knowledge, and transport costs. Applying these interventions to routine pediatric immunizations may improve vaccination coverage and timeliness. Objective: The Mobile Solutions for Immunization (M-SIMU) trial aims to determine if text message reminders, either with or without mobile phone–based incentives, sent to infant’s parents can improve immunization coverage and timeliness of routine pediatric vaccines in rural western Kenya. Methods: This is a four-arm, cluster, randomized controlled trial. Villages are randomized to one of four study arms prior to enrollment of participants. The study arms are: (1) no intervention (a general health-related text message will be texted to this group at the time of enrollment), (2) text message reminders only, (3) text message reminders and a 75 Kenyan Shilling (KES) incentive, or (4) text message reminders and a KES200 incentive. Participants assigned to study arms 2-4 will receive two text message reminders; sent 3 days before and one day before the scheduled immunization visit at 6, 10, and 14 weeks for polio and pentavalent (containing diphtheria, tetanus, pertussis, hepatitis B, and Haemophilus influenza type b antigens) type b antigens) vaccines, and at 9 months for measles vaccine. Participants in incentive arms will, in addition to text message reminders as above, receive mobile phone–based incentives after each timely vaccination, where timely is defined as vaccination within 2 weeks of the scheduled date for each of the four routine expanded program immunization (EPI) vaccination visits. Mother-infant pairs will be followed to 12 months of age where the primary outcome, a fully immunized child, will be ascertained. A fully immunized child is defined as a child receiving vaccines for bacille Calmette-Guerin, three doses of pentavalent and polio, and measles by 12 months of age. General estimating equation (GEE) models that account for clustering will be employed for primary outcome analyses. Results: Enrollment was completed in October 2014. Twelve month follow-up visits to ascertain immunization status from the maternal and child health booklet were completed in February 2016. Conclusions: This is one of the first studies to examine the effect of text message reminders on immunization coverage and timeliness in a lower income country and is the first study to assess the effect of mobile money-based incentives to improve immunization coverage. Trial Registration: Clinicaltrials.gov NCT01878435; https://clinicaltrials.gov/ct2/show/NCT01878435 (Archived by WebCite at http://www.webcitation.org/6hQlwGYJR)

  • aMASE Study Logo.
Created by Ibidun Fakoya (author), who holds the copyright.

    Advancing Migrant Access to Health Services in Europe (AMASE): Protocol for a Cross-sectional Study

    Abstract:

    Background: Migrants form a substantial proportion of the population affected by the human immunodeficiency virus (HIV) epidemic in Europe, yet HIV prevention for this population is hindered by poor understanding of access to care and of postmigration transmission dynamics. Objective: We present the design and methods of the advancing Migrant Access to health Services in Europe (aMASE) study, the first European cross-cultural study focused on multiple migrant populations. It aims to identify the structural, cultural, and financial barriers to HIV prevention, diagnosis, and treatment and to determine the likely country of HIV acquisition in HIV-positive migrant populations. Methods: We delivered 2 cross-sectional electronic surveys across 10 countries (Belgium, France, Germany, Greece, Italy, the Netherlands, Portugal, Spain, Switzerland, and United Kingdom). A clinic survey aimed to recruit up to 2000 HIV-positive patients from 57 HIV clinics in 9 countries. A unique study number linked anonymized questionnaire data to clinical records data (viral loads, CD4 cell counts, viral clades, etc). This questionnaire was developed by expert panel consensus and cognitively tested, and a pilot study was carried out in 2 countries. A Web-based community survey (n=1000) reached those living with HIV but not currently accessing HIV clinics, as well as HIV-negative migrants. It was developed in close collaboration with a community advisory group (CAG) made up of representatives from community organizations in 9 of the participating countries. The CAG played a key role in data collection by promoting the survey to higher-risk migrant groups (sub-Saharan Africans, Latin Americans, men who have sex with men, and people who inject drugs). The questionnaires have considerable content overlap, allowing for comparison. Questions cover ethnicity, migration, immigration status, HIV testing and treatment, health-seeking behavior, sexual risk, and drug use. The electronic questionnaires, which were available in 15 languages, allowed for complex routing, preventing respondents from answering irrelevant questions. Results: In total, we recruited 2249 participants from 57 HIV clinics as part of the clinic survey and retrieved 1637 complete responses as part of the community survey. Conclusions: The findings will provide much-needed information for improving HIV prevention interventions and access to services for migrant communities.

  • Tawazon App on Smartphone held by authors. Source and copyright: authors, Aroub Alnasser et al.

    Development of ‘Twazon’: An Arabic App for Weight Loss

    Abstract:

    Background: Weight gain and its related illnesses have become a major public health issue across the world, with Saudi Arabia and other Gulf countries seeing dramatic increases in obesity and overweight, and yet there is very little information on how to intervene with this demographic due to cultural and linguistic barriers. As the use of smartphones and apps has also increased in the region, information communication technologies could be a cost-effective means of facilitating the delivery of behavior-modification interventions directly to the target population. Although there are existing apps that offer lifestyle-modification tools, they do not give consideration to the evidence-based practices for weight management. This offers an opportunity to create an Arabic language weight loss app that offers localized content and adheres to evidence-informed practices that are needed for effective weight loss. Objective: This paper describes the process of developing an Arabic weight loss app designed to facilitate the modification of key nutritional and physical activity behaviors among Saudi adults, while taking into consideration cultural norms. Methods: The development of the Twazon app involved: (1) reviewing all available Arabic weight loss apps and compared with evidence-based practices for weight loss, (2) conducting a qualitative study with overweight and obese Saudi women to ascertain their preferences, (3) selecting which behavioral change strategies and guidelines to be used in the app, (4) creating the Saudi Food Database, (5) deciding on graphic design for both iPhone operating system and Android platforms, including user interface, relational database, and programming code, and (6) testing the beta version of the app with health professionals and potential users. Results: The Twazon app took 23 months to develop and included the compilation of an original Saudi Food database. Eight subjects gave feedback regarding the content validity and usability of the app and its features during a pilot study. The predominant issue among the group was the lack of information explaining how to use the app. This has since been resolved through the implementation of a tutorial. No other changes were required to be made. Conclusions: Information communication technologies, such as smartphone apps, may be an effective tool for facilitating the modification of unhealthy lifestyle habits in Saudi; however, consideration must be given to the target population, cultural norms, and changing trends in the global market. The effectiveness of the app will be better determined during a 6-month intervention with 200 overweight and obese Saudi women.

  • Source: https://commons.wikimedia.org/wiki/File:Colon_cancer_2.jpg, CC-BY-3.0 Licensed.

    Determination of the Role of CBP- and p300-Mediated Wnt Signaling on Colonic Cells

    Abstract:

    Background: The Wnt signaling pathway, mediated through active beta-catenin, is responsible for initiating the majority of cases of human colorectal cancer (CRC), and we have previously shown that hyperactivation of this pathway by histone deacetylase inhibitors (HDACis), such as butyrate, can induce the death of CRC cells. An important cellular switch that mediates the effects of Wnt-signaling activation is variation in the association between beta-catenin and the transcriptional coactivators cAMP response element binding (CREB) binding protein (CBP) and p300. Association of CBP with beta-catenin is thought to activate a set of genes linked to cell proliferation, while the p300-mediated Wnt genetic program is believed to promote cell differentiation. Small molecule agents have been discovered that modulate CBP/p300 Wnt transcriptional programs by altering the association of CBP and p300 to beta-catenin. ICG-001 and ICG-427 inhibit CBP- and p300-mediated Wnt activity, respectively, while IQ-1 prevents the shift from CBP-mediated to a p300-mediated Wnt activity. Objective: Aim 1 of this proposal is designed to determine the role of CBP- and p300-mediated Wnt signaling in the response of CRC cells to HDACis. Aim 2 is to determine the role of CBP and p300 in the maintenance of high- and low-Wnt fractions in CRC cell line. Aim 3 will compare the effects of CBP- and p300-mediated Wnt activity on CRC initiation and progression. Methods: In Aim 1, cells will be cotreated with HDACis and ICG-001, ICG-427, or IQ-1 and the levels of Wnt activity, apoptosis, proliferation, differentiation, and CBP- or p300-beta-catenin binding measured. Aim 2 of this proposal may mirror similar heterogeneity observed in human tumors and which may be of clinical significance. Aim 3 will use CRC cell line model systems of initiation and progression: the normal colon cell lines CCD-841CoN, the adenoma line LT97, the primary colon carcinoma cell line SW480, and the lymph node metastasis cell line SW620. Cells will be treated with HDACis and the small molecule agents, and assayed as described above. Results: We will also attempt to use changes in CBP- and p300-mediated Wnt signaling to shift colonic cells between cell type, modifying CBP- and p300-mediated gene expression in the LT97 adenoma line to shift the adenoma phenotype to more characteristic of the CCD-841CoN normal cells, or the SW480 carcinoma cells. We will use microarray analyses to determine the patterns of gene expression responsible for these CBP- or p300-mediated changes in colonic neoplastic phenotype. Conclusions: The findings generated from this study will lead to future, more in-depth projects to further dissect the action of CBP/p300 Wnt–mediated transcriptional programs in colonic neoplasia, with an emphasis on methods to modulate these genetic programs for chemopreventive effect.

  • Source: https://www.pexels.com/photo/smartphone-mockup-mobile-phone-screen-3066, CC0 Licensed, modified using screenshot of app from authors.

    A Multimodal mHealth Intervention (FeatForward) to Improve Physical Activity Behavior in Patients with High Cardiometabolic Risk Factors: Rationale and...

    Abstract:

    Background: Physical inactivity is one of the leading risk factors contributing to the rising rates of chronic diseases and has been associated with deleterious health outcomes in patients with chronic disease conditions. We developed a mobile phone app, FeatForward, to increase the level of physical activity in patients with cardiometabolic risk (CMR) factors. This intervention is expected to result in an overall improvement in patient health outcomes. Objective: The objective of this study is to evaluate the effect of a mobile phone–based app, FeatForward, on physical activity levels and other CMR factors in patients with chronic conditions. Methods: The study will be implemented as a 2-arm randomized controlled trial with 300 adult patients with chronic conditions over a 6-month follow-up period. Participants will be assigned to either the intervention group receiving the FeatForward app and standard care versus a control group who will receive only usual care. The difference in physical activity levels between the control group and intervention group will be measured as the primary outcome. We will also evaluate the effect of this intervention on secondary measures including clinical outcome changes in global CMR factors (glycated hemoglobin, fasting blood glucose, blood pressure, waist circumference, Serum lipids, C-reactive protein), health-related quality of life, health care usage, including attendance of scheduled clinic visits and hospitalizations, usability, and satisfaction, participant engagement with the FeatForward app, physician engagement with physician portal, and willingness to engage in physical activity. Instruments that will be used in evaluating secondary outcomes include the Short-Form (SF)-12, app usability and satisfaction questionnaires, physician satisfaction questionnaire. The intention-to-treat approach will be used to evaluate outcomes. All outcomes will be measured longitudinally at baseline, midpoint (3 months), and 6 months. Our primary outcome, physical activity, will be assessed by mixed-model analysis of variance with intervention assignment as between-group factor and time as within-subject factor. A similar approach will be used to analyze continuous secondary outcomes while categorical outcomes will be analyzed by chi-square test. Results: The study is still in progress and we hope to have the results by the end of 2016. Conclusions: The mobile phone–based app, FeatForward, could lead to significant improvements in physical activity and other CMR factors in patients.

  • Image Source: Public exercise park, copyright Mills Baker,
http://tinyurl.com/jtp45xb,
Licensed under Creative Commons Attribution cc-by 2.0 https://creativecommons.org/licenses/by/2.0/.

    Effects of a Community-Based, Post-Rehabilitation Exercise Program in COPD: Protocol for a Randomized Controlled Trial With Embedded Process Evaluation

    Abstract:

    Objectives: This manuscript (1) outlines the intervention, (2) describes how its effectiveness is being evaluated in a pragmatic randomized controlled trial, and (3) summarizes the embedded process evaluation aiming to understand key barriers and facilitators for implementation in new environments. Methods: Participating centers refer eligible individuals with COPD following discharge from their local PR program. Consenting patients are assigned to a year-long community exercise program or usual care using block randomization and stratifying for supplemental oxygen use. Patients in the intervention arm are asked to attend an exercise session at least twice per week at their local community facility where their progress is supervised by a case manager. Each exercise session includes a component of aerobic exercise, and activities designed to optimize balance, flexibility, and strength. All study participants will have access to routine follow-up appointments with their respiratory physician, and additional health care providers as part of their usual care. Assessments will be completed at baseline (post-PR), 6, and 12 months, and include measures of functional exercise capacity, quality of life, self-efficacy, and health care usage. Intervention effectiveness will be assessed by comparing functional exercise capacity between intervention and control groups. A mixed-methods process evaluation will be conducted to better understand intervention implementation, guided by Normalization Process Theory and the Consolidated Framework for Implementation Research. Results: Based on results from our pilot work, we anticipate a maintenance of exercise capacity and improved health-related quality of life in the intervention group, compared with a decline in exercise capacity in the usual care group. Discussion: Findings from this study will improve our understanding of the effectiveness of community-based exercise programs for maintaining benefits following PR in patients with COPD and provide information on how best to implement them. If effective, the intervention represents an opportunity to transition patients from institutionally-based rehabilitative management to community-based care. The results of the process evaluation will contribute to the science of translating evidence-based programs into regular practice.

  • Study logo. Source: Provided by Marjan Tabesh et al. Copyright owned by Marjan Tabesh et al.

    Improving Vitamin D Status and Related Health in Young Women: The Safe-D study – Part B

    Abstract:

    Background: Vitamin D deficiency is highly prevalent and associated with increased risk of a number of chronic health conditions including cardiovascular disease, poor bone and muscle health, poor mental health, infection, and diabetes. Vitamin D deficiency affects millions of Australians, potentially causing considerable suffering, economic loss, and mortality. Objective: To measure the effectiveness of a (1) mobile-based app (behavioral) and (2) pharmacological intervention to increase circulating 25-hydroxyvitamin D (serum 25 OHD) levels and health outcomes over 4 months of intervention compared with usual care in a cohort of young women with suboptimal serum 25 OHD levels (25-75 nmol/L). Methods: Participants with 25 OHD levels 25 to 75 nmol/L are invited to participate in this study. Participants are randomized to one of three groups in 1:1:1 ratio: a mobile phone–based application, vitamin D supplementation (1000 IU/day), and a control group. Data collection points are at baseline, 4, and 12 months post baseline with the major endpoints being at 4 months. A wide-range of information is collected from participants throughout the course of this study. General health, behavioral and demographic information, medications, smoking, alcohol and other substance use, health risk factors, nutrition, eating patterns and disorders, and mental health data are sourced from self-administered, Web-based surveys. Clinical data include anthropometric measurements, a silicone skin cast of the hand, cutaneous melanin density, bone mineral density, and body composition scans obtained through site visits. Main analyses will be conducted in two ways on an intention-to-treat (ITT) basis using the last observation carried forward approach as an imputation for missing data, and on a per protocol basis to compare the intervention arms against the control group at 4 and 12 months. Results: Publication of trial results is anticipated in 2017. Conclusions: The study will allow assessment of the effects of a mobile-based app behavioral intervention and vitamin D supplementation on vitamin D status and will evaluate the effects of improving vitamin D levels on several health outcomes.

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  • A Cross-Sectional Comparison of Drugable Mutations in Primary Tumors, Metastatic Tissue, Circulating Tumor Cells and Cell-Free Circulating DNA in Patients with Metastatic Breast Cancer: The MIRROR Study Protocol

    Date Submitted: May 24, 2016

    Open Peer Review Period: May 24, 2016 - Jun 1, 2016

    Background: Characterization of the driver mutations in an individual metastatic breast cancer (MBC) patient is critical to selecting effective targeted therapies. Currently, it is believed that the l...

    Background: Characterization of the driver mutations in an individual metastatic breast cancer (MBC) patient is critical to selecting effective targeted therapies. Currently, it is believed that the limited efficacy of many targeted drugs may be due to the expansion of drug resistant clones with different genotypes that were already present in the primary tumor. Identifying the genomic alterations of these clones and introducing combined or sequential targeted regimens could lead to a significant increase in the efficacy of currently available targeted therapies. Objective: The primary objective of this study is to assess the concordance/discordance of mutations between the primary tumor and metastatic tissue in these patients. Secondary objectives include comparing the genomic profiles of circulating tumor cells (CTCs) and circulating free DNA (cfDNA) from peripheral blood with those of the primary tumor and metastatic tissue for each patient, evaluating these mutations in the signaling pathways that are relevant to the disease, and testing the feasibility of introducing liquid biopsy as a translational laboratory tool in clinical practice. Methods: The multicenter, transversal, observational MIRROR study is currently ongoing in 3 participating hospitals. All consecutive patients with MBC confirmed by radiologic findings, either at first relapse or with tumor regrowth while on treatment for metastatic disease, will be screened for eligibility. Results: Patient’s recruitment is currently ongoing. To date, 41 patients have a complete set of tissue samples available (plasma, CTCs, and formalin-fixed, paraffin-embedded primary tumor and metastatic tumor). However, none of these samples have undergone nucleic acids extraction and targeted deep sequencing yet. Conclusions: The results of this study might have a significant influence on the practical management of patients with MBC, as they may provide clues to clinicians towards a better stratification of patients so that they receive more selective and less toxic treatments. Additionally, if genomic mutations found in metastatic tissues are similar to those detected in CTCs and/or cfDNA, then liquid biopsy could be a more convenient, non-invasive and easily accessible source of genomic material for the analysis of mutations and other genomic aberrations in MBC. Clinical Trial: ClinicalTrials.gov: NCT02626039

  • Study Protocol of Carotid Endarterectomy and Carotid Artery Stenting in Brazil: An Observational Registry

    Date Submitted: May 20, 2016

    Open Peer Review Period: May 20, 2016 - Jun 3, 2016

    Introdution: Carotid artery stenting (CAS) and carotid endarterectomy (CEA) are alternative strategies for stroke prevention in patients with atherosclerotic carotid disease. CEA has been considered t...

    Introdution: Carotid artery stenting (CAS) and carotid endarterectomy (CEA) are alternative strategies for stroke prevention in patients with atherosclerotic carotid disease. CEA has been considered the first-line treatment for carotid stenosis worldwide, and the safety and efficacy of CAS compared with CEA remain in question. The purpose of this study is to compare the practice and outcomes of CAS and CEA in a real-world setting within public university hospitals in Brazil. Methods and Analysis: This will be a prospective 5-year analysis of treatment for atherosclerotic carotid stenosis with CEA and CAS performed at 5 centres affiliated with the Vascular Study Group at public university hospitals in Brazil. The indications for the procedure will be determined by each surgeon’s individual discretion, in accordance with preoperative risk evaluation. The primary outcome measures are (1) any in-hospital stroke or death and (2) any per-procedural stroke, death, or myocardial infarction (MI). Patients undergoing CEA in conjunction with cardiac surgery will be excluded. Multivariate logistic regression will be performed to identify predictors of stroke or death in patients undergoing CEA and CAS. All tests of significance will be performed at the 0.05 level. Ethics and Dissemination: This study was approved by Committee of Ethics in Research of University Hospital of Ribeirao Preto Medical School and in all other participating institutions linked to National Research System and National Board of Health in BRAZIL (Process 15695/2011) and the recruitment is currently on-going, the last patient is expected to be included by the end of 2018. The analysis of the primary end point and all others variables of the study are expected to be published in 2019 in a peer reviewed journal and results will also be presented at scientific meetings and summary results published online. .

  • MHealth to improve measles immunization in Guinea-Bissau: Study Protocol for a Randomized Controlled Trial

    Date Submitted: May 11, 2016

    Open Peer Review Period: May 12, 2016 - May 26, 2016

    Background: Recent studies reveal a low measles vaccination rate in Guinea-Bissau that has not increased in accordance with the increase in vaccination coverage of other vaccinations. Measles is the m...

    Background: Recent studies reveal a low measles vaccination rate in Guinea-Bissau that has not increased in accordance with the increase in vaccination coverage of other vaccinations. Measles is the most deadly of all childhood rash/fever illnesses and spreads easily so if the vaccination coverage is declining there is a significant risk of new outbreaks of measles. Meanwhile, mHealth (i.e. the use of mobile phones for health interventions) has generated much enthusiasm, and shown potential in improving health service delivery in other contexts. Objective: The aim of this study is to evaluate the efficiency of mHealth as a tool for improving measles vaccination coverage while contributing to the mHealth evidence base. Methods: The study takes place at three health centers in different regions of Guinea-Bissau. Participants will be enrolled when they arrive at the health center to receive the BCG vaccination - usually within one month of birth. Enrolment will continue until a study population of 900 children has been reached. The participants will be allocated by randomization to either a control group or one of two groups receiving intervention. Each of the three groups will have 300 participants distributed equally between health centers. Participants in the first treatment group will receive a scheduled SMS (Short Message Service) message reminding them of the measles vaccination. Participants in the second treatment group will receive a voice call in addition to the SMS message. Since measles vaccine is scheduled to be administered at 9 months of age and local policy in Guinea-Bissau prevents children aged more than 12 months from receiving the vaccination, the study will follow-up after 12 months of age. Children who have not yet received the measles vaccine will be offered vaccination by the project group. Results: The study will analyze the efficiency of the intervention by determining its overall effect on measles vaccination coverage and timeliness at 12 months of age. The main analysis will be stratified by intervention group, health center, level of education, etc. Secondary outcomes include the average number of visits with intention to obtain the measles vaccination required before successful administration. Conclusions: Despite the rapid proliferation of mHealth projects, only few of them have been evaluated in terms of direct links to health outcomes. This leaves a need for solid evidence on which policy-makers can base decisions. This study is assumed to produce significant knowledge about mHealth implementation within a Sub-Saharan context while creating data supported evidence. Clinical Trial: Clinicaltrials.gov: NCT02662595

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