JMIR Publications

JMIR Research Protocols

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


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:

  • Author photo. Image sourced and copyright held by authors 	Sarah C Thomsen et al.

    Voice-Message–Based mHealth Intervention to Reduce Postoperative Penetrative Sex in Recipients of Voluntary Medical Male Circumcision in the Western Cape,...


    Background: There is an increased risk of transmission of sexually transmitted infections (STIs), including HIV, in the postoperative period after receiving voluntary medical male circumcision (VMMC). In South Africa, over 4 million men are being targeted with VMMC services but the health system is not able to offer quality counseling. More innovative strategies for communicating with and altering behavior in men and their partners in the postoperative period after VMMC are needed. Objective: This paper presents a study protocol to test the effectiveness of an mHealth intervention designed to task-shift behavior change communication from health care personnel to an automated phone message system, encouraging self-care. Methods: A single-blind, randomized controlled trial will be used. A total of 1188 participants will be recruited by nurses or clinicians at clinics in the study districts that have a high turnover of VMMC clients. The population will consist of men aged 18 years and older who indicate at the precounseling session that they possess a mobile phone and consent to participating in the study. Consenting participants will be randomized into either the control or intervention arm before undergoing VMMC. The control arm will receive the standard of care (pre- and postcounseling). The intervention arm will received standard of care and will be sent 38 messages over the 6-week recovery period. Patients will be followed up after 42 days. The primary outcome is self-reported sexual intercourse during the recovery period. Secondary outcomes include nonpenetrative sexual activity, STI symptoms, and perceived risk of acquiring HIV. Analysis will be by intention-to-treat. Results: Enrollment is completed. Follow-up is ongoing. Loss to follow-up is under 10%. No interim analyses have been conducted. Conclusions: The intervention has the potential of reducing risky sexual behavior after VMMC. The platform itself can be used for many other areas of health that require task shifting to patients for better efficiency and access. Trial Registration: Pan-African Clinical Trial Registry: PACTR201506001182385

  • Wearable Device. Image sourced and copyright held by authors Alexa M Ortiz et al.

    ActiviTeen: A Protocol for Deployment of a Consumer Wearable Device in an Academic Setting


    Background: Regular physical activity (PA) can be an important indicator of health across an individual’s life span. Consumer wearables, such as Fitbit or Jawbone, are becoming increasingly popular to track PA. With the increased adoption of activity trackers comes the increased generation of valuable individual-based data. Generated data has the potential to provide detailed insights into the user’s behavior and lifestyle. Objective: The primary objective of the described study is to evaluate the feasibility of individual data collection from the selected consumer wearable device (the Fitbit Zip). The rate of user attrition and barriers preventing the use of consumer wearable devices will also be evaluated as secondary objectives. Methods: The pilot study will occur in two stages and employs a long-term review and analysis with a convenience sample of 30 students attending Research Triangle High School. For the first stage, students will initially be asked to wear the Fitbit Zip over the course of 4 weeks. During which time, their activity data and step count will be collected. Students will also be asked to complete a self-administered survey at the beginning and conclusion of the first stage. The second stage will continue to collect students’ activity data and step count over an additional 3-month period. Results: We are anticipating results for this study by the end of 2016. Conclusion: This study will provide insight into the data collection procedures surrounding consumer wearable devices and could serve as the future foundation for other studies deploying consumer wearable devices in educational settings.

  • Image Source: Facebook, copyright Sarah Marshall,, Licensed under Creative Commons Attribution cc-by 2.0

    Targeted Facebook Advertising is a Novel and Effective Method of Recruiting Participants into a Human Papillomavirus Vaccine Effectiveness Study


    Background: Targeted advertising using social networking sites (SNS) as a recruitment strategy in health research is in its infancy. Objective: The aim of this study was to determine the feasibility of targeted Facebook advertisements to increase recruitment of unvaccinated women into a human papillomavirus (HPV) vaccine effectiveness study. Methods: Between September 2011 and November 2013, females aged 18 to 25 years, residing in Victoria, Australia, were recruited through Facebook advertisements relating to general women’s health. From November 2013 to June 2015, targeted advertising campaigns were implemented to specifically recruit women who had not received the HPV vaccine. Consenting participants were invited to complete an online questionnaire and those who had ever had sexual intercourse were asked to provide a self-collected vaginal swab. The HPV vaccination status of participants was confirmed from the National HPV Vaccination Program Register (NHVPR). Results: The campaign comprised 10 advertisements shown between September 2011 and June 2015 which generated 55,381,637 impressions, yielding 23,714 clicks, at an overall cost of AUD $22,078.85. A total of 919 participants were recruited. A greater proportion of unvaccinated women (50.4%, 131/260) were recruited into the study following targeted advertising, compared with those recruited (19.3%, 127/659) prior to showing the modified advertisement (P<.001). A greater proportion of the total sample completed tertiary education and resided in inner regional Victoria, compared with National population census data (P<.001), but was otherwise representative of the general population. Conclusions: Targeted Facebook advertising is a rapid and cost-effective way of recruiting young unvaccinated women into a HPV vaccine effectiveness study.

  • Image Source: Rapprochement, copyright Jonas Boni,, Licensed under Creative Commons Attribution cc-by 2.0

    Evaluation of the Digital Alzheimer Center: Testing Usability and Usefulness of an Online Portal for Patients with Dementia and Their Carers


    Background: Dementia is a progressive and highly disabling neurodegenerative disease that will likely become highly prevalent in the future due to the globally aging population. To improve health care efficiency and quality for dementia care, eHealth could help with, for example, an online portal, such as the Digital Alzheimer Center (DAC) of the Vrije Universiteit Medical Center Amsterdam. It provides up-to-date disease information, peer-to-peer contact, and methods for contacting the hospital and health professionals. Objective: We aimed to investigate the usability and usefulness of the DAC for patients with dementia and carers to get insight into the feasibility and value of this eHealth app in dementia care and to recommend potential improvements. Methods: A descriptive study among patients, carers, and health care professionals was performed. Mixed methods were used, consisting of observations (n=10, 4 people with dementia, 6 carers), an online survey (n=287; 88 patients, 199 carers), and semistructured interviews (n=18; 6 patients, 6 carers, 6 health care professionals). During the observations, participants performed a set of five different prescribed tasks on the portal. Speed, number of errors, and navigation were noted. The online survey aimed to assess users’ opinions on the portal’s usability and usefulness. Semistructured interviews were conducted in a subsample of patients, carers, and health care professionals to gain more in-depth information. Results: In the usability assessment, eight categories of errors were distinguished, of which three were of critical, two of medium, and three of low severity. In the survey, 45% (40/88) of the patients and 53% (105/199) of the carers indicated they used the portal. In all, 33% (12/36) of patients and 61% (62/102) of carers found it easy to learn to work with the portal. Most considered the DAC generally useful: 65% (17/26) of patients and 78% (67/86) of carers found the DAC useful, especially for understanding dementia (patients: 64%, 16/25; carers: 62%, 53/86). In the semistructured interviews, the site was generally rated positively on usability and usefulness and being well designed. People with dementia and carers indicated it helped them to understand and deal with dementia. Conclusions: To our knowledge, this is the first study investigating the usability and usefulness of an Internet portal especially designed for people with dementia and their carers. An online patient portal could be a useful means to help to support patients and carers in dealing with dementia: the majority of users positively evaluated usability and usefulness of the portal, and appreciated the information on it. However, only a minority of patients found it easy to work with the portal. Good design and frequent usability testing is essential to offer a good online portal.

  • DiaFOTo Illustration by Hilde Thomsen. Source and copyright: the authors; license to use under CC-SA-4.0.

    Telemedicine Versus Standard Follow-Up Care for Diabetes-Related Foot Ulcers: Protocol for a Cluster Randomized Controlled Noninferiority Trial (DiaFOTo)


    Background: This paper presents the protocol for an ongoing study to evaluate a telemedicine follow-up intervention for patients with diabetes-related foot ulcers. Diabetes-related foot ulcers represent challenges for patients and the health services. The large increase in the prevalence of diabetes, combined with the aging population, means that the absolute number of patients with diabetes-related foot ulcers is likely to continue to increase. Health care services therefore need to provide close clinical follow-up care for people with diabetes both in primary and specialist care. Information and communication technologies may enable more integrated treatment and care pathways across organizational boundaries. However, we lack knowledge about the effect of telemedicine follow-up and how such services can be optimally organized. Objective: To present the design and methods of a study evaluating a telemedicine follow-up intervention for patients with diabetes-related foot ulcers. Methods: The study is designed as a cluster randomized controlled trial (noninferiority trial) involving municipalities or municipality districts (clusters) belonging to one clinical site in Western Norway. The study includes patients with type 1 and type 2 diabetes presenting with a new foot ulcer at the initial visit to the clinic. Patients in the intervention group receive telemedicine follow-up care in the community. The key ingredient in the intervention is the close integration between health care levels. The intervention is facilitated by the use of an interactive wound platform consisting of a Web-based ulcer record combined with a mobile phone, enabling counseling and communication between nurses in the community and specialist health care. Patients in the control group receive standard hospital outpatient care. The primary endpoint in the trial is healing time; secondary outcomes include amputation and death, patient-reported outcome measures, and follow-up data on the recurrence of foot ulcers. In addition, qualitative substudies are being performed to provide a more comprehensive evaluation of the ongoing processes during the trial with the patients in the intervention and control groups and those health care professionals either working in primary care or in specialist care delivering the intervention. Results: The project has been funded. The inclusion of patients started in September 2012. Because recruitment goals were not met in the initial period, two more clinical sites have been included to meet sample size requirements. Patient recruitment will continue until June 2016. Data collection in the qualitative substudies has been completed. Conclusions: This telemedicine trial operates in a novel setting and targets patients with diabetes-related foot ulcers during a 12-month follow-up period. The trial addresses whether integrated care using telemedicine between primary and specialist health care can be an equivalent alternative to standard outpatient care. Trial Registration: NCT01710774; (Archived by WebCite at

  • Urine 2D-chromatogram. Source and copyright: the authors, license to use under CCSA-4.0.

    The Karlsruhe Metabolomics and Nutrition (KarMeN) Study: Protocol and Methods of a Cross-Sectional Study to Characterize the Metabolome of Healthy Men and Women


    Background: The human metabolome is influenced by various intrinsic and extrinsic factors. A precondition to identify such biomarkers is the comprehensive understanding of the composition and variability of the metabolome of healthy humans. Sample handling aspects have an important impact on the composition of the metabolome; therefore, it is crucial for any metabolomics study to standardize protocols on sample collection, preanalytical sample handling, storage, and analytics to keep the nonbiological variability as low as possible. Objective: The main objective of the KarMeN study is to analyze the human metabolome in blood and urine by targeted and untargeted metabolite profiling (gas chromatography-mass spectrometry [GC-MS], GC×GC-MS, liquid chromatography-mass spectrometry [LC-MS/MS], and1H nuclear magnetic resonance [NMR] spectroscopy) and to determine the impact of sex, age, body composition, diet, and physical activity on metabolite profiles of healthy women and men. Here, we report the outline of the study protocol with special regard to all aspects that should be considered in studies applying metabolomics. Methods: Healthy men and women, aged 18 years or older, were recruited. In addition to a number of anthropometric (height, weight, body mass index, waist circumference, body composition), clinical (blood pressure, electrocardiogram, blood and urine clinical chemistry) and functional parameters (lung function, arterial stiffness), resting metabolic rate, physical activity, fitness, and dietary intake were assessed, and 24-hour urine, fasting spot urine, and plasma samples were collected. Standard operating procedures were established for all steps of the study design. Using different analytical techniques (LC-MS, GC×GC-MS,1H NMR spectroscopy), metabolite profiles of urine and plasma were determined. Data will be analyzed using univariate and multivariate as well as predictive modeling methods. Results: The project was funded in 2011 and enrollment was carried out between March 2012 and July 2013. A total of 301 volunteers were eligible to participate in the study. Metabolite profiling of plasma and urine samples has been completed and data analysis is currently underway. Conclusions: We established the KarMeN study applying a broad set of clinical and physiological examinations with a high degree of standardization. Our experimental approach of combining scheduled timing of examinations and sampling with the multiplatform approach (GC×GC-MS, GC-MS, LC-MS/MS, and1H NMR spectroscopy) will enable us to differentiate between current and long-term effects of diet and physical activity on metabolite profiles, while enabling us at the same time to consider confounders such as age and sex in the KarMeN study. Trial Registration: German Clinical Trials Register DRKS00004890; navigationId=trial.HTML&TRIAL_ID=DRKS00004890 (Archived by WebCite at

  • Source:; CC2.0, Attribution: Steven Depolo.

    The Deckled Incision: Study Protocol for a Randomized Controlled Trial


    Background: Scar visibility is multifactorial and skin closure technique is thought to play an important role. It is an established principle in plastic surgery that Z plasties generally reduce scar contracture by breaking up the lines of tension in a wound. As an extension of this principle, it is postulated that irregular “deckled” skin incisions made during tumor excision would produce aesthetically superior scars. Objective: The primary objective of this study is to assess both the clinician and patient opinion of scar quality using the Patient and Observer Scar Assessment Scale (POSAS). Secondary objectives include the proportion of scars judged as good by the both the patient and clinician (less than or equal to 5 on the overall PSOAS scale), the number of adverse events, and the proportion of the scar visible at 1 meter. Methods: The deckling study will be a patient-blinded, simple randomized controlled trial (RCT) at a single center institution. The two groups will be equally allocated on a 1:1 ratio into the control and treatment arms. All patients greater than 18 years of age undergoing a plastic surgery procedure involving excision of skin lesions will be enrolled. Any patients requiring re-excision through the wound or undergoing injectable corticosteroid therapy will be excluded. A total of 500 patients will be enrolled. The patients will be followed-up at 1 week, 3 months, and 6 months post-operatively. Results: The study is expected to begin enrolment in August 2016. We anticipate that the deckling study group will have superior scar outcomes when compared to the straight line incision. From clinical experience this is especially true for lesions involving the face and in those areas of the skin that have undergone radiation therapy. The study will be funded by the Plastics and Reconstructive Surgery Department at St Vincent’s Hospital, Sydney, Australia. Ethics approval has been obtained for the study. Conclusion: We believe this will be an important study to assess a novel method to improve the appearance of post-operative scars. The deckling study is simple to master, can be applicable to almost any surgical procedure, and can have good generalizability to a large population cohort. Conclusions: We believe this will be an important study to assess a novel method to improve the appearance of post-operative scars. The deckling study is simple to master, can be applicable to almost any surgical procedure, and can have good generalizability to a large population cohort. Trial Registration: Australian New Zealand Clinical Trials Registry (ANZCTR): ACTRN12616000193471; (Archived by Webcite at

  • Source: Created by the Truth Initiative. License to use under CC-SA4.0.

    Young Adult Utilization of a Smoking Cessation Website: An Observational Study Comparing Young and Older Adult Patterns of Use


    Background: There is little research on how young adults or young adult subgroups utilize and engage with Web-based cessation interventions when trying to quit smoking. Addressing this knowledge gap is important to identify opportunities to optimize the effectiveness of online cessation programs across diverse young adult users. Objective: This study examines utilization of the smoking cessation website among young adults and young adult subgroups compared with older adults to identify patterns of use by age, gender, and race/ethnicity. Methods: Study participants were 5983 new registered users on a free smoking cessation website who were aged 18 to 70 years. Website utilization was tracked for 6 months; metrics of use included website visits, pages per visit, length of visit, and interaction with specific website features. Differences in website use by age were examined via bivariate analyses and multivariate logistic regression adjusted for age, gender, and race/ethnicity. Interactions were examined to determine differences by gender and race/ethnicity within young (18- to 24-year-olds and 25- to 34-year-olds) and older (35 years and older) adult segments. Results: A greater percentage of young adults aged 18 to 34 years visited the site only once compared with older adults aged 35 years and older (72.05% vs 56.59%, respectively; P<.001). Young adults also spent less time on the site and viewed fewer pages than older adults. In adjusted analyses, young adults were significantly less likely than older adults to visit the site more than once (18-24 years: adjusted odds ratio [AOR] 0.58, 95% CI 0.49-0.68, P<.001; 25-34 years: AOR 0.56, 95% CI 0.50-0.64, P<.001), spend more than 3 minutes on the site (18-24 years: AOR 0.67, 95% CI 0.57-0.79, P<.001; 25-34 years: AOR 0.56, 95% CI 0.49-0.64, P<.001), view 12 or more pages (18-24 years: AOR 0.72, 95% CI 0.61-0.83; P<.001; 25-34 years: AOR 0.67, 95% CI 0.59-0.76, P<.001), utilize the community (18-24 years: AOR 0.61, 95% CI 0.48-0.79, P<.001; 25-34 years: AOR 0.73, 95% CI 0.60-0.88, P<.001), or utilize Separation Exercises (18-24 years: AOR 0.68, 95% CI 0.51-0.89, P<.01; 25-34 years: AOR 0.77, 95% CI 0.63-0.94, P<.01). Gender differences in utilization were more pronounced among young adults compared with older adults, with lower levels of utilization among young men than young women. For all age groups, utilization was higher among whites and African Americans than among Hispanics and other racial minorities, with one exception— community utilization was significantly higher among Hispanic young adults compared with white and African American young adults. Conclusions: Results point to important areas of inquiry for future research and development efforts. Research should focus on enhancing demand and increasing engagement among younger adults and men, examining strategies for capitalizing on young adult developmental needs, and increasing utilization of effective site features among diverse young adult users.

  • Videoconference between a neonatal nurse and a mother with a preterm infant receiving neonatal home care. Source and copyright: the authors.

    Telemedicine in Neonatal Home Care: Identifying Parental Needs Through Participatory Design


    Background: For the majority of preterm infants, the last weeks of hospital admission mainly concerns tube feeding and establishment of breastfeeding. Neonatal home care (NH) was developed to allow infants to remain at home for tube feeding and establishment of breastfeeding with regular home visits from neonatal nurses. For hospitals covering large regions, home visits may be challenging, time consuming, and expensive and alternative approaches must be explored. Objective: To identify parental needs when wanting to provide neonatal home care supported by telemedicine. Methods: The study used participatory design and qualitative methods. Data were collected from observational studies, individual interviews, and focus group interviews. Two neonatal units participated. One unit was experienced in providing neonatal home care with home visits, and the other planned to offer neonatal home care with telemedicine support. A total of 9 parents with preterm infants assigned to a neonatal home care program and 10 parents with preterm infants admitted to a neonatal unit participated in individual interviews and focus group interviews, respectively. Results: Three overall themes were identified: being a family, parent self-efficacy, and nurse-provided security. Parents expressed desire for the following: (1) a telemedicine device to serve as a “bell cord” to the neonatal unit, giving 24-hour access to nurses, (2) video-conferencing to provide security at home, (3) timely written email communication with the neonatal unit, and (4) an online knowledge base on preterm infant care, breastfeeding, and nutrition. Conclusions: Our findings highlight the importance of neonatal home care. NH provides parents with a feeling of being a family, supports their self-efficacy, and gives them a feeling of security when combined with nursing guidance. Parents did not request hands-on support for infant care, but instead expressed a need for communication and guidance, which could be met using telemedicine.

  • Source:; CC2.0, Attribution: Giulia Forsythe.

    Using Competency-Based Digital Open Learning Activities to Facilitate and Promote Health Professions Education (OLAmeD): A Proposal


    Background: Traditional learning in medical education has been transformed with the advent of information technology. We have recently seen global initiatives to produce online activities in an effort to scale up learning opportunities through learning management systems and massive open online courses for both undergraduate and continued professional education. Despite the positive impact of such efforts, factors such as cost, time, resources, and the specificity of educational contexts restrict the design and exchange of online medical educational activities. Objective: The goal is to address the stated issues within the health professions education context while promoting learning by proposing the Online Learning Activities for Medical Education (OLAmeD) concept which builds on unified competency frameworks and generic technical standards for education. Methods: We outline how frameworks used to describe a set of competencies for a specific topic in medical education across medical schools in the United States and Europe can be compared to identify commonalities that could result in a unified set of competencies representing both contexts adequately. Further, we examine how technical standards could be used to allow standardization, seamless sharing, and reusability of educational content. Results: The entire process of developing and sharing OLAmeD is structured and presented in a set of steps using as example Urology as a part of clinical surgery specialization. Conclusions: Beyond supporting the development, sharing, and repurposing of educational content, we expect OLAmeD to work as a tool that promotes learning and sets a base for a community of medical educational content developers across different educational contexts.

  • Source and copyright: the authors.

    Optimizing Rehabilitation for Phantom Limb Pain Using Mirror Therapy and Transcranial Direct Current Stimulation: A Randomized, Double–Blind Clinical Trial...


    Background: Despite the multiple available pharmacological and behavioral therapies for the management of chronic phantom limb pain (PLP) in lower limb amputees, treatment for this condition is still a major challenge and the results are mixed. Given that PLP is associated with maladaptive brain plasticity, interventions that promote cortical reorganization such as non-invasive brain stimulation and behavioral methods including transcranial direct current stimulation (tDCS) and mirror therapy (MT), respectively, may prove to be beneficial to control pain in PLP. Due to its complementary effects, a combination of tDCS and MT may result in synergistic effects in PLP. Objective: The objective of this study is to evaluate the efficacy of tDCS and MT as a rehabilitative tool for the management of PLP in unilateral lower limb amputees. Methods: A prospective, randomized, placebo-controlled, double-blind, factorial, superiority clinical trial will be carried out. Participants will be eligible if they meet the following inclusion criteria: lower limb unilateral traumatic amputees that present PLP for at least 3 months after the amputated limb has completely healed. Participants (N=132) will be randomly allocated to the following groups: (1) active tDCS and active MT, (2) sham tDCS and active MT, (3) active tDCS and sham MT, and (4) sham tDCS and sham MT. tDCS will be applied with the anodal electrode placed over the primary motor cortex (M1) contralateral to the amputation side and the cathode over the contralateral supraorbital area. Stimulation will be applied at the same time of the MT protocol with the parameters 2 mA for 20 minutes. Pain outcome assessments will be performed at baseline, before and after each intervention session, at the end of MT, and in 2 follow-up visits. In order to assess cortical reorganization and correlate with clinical outcomes, participants will undergo functional magnetic resonance imaging (fMRI) and transcranial magnetic stimulation (TMS) before and after the intervention. Results: This clinical trial received institutional review board (IRB) approval in July of 2015 and enrollment started in December of 2015. To date 2 participants have been enrolled. The estimate enrollment rate is about 30 to 35 patients per year; thus we expect to complete enrollment in 4 years. Conclusions: This factorial design will provide relevant data to evaluate whether tDCS combined with MT is more effective than each therapy alone, as well as with no intervention (sham/sham) in patients with chronic PLP after unilateral lower limb amputation. In addition, this randomized clinical trial will help to investigate the neurophysiological mechanisms underlying the disease, which could potentially provide relevant findings for further management of this chronic condition and also help to optimize the use of this novel intervention. Trial Registration: NCT02487966; (Archived by WebCite at

  • Image Source: BRIGHT Run ~ 2014, copyright Rick Harris,,
Licensed under Creative Commons Attribution cc-by 2.0

    Protocol for Autologous Fat Grafting for Immediate Reconstruction of Lumpectomy Defects Following Surgery for Breast Cancer

    Authors List:


    Background: For women undergoing breast conservative surgery or lumpectomy for early stage breast carcinoma, there are limited options for reconstruction. Options include the use of flap surgery and/or implants, and have a significant associated morbidity and cost. Autologous fat grafting is a new alternative that can achieve a good cosmetic result, while reducing patient morbidity and cost by avoiding more extensive surgery. Objective: The primary objectives are to assess patient satisfaction using the Breast-Q questionnaire and to evaluate fat graft volume. The secondary objectives are fat survival and assessment for complication (eg, fat necrosis, cysts), local recurrence, and the number of sessions needed for a satisfactory outcome. Methods: This study is a case series of 100 patients, at a single-center institute spanning one year. The inclusion criteria include: female sex, age 18 to 75, early state breast cancer (confirmed on ultrasound/ positron emission tomography-computed tomography and cytology), amenable to breast conservative surgery, and at least 6 months post-completion of radiotherapy/ hormone/chemotherapy. Exclusion criteria include patients with more advanced stages of breast cancer necessitating total mastectomy, those unsuitable for surgical excision, and those in whom lumpectomy is not feasible. The patients will have follow-up data collected at 6 months, 12 months and 5 years post-operatively. Results: This study will begin enrolment in January 2017. We anticipate that there will be good patient satisfaction with fat grafting. The risk for long-term breast cancer recurrence hasn’t been evaluated extensively in literature, however some clinical studies have shown no increased risk of breast cancer in appropriately selected patients at one year. Although some patients may develop complications from fat grafting (eg, necrosis/cysts) this should not confuse the radiological detection of breast cancer recurrence. Conclusions: Fat grafting is proving to be a viable option for reconstruction of lumpectomy defects with good patient satisfaction. The heterogeneous methods of reporting the harvesting of fat in literature may account for the variable outcomes described, and makes it difficult to compare results with similar studies. The long-term risk of breast cancer recurrence with fat grafting for lumpectomy defects is unknown.

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  • ENHANCE—(ElectroNic Hydroxyurea AdhereNCE): An Adherence Strategy Protocol to Improve Hydroxyurea Adherence in Patients with Sickle Cell Disease

    Date Submitted: Jul 25, 2016

    Open Peer Review Period: Jul 25, 2016 - Aug 8, 2016

    Background: Hydroxyurea (HU) is the only disease-modifying medication for patients with sickle cell disease (SCD). HU can reduce SCD-related complications but only 35-50% of pediatric patients adhere...

    Background: Hydroxyurea (HU) is the only disease-modifying medication for patients with sickle cell disease (SCD). HU can reduce SCD-related complications but only 35-50% of pediatric patients adhere to HU at the rates achieved in clinical trials and this limits its clinical effectiveness. Objective: Mobile Directly Observed Therapy (Mobile DOT) is a pilot-tested, electronic, multi-dimensional HU adherence intervention that targets many components of the Health Behavior Model. The aim of this study is to evaluate the impact of Mobile DOT on HU adherence in children with SCD and the objective of this manuscript is to inform the development of future adherence interventions and pediatric SCD protocols. Methods: This is a single arm cross-over study of pediatric patients with SCD. Participants self-record videos of their daily HU administrations and receive (SMS) alerts to take HU, feedback on their HU adherence, and incentives when they achieve adherence goals during the six month Mobile DOT phase. Participants’ HU adherence during the Mobile DOT phase is compared to their baseline HU adherence (six months prior to study entry) and to their HU adherence six months after completing the Mobile DOT phase. The primary outcome of this study is HU adherence measured by medication possession ratio. Results: The trial is ongoing. Preliminary review of participant satisfaction results suggest that most participants can complete Mobile DOT in less than five minutes per day and are satisfied with the intervention. Conclusions: If effective, the Mobile DOT strategy will increase HU adherence and this could improve patients’ clinical outcomes and reduce costs of care. Clinical Trial: NCT02578017

  • Do patients with ACL reconstruction who use eHealth to support their self-management plans have equal or improved function and self-efficacy with decreased health resource use, compared to a usual care group? A feasibility study

    Date Submitted: Jul 25, 2016

    Open Peer Review Period: Jul 25, 2016 - Aug 8, 2016

    Background: Rupture of the anterior cruciate ligament (ACL) is common, especially in the active population. Most patients are managed surgically and rehabilitation is essential but the optimal way for...

    Background: Rupture of the anterior cruciate ligament (ACL) is common, especially in the active population. Most patients are managed surgically and rehabilitation is essential but the optimal way for delivering rehabilitation is not clear. This study’s purpose is to assess the feasibility of a randomised controlled trial of eHealth to support service delivery in the ACL rehabilitation population. Current methods of service delivery in the NHS struggle to cater for large volumes of patients and the lengthy time span over which rehabilitation is delivered. This study can provide insights into how to address the challenges of service provision while still improving the patient experience. ‘eHealth’ refers to the use of the internet in healthcare. The use of eHealth has been successful at delivering behaviour change to a number of diverse patient groups. An eHealth intervention called TRAK – (Taxonomy for the RehAbilitaion of Knee conditions) specifically for knee conditions to support self-management has been developed and acceptability studies have yielded positive results. TRAK is not an exercise rehabilitation package, it is an adjunct to improve self-management and behaviour change that contains an individualised exercise package. This novel platform is directly in line with current NHS England, National Institute for Health and Care Excellence and NHS Improvement agendas call for initiatives around rehabilitation using both technology and support for patients to self-manage. Given the promising results of TRAK the next stage is to address the feasibility of eHealth to support delivery of ACL rehabilitation in the NHS, based on a standard model of care. Patients’ exercise programmes and duration of treatment are still based on individual needs but use of a website or app may offer improved self-management and function and reduced health resource use. Objective: The primary objective is to assess the feasibility of undertaking an eHealth intervention RCT in the ACL population. Secondary objectives include the feasibility of collecting costings data and patient rated outcomes and to develop an RCT protocol Methods: This is a feasibility randomised controlled non-inferiority trial comparing two groups: standard care and standard care plus eHealth. It will use convergent parallel mixed methods where both qualitative and quantitative data are sought for a more thorough understanding of the objectives (52, 53). Primary outcomes relate to feasibility, including recruitment, retention and usage. Secondary outcomes relate to health resource use and patient rated outcome measures. Results: This research expects to establish the feasibility of a full scale non-inferiority randomised control trial to explore whether patients who use an eHealth intervention to support ACL rehabilitation have better or equal outcomes plus improved self efficacy and reduced health resource use than a usual care group. Conclusions: The study will provide essential information to support the development and powering of a future clinical trial of eHealth and physiotherapy for patients with ACL reconstruction in the NHS. Clinical Trial: N/A

  • High Touch and High Tech (HT2): Transforming Patient Engagement Throughout the Continuum of Care by Engaging Patients with Portal Technology at the Bedside

    Date Submitted: Jul 18, 2016

    Open Peer Review Period: Jul 19, 2016 - Aug 2, 2016

    For patients with complex care needs, engagement in disease management activities is critical. Chronic illnesses touch almost every person in the U.S. The costs are real, personal and pervasive. In re...

    For patients with complex care needs, engagement in disease management activities is critical. Chronic illnesses touch almost every person in the U.S. The costs are real, personal and pervasive. In response, patients often seek tools to help them manage their health. Patient portals -- a Personal Health Record tethered to an Electronic Health Record -- show promise as tools that patients value and that can improve health. Although patient portals currently focus on the outpatient experience, the Ohio State University Wexner Medical Center has deployed a portal designed specifically for the inpatient experience that is connected to the ambulatory patient portal available after discharge. While this inpatient technology is in active use at only one other hospital in the U.S., healthcare facilities are currently investing in infrastructure necessary to support large-scale deployment. Times of acute crisis such as hospitalization may increase a patient’s focus on his/her health. During this time, patients may be more engaged with their care and especially interested in using tools to manage their health after discharge. Evidence shows that enhanced patient self-management can lead to better control of chronic illness. Patient portals may serve as a mechanism to facilitate increased engagement. Our proposed four-year study uses a mixed-methods approach to evaluate a randomized controlled trial studying the effectiveness of a High Tech Intervention (MyChart Bedside, the inpatient portal), and an accompanying High Touch Intervention (training patients to use the portal to manage their care and conditions) in a sample of hospitalized patients with two or more chronic conditions. This study measures how access to a patient portal tailored to the inpatient stay can improve patient experience and increase patient engagement by 1) improving patients’ perceptions of the process of care while in the hospital, 2) increasing patients’ self-efficacy for managing chronic conditions, and 3) facilitating continued use of a patient portal for care management after discharge. In addition, we aim to enhance patients’ use of the portal available to outpatients, MyChart Ambulatory, once they are discharged. Our specific aims are: 1. To study the independent effects of providing both High Tech and High Touch interventions on patient-reported outcomes at discharge, including patients’ self-efficacy for managing chronic conditions and satisfaction with care. 2. To conduct a mixed-methods analysis to determine how providing patients with access to MCB (High Tech) and training/education on patient portals and MCA (High Touch) will influence engagement with the patient portal and relate to longer-term outcomes. Providing patients real-time access to health information can be a positive force for change in the way care is provided. Meaningful Use policies require minimum demonstrated use of patient portal technology, most often in the ambulatory setting. However, as the technology matures to bridge the care transition, there is a greater need to understand how patient portals transform care delivery. By working in concert with patients to address and extend current technologies, our study aims to advance efforts to increase patients’ engagement in their care and develop a template for how other hospitals might integrate similar technologies.

  • The effects of e-mental health program and job coaching on the risk of major depression and productivity in Canadian male workers: Protocol for a randomized controlled trial

    Date Submitted: Jul 18, 2016

    Open Peer Review Period: Jul 19, 2016 - Aug 2, 2016

    Background: Background: Major depression (MDE) is prevalent in men and affects men’s health and productivity. Because of the stigma against depression and social/gender norms, men are less likely to...

    Background: Background: Major depression (MDE) is prevalent in men and affects men’s health and productivity. Because of the stigma against depression and social/gender norms, men are less likely to seek help for emotion and stress-related issues. Therefore, innovative solutions tailored for men are needed. With rapid development of the Internet and information technologies, one promising solution that has drawn considerable attentions is e-mental health programs and services. Objective: Objectives: To evaluate the effectiveness of an e-mental health program (BroHealth) on reducing the risk of having major depression, improving productivity and return to investment. Methods: Methods: The target population are Canadian working men who are at high risk of having major depression (N = 1200). Participants will be recruited using the method of random digit dialing across the country and workplace advertisement. Eligible participants will be randomly allocated into three groups: 1) a control group, 2) a group receiving BroHealth only, and 3) a group receiving BroHealth and telephone-based job coaching service. The groups will be assessed at 6- and 12-month after randomization. Results: Results: This study has been approved by the Conjoint Health Research Ethics Review Board of the University of Calgary. The trial is funded by a team grant from the Movember Foundation, a global charity for men’s health. BroHealth was developed at the Digital Health Office, University of British Columbia, and the usability testing has been completed. The proposed trial is registered at (registration number: NCT02777112). Conclusions: Conclusions: BroHealth was developed based on men’s needs. We hypothesis that BroHealth will be an effective, acceptable and sustainable product for early prevention of depression in workplaces. Clinical Trial: registration number: NCT02777112