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Ongoing Trials, Grant Proposals, Formative Research, Methods, Early Results
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 2016: 5.175)
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)
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Background: forward head and round shoulder posture is believed to alter scapular kinematics and muscle activity placing increased stress on the shoulder, leading to shoulder pain and dysfunction. Obj...
Background: forward head and round shoulder posture is believed to alter scapular kinematics and muscle activity placing increased stress on the shoulder, leading to shoulder pain and dysfunction. Objective: The purpose of this study was to evaluate the effect of a six-week combined treatment consisting of manual therapy and stabilizing exercises, with a one-month follow-up, on neck pain with forward head and rounded shoulder postures. Methods: A total of 60 women aged 32-42 years of age with neck pain, and forward head and rounded shoulder postures were randomized into three groups: group 1 performed stabilizing exercises and received manual therapy (n=20), group 2 performed stabilizing exercises (n=20), and group 3 (control group) performed home exercises (n=20) over six weeks.The follow-up time was one month after the post test. The craniocervical and rounded shoulder angles, pain, and function were measured before and after six-week interventions, and a one-month follow- up. Results: The results showed significant positive changes within the experimental groupsin all variables, but there were minor changes in the control group in all variables before and after the intervention. Also, there were significant function and pain improvement in the experimental group 1 comparing to group 2. There were no differences between post intervention and one-month follow-up on posture and function in the experimental groups. Conclusions: These findings suggest that both interventions were significantly effective for reducing neck pain, and improving function and posture in patients with chronic neck pain, and forward head and rounded shoulder postures. However, the improvement in function and pain was more effective in group 1 than those of group 2 suggesting that manual therapy can be used as a supplement method to the stabilizing intervention in the treatment of neck pain. More research is needed to confirm the result of this study.
Background: Traditionally pre and post-operative information for patients undergoing a hip replacement has been provided by paper based patient information. eHealth programs to support individualised...
Background: Traditionally pre and post-operative information for patients undergoing a hip replacement has been provided by paper based patient information. eHealth programs to support individualised patient preoperative preparation, in-patient and home rehabilitation have potential to increase patient engagement, enhance patient recovery and reduce potential post-operative complications. Objective: The aim of this study is to compare an eHealth program versus standard care on patient outcomes for primary total hip replacement. Methods: One hundred patients undergoing a primary elective total hip replacement will be recruited from a metropolitan hospital in Western Australia to participate in a six-month parallel, non-inferiority randomized control trial. Participants randomized to the standard care group (n=50) will be given the education booklet and enrolled to attended a one-hour education session. The intervention group (n=50) will receive the same as the standard care plus access to an eHealth program titled ‘My Hip Journey’. The eHealth program encourages the patient to log in daily, from two weeks prior to surgery to thirty days’ post-surgery. The information on the platform aligns with the patient's journey including the exercises to be completed each day. The primary outcome measure is the Hip Dysfunction and Osteoarthritis Outcome Score version LK 2.0. Secondary outcome measures include the EuroQoL EQ-5D-5L, a 5-level 5-dimension quality of life measure, and the Self-Efficacy for Managing Chronic Disease Scale. Data will be collected pre-admission, and at six weeks, three months and six months’ post-surgery. A patient satisfaction survey will be completed six weeks’ post-surgery and web-based analytics will be collected at six months’ post-surgery. A cost-effectiveness analysis, using intention-to-treat, will be conducted from the hospital’s perspective. Results: N/A Conclusions: This study will compare the outcomes and cost of using an eHealth program to support a patient’s recovery from a hip replacement, with standard care. If the eHealth program is found to be effective, further implementation across clinical practice could lead to improvement in patient outcomes and other surgical areas could be incorporated. Clinical Trial: Australian New Zealand Clinical Trial Registry ACTRN12617001433392, registered on 10th October, 2017.
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Background: While electronic medication administration record (eMAR) systems have been implemented in settings where nurses work, nursing students commonly lack robust learning opportunities to practi...
Background: While electronic medication administration record (eMAR) systems have been implemented in settings where nurses work, nursing students commonly lack robust learning opportunities to practice the skills and workflow of digitalized medication administration during their formative education. As a result, nursing student performance administering medication facilitated by technology is often poor. Serious gaming has been recommended as a possible intervention to improve nursing students’ performance with electronic medication administration in nursing education. Objective: The objectives of this study are to examine whether the use of a gamified electronic medication administration simulator: (1) improves nursing students’ attention to medication administration safety within simulated practice; (2) increases student self-efficacy and knowledge of the medication administration process; and, (3) improves motivational and cognitive processing attributes related to student learning in a technology-enabled environment. Methods: This study is comprised of the development of a gamified electronic medication administration record simulator, and its evaluation in two phases. Phase one consists of a prospective, pragmatic randomized controlled trial with second year baccalaureate nursing students at a Canadian university. Phase two consists of qualitative focus group interviews with a cross-section of nursing student participants. Results: The gamified medication administration simulator has been developed, and data collection is currently underway. Conclusions: If the gamified electronic medication administration simulator is found to be effective, it could be used to support other health professional simulated education and scaled more widely in nursing education programs. Clinical Trial: https://clinicaltrials.gov/show/NCT03219151
Background: A significant part of neurological rehabilitation focuses on facilitating the learning of motor skills. Training can adopt either (more) explicit or (more) implicit forms of motor learning...
Background: A significant part of neurological rehabilitation focuses on facilitating the learning of motor skills. Training can adopt either (more) explicit or (more) implicit forms of motor learning. Gait is one of the most practiced motor skills within rehabilitation in people after stroke, since it is an important criterion for discharge and requirement for functioning at home. Objective: To describe the design of a randomised controlled study assessing the effects of implicit compared to explicit motor learning in gait rehabilitation of people suffering from stroke. Methods: The study adopts a randomised, controlled, single blinded study design. People after stroke will be eligible for participation when they are in the chronic stage of recovery (>6 months after stroke), would like to improve walking performance, have a slow walking speed (<10 m/s), can communicate in Dutch, and complete a 3-stage command. People will be excluded if they cannot walk a minimum of 10 meters, or have other additional impairments that (severely) influence gait. Participants will receive nine gait training sessions over a three-week period and will be randomly allocated to an implicit or explicit group. Therapists are aware of the intervention they provide, the assessors are blind to the intervention participants receive. Outcome will be assessed, at baseline (T0), directly after the intervention (T1) and after one month (T2). The primary outcome parameter is walking velocity. Walking performance will be assessed with the 10 Meter Walking Test, Dynamic Gait Index and while performing a secondary task (dual task). Self-reported measures are the Movement Specific Reinvestment Scale, Verbal Protocol, Stroke and Aphasia Quality of Life Scale, and the Global Perceived Effect scale. A process evaluation will take place to identify how the therapy was perceived and identify factors that may have influenced the effectiveness of the intervention. Statistical analysis will be conducted to determine significant and clinical relevant differences between groups and over time. Results: Data collection is currently ongoing and results are expected in 2019. Conclusions: The relevance of the study as well as the advantages and disadvantages of several aspects of the chosen design are discussed e.g. personalised approach and choice of measurements. Clinical Trial: NTR6272
Background: Although many mHealth interventions have shown efficacy in research, few have been effectively implemented and sustained in real-world health system settings. Despite this programmatic gap...
Background: Although many mHealth interventions have shown efficacy in research, few have been effectively implemented and sustained in real-world health system settings. Despite this programmatic gap, there is limited conclusive evidence identifying the factors that affect the implementation and successful integration of mHealth into a health system. Objective: The purpose of this study is to examine the individual, organizational and external level factors associated with the successful implementation of WelTel, mHealth intervention designed to support outpatient medication adherence and engagement in care in Africa and North America. Methods: We will adapt the Consolidated Framework for Implementation Research (CFIR) constructs for evaluation of digital healthcare implementation including a scoring and monitoring system. We will apply the adapted tool to identify facilitators and barriers to implementation of the WelTel mHealth intervention in order to determine how the technology platform is perceived, diffused, adapted and used by different mHealth project teams and health system actors in Africa and North America. We will utilize a mixed-methods approach to quantitatively test whether the factors identified in the CFIR framework are associated with the successful uptake of the mHealth intervention toward implementation goals. We will triangulate these data through interviews with project stakeholders, exploring factors associated with successful implementation and sustainment of these interventions. Results: The results of this study will provide an in-depth understanding of individual- and organizational-level factors that influence the successful implementation of mHealth in different health systems and geographic contexts over time. Via the tool’s unique scoring system connected to qualitative descriptors, these data will inform the most critical implementation targets and contribute to the tailoring of strategies that will assist the health system in overcoming barriers to implementation, and ultimately, improve treatment adherence and engagement in care. Conclusions: The results of this study will provide an in-depth understanding of individual- and organizational-level factors that influence the successful implementation of mHealth in different health systems and geographic contexts over time. Via the tool’s unique scoring system connected to qualitative descriptors, these data will inform the most critical implementation targets and contribute to the tailoring of strategies that will assist the health system in overcoming barriers to implementation, and ultimately, improve treatment adherence and engagement in care.
The Specialised Services Pathway for Severe Asthma (NHS Commissioning Board, 2012/2013) recognises the burden of uncontrolled disease, ordinarily amenable to anti-inflammatory medications and the prog...
The Specialised Services Pathway for Severe Asthma (NHS Commissioning Board, 2012/2013) recognises the burden of uncontrolled disease, ordinarily amenable to anti-inflammatory medications and the progression to longer term ‘severe’ disease necessitating high-cost therapies (e.g. Bronchial Thermoplasty). The identification and appropriate referral to a specialist asthma service is often delayed by several months or years due to poor recognition and understanding of symptom severity. Current severe asthma services may take several months to provide a comprehensive multi-disciplinary assessment often necessitating multiple hospital visits and costing up to £5000 per patient. MISSION – Modern Innovative Solutions to Improve Outcomes in Severe Asthma is a novel service model pilot developed by asthma specialists from Portsmouth and Southampton asthma services. MISSION Severe Asthma identified patients with poorly controlled disease from General Practice (GP) databases who had not been under secondary outpatient care in the last 12 months or who were not known to secondary care. In one-or two-stop assessments, a thorough review of diagnosis, disease phenotype and control is undertaken. This Protocol outlines a mixed methods study to assess the impact on disease control, unscheduled healthcare usage and quality of life in patients seen in the MISSION clinic compared to a closely matched cohort who declined to attend.