JMIR Publications

Recent Articles:

• 

  RCTs - Protocols/Proposals (eHealth)

  Jul 3, 2020

  COVID-19 Modifications for Remote Teleassessment and Teletraining of a Complementary Alternative Medicine Intervention for People With Multiple Sclerosis:...

  View Authors View Abstract

  Authors List:

  • Byron Lai  
  • Chia-Ying Chiu  
  • Emily Pounds  
  • Tracy Tracy  
  • Tapan Mehta  
  • Hui-Ju Young  
  • Emily Riser  
  • James Rimmer  

  Abstract:

  Background: Access to comprehensive exercise and rehabilitation services for people with multiple sclerosis (MS) remains a major challenge, especially in rural, low-income areas. Hence, the Tele-Exercise and Multiple Sclerosis (TEAMS) study aims to provide patient-centered, coordinated care by implementing a 12-week complementary and alternative medicine (CAM) intervention for adults with MS. However, due to the societal impact of coronavirus disease (COVID-19) in mid-March 2020, the University of Alabama at Birmingham announced a limited business model halting all nonessential research requiring on-site visits, which includes the TEAMS study. Objective: In compliance with the shelter-in-place policy and quarantine guidance, a modified testing and training protocol was developed to allow participants to continue the study. Methods: The modified protocol, which replaces on-site data collection and training procedures, includes a teleassessment package (computer tablet, blood pressure cuff, hand dynamometer, mini disc cone, measuring tape, an 8” step, and a large-print 8” × 11” paper with ruler metrics and wall-safe tape) and a virtual meeting platform for synchronous interactive training between the therapist and the participant. The teleassessment measures include resting blood pressure and heart rate, grip strength, Five Times Sit to Stand, Timed Up & Go, and the Berg Balance Scale. The teletraining component includes 20 sessions of synchronous training sessions of dual tasking, yoga, and Pilates exercises designed and customized for a range of functional levels. Teletraining lasts 12 weeks and participants are instructed to continue exercising for a posttraining period of 9 months. Results: The protocol modifications were supported with supplemental funding (from the Patient-Centered Outcomes Research Institute) and approved by the University Institutional Review Board for Human Use. At the time nonessential research visits were halted by the university, there were 759 people enrolled and baseline tested, accounting for 92.5% of our baseline testing completion target (N=820). Specifically, 325 participants completed the 12-week intervention and follow-up testing visits, and 289 participants needed to complete either the intervention or follow-up assessments. A modified analysis plan will include sensitivity analyses to ensure the robustness of the study results in the presence of uncertainty and protocol deviations. Study results are projected to be published in 2021. Conclusions: This modified remote teleassessment/teletraining protocol will impact a large number of participants with MS who would otherwise have been discontinued from the study. Trial Registration: ClinicalTrials.gov NCT03117881; https://clinicaltrials.gov/ct2/show/NCT03117881

  • JMIR Res Protoc 2020;9(7):e18415

  • Choose one of the following formats:

  • Share this article:

    Or, copy the article link to your clipboard:

    Article URL

  • Citation

    • END

      for: Endnote

    • BibTeX

      for: BibDesk and LaTeX

    • RIS

      for: RefMan, Procite, Endnote, RefWorks

    Add this article to your Mendeley library Add this article to your CiteULike library Copy Citation to Clipboard

  • Metrics

    Discover Social Media mentions by hovering over the donut. Click the 'details' link for a full report.

• 

  Systematic Review Protocols

  Jul 1, 2020

  Guideline Recommendations for Oral Care After Acquired Brain Injury: Protocol for a Systematic Review

  View Authors View Abstract

  Authors List:

  • Nalia Gurgel-Juarez  
  • Marie-France Perrier  
  • Tammy Hoffmann  
  • Natasha Lannin  
  • Laura Jolliffe  
  • Rachel Lee  
  • Lucie Brosseau  
  • Heather Flowers  

  Abstract:

  Background: Oral care is important to prevent buccal and systemic infections after an acquired brain injury (ABI). Despite recent advancements in the development of ABI clinical practice guidelines, recommendations for specific clinical processes and actions to attain adequate oral care often lack information. Objective: This systematic review will (1) identify relevant ABI clinical practice guidelines and (2) appraise the oral care recommendations existing in the selected guidelines. Methods: A search strategy was developed based on a recent systematic review of clinical practice guidelines for ABI. The protocol includes a search of MEDLINE, EMBASE, and DynaMed Plus databases, as well as organizational and best-practice websites and reference lists of accepted guidelines. Search terms will include medical subject headings and user-defined terms. Guideline appraisal will involve the Appraisal of Guidelines for Research and Evaluation II ratings, followed by a descriptive synopsis for oral care recommendations according to the National Health and Medical Research Council evidence levels. Results: This project started in April 2019, when we developed the search strategy. The preliminary search of databases and websites yielded 863 and 787 citations, respectively, for a total of 1650 citations. Data collection will start in August 2020 and we expect to begin disseminating the results in May 2021. Conclusions: Nursing staff may not have detailed recommendations on how to provide oral care for neurologically impaired patients. The findings of this review will explore the evidence for oral care in existing guidelines and improve outcomes for patients with ABI. We expect to provide adequate orientations to clinicians, inform policy and guidelines for best practices, and contribute to future directions for research in the ABI realm.

  • JMIR Res Protoc 2020;9(7):e17249

  • Choose one of the following formats:

  • Share this article:

    Or, copy the article link to your clipboard:

    Article URL

  • Citation

    • END

      for: Endnote

    • BibTeX

      for: BibDesk and LaTeX

    • RIS

      for: RefMan, Procite, Endnote, RefWorks

    Add this article to your Mendeley library Add this article to your CiteULike library Copy Citation to Clipboard

  • Metrics

    Discover Social Media mentions by hovering over the donut. Click the 'details' link for a full report.

• 

  Non-randomized Protocols and Methods...

  Jul 1, 2020

  Prospective Study Evaluating a Pain Assessment Tool in a Postoperative Environment: Protocol for Algorithm Testing and Enhancement

  View Authors View Abstract

  Authors List:

  • Emad Kasaeyan Naeini  
  • Mingzhe Jiang  
  • Elise Syrjälä  
  • Michael-David Calderon  
  • Riitta Mieronkoski  
  • Kai Zheng  
  • Nikil Dutt  
  • Pasi Liljeberg  
  • Sanna Salanterä  
  • Ariana M Nelson  
  • Amir M Rahmani  

  Abstract:

  Background: Assessment of pain is critical to its optimal treatment. There is a high demand for accurate objective pain assessment for effectively optimizing pain management interventions. However, pain is a multivalent, dynamic, and ambiguous phenomenon that is difficult to quantify, particularly when the patient’s ability to communicate is limited. The criterion standard of pain intensity assessment is self-reporting. However, this unidimensional model is disparaged for its oversimplification and limited applicability in several vulnerable patient populations. Researchers have attempted to develop objective pain assessment tools through analysis of physiological pain indicators, such as electrocardiography, electromyography, photoplethysmography, and electrodermal activity. However, pain assessment by using only these signals can be unreliable, as various other factors alter these vital signs and the adaptation of vital signs to pain stimulation varies from person to person. Objective pain assessment using behavioral signs such as facial expressions has recently gained attention. Objective: Our objective is to further the development and research of a pain assessment tool for use with patients who are likely experiencing mild to moderate pain. We will collect observational data through wearable technologies, measuring facial electromyography, electrocardiography, photoplethysmography, and electrodermal activity. Methods: This protocol focuses on the second phase of a larger study of multimodal signal acquisition through facial muscle electrical activity, cardiac electrical activity, and electrodermal activity as indicators of pain and for building predictive models. We used state-of-the-art standard sensors to measure bioelectrical electromyographic signals and changes in heart rate, respiratory rate, and oxygen saturation. Based on the results, we further developed the pain assessment tool and reconstituted it with modern wearable sensors, devices, and algorithms. In this second phase, we will test the smart pain assessment tool in communicative patients after elective surgery in the recovery room. Results: Our human research protections application for institutional review board review was approved for this part of the study. We expect to have the pain assessment tool developed and available for further research in early 2021. Preliminary results will be ready for publication during fall 2020. Conclusions: This study will help to further the development of and research on an objective pain assessment tool for monitoring patients likely experiencing mild to moderate pain.

  • JMIR Res Protoc 2020;9(7):e17783

  • Choose one of the following formats:

  • Share this article:

    Or, copy the article link to your clipboard:

    Article URL

  • Citation

    • END

      for: Endnote

    • BibTeX

      for: BibDesk and LaTeX

    • RIS

      for: RefMan, Procite, Endnote, RefWorks

    Add this article to your Mendeley library Add this article to your CiteULike library Copy Citation to Clipboard

  • Metrics

    Discover Social Media mentions by hovering over the donut. Click the 'details' link for a full report.

• 

  RCTs - Protocols/Proposals (eHealth)

  Jun 29, 2020

  Physical Activity With Tailored mHealth Support for Individuals With Intellectual Disabilities: Protocol for a Randomized Controlled Trial

  View Authors View Abstract

  Authors List:

  • Henriette Michalsen  
  • Silje Camilla Wangberg  
  • Gunnar Hartvigsen  
  • Letizia Jaccheri  
  • Miroslav Muzny  
  • André Henriksen  
  • Monica Isabel Olsen  
  • Gyrd Thrane  
  • Reidun Birgitta Jahnsen  
  • Gunn Pettersen  
  • Cathrine Arntzen  
  • Audny Anke  

  Abstract:

  Background: Individuals with intellectual disabilities (IDs) have lower levels of physical activity (PA) and greater barriers for participation in fitness activities compared with members of the general population. As increased PA has positive effects on cardiovascular and psychosocial health, it is exceedingly important to identify effective interventions for use in everyday settings. Mobile health (mHealth) methods such as motion sensor games (exergames) and smartphone reminders for PA have been explored and found to be promising in individuals with IDs. Objective: The purpose of this study is to examine the effectiveness of an individually tailored PA program with motivational mHealth support on daily levels of PA in youth and adults with IDs. Methods: The trial uses a randomized controlled design comprising 30 intervention participants and 30 control group participants, aged 16 to 60 years, with sedentary lifestyles or low PA levels. While the controls will receive standard care, the intervention aims to increase the level of PA, measured as steps per day, as the primary outcome. Secondary outcome variables are body mass index, blood pressure, physical performance, social support for PA, self-efficacy in a PA setting, behavior problems, and goal attainment. The intervention involves the delivery of tailored mHealth support, using smartphones or tablets to create structure with focus on the communicative abilities of individual participants. Rewards and feedback are provided in order to motivate individuals to increase participation in PA. Participants in the intervention group, their close relatives, and care staff will be invited to participate in a preintervention goal-setting meeting, where goal attainment scaling will be used to select the participants’ PA goals for the intervention period. All participants will be assessed at baseline, at 3 months, and at 6 months. Results: Enrollment was planned to start in April 2020 but will be delayed due to the pandemic situation. The main contribution of this paper is a detailed plan to run our study, which will produce new knowledge about tailored mHealth to support PA in individuals with intellectual disabilities. Conclusions: We expect the new intervention to perform better than standard care in terms of improved PA, improved self-efficacy, and social support for activities. Technology offers new opportunities to promote healthy behaviors. The results of the study will determine the effectiveness and sustainability of a tailored mHealth support intervention to increase PA in youth and adults with IDs. Trial Registration: ClinicalTrials.gov NCT04079439; https://clinicaltrials.gov/ct2/show/NCT04079439

  • JMIR Res Protoc 2020;9(6):e19213

  • Choose one of the following formats:

  • Share this article:

    Or, copy the article link to your clipboard:

    Article URL

  • Citation

    • END

      for: Endnote

    • BibTeX

      for: BibDesk and LaTeX

    • RIS

      for: RefMan, Procite, Endnote, RefWorks

    Add this article to your Mendeley library Add this article to your CiteULike library Copy Citation to Clipboard

  • Metrics

    Discover Social Media mentions by hovering over the donut. Click the 'details' link for a full report.

• 

  Non-randomized Protocols and Methods...

  Jun 26, 2020

  A Telerehabilitation Intervention for Youths With Arthrogryposis Multiplex Congenita: Protocol for a Pilot Study

  View Authors View Abstract

  Authors List:

  • Marianne Gagnon  
  • Jessica Collins  
  • Caroline Elfassy  
  • Gabriela Marino Merlo  
  • Jacquelyn Marsh  
  • Bonita Sawatzky  
  • Rita Yap  
  • Reggie Hamdy  
  • Louis-Nicolas Veilleux  
  • Noémi Dahan-Oliel  

  Abstract:

  Background: Arthrogryposis multiplex congenita (AMC) is characterized by joint contractures present in at least two body areas. In addition to these contractures, individuals with AMC can have decreased muscle mass, leading to limitations in activities of daily living. Exercise has the potential to maintain or improve the range of motion and muscle strength. However, this type of intervention necessitates frequent follow ups that are currently difficult to provide for youths with AMC because they often live far from a specialized hospital. To overcome this distance challenge, telecommunication technologies can be used to deliver rehabilitation remotely, which is called telerehabilitation. The study protocol for one such type of rehabilitation will be presented in this paper. Objective: This pilot study aims to (1) evaluate the feasibility of using telerehabilitation to provide a home exercise program for youths with AMC, and (2) assess the effectiveness of a home exercise program. Methods: A total of 10 youths aged 8-21 years with AMC will be recruited. The intervention consists of a 12-week individualized home-based exercise program delivered remotely using telerehabilitation. At baseline, youths will complete the Physical Activity Questionnaire for Adolescents and the Pediatrics Outcomes Data Collection Instrument to assess pain, function, and level of physical activity. During the first telerehabilitation meeting, the rehabilitation therapists will measure range of motion using a virtual goniometer and assess the youth’s functional level. The therapists will then use the Goal Attainment Scale to set objectives and develop the individualized intervention. Follow ups will occur every 3 weeks to make sure exercises are performed safely and to progress the exercises when needed. At the end of the 12-week intervention, rehabilitation therapists will re-evaluate the youth using the same outcome measures as the initial evaluation. The youths will be asked to complete the same questionnaires, with the addition of questions about their satisfaction regarding the intervention. Nonparametric and descriptive statistics will be used to evaluate the feasibility and effectiveness. Results: Ethics approval was obtained in October 2018. Recruitment and data collection started in January 2019 and was completed in May 2020. Conclusions: This pilot study will help us learn how a large-scale project may work in practice to improve outcomes in physical activity, pain, and function, and goal attainment among youths with AMC, thus informing a future clinical trial.

  • JMIR Res Protoc 2020;9(6):e18688

  • Choose one of the following formats:

  • Share this article:

    Or, copy the article link to your clipboard:

    Article URL

  • Citation

    • END

      for: Endnote

    • BibTeX

      for: BibDesk and LaTeX

    • RIS

      for: RefMan, Procite, Endnote, RefWorks

    Add this article to your Mendeley library Add this article to your CiteULike library Copy Citation to Clipboard

  • Metrics

    Discover Social Media mentions by hovering over the donut. Click the 'details' link for a full report.

• 

  RCTs - Protocols/Proposals (non-eHealth)

  Jun 26, 2020

  Interactive Guidance Intervention to Address Sustained Social Withdrawal in Preterm Infants in Chile: Protocol for a Randomized Controlled Trial

  View Authors View Abstract

  Authors List:

  • Jorge Bustamante Loyola  
  • Marcela Perez Retamal  
  • Monica Isabel Morgues Nudman  
  • Andres Maturana  
  • Ricardo Salinas Gonzalez  
  • Horacio Cox  
  • José Miguel González Mas  
  • Lucia Muñoz  
  • Lilian Lopez  
  • Andrés Mendiburo-Seguel  
  • Sandra Simó  
  • Pascual Palau Subiela  
  • Antoine Guedeney  

  Abstract:

  Background: Preterm newborns can be exposed early to significant perinatal stress, and this stress can increase the risk of altered socioemotional development. Sustained social withdrawal in infants is an early indicator of emotional distress which is expressed by low reactivity to the environment, and if persistent, is frequently associated with altered psychological development. Infants born prematurely have a higher probability of developing sustained social withdrawal (adjusted odds ratio 1.84, 95% CI 1.04-3.26) than infants born full term, and there is a correlation between weight at birth and sustained social withdrawal at 12 months of age. Objective: The aims of this study are to compare the effect of the interactive guidance intervention to that of routine pediatric care on sustained social withdrawal in infants born moderately or late preterm and to explore the relationship between sustained social withdrawal in these infants and factors such as neonatal intensive care unit hospitalization variables, parental depression, and posttraumatic stress symptoms. Methods: This study is designed as a multicenter randomized controlled trial. Moderate and late preterm newborns and their parents were recruited and randomized (1:1 allocation ratio) to control and experimental groups. During neonatal intensive care unit hospitalization, daily duration of skin-to-skin contact, breastfeeding, and parental visits were recorded. Also, a daily score for neonatal pain and painful invasive procedures were recorded. After discharge from neonatal intensive care, for the duration of the study, both groups will attend follow-up consultations with neonatologists at 2, 6, and 12 months of age (corrected for gestational age) and will receive routine pediatric care. Every consultation will be recorded and assessed with the Alarm Distress Baby Scale to detect sustained social withdrawal (indicated by a score of 5 or higher). The neonatologists will perform an interactive guidance intervention if an infant in the intervention group exhibits sustained social withdrawal. In each follow-up consultation, parents will fill out the Edinburgh Postnatal Depression Scale, the modified Perinatal Posttraumatic Stress Disorder Questionnaire, and the Impact of Event Scale–revised. Results: Recruitment for this trial started in September 2017. As of May 2020, we have completed enrollment (N=110 infants born moderately or late preterm). We aim to publish the results by mid-2021. Conclusions: This is the first randomized controlled trial with a sample of infants born moderately or late preterm infants who will attend pediatric follow-up consultations during their first year (corrected for gestational age at birth) with neonatologists trained in the Alarm Distress Baby Scale and who will receive this interactive guidance intervention. If successful, this early intervention will show significant potential to be implemented in both public and private health care, given its low cost of training staff and that the intervention takes place during routine pediatric follow-up. Trial Registration: ClinicalTrials.gov NCT03212547; https://clinicaltrials.gov/ct2/show/NCT03212547.

  • JMIR Res Protoc 2020;9(6):e17943

  • Choose one of the following formats:

  • Share this article:

    Or, copy the article link to your clipboard:

    Article URL

  • Citation

    • END

      for: Endnote

    • BibTeX

      for: BibDesk and LaTeX

    • RIS

      for: RefMan, Procite, Endnote, RefWorks

    Add this article to your Mendeley library Add this article to your CiteULike library Copy Citation to Clipboard

  • Metrics

    Discover Social Media mentions by hovering over the donut. Click the 'details' link for a full report.

• 

  RCTs - Pilots/Feasibility Studies...

  Jun 26, 2020

  Improving the Lifestyle of Adolescents Through Peer Education and Support in Vietnam: Protocol for a Pilot Cluster Randomized Controlled Trial

  View Authors View Abstract

  Authors List:

  • Hong K Tang  
  • Ngoc-Minh Nguyen  
  • Michael J Dibley  
  • Trang H H D Nguyen  
  • Ashraful Alam  

  Abstract:

  Background: In Ho Chi Minh City, Vietnam, recent studies found a rapid increase in overweight and obesity in adolescents. There is a need for effective health promotion interventions to support healthy diets and encourage a physically active lifestyle. This study will help fill an evidence gap on effective interventions to prevent excess weight gain in adolescents and generate new insights about peer-led education to promote healthy lifestyles. Objective: We aim to assess the feasibility and acceptability of a combined peer-led and peer support intervention among junior high school students in Ho Chi Minh City. Additionally, the efficacy of the intervention on adolescents’ dietary practices and time spent on physical activity will also be measured in this pilot study. Methods: The Peer Education and Peer Support (PEPS) project is a pilot cluster randomized controlled trial with 2 intervention and 2 control schools. The intervention consists of 4 weekly education sessions of why and how to choose healthy food and drinks and how to be more physically active. Additionally, the intervention includes a school-based and online support system to help maintain student engagement during the intervention. We will use in-depth interviews with students, peer leaders, teachers, and parents; focus group discussions with peer educators; and direct observation of the school environment and peer leaders’ interactions with the students. Acceptability and feasibility of the intervention will be assessed. We will also quantitatively assess limited efficacy by measuring changes in student’ physical activity levels and dietary behaviors. Results: We delivered the peer education intervention at the start of each school year over 3 months for all new grade 6 adolescents in the selected schools, followed by peer support and home engagement activities over 6 months until the end of the school year. There was a baseline assessment and 2 post-intervention assessments: the first immediately after the intervention to assess the short-term impact and the second at the end of the school year to assess the sustained impact on changes in adiposity, diet, and physical activity. Conclusions: The findings of this study will be used to develop a larger-scale cluster randomized controlled trial to examine the impact of a multicomponent, school- and home-based health promotion intervention. The trial will use innovative peer education methods to reduce overweight and obesity and improve dietary choices and physical activity levels in Vietnamese adolescents. Clinical Trial: Australian New Zealand Clinical Trials Registry ACTRN12619000421134; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=376690&isReview=true

  • JMIR Res Protoc 2020;9(6):e15930

  • Choose one of the following formats:

  • Share this article:

    Or, copy the article link to your clipboard:

    Article URL

  • Citation

    • END

      for: Endnote

    • BibTeX

      for: BibDesk and LaTeX

    • RIS

      for: RefMan, Procite, Endnote, RefWorks

    Add this article to your Mendeley library Add this article to your CiteULike library Copy Citation to Clipboard

  • Metrics

    Discover Social Media mentions by hovering over the donut. Click the 'details' link for a full report.

• 

  RCTs - Protocols/Proposals (eHealth)

  Jun 25, 2020

  Evaluation of the Clinical and Economic Effects of a Primary Care Anchored, Collaborative, Electronic Health Lifestyle Coaching Program in Denmark: Protocol...

  View Authors View Abstract

  Authors List:

  • Carl J Brandt  
  • Jeanette Reffstrup Christensen  
  • Jørgen T Lauridsen  
  • Jesper Bo Nielsen  
  • Jens Søndergaard  
  • Camilla Sortsø  

  Abstract:

  Background: Obesity is linked to a number of chronic health conditions, such as type 2 diabetes, heart disease, and cancer, and weight loss interventions are often expensive. Recent systematic reviews concluded that app and web-based interventions can improve lifestyle behaviors and weight loss at a reasonable cost, but long-term sustainability needs to be demonstrated. Objective: This study protocol is for a 2-year randomized controlled trial that aims to evaluate the clinical and economic effects of a primary care, anchored, collaborative, electronic health (eHealth) lifestyle coaching program (long-term Lifestyle change InterVention and eHealth Application [LIVA] 2.0) in obese participants with and without type 2 diabetes. The program’s primary outcome is weight loss. Its secondary outcome is the hemoglobin A_1c (HbA_1c) level, and its tertiary outcomes are retention rate, quality of life (QOL), and cost effectiveness. Analytically, the focus is on associations of participant characteristics with outcomes and sustainability. Methods: We conduct a multicenter trial with a 1-year intervention and 1-year retention. LIVA 2.0 is implemented in municipalities within administrative regions in Denmark, specifically eight municipalities located within the Region of Southern Denmark and two municipalities located within the Capital Region of Denmark. The participants are assessed at baseline and at 6-, 12-, and 24-month follow-ups. Individual data from the LIVA 2.0 platform are combined with clinical measurements, questionnaires, and participants’ usage of municipality and health care services. The participants have a BMI ≥30 but ≤45 kg/m2, and 50% of the participants have type 2 diabetes. The participants are randomized in an approximately 60:40 manner, and based on sample size calculations on weight loss and intention-to-treat statistics, 200 participants are randomized to an intervention group and 140 are randomized to a control group. The control group is offered the conventional preventive program of the municipality, and it is compared to the intervention group, which follows the LIVA 2.0 in addition to the conventional preventive program. Results: The first baseline assessments have been carried out in March 2018, and the 2-year follow-up will be carried out between March 2020 and April 2021. The hypothesis is that the trial results will demonstrate decreased body weight and that the number of patients who show normalization of their HbA_1c levels in the intervention group will be much higher than that in the control group. The participants in the intervention group are also expected to show a greater decrease in their use of glucose-lowering medication and a greater improvement in their QOL when compared with the control group. Operational costs are expected to be lower than standard care, and the intervention is expected to be cost-effective. Conclusions: This is the first time that an app and web-based eHealth lifestyle coaching program implemented in Danish municipalities will be clinically and economically evaluated. If the LIVA 2.0 eHealth lifestyle coaching program is proven to be effective, there is great potential for decreasing the rates of obesity, diabetes, and related chronic diseases. Trial Registration: ClinicalTrials.gov NCT03788915; https://clinicaltrials.gov/ct2/show/NCT03788915

  • JMIR Res Protoc 2020;9(6):e19172

  • Choose one of the following formats:

  • Share this article:

    Or, copy the article link to your clipboard:

    Article URL

  • Citation

    • END

      for: Endnote

    • BibTeX

      for: BibDesk and LaTeX

    • RIS

      for: RefMan, Procite, Endnote, RefWorks

    Add this article to your Mendeley library Add this article to your CiteULike library Copy Citation to Clipboard

  • Metrics

    Discover Social Media mentions by hovering over the donut. Click the 'details' link for a full report.

• 

  RCTs - Protocols/Proposals (funded,...

  Jun 25, 2020

  Determining the Impact of a School-Based Health Education Package for Prevention of Intestinal Worm Infections in the Philippines: Protocol for a Cluster...

  View Authors View Abstract

  Authors List:

  • Mary Lorraine S Mationg  
  • Gail M Williams  
  • Veronica L Tallo  
  • Remigio M Olveda
  • Eindra Aung  
  • Portia Alday  
  • Mark Donald Reñosa  
  • Chona Mae Daga  
  • Jhoys Landicho  
  • Maria Paz Demonteverde  
  • Eunice Dianne Santos  
  • Thea Andrea Bravo  
  • Franziska A Angly Bieri  
  • Yuesheng Li  
  • Archie C A Clements  
  • Peter Steinmann  
  • Kate Halton  
  • Donald E Stewart  
  • Donald P McManus  
  • Darren J Gray  

  Abstract:

  Background: Repeated mass drug administration (MDA) of antihelminthics to at-risk populations is still the main strategy for the control of soil-transmitted helminth (STH) infections. However, MDA, as a stand-alone intervention, does not prevent reinfection. Accordingly, complementary measures to prevent STH reinfection, such as health education and improved sanitation, as part of an integrated control approach, are required to augment the effectiveness of MDA for optimal efficiency and sustainability. Objective: The aim of this study is to determine the impact and generalizability of a school-based health education package entitled The Magic Glasses for STH prevention in the Philippines. Methods: We conducted a cluster randomized controlled intervention trial, involving 2020 schoolchildren aged 9-10 years, in 40 schools in Laguna Province, Philippines, to evaluate the impact of the school-based health education package for the prevention of STHs. The trial was conducted over the course of 1 year (June 2016 to July 2017). A total of 20 schools were randomly assigned to the intervention arm, in which The Magic Glasses Philippines health education package was delivered with the standard health education activities endorsed by the Philippines Department of Health (DOH) and the Department of Education (DepEd). The other 20 schools comprised the control arm of the study, where the DOH/DepEd’s standard health education activities were done. At baseline, parasitological assessments and a knowledge, attitude, and practice survey were carried out in all schools. In addition, height, weight, and hemoglobin levels were obtained from each child (after parental consent), and their school attendance and academic performance in English and mathematics were accessed from the school records. The baseline and 2 follow-up surveys were completed using the same study measurements and quality-control assessments. Results: Key results from this cluster randomized intervention trial will shed light on the impact that The Magic Glasses health education package will have against STH infections in schoolchildren in the province of Laguna, located on the Island of Luzon, in the Calabarzon Region of the Philippines. Conclusions: The results of the trial will be used to assess the generalizability of the impact of The Magic Glasses health education package in different epidemiological and cultural settings, providing evidence for translation of this health education package into public health policy and practice in the Asian region and beyond. Trial Registration: Australian New Zealand Clinical Trials Registry number ACTRN12616000508471; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=368849

  • JMIR Res Protoc 2020;9(6):e18419

  • Choose one of the following formats:

  • Share this article:

    Or, copy the article link to your clipboard:

    Article URL

  • Citation

    • END

      for: Endnote

    • BibTeX

      for: BibDesk and LaTeX

    • RIS

      for: RefMan, Procite, Endnote, RefWorks

    Add this article to your Mendeley library Add this article to your CiteULike library Copy Citation to Clipboard

  • Metrics

    Discover Social Media mentions by hovering over the donut. Click the 'details' link for a full report.

• 

  RCTs - Protocols/Proposals (funded,...

  Jun 24, 2020

  Remote Monitoring Telemedicine (REMOTE) Platform for Patients With Anxiety Symptoms and Alcohol Use Disorder: Protocol for a Case-Control Study

  View Authors View Abstract

  Authors List:

  • Núria Pastor  
  • Elizabeth Khalilian  
  • Elsa Caballeria  
  • Danielle Morrison  
  • Unai Sanchez Luque  
  • Silvia Matrai  
  • Antoni Gual  
  • Hugo López-Pelayo  

  Abstract:

  Background: Monitoring mental health outcomes has traditionally been based on heuristic decisions, often based on scarce, subjective evidence, making the clinical decisions made by professionals, as well as the monitoring of these diseases, subject to flaws. However, the digital phenotype, which refers to the analysis of data collected by measuring human behavior with mobile sensors and smart bracelets, is a promising tool for filling this gap in current clinical practice. Objective: The objectives of this study are to develop the digital phenotyping of patients with alcohol use disorder and anxiety symptoms using data collected from a mobile device (ie, smartphone) and a wearable sensor (ie, Fitbit) and to analyze usability and patient satisfaction with the data collection service provided by the app. Methods: We propose to conduct a study among a group of 60 participants split into two subgroups—experimental and control—of 30 participants each. The experimental group will be recruited by physicians from the Hospital Clínic de Barcelona, and the control group will be recruited on a volunteer basis through fliers and social media. All participants will go through pretraining to ensure technological capability and understanding of tasks, then each participant will download the HumanITcare app and will be given a wearable sensor (ie, Fitbit). Throughout the 4-month period, participants will be monitored on a range of factors, including sleep cycle, heart rate, movement patterns, and sociability. All data from the wearable sensors and the mobile devices will be saved and sent to the HumanITcare server. Participants will be asked to complete weekly questionnaires about anxiety, depression, and alcohol use disorder symptoms. Research assistants will ensure timely responses. The data from both sensors will then be compared to the questionnaire responses to determine how accurately the devices can predict the same symptoms. Results: The recruitment phase was completed in November 2019 and all the data were collected by the end of December 2019. Data are being processed; this process is expected to be completed by October 2020. Conclusions: This study was created and conducted as a pilot study with the Hospital Clínic de Barcelona, with the purpose of exploring the feasibility of our approach. The study is focused on patients diagnosed with anxiety and alcohol use disorder, but participants were also monitored for depressive symptoms throughout the trial, although these were not part of the initial inclusion criteria. A limitation to our study was the exclusive use of Android smartphones over iOS devices; this could result in a potential selection bias, due to the accessibility and affordability of Android phones as opposed to iOS-based phones. Another limitation might be that reviews of usability and satisfaction could be confounded by factors such as age and familiarity. An additional function that we might add in future studies is the ability for patients to manage their own data.

  • JMIR Res Protoc 2020;9(6):e16964

  • Choose one of the following formats:

  • Share this article:

    Or, copy the article link to your clipboard:

    Article URL

  • Citation

    • END

      for: Endnote

    • BibTeX

      for: BibDesk and LaTeX

    • RIS

      for: RefMan, Procite, Endnote, RefWorks

    Add this article to your Mendeley library Add this article to your CiteULike library Copy Citation to Clipboard

  • Metrics

    Discover Social Media mentions by hovering over the donut. Click the 'details' link for a full report.

• 

  RCTs - Protocols/Proposals (eHealth)

  Jun 24, 2020

  Guided Internet-Based Cognitive Behavioral Therapy in Japanese Patients With Obsessive-Compulsive Disorder: Protocol for a Randomized Controlled Trial

  View Authors View Abstract

  Authors List:

  • Kazuki Matsumoto  
  • Sayo Hamatani  
  • Takuya Makino  
  • Taku Uemura  
  • Futoshi Suzuki  
  • Seina Shinno  
  • Tomoki Ikai  
  • Hiroyuki Hayashi  
  • Chihiro Sutoh  
  • Eiji Shimizu  

  Abstract:

  Background: Cognitive behavioral therapy for obsessive-compulsive disorder has been established, but access to this therapy in Japan is limited. Internet-based cognitive behavioral therapy may improve treatment accessibility and sufficiently improve obsessive-compulsive symptoms. There are few randomized controlled trials examining the effectiveness of internet-based cognitive behavioral therapy in patients with obsessive-compulsive disorder. We designed a randomized controlled trial protocol to assess the effectiveness of guided internet-based cognitive behavioral therapy in Japanese patients with obsessive-compulsive disorder. Objective: We aimed to develop a protocol for a randomized controlled trial of internet-based cognitive behavioral therapy in Japanese patients with obsessive-compulsive disorder. Methods: The randomized controlled trial will compare internet-based cognitive behavioral therapy treatment and usual care groups, each consisting of 15 participants (n=30) diagnosed with obsessive-compulsive disorder. We will evaluate the effectiveness of a 12-week intervention. The primary outcome of symptom severity will be measured using the Yale-Brown Obsessive-Compulsive Scale. Secondary outcomes will be assessed with the Obsessive-Compulsive Inventory, Beck Anxiety Inventory, Patient Health Questionnaire-9, Generalized Anxiety Disorder-7, Working Alliance Inventory-Short Form, and the Euro Qol – 5 Dimension. All measures will be assessed at weeks 0 (baseline) and 12 (follow-up). In the statistical analysis comparing treatment effects, the least-squares means and their 95% CIs will be estimated by analysis of covariance with the change in total outcomes scores at week 12. All comparisons are planned, and all P values will be two-sided, with values <.05 considered statistically significant. Results: The study will be performed from January 2020 to March 2021, and results are expected to be available in mid-2021. Conclusions: The trial will demonstrate whether internet-based cognitive behavioral therapy improves access and is more effective than more usual care for patients with obsessive-compulsive disorder in Japan. Clinical Trial: University Hospital Medical Information Network (UMIN) 000039375; https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000044422

  • JMIR Res Protoc 2020;9(6):e18216

  • Choose one of the following formats:

  • Share this article:

    Or, copy the article link to your clipboard:

    Article URL

  • Citation

    • END

      for: Endnote

    • BibTeX

      for: BibDesk and LaTeX

    • RIS

      for: RefMan, Procite, Endnote, RefWorks

    Add this article to your Mendeley library Add this article to your CiteULike library Copy Citation to Clipboard

  • Metrics

    Discover Social Media mentions by hovering over the donut. Click the 'details' link for a full report.

• 

  Non-randomized Protocols and Methods...

  Jun 24, 2020

  Intersectoral Cooperation in 12 European Case Studies Aiming for Better Health, Environmental Sustainability, and Health Equity: Protocol for a Qualitative...

  View Authors View Abstract

  Authors List:

  • Nina van der Vliet  
  • Lea Den Broeder  
  • María Romeo-Velilla  
  • Hanneke Kruize  
  • Brigit Staatsen  
  • Jantine Schuit  

  Abstract:

  Background: The INHERIT (INtersectoral Health and Environment Research for InnovaTion) project has evaluated intersectoral cooperation (IC) in 12 European case studies attempting to promote health, environmental sustainability, and equity through behavior and lifestyle changes. These factors are the concerns of multiple sectors of government and society. Cooperation of health and environmental sectors with other sectors is needed to enable effective action. IC is thus essential to promote a triple win of health, sustainability, and equity. Objective: This paper describes the design of a qualitative study to gain insights into successful organization of IC, facilitators and barriers, and how future steps can be taken to improve IC in the evaluated case studies. Methods: Each case study was assessed qualitatively through a focus group. A total of 12 focus groups in 10 different European countries with stakeholders, implementers, policymakers, and/or citizens were held between October 2018 and March 2019. Five to eight participants attended each focus group. The focus group method was based on appreciative inquiry, which is an asset-based approach focusing on what works well, why it is working well, and how to strengthen assets in the future. A stepped approach was used, with central coordination and analysis, and local implementation and reporting. Local teams were trained to apply a common protocol using a webinar and handbook on organizing, conducting, and reporting focus groups. Data were gathered in each country in the local language. Translated data were analyzed centrally using deductive thematic analysis, with consideration of further emerging themes. Analyses involved the capability, opportunity, motivation-behavior (COM-b) system to categorize facilitators and barriers into capability, motivation, or opportunity-related themes, as these factors influence the behaviors of individuals and groups. Web-based review sessions with representatives from all local research teams were held to check data analysis results and evaluate the stepped approach. Results: Data collection has been completed. A total of 76 individuals participated in 12 focus groups. In December 2019, data analysis was nearly complete, and the results are expected to be published in fall 2020. Conclusions: This study proposes a stepped approach that allows cross-country focus group research using a strict protocol while dealing with language and cultural differences. The study generates insights into IC processes and facilitators in different countries and case studies to filter out which facilitators are essential to include. Simultaneously, the approach can strengthen cooperation among stakeholders by looking at future cooperation possibilities. By providing knowledge on how to plan for, improve, and sustain IC successfully to deal with today’s multisectoral challenges, this study can contribute to better intersectoral action for the triple win of better health, sustainability, and equity. This protocol can serve as a tool for other researchers who plan to conduct cross-country qualitative research.

  • JMIR Res Protoc 2020;9(6):e17323

  • Choose one of the following formats:

  • Share this article:

    Or, copy the article link to your clipboard:

    Article URL

  • Citation

    • END

      for: Endnote

    • BibTeX

      for: BibDesk and LaTeX

    • RIS

      for: RefMan, Procite, Endnote, RefWorks

    Add this article to your Mendeley library Add this article to your CiteULike library Copy Citation to Clipboard

  • Metrics

    Discover Social Media mentions by hovering over the donut. Click the 'details' link for a full report.