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View (E39) Richard Ofori-Asenso, Ella Zomer, Andrea Curtis, Andrew Tonkin, Mark Nelson, Manoj Gambhir, Danny Liew, Sophia Zoungas JMIR Research Protocols Ongoing Trials, Grant Proposals, Formative Research, Methods, Early Results Volume 6 (2017), Issue 3 ISSN: 1929-0748 Contents Protocols Telerehabilitation Versus Traditional Care Following Total Hip Replacement: A Randomized Controlled Trial Protocol (e34) Mark Nelson, Michael Bourke, Kay Crossley, Trevor Russell. 3 Bioengineered Temporomandibular Joint Disk Implants: Study Protocol for a Two-Phase Exploratory Randomized Preclinical Pilot Trial in 18 Black Merino Sheep (TEMPOJIMS) (e37) David Ângelo, Florencio Monje, Raúl González-García, Christopher Little, Lisete Mónico, Mário Pinho, Fábio Santos, Belmira Carrapiço, Sandra Gonçalves, Pedro Morouço, Nuno Alves, Carla Moura, Yadong Wang, Eric Jeffries, Jin Gao, Rita Sousa, Lia Neto, Daniel Caldeira, Francisco Salvado. 12 Home-Based Intervention Program to Reduce Food Insecurity in Elderly Populations Using a TV App: Study Protocol of the Randomized Controlled Trial Saúde.Come Senior (e40) Ana Rodrigues, Maria Gregório, Pierre Gein, Mónica Eusébio, Maria Santos, Rute de Sousa, Pedro Coelho, Jorge Mendes, Pedro Graça, Pedro Oliveira, Jaime Branco, Helena Canhão. 22 Writing for Health: Rationale and Protocol for a Randomized Controlled Trial of Internet-Based Benefit-Finding Writing for Adults With Type 1 or Type 2 Diabetes (e42) Joanna Crawford, Kay Wilhelm, Lisa Robins, Judy Proudfoot. 36 Automated Adherence Reminders for High Risk Children With Asthma: A Research Protocol (e48) Sarah Adams, Michelle Leach, Chris Feudtner, Victoria Miller, Chén Kenyon. 52 Effectiveness of a 16-Week Multimodal Exercise Program on Individuals With Dementia: Study Protocol for a Multicenter Randomized Controlled Trial (e35) Sandra Trautwein, Andrea Scharpf, Bettina Barisch-Fritz, Christina Niermann, Alexander Woll. 61 Protocol for Combined Analysis of FOXFIRE, SIRFLOX, and FOXFIRE-Global Randomized Phase III Trials of Chemotherapy +/- Selective Internal Radiation Therapy as First-Line Treatment for Patients With Metastatic Colorectal Cancer (e43) Pradeep Virdee, Joanna Moschandreas, Val Gebski, Sharon Love, E Francis, Harpreet Wasan, Guy van Hazel, Peter Gibbs, Ricky Sharma. 77 Supporting the Delivery of Total Knee Replacements Care for Both Patients and Their Clinicians With a Mobile App and Web-Based Tool: Randomized Controlled Trial Protocol (e32) M Hussain, Jane Li, Emily Brindal, Yasmin van Kasteren, Marlien Varnfield, Andrew Reeson, Shlomo Berkovsky, Jill Freyne. 88 JMIR Research Protocols 2017 | vol. 6 | iss. 3 | p.1 XSL·FO RenderX Innovations in the Management of Musculoskeletal Pain With Alpha-Lipoic Acid (IMPALA Trial): Study protocol for a Double-Blind, Randomized, Placebo-Controlled Crossover Trial of Alpha-Lipoic Acid for the Treatment of Fibromyalgia Pain (e41) Ian Gilron, Dongsheng Tu, Ronald Holden, Tanveer Towheed, Dan Ziegler, Louie Wang, Roumen Milev, Christopher Gray. 101 Patterns and Predictors of Adherence to Statin Therapy Among Older Patients: Protocol for a Systematic Review (e39) Richard Ofori-Asenso, Ella Zomer, Andrea Curtis, Andrew Tonkin, Mark Nelson, Manoj Gambhir, Danny Liew, Sophia Zoungas. 111 Enhancing mHealth Technology in the Patient-Centered Medical Home Environment to Activate Patients With Type 2 Diabetes: A Multisite Feasibility Study Protocol (e38) Ronald Gimbel, Lu Shi, Joel Williams, Cheryl Dye, Liwei Chen, Paul Crawford, Eric Shry, Sarah Griffin, Karyn Jones, Windsor Sherrill, Khoa Truong, Jeanette Little, Karen Edwards, Marie Hing, Jennie Moss. 131 Biometrics and Policing: A Protocol for Multichannel Sensor Data Collection and Exploratory Analysis of Contextualized Psychophysiological Response During Law Enforcement Operations (e44) Robert Furberg, Travis Taniguchi, Brian Aagaard, Alexa Ortiz, Meghan Hegarty-Craver, Kristin Gilchrist, Ty Ridenour. 147 Workability and Muscle Strength in Patients With Seropositive Rheumatoid Arthritis: Survey Study Protocol (e36) Carolin Berner, Ludwig Erlacher, Michael Quittan, Karl Fenzl, Thomas Dorner. 167 Gender-Specific Combination HIV Prevention for Youth in High-Burden Settings: The MP3 Youth Observational Pilot Study Protocol (e22) Jasmine Buttolph, Irene Inwani, Kawango Agot, Charles Cleland, Peter Cherutich, James Kiarie, Alfred Osoti, Connie Celum, Jared Baeten, Ruth Nduati, John Kinuthia, Timothy Hallett, Ramzi Alsallaq, Ann Kurth. 176 Original Papers A Personal Electronic Health Record: Study Protocol of a Feasibility Study on Implementation in a Real-World Health Care Setting (e33) Dominik Ose, Aline Kunz, Sabrina Pohlmann, Helene Hofmann, Markus Qreini, Johannes Krisam, Lorenz Uhlmann, Christian Jacke, Eva Winkler, Hans-Joachim Salize, Joachim Szecsenyi. 120 Get+Connected: Development and Pilot Testing of an Intervention to Improve Computer and Internet Attitudes and Internet Use Among Women Living With HIV (e50) Gabriela Seplovich, Keith Horvath, Lorlette Haughton, Oni Blackstock. 158 Implementation of a Home Monitoring System for Heart Failure Patients: A Feasibility Study (e46) Martin Kohn, Jeffrey Haggard, Jack Kreindler, Kade Birkeland, Ilan Kedan, Raymond Zimmer, Raj Khandwalla. 193 Use of the Total Cancer Care System to Enrich Screening for CD30-Positive Solid Tumors for Patient Enrollment Into a Brentuximab Vedotin Clinical Trial: A Pilot Study to Evaluate Feasibility (e45) Bin Li, Steven Eschrich, Anders Berglund, Melissa Mitchell, David Fenstermacher, Hadi Danaee, Hongyue Dai, Daniel Sullivan, William Trepicchio, William Dalton. 201 Internet-based Self-Management Support for Patients With Well-Controlled Type 2 Diabetes: A Real-Life Study (e47) Huberta Hart, Inge Geilen, Elke de Leeuw, Guy Rutten, Rimke Vos. 214 JMIR Research Protocols 2017 | vol. 6 | iss. 3 | p.2 XSL·FO RenderX JMIR RESEARCH PROTOCOLS Nelson et al Protocol Telerehabilitation Versus Traditional Care Following Total Hip Replacement: A Randomized Controlled Trial Protocol Mark Nelson1, B Phty; Michael Bourke2, B Phty, PhD; Kay Crossley3, B Phty, PhD; Trevor Russell2, B Phty, PhD 1Physiotherapy Department, Queen Elizabeth II Jubilee Hospital, Brisbane, Australia 2School of Health and Rehabilitation Sciences, University of Queensland, Brisbane, Australia 3La Trobe Sport and Exercise Medicine Research Centre, College of Science, Health and Engineering, La Trobe University, Melbourne, Australia Corresponding Author: Mark Nelson, B Phty Physiotherapy Department Queen Elizabeth II Jubilee Hospital Cnr Kessels and Troughton Roads, Coopers Plains Brisbane, Australia Phone: 61 431673389 Fax: 61 0731826579 Email: [email protected] Abstract Background: Total hip replacement (THR) is the gold standard treatment for severe hip osteoarthritis. Effectiveness of physical rehabilitation for THR patients following discharge from hospital is supported by evidence; however, barriers such as geographical location and transport can limit access to appropriate health care. One solution to this issue is using an alternative model of care using telerehabilitation technology to deliver rehabilitation programs directly into patients' homes. A telerehabilitation model may also have potential health care cost savings for health care providers. Objective: This study aims to determine if a telerehabilitation model of care delivered remotely is as effective as face-to-face rehabilitation in the THR population and cost effective for health care providers and patients. Methods: A total of 70 people undergoing THR will be recruited to participate in a randomized, single-blind, controlled noninferiority clinical trial. The trial will compare a technology-based THR rehabilitation program to in-person care. On discharge from hospital, participants randomized to the in-person group will receive usual care, defined as a paper home exercise program (HEP) targeting strengthening exercises for quadriceps, hip abductors, extensors, and flexors; they will be advised to perform their HEP 3 times per day. At 2, 4, and 6 weeks postoperatively, they will receive a 30-minute in-person physiotherapy session with a focus on gait retraining and reviewing and progressing their HEP. The telerehabilitation protocol will involve a program similar in content to the in-person rehabilitation program, except delivery will be directly into the homes of the participants via telerehabilitation technology on an iPad. Outcomes will be evaluated preoperatively, day of discharge from in-patient physiotherapy, 6 weeks and 6 months postoperatively. The primary outcome will be the quality of life subscale of the hip disability and osteoarthritis outcome score, measured at 6 weeks. Both intention-to-treat and per-protocol analyses as recommended in the extension of the Consolidated Standards for Reporting Trials (CONSORT) guideline for noninferiority trials will be performed. Results: Recruitment commenced in September 2015 and is expected to be completed by June 2017. Data collection will be completed by December 2017. It is anticipated the results from this trial will be published by July 2018. Conclusions: Previous research investigating telerehabilitation in postoperative orthopedic conditions has yielded promising results. If shown to be as effective as in-person care, telerehabilitation after THR could be helpful in addressing access issues in this population. Furthermore, it may help reduce the cost of health care provision by enabling patients to take a more independent approach to their rehabilitation. Trial Registration: Australian New Zealand Clinical Trials Registry ACTRN12615000824561; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=364010
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