A novel smartphone application integrated with wearable devices for knee osteoarthritis clinical trials: a feasibility study

• Grant number: 18/07462-3
• Support Opportunities: Scholarships abroad - Research Internship - Doctorate (Direct)
• Effective date (Start): September 01, 2018
• Effective date (End): August 31, 2019
• Field of knowledge: Health Sciences - Physiotherapy and Occupational Therapy
• Principal Investigator: Tania de Fatima Salvini
• Grantee: Lucas Ogura Dantas
• Supervisor: Timothy E. McAlindon
• Host Institution: Centro de Ciências Biológicas e da Saúde (CCBS). Universidade Federal de São Carlos (UFSCAR). São Carlos , SP, Brazil
• Research place: Tufts University, United States
• Associated to the scholarship: 15/21422-6 - The effect of cryotherapy in pain control, function and quality of life in individuals with knew osteoarthritis: randomized clinical trial, BP.DD

Abstract

Knee osteoarthritis (KOA) is a prevalent and costly chronic musculoskeletal condition associated with pain and disability. Clinical guidelines emphasize that a combination of non-pharmacological treatments, including patient education, exercise and lifestyle changes; associated with pharmacological treatments are recommended for an optimal nonsurgical approach. However, changing patient's behavior outside the clinical environment, remains a challenge. Advancements in the use of portable technologies to support rehabilitation, could offer new opportunities to increase treatment effectiveness, outside the clinical setting. Mobile health apps have been shown to be useful tools to promote behavioral change, improve patient's health outcomes and lifestyle. The use of mobile applications associated with wearable devices could offer the possibility to record quantitative data, to track and analyze patients for more accurate objective measures. Thus, the goal of this study is to verify the feasibility of a new mobile application in individuals with symptomatic knee osteoarthritis. Methods/Design: This will be an un-blinded, two-arm, randomized controlled trial (RCT), with a stepped-wedge design that will last 8 weeks. The study will be performed at Tufts Medical Center, Boston, Massachusetts, USA; between September 2018 to September 2019 and will be approved by the Institutional Review Board of Tufts Medical Center. Moreover, it will be registered on ClinicalTrials.gov. This study will focus on assessing recruitment capability and resulting sample characteristics, data collection procedures and outcome measures, acceptability of the intervention and study procedures, resources and ability to manage and implement the study and intervention, and preliminary evaluation of participant responses to the intervention. The primary outcome will be wearable device objective measures of physical activity data. The secondary outcomes of interest will be a Numeric Rating Scale (NRS) and, the Western Ontario & McMaster Universities Osteoarthritis questionnaire (WOMAC) and sleep measures. The new mobile application will run on both Android and iOS mobile operating systems and will be integrated with wearable devices. It will allow researchers to add/remove information such as scales, questionnaires or physical functional tests. All the individuals will be asked to wear a wearable device 24 hours/day, 7 days/week (unless charging) for the intervention period of the study to monitor daily activities and other important data. A convenience sample will be determined to allow the estimates of the feasibility measures and the analyses will be performed by a blinded biostatistician. (AU)