A technology-enabled Counselling program versus a delayed treatment control to support physical activity participation in people with inflammatory arthritis: study protocol for the OPAM-IA randomized controlled trial

Linda C Li, Lynne M Feehan, Chris Shaw, Hui Xie, Eric C Sayre, Antonio Aviña-Zubeita, Navi Grewal, Anne F Townsend, Diane Gromala, Greg Noonan, Catherine L Backman, Linda C Li, Lynne M Feehan, Chris Shaw, Hui Xie, Eric C Sayre, Antonio Aviña-Zubeita, Navi Grewal, Anne F Townsend, Diane Gromala, Greg Noonan, Catherine L Backman

Abstract

Background: Being physically active is an essential component of successful self-management for people with inflammatory arthritis; however, the vast majority of patients are inactive. This study aims to determine whether a technology-enabled counselling intervention can improve physical activity participation and patient outcomes.

Methods: The Effectiveness of Online Physical Activity Monitoring in Inflammatory Arthritis (OPAM-IA) project is a community-based randomized controlled trial with a delayed control design. We will recruit 130 people with rheumatoid arthritis or systemic lupus erythematosus, who can be physically active without health professional supervision. Randomization will be stratified by diagnosis. In Weeks 1-8, participants in the Immediate Group will: 1) receive education and counselling by a physical therapist (PT), 2) use a Fitbit and a new web-based application, FitViz, to track and obtain feedback about their physical activity, 3) receive 4 biweekly follow-up calls from the PT. Those in the Delayed Group will receive the same program in Week 10. We will interview a sample of participants about their experiences with the intervention. Participants will be assessed at baseline, and Weeks 9, 18 and 27. The primary outcome measure is time spent in moderate/vigorous physical activity in bouts of ≥ 10 min, measured with a portable multi-sensor device in the free-living environment. Secondary outcomes include step count, time in sedentary behaviour, pain, fatigue, mood, self-management capacity, and habitual behaviour.

Discussion: A limitation of this study is that participants, who also administer the outcome measures, will not be blinded. Nonetheless, by customizing existing self-monitoring technologies in a patient-centred manner, individuals can be coached to engage in an active lifestyle and monitor their performance. The results will determine if this intervention improves physical activity participation. The qualitative interviews will also provide insight into a paradigm to integrate this program to support self-management.

Trial registration: Date of last update in ClinicalTrials.gov: September 18, 2015. ClinicalTrials.gov Identifier: NCT02554474.

Keywords: Arthritis; Behavioural interventions; Counselling; Physical activity; Wearables.

Conflict of interest statement

Dr. Linda Li is supported by the Harold Robinson/Arthritis Society Chair in Arthritic Diseases award, the Canada Research Chair Program, and the Michael Smith Foundation for Health Research (MSFHR) Scholar Award. Dr. Hui Xie is supported by the Maureen and Milan Ilich / Merck Chair in Statistics for Arthritis and Musculoskeletal Diseases award. Dr. Antonio Aviña-Zubeita is supported the BC Lupus Association Scholar Award and the MSFHR Scholar Award. Dr. Diane Gromala is supported by the Canada Research Chair Program.The research protocol has been approved by the University of British Columbia Clinical Research Ethics Board (H15–01843), and published in ClinicalTials.gov (NCT02554474). Written consent will be obtained from all participants.Not applicable.The authors declare that they have no competing interests.Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

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Fig. 1
CONSORT flow diagram

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