an On-demand Program to EmpoweR Active Self-management (OPERAS)

Sponsor
University of British Columbia
Study ID
NCT03404245
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Education, Fitbit/self-management app, physiotherapist counselling. — BEHAVIORAL
    Participants will receive a brief education session, use a physical activity tracker Fitbit Flex paired with a self-management app, and remote counseling by a PT. Intervention will be received immediately.
  • Same intervention with a 6 month delay — BEHAVIORAL
    The Delayed Intervention Group will receive the same intervention as the Immediate Intervention Group, but with a 6 month delay.

Study Details

Self-management is a key component of successful chronic disease management and patients can benefit from learning about how daily activities and treatments relate to their symptoms and health status on an ongoing basis. The primary goal of this randomized controlled trial is to assess the efficacy of an e-health intervention, OPERAS, which includes two components: 1) the use of a newly developed web app to self-monitor symptoms/disease activity and treatment use, and help patients identify when a medical visit or treatment change is needed; 2) remote activity counselling provided by a physiotherapist, with the use of a wearable device (Fitbit) and the app to provide activity level feedback. The app component of OPERAS is hosted by the secure network of Arthritis Research Canada.

Key Dates

Start date
Jan 23, 2019
Status verified
Jan 2026
Primary completion
Dec 30, 2022
Completion
Jan 31, 2023

Study Design

Enrollment
132 participants (actual)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE

Arms

  • Active Comparator: Immediate Intervention Group
    Education, Fitbit/self-management web app, physiotherapist counselling. These 3 components will be delivered to the participants in Months 1 and 2. The session will include a short presentation about physical activity in everyday life, an individual goal-setting session with a registered physical therapist (PT), and an orientation to the Fitbit device and the web app. Participants will be provided access to a Fitbit and an app account. The PT will review physical activity goals with participants via bi-weekly phone calls and progressively modify their activities. In Month 3-6, participants will continue using Fitbit and the app and have access to a PT via email as needed, but no phone call. In Months 7-12, participants may keep their Fitbit and app account, but will not have access to a PT.
  • Placebo Comparator: Delayed Intervention Group
    Same intervention with a 6 month delay: The full intervention will be initiated in Month 7 and 8 with a brief education session, use of a Fitbit paired with the self-management web app, and counseling by a physical therapist (PT). In Month 9-12, participants will continue the intervention without the PT phone calls, but will have email access to PT, if needed.

Primary Outcome Measure

Patient Activation Measure [ Time Frame: Baseline, 27 weeks, 53 weeks ]

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