NCT03404245

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

Empowering Active Self-management of Arthritis: Raising the Bar With OPERAS (an On-demand Program to EmpoweR Active Self-management)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 132 (actual)
• Sponsor: University of British Columbia · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

Self-management is a fundamental component in arthritis care, however, it is often neglected as most models of arthritis care focus on early access to medical consultation and surgical interventions. Patient self-management refers to the active participation of patients in a variety of activities that contribute to lessening the physical and emotional impact of illnesses. There are several factors attributing to a lack of self-management practice, such as frustration from managing health on a trial-and-error basis, a lack of knowledge to effectively monitor symptoms and disease, and being unsure about how to manage physical activities without aggravating symptoms. The variety of risk factors highlight the need for a multifaceted approach that provides support in terms of knowledge, skill development and timely advice from health professionals, as well as motivational support for patients to be engaged in their care and to stay physically active. Our primary objective is to assess the efficacy of an e-health intervention, OPERAS, which integrates the Arthritis Health Journal and a Physical Activity Counselling program, to improve self-management ability. Our secondary objectives are to explore the effect of the intervention on disease status and physical activity levels and to assess barriers to implementation and sustainability of the e-health intervention in (rheumatoid arthritis) RA management. The investigators will use a mixed-methods approach, involving a randomized controlled trial (RCT) and in-depth interviews. The proof-of-concept study will employ a stepped wedge RCT design, whereby the intervention will be sequentially rolled out to participants over a number of time periods. The order in which individuals receive the intervention will be determined at random. The strength of this design is that it can properly address the efficacy question, while avoiding the dilemma of withholding the intervention to some participants, as in a parallel group design.

Conditions

• Joint Disease
• Rheumatoid Arthritis

Interventions

Type	Name	Description
BEHAVIORAL	Education, Fitbit/self-management app, physiotherapist counselling.	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.
BEHAVIORAL	Same intervention with a 6 month delay	The Delayed Intervention Group will receive the same intervention as the Immediate Intervention Group, but with a 6 month delay.

Timeline

• Start date: 2019-01-23
• Primary completion: 2022-12-30
• Completion: 2023-01-31
• First posted: 2018-01-19
• Last updated: 2026-02-13
• Results posted: 2026-02-13

Locations

1 site across 1 country: Canada