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

NCT03404245 | Completed Results

• 1 other identifier: H17-03424
• Study Type: interventional
• Target: 132
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Joint Disease; Rheumatoid Arthritis

Keywords

Physical Activity; Exercise; Rheumatoid; Arthritis; Self-management; Symptoms

Outcome Measures

Primary Outcomes (1)

• Patient Activation Measure

  Patient Activation Measure is a 13-item self-reported measure of individuals' confidence in managing chronic diseases. Each item has a 4-point response (1 "strongly disagree"; 4 "strongly agree"), with the aggregate raw score converted to 0-100. Hibbard et al presented a 4-stage activation model derived from the standardized scores: 1) Believing an active role is important (PAM score \<47); 2) Having confidence and knowledge to take action (47.1 - 55.1); 3) Taking action (55.2 - 67); 4) Maintaining healthy behaviours despite setbacks (\> 67.1).

  Baseline, 27 weeks, 53 weeks

Secondary Outcomes (9)

• Rheumatoid Arthritis Disease Activity Index

  Baseline, 27 weeks, 53 weeks

• McGill Pain Questionnaire

  Baseline, 27 weeks, 52 weeks

• Fatigue Severity Scale

  Baseline, 27 weeks, 53 weeks

• The Patient Health Questionnaire-9 (PHQ-9)

  Baseline, 27 weeks, 53 weeks

• The Self-Reported Habit Index (SRHI) - Sitting at Work Index

  Baseline, 27 weeks, 52 weeks

Study Arms (2)

Immediate Intervention Group

ACTIVE COMPARATOR

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.

Behavioral: Education, Fitbit/self-management app, physiotherapist counselling.

Delayed Intervention Group

PLACEBO COMPARATOR

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.

Behavioral: Same intervention with a 6 month delay

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.

Immediate Intervention Group

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.

Delayed Intervention Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• a physician confirmed diagnosis of RA
• no joint surgery in the past 6 months
• no history of acute injury to any joints in the past 6 months
• an email address and daily access to a computer or mobile device.

You may not qualify if:

• people who should not be physically active without medical supervision.

Sponsors & Collaborators

• University of British Columbia: lead
• Simon Fraser University: collaborator
• Arthritis Research Centre of Canada: collaborator
• Vancouver General Hospital: collaborator
• The Arthritis Society, Canada: collaborator
• Fraser Health: collaborator

Study Sites (1)

Arthritis Research Canada

Vancouver, British Columbia, V5Y 3P2, Canada

Location

Related Publications (2)

• Feehan L, Xie H, Lu N, Li LC. Twenty-four hour physical activity, sedentary behaviour and sleep profiles in adults living with rheumatoid arthritis: a cross-sectional latent class analysis. J Act Sedentary Sleep Behav. 2024 Apr 17;3(1):10. doi: 10.1186/s44167-024-00049-5.

  PMID: 40217417 DERIVED

• Tam J, Lacaille D, Liu-Ambrose T, Shaw C, Xie H, Backman CL, Esdaile JM, Miller K, Petrella R, Li LC. Effectiveness of an online self-management tool, OPERAS (an On-demand Program to EmpoweR Active Self-management), for people with rheumatoid arthritis: a research protocol. Trials. 2019 Dec 11;20(1):712. doi: 10.1186/s13063-019-3851-0.

  PMID: 31829286 DERIVED

MeSH Terms

Conditions

Joint Diseases; Arthritis, Rheumatoid; Motor Activity; Arthritis

Interventions

Educational Status

Condition Hierarchy (Ancestors)

Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Behavior

Intervention Hierarchy (Ancestors)

Socioeconomic Factors; Population Characteristics

Limitations and Caveats

1. Individuals were already activated when they enrolled (high PAM-13 scores); the results may not be generalizable to patients had different needs for self-management support. 2. 92% identified as women; the results may not be generalizable to individuals of other gender identities. 3. Participants' race/ethnicity were not collected; we are unable to comment on the generalizability for different backgrounds.

Results Point of Contact

• Title: Linda Li
• Organization: University of British Columbia

lli@arthritisresearch.ca

604-207-4020

Study Officials

• Linda Li, PhD

  Professor

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 11, 2018
• First Posted: January 19, 2018
• Study Start: January 23, 2019
• Primary Completion: December 30, 2022
• Study Completion: January 31, 2023
• Last Updated: February 13, 2026
• Results First Posted: February 13, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)