an On-demand Program to EmpoweR Active Self-management (OPERAS) (OPERAS)
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ClinicalTrials.gov Identifier: NCT03404245 |
Recruitment Status :
Recruiting
First Posted : January 19, 2018
Last Update Posted : April 20, 2021
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Condition or disease | Intervention/treatment | Phase |
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Joint Disease Rheumatoid Arthritis | Behavioral: Education, Fitbit/self-management app, physiotherapist counselling. Behavioral: Same intervention with a 6 month delay | Not Applicable |
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 RA management.
The investigators will use a mixed-methods approach, involving a 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.
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 134 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | Single (Outcomes Assessor) |
Primary Purpose: | Supportive Care |
Official Title: | Empowering Active Self-management of Arthritis: Raising the Bar With OPERAS (an On-demand Program to EmpoweR Active Self-management) |
Actual Study Start Date : | January 23, 2019 |
Estimated Primary Completion Date : | January 15, 2022 |
Estimated Study Completion Date : | June 15, 2023 |

Arm | Intervention/treatment |
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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 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.
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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. |
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 PT. In Month 9-12, participants will continue the intervention without the PT phone calls, but will have email access to PT, if needed.
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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. |
- Patient Activation Measure [ Time Frame: Baseline ]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).
- Patient Activation Measure [ Time Frame: 6 months ]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).
- Patient Activation Measure [ Time Frame: 12 months ]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).
- Rheumatoid Arthritis Disease Activity Index [ Time Frame: Baseline ]Rheumatoid Arthritis Disease Activity Index consists of: 1) global disease activity; 2) joint tenderness/swelling; 3) pain; 4) morning stiffness; 5) number/severity of painful joints. Score ranges from 0 - 10; lower = better.
- Rheumatoid Arthritis Disease Activity Index [ Time Frame: 6 months ]Rheumatoid Arthritis Disease Activity Index consists of: 1) global disease activity; 2) joint tenderness/swelling; 3) pain; 4) morning stiffness; 5) number/severity of painful joints. Score ranges from 0 - 10; lower = better.
- Rheumatoid Arthritis Disease Activity Index [ Time Frame: 12 months ]Rheumatoid Arthritis Disease Activity Index consists of: 1) global disease activity; 2) joint tenderness/swelling; 3) pain; 4) morning stiffness; 5) number/severity of painful joints. Score ranges from 0 - 10; lower = better.
- Daily Moderate/Vigorous Physical Activity time [ Time Frame: Baseline ]Time spent in Moderate/Vigorous Physical Activity (MVPA) is measured with a SenseWear Mini sensor over a 7-day period. We will calculate the mean time spent in bouted MVPA per day. A bout is defined as >= 10 consecutive minutes or more at the level of >= 3 METs (i.e., the lower bound of MVPA), with allowance for interruption of up to one minute below the threshold.
- Daily Moderate/Vigorous Physical Activity time [ Time Frame: 6 months ]Time spent in Moderate/Vigorous Physical Activity (MVPA) is measured with a SenseWear Mini sensor over a 7-day period. We will calculate the mean time spent in bouted MVPA per day. A bout is defined as >= 10 consecutive minutes or more at the level of >= 3 METs (i.e., the lower bound of MVPA), with allowance for interruption of up to one minute below the threshold.
- Daily Moderate/Vigorous Physical Activity time [ Time Frame: 12 months ]Time spent in Moderate/Vigorous Physical Activity (MVPA) is measured with a SenseWear Mini sensor over a 7-day period. We will calculate the mean time spent in bouted MVPA per day. A bout is defined as >= 10 consecutive minutes at the level of >= 3 METs (i.e., the lower bound of MVPA), with allowance for interruption of up to one minute below the threshold.
- Daily sedentary time [ Time Frame: Baseline ]Time spent in sedentary activity is measured with a SenseWear Mini sensor over a 7-day period. We will calculate the mean daily time spent in sedentary activity, with an energy expenditure of <=1.5 METs, occurring in bouts of >= 20 minutes during waking hours
- Daily sedentary time [ Time Frame: 6 months ]Time spent in sedentary activity is measured with a SenseWear Mini sensor over a 7-day period. We will calculate the mean daily time spent in sedentary activity, with an energy expenditure of <=1.5 METs, occurring in bouts of >= 20 minutes during waking hours
- Daily sedentary time [ Time Frame: 12 months ]Time spent in sedentary activity is measured with a SenseWear Mini sensor over a 7-day period. We will calculate the mean daily time spent in sedentary activity, with an energy expenditure of <=1.5 METs, occurring in bouts of >= 20 minutes during waking hours

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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.
Exclusion Criteria:
- people who should not be physically active without medical supervision.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03404245
Contact: Johnathan Tam, BSc | 604-207-4027 | jtam@arthritisresearch.ca | |
Contact: Stephanie Therrien, BSc | 604-207-4053 | stherrien@arthritisresearch.ca |
Canada, British Columbia | |
Arthritis Research Canada | Recruiting |
Richmond, British Columbia, Canada, V6X 2C7 | |
Contact: Johnathan Tam, BSc 604-207-4027 jtam@arthritisresearch.ca |
Principal Investigator: | Linda Li, PhD | Professor |
Responsible Party: | Linda Li, Professor, University of British Columbia |
ClinicalTrials.gov Identifier: | NCT03404245 |
Other Study ID Numbers: |
H17-03424 |
First Posted: | January 19, 2018 Key Record Dates |
Last Update Posted: | April 20, 2021 |
Last Verified: | April 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Physical Activity Exercise Rheumatoid |
Arthritis Self-management Symptoms |
Arthritis Joint Diseases Musculoskeletal Diseases |