Joint DiseaseOPERASNCT03404245
an On-demand Program to EmpoweR Active Self-management (OPERAS)
A study testing Education, Fitbit/self-management app, physiotherapist counselling. and Same intervention with a 6 month delay in people with Joint Disease and Rheumatoid Arthritis, run by University of British Columbia at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Joint Disease, Rheumatoid Arthritis
- What is being tested?
- Education, Fitbit/self-management app, physiotherapist counselling. and Same intervention with a 6 month delay
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 132 participants
- Where
- 1 siteCanada
- Study dates
- 23 Jan 2019to 31 Jan 2023
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- people who should not be physically active without medical supervision.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Empowering Active Self-management of Arthritis: Raising the Bar With OPERAS (an On-demand Program to EmpoweR Active Self-management)
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.
Read the 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
- Being tested
- Education, Fitbit/self-management app, physiotherapist counselling., Same intervention with a 6 month delay
- Keywords
- Physical Activity, Exercise, Rheumatoid, Arthritis, Self-management, Symptoms
- Medical subject headings
- Joint Diseases, Arthritis, Rheumatoid, Motor Activity, Arthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Education, Fitbit/self-management app, physiotherapist counselling.Behavioural
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 delayBehavioural
The Delayed Intervention Group will receive the same intervention as the Immediate Intervention Group, but with a 6 month delay.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Same intervention with a 6 month delay |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Baseline, 27 weeks, 53 weeks
Secondary outcomes (9)
Rheumatoid Arthritis Disease Activity Index
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.
Measured: Baseline, 27 weeks, 53 weeks
McGill Pain Questionnaire
The MPQ-SF contains 15 pain-related words, which can be rated from 0 to 3. Range 0 - 45; higher=more severe pain.
Measured: Baseline, 27 weeks, 52 weeks
Fatigue Severity Scale
The Fatigue Severity Scale consists of 9 questions and measures the impact of fatigue. A total score is calculated by averaging the rating from each question. Range 1-7; lower score = less fatigue.
Measured: Baseline, 27 weeks, 53 weeks
The Patient Health Questionnaire-9 (PHQ-9)
The PHQ-9 consists of nine questions (rated from 0 to 3) that correspond to nine diagnostic criteria for major depressive disorder. Range 0-27; lower score = less depressive symptoms),
Measured: Baseline, 27 weeks, 53 weeks
The Self-Reported Habit Index (SRHI) - Sitting at Work Index
The SRHI is a 12-item scale, rated on a 7-point Likert scale, that measures characteristics of habitual behavior. Participants rated their strength of habit of sitting at work. A higher score indicates a stronger habit or behavior that is done frequently, automatically, and done without thinking about it. Range 1-7; higher score = stronger habit.
Measured: Baseline, 27 weeks, 52 weeks
The Self-Reported Habit Index (SRHI) - Sitting at Leisure Index
The SRHI is a 12-item scale, rated on a 7-point Likert scale, that measures characteristics of habitual behavior. Participants rated their strength of habit of sitting at leisure. A higher score indicates a stronger habit or behavior that is done frequently, automatically, and done without thinking about it. Range 1-7; higher score = stronger habit.
Measured: Baseline, 27 weeks, 52 weeks
The Self-Reported Habit Index (SRHI) - Walking Index
The SRHI is a 12-item scale, rated on a 7-point Likert scale, that measures characteristics of habitual behavior. Participants rated their strength of walking habit. A higher score indicates a stronger habit or behavior that is done frequently, automatically, and done without thinking about it. Range 1-7; higher score = stronger habit.
Measured: Baseline, 27 weeks, 52 weeks
Daily Time in Moderate/Vigorous Physical Activity (MVPA)
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.
Measured: Baseline, 27 weeks, 53 weeks
Daily Sedentary Time
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
Measured: Baseline, 27 weeks, 53 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2018
- Study start23 Jan 2019
- Primary completion30 Dec 2022
- Study completion31 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Joint DiseaseStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 132 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- Simon Fraser University, Arthritis Research Centre of Canada, Vancouver General Hospital, The Arthritis Society, Canada, Fraser Health
- Responsible party
- Principal investigator, Linda Li, University of British Columbia
- Investigators
- Linda Li, PhD, Principal investigator, Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03404245
- Sponsor's protocol ID
- H17-03424
- Acronym
- OPERAS
- Status last verified
- Jan 2026
- First submitted
- 11 Jan 2018
- Last updated
- 13 Feb 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 40217417Tam 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.
PubMed 31829286