An interventional study of Education, Fitbit/self-management app, physiotherapist counselling. and Same intervention with a 6 month delay in Joint Disease and Rheumatoid Arthritis, sponsored by University of British Columbia. Completed at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-02-13.
Sponsored by University of British Columbia · Not applicable, Interventional, and Supportive care
Among 251 studies in Arthritis, Rheumatoid with a site in Canada — 17 open to participants now, 32 under way, 3 of them phase 3. Arthritis, Rheumatoid · Canada.
Among the 251 studies in Arthritis, Rheumatoid with a site in Canada, this one is the 164th largest by enrollment of the 214 interventional ones that give a count, is one of 6 that started in 2019, is one of 34 with no phase, and was the 207th registered.
3,332 studies on the registry are indexed under Arthritis, Rheumatoid; 443 are open to participants now.
Browse Arthritis, Rheumatoid studies →17 of the 251 studies in Arthritis, Rheumatoid with a site in Canada are open now. Recruiting first, the newest first:
Sunnybrook Health Sciences Centre · Sites in Canada
Ages 18+
AstraZeneca · Sites in Canada, United States, Argentina and 14 more countries
Ages 18+
AbbVie · Sites in Canada, United States, Czechia and 9 more countries
Ages 18+
Western University, Canada · Sites in Canada
Ages 18–80
AstraZeneca · Sites in Canada, United States, China and 7 more countries
Ages 18–70
A study can be open while its sites in Canada have not opened yet or have stopped. Only those recruiting at a site in Canada →
Of the 293 Arthritis, Rheumatoid studies recruiting now, 150 (51%) set no upper age limit and 109 (37%) stop at 75 or younger; 15 take children under 18; 36 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
251 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 12 · Phase 2 61 · Phase 3 92 · Phase 4 22
First in 1996; this study’s year is marked. 6 started in 2019.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 132 is above the median of 96 across 2,220 interventional studies indexed under Arthritis, Rheumatoid.
Median enrollment 303 across the 214 interventional studies, 211 across the 36 observational. Of the 207 that completed or were terminated, 131 (63%) have results posted.
This tab as a report to print or save as PDF → With an account.
202 of 251 have an industry lead sponsor. The 10 most frequent:
University of British Columbia is the lead sponsor of 1,339 studies on the registry; 259 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 1 (17%) have results posted.
University of British Columbia has 7 studies filed under Arthritis, Rheumatoid — fewer than ten, so there is no comparison to draw.
7 of the studies in Arthritis, Rheumatoid with a site in Canada that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT03626038Zimmer BiometPost Market Clinical Follow-up (PMCF) Study of the A.L.P.S. Proximal Humerus Plating System | 2026-12 |
| NCT06972446AbbVieA Study to Evaluate Different Targeted Therapies for Patients With Rheumatoid Arthritis | 2027-02 |
| NCT06916806AstraZenecaA Study to Investigate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AZD5492 in Adult Participants With Systemic Lupus Erythematosus or Idiopathic Inflammatory Myopathies or Rheumatoid Arthritis. | 2027-05-05 |
| NCT02351414MicroPort Orthopedics Inc.Post Market Follow-Up Study of the EVOLUTION® Total Knee Arthroplasty System With Cruciate Sacrificing Inserts | 2027-06 |
| NCT02038140Zimmer BiometZimmer Trabecular Metal Total Ankle PMCF | 2027-09 |
Among the 251 studies in Arthritis, Rheumatoid with a site in Canada, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
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.
3,332 studies on the registry are indexed under Arthritis, Rheumatoid; 443 are open to participants now.
This study's enrollment of 132 is above the median of 96 across 2,220 interventional studies indexed under Arthritis, Rheumatoid.
Browse Arthritis, Rheumatoid studies →University of British Columbia is the lead sponsor of 1,339 studies on the registry; 259 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 1 (17%) have results posted.
Compared within Arthritis, Rheumatoid, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Joint Diseases. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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.
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
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.
The Delayed Intervention Group will receive the same intervention as the Immediate Intervention Group, but with a 6 month delay.
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).
Time frame: Baseline, 27 weeks, 53 weeks
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.
Time frame: 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.
Time frame: 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.
Time frame: 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),
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: Baseline, 27 weeks, 53 weeks
Participants were recruited from rheumatology clinics in Metro Vancouver and through the network of patient groups, including Arthritis Consumer Experts and Arthritis Research Canada's Arthritis Patient Advisory Board. We also posted study information on social media (Facebook, Twitter, Kajiji, and Craigslist) and Arthritis Research Canada's website.
| Milestone | Immediate Intervention Group | Delayed Intervention Group |
|---|---|---|
| Started | 66 | 66 |
| Completed | 65 | 66 |
| Not completed | 1 | 0 |
| Withdrew: Erroneously randomized | 1 | 0 |
| Milestone | Immediate Intervention Group | Delayed Intervention Group |
|---|---|---|
| Started | 65 | 66 |
| Completed | 58 | 62 |
| Not completed | 7 | 4 |
| Withdrew: Withdrawal by subject | 4 | 3 |
| Withdrew: Lost to follow-up | 2 | 0 |
| Withdrew: Covid related reasons | 0 | 1 |
| Withdrew: Natural disaster evacuation | 1 | 0 |
| Milestone | Immediate Intervention Group | Delayed Intervention Group |
|---|---|---|
| Started | 58 | 62 |
| Completed | 55 | 55 |
| Not completed | 3 | 7 |
| Withdrew: Withdrawal by subject | 1 | 7 |
| Withdrew: Moved out of province | 1 | 0 |
| Withdrew: Health reason | 1 | 0 |
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).
| score on a scale | Immediate Intervention Group | Delayed Intervention Group |
|---|---|---|
| Baseline | 65.1 ± 13.7 | 68.3 ± 13.9 |
| 27 weeks | 69.8 ± 17.2 | 67.1 ± 13.5 |
| 53 weeks | 67.3 ± 15.1 | 72.2 ± 17.5 |
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.
| score on a scale | Immediate Intervention Group | Delayed Intervention Group |
|---|---|---|
| Baseline | 3.6 ± 1.9 | 3.7 ± 1.9 |
| 27 weeks | 3.0 ± 2.0 | 3.6 ± 1.8 |
| 53 weeks | 2.8 ± 2.0 | 2.8 ± 1.8 |
The MPQ-SF contains 15 pain-related words, which can be rated from 0 to 3. Range 0 - 45; higher=more severe pain.
| score on a scale | Immediate Intervention Group | Delayed Intervention Group |
|---|---|---|
| Baseline | 11.0 ± 8.2 | 10.2 ± 7.5 |
| 27 weeks | 9.1 ± 8.0 | 10.0 ± 7.1 |
| 53 weeks | 9.2 ± 7.9 | 9.5 ± 8.5 |
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.
| score on a scale | Immediate Intervention Group | Delayed Intervention Group |
|---|---|---|
| Baseline | 4.7 ± 1.4 | 4.6 ± 1.3 |
| 27 weeks | 4.3 ± 1.5 | 4.6 ± 1.3 |
| 53 weeks | 4.5 ± 1.5 | 4.4 ± 1.5 |
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),
| score on a scale | Immediate Intervention Group | Delayed Intervention Group |
|---|---|---|
| Baseline | 7.6 ± 5.6 | 7.0 ± 4.9 |
| 27 weeks | 5.0 ± 3.8 | 6.3 ± 5.3 |
| 53 weeks | 4.8 ± 4.0 | 5.4 ± 5.0 |
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.
| score on a scale | Immediate Intervention Group | Delayed Intervention Group |
|---|---|---|
| Baseline | 4.6 ± 1.4 | 4.7 ± 1.7 |
| 27 weeks | 4.6 ± 1.4 | 4.6 ± 1.6 |
| 53 weeks | 4.5 ± 1.6 | 4.6 ± 1.8 |
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.
| score on a scale | Immediate Intervention Group | Delayed Intervention Group |
|---|---|---|
| Baseline | 4.5 ± 1.4 | 4.6 ± 1.3 |
| 27 weeks | 4.5 ± 1.1 | 4.7 ± 1.5 |
| 53 weeks | 4.4 ± 1.3 | 4.6 ± 1.6 |
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.
| score on a scale | Immediate Intervention Group | Delayed Intervention Group |
|---|---|---|
| Baseline | 4.5 ± 1.6 | 4.5 ± 1.8 |
| 27 weeks | 4.6 ± 1.7 | 4.3 ± 1.9 |
| 53 weeks | 4.8 ± 1.6 | 4.7 ± 1.7 |
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.
| minutes | Immediate Intervention Group | Delayed Intervention Group |
|---|---|---|
| Baseline | 36.8 ± 35.9 | 38.4 ± 38.6 |
| 27 weeks | 42.0 ± 41.5 | 45.5 ± 54.5 |
| 53 weeks | 42.4 ± 44.0 | 47.8 ± 55.8 |
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
| minutes | Immediate Intervention Group | Delayed Intervention Group |
|---|---|---|
| Baseline | 514.9 ± 176.1 | 467.8 ± 175.2 |
| 27 weeks | 539.8 ± 186.9 | 504.2 ± 184.4 |
| 53 weeks | 546.7 ± 163.2 | 504.0 ± 164.2 |
Collected over 53 weeks. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Immediate Intervention Group | 0/65 (0%) | 0/65 (0%) | 3/65 (4.6%) |
| Delayed Intervention Group | 0/66 (0%) | 0/66 (0%) | 2/66 (3%) |
| Event | Immediate Intervention Group | Delayed Intervention Group |
|---|---|---|
| Falls, unrelated to the interventionMusculoskeletal and connective tissue disorders | 2/65 | 2/66 |
| Muscle painMusculoskeletal and connective tissue disorders | 1/65 | 0/66 |
One individual in the Immediate Group revealed that he did not have RA after randomization; hence, 131 were included in the analysis (Immediate: 65, Delayed: 66).
| Age, Continuous(Years) | Immediate Intervention Group | Delayed Intervention Group | Total |
|---|---|---|---|
| Mean | 54.8 ± 13.1 | 56.9 ± 13.2 | 55.8 ± 13.1 |
| Sex: Female, Male(Participants) | Immediate Intervention Group | Delayed Intervention Group | Total |
|---|---|---|---|
| Female | 60 | 60 | 120 |
| Male | 5 | 6 | 11 |
| Race and Ethnicity Not Collected(Participants) | Immediate Intervention Group | Delayed Intervention Group | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
| Marital status(Participants) | Immediate Intervention Group | Delayed Intervention Group | Total |
|---|---|---|---|
| Married/Common law | 44 | 44 | 88 |
| Separated/Divorced | 14 | 9 | 23 |
| Widowed/Never married | 7 | 13 | 20 |
| Gross annual household Income in Canadian dollars(Participants) | Immediate Intervention Group | Delayed Intervention Group | Total |
|---|---|---|---|
| $40 000 or under | 11 | 11 | 22 |
| $40 001-$80 000 | 12 | 16 | 28 |
| Over $80 000 | 37 | 25 | 62 |
| No answer | 5 | 14 | 19 |
| Disease duration(Years) | Immediate Intervention Group | Delayed Intervention Group | Total |
|---|---|---|---|
| Mean | 9.2 ± 10.9 | 11.7 ± 11.2 | 10.5 ± 11.0 |
| Body mass index(kg/m2) | Immediate Intervention Group | Delayed Intervention Group | Total |
|---|---|---|---|
| Mean | 27.7 ± 6.8 | 26.0 ± 6.0 | 26.9 ± 6.4 |
| Experience with health apps(Participants) | Immediate Intervention Group | Delayed Intervention Group | Total |
|---|---|---|---|
| Less than 1 year | 37 | 36 | 73 |
| 1-3 years | 10 | 13 | 23 |
| 4 or more years | 11 | 9 | 20 |
| No answer | 7 | 8 | 15 |
1 further baseline measures are reported on the registry.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Jan 2019 to primary completion in Dec 2022, 47 months.
Results were first posted in Feb 2026, 3 years 1 month after primary completion.
Of 292 non-industry interventional studies with no phase under Arthritis, Rheumatoid, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 39. This study's 47 months is above that.
Counting every sponsor, half of 348 studies reached it within 27 months; a quarter within 13 and three quarters within 47.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.
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University of British Columbia →