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

Browse trials for

• Joint Diseases 712
• Arthritis, Rheumatoid 2,883
• Motor Activity 2,385
• Arthritis 3,556

Keywords

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

Study arms

• 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 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.

• 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 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

• BehavioralEducation, 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.

• BehavioralSame 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.

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).

   Time frame: Baseline, 27 weeks, 53 weeks

Secondary outcomes

1. 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

2. 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

3. 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

4. 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

5. 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

6. 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

7. 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

8. 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

9. 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

Baseline characteristics

1 further baseline measures are reported on the registry.

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 40217417 ↗
• 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. PubMed 31829286 ↗

Study documents

• Protocol and statistical analysis plan · Oct 22, 2019

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No