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Completed

NCT Number: NCT03404245

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

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.

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Key information

Conditions

Joint Disease Arthritis Arthritis, Rheumatoid Autoimmune Diseases Behavior Connective Tissue Diseases Immune System Diseases Joint Diseases Motor Activity Musculoskeletal Diseases Rheumatic Diseases Rheumatoid Arthritis Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Arthritis Research Canada

Vancouver, British Columbia, V5Y 3P2, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

  1. Patient Activation Measure

    Time frame: Baseline, 27 weeks, 53 weeks

    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).

Secondary outcomes

  1. Rheumatoid Arthritis Disease Activity Index

    Time frame: Baseline, 27 weeks, 53 weeks

    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.

  2. McGill Pain Questionnaire

    Time frame: Baseline, 27 weeks, 52 weeks

    The MPQ-SF contains 15 pain-related words, which can be rated from 0 to 3. Range 0 - 45; higher=more severe pain.

  3. Fatigue Severity Scale

    Time frame: Baseline, 27 weeks, 53 weeks

    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.

  4. The Patient Health Questionnaire-9 (PHQ-9)

    Time frame: Baseline, 27 weeks, 53 weeks

    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),

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

    Time frame: Baseline, 27 weeks, 52 weeks

    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.

  6. The Self-Reported Habit Index (SRHI) - Sitting at Leisure Index

    Time frame: Baseline, 27 weeks, 52 weeks

    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.

  7. The Self-Reported Habit Index (SRHI) - Walking Index

    Time frame: Baseline, 27 weeks, 52 weeks

    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.

  8. Daily Time in Moderate/Vigorous Physical Activity (MVPA)

    Time frame: Baseline, 27 weeks, 53 weeks

    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.

  9. Daily Sedentary Time

    Time frame: Baseline, 27 weeks, 53 weeks

    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

Sponsors and collaborators

Lead sponsor

University of British Columbia

Other

Collaborators

  • Arthritis Research Centre of Canada
  • Fraser Health
  • Simon Fraser University
  • The Arthritis Society, Canada
  • Vancouver General Hospital

Registry information

Official study title

Empowering Active Self-management of Arthritis: Raising the Bar With OPERAS (an On-demand Program to EmpoweR Active Self-management)

Acronym: OPERAS

Important dates

Study start
2019
Primary completion
2022
Study completion
2023
First posted
Jan 19, 2018
Registry last updated
Feb 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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