OPAM-IA: Using Digital Activity Trackers to Improve Physical Activity in Inflammatory Arthritis
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|ClinicalTrials.gov Identifier: NCT02554474|
Recruitment Status : Recruiting
First Posted : September 18, 2015
Last Update Posted : April 3, 2018
|Condition or disease||Intervention/treatment||Phase|
|Joint Diseases Rheumatoid Arthritis Systemic Lupus Erythematosus||Behavioral: Education, Fitbit/FitViz, physiotherapist counselling. Behavioral: Same intervention with a 2 month delay||Not Applicable|
Patient self-management is a fundamental component in arthritis care that is often neglected. Physical activity is an essential part of self-management, however, less than half of people with arthritis are active. There are several factors that are associated with low physical activity participation such as motivation, doubts about the effectiveness of prescribed exercises, and lack of health professional advice on ways to progress physical activity. The variety of risk factors highlights 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 to stay active.
Our primary objective is to assess the efficacy of a physical activity counselling model, involving the use of a Fitbit Flex (wireless physical activity tracker) paired with a FitViz application (app), a group education session, and telephone counselling by a physiotherapist, to improve physical activity participation in patients with rheumatoid arthritis (RA) and systemic lupus erythematosus (SLE). Our secondary objective is to assess the effect of the intervention on reducing patients' sedentary time, and improving fatigue, mood, pain, and self-efficacy in arthritis management. We will carry out three aims: 1) To develop the FitViz app to pair with Fitbit to enhance user experience, 2) To conduct a pilot test for the Fitbit/FitViz intervention, 3) To evaluate the effect of the physical activity coaching model in patients with RA and SLE. In this proof-of-concept randomized controlled trial (RCT), the investigators hypothesize that compared to a control group (i.e. the Delayed Intervention group), participants in the Immediate Intervention Group will 1) increase moderate/vigorous physical activity (MVPA), 2) reduce sedentary time, 3) improve in fatigue, mood, and pain levels, and 4) improve in their self-efficacy in disease 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 :||130 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Single (Outcomes Assessor)|
|Primary Purpose:||Supportive Care|
|Official Title:||Effective of Online Physical Activity Monitoring in Inflammatory Arthritis (OPAM-IA): A New Model of Care|
|Actual Study Start Date :||January 2017|
|Estimated Primary Completion Date :||April 2019|
|Estimated Study Completion Date :||August 2019|
Active Comparator: Immediate Intervention Group
Education, Fitbit/FitViz, 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 and FitViz app. Participants will use the Fitbit/FitViz. The PT will review the progress with participants via bi-weekly phone calls and progressively modify their activities. In Month 3-6, participants will continue using the Fitbit/FitViz and have access to a PT via email as needed, but no bi-weekly phone calls.
Behavioral: Education, Fitbit/FitViz, physiotherapist counselling.
Participants will receive a brief education session, use a physical activity tracker Fitbit Flex with paired with a FitViz app, and remote counseling by a PT. Intervention will be received immediately.
Placebo Comparator: Delayed Intervention Group
Same intervention with a 2 month delay: The full intervention will be initiated in Month 3 and 4 with a brief education session, use of a Fitbit paired with the FitViz app, and counseling by a PT. In Month 5-6, participants will continue the intervention without the PT phone calls, but will have email access to PT, if needed.
Behavioral: Same intervention with a 2 month delay
The Delayed Intervention Group will receive the same intervention as the Immediate Intervention Group, but with a 2 month delay.
- Time spent in Moderate to Vigorous Physical Activity (MVPA) [ Time Frame: Change from baseline in time spent in MVPA at 2 months, 4 months, and 6 months. ]Participants will wear a SenseWear Mini accelerometer for 7 days at baseline, and at the end of Months 2, 4, and 6. We will calculate the average daily MVPA accumulated in bouts per day. A bout is defined as greater than or equal to 10 consecutive minutes at the level of 3 or higher METs, with allowance for interruption of up to 2 minutes below the threshold.
- Time spent in sedentary behaviors [ Time Frame: Change from baseline in time spent sedentary behaviors at 2 months, 4 months, and 6 months. ]We will calculate the average daily time spent with an energy expenditure of 1.5 METs or lower, occurring in bouts of > 20 minutes during waking hours.
- Fatigue Severity Scale [ Time Frame: Change from baseline in fatigue at 2 months, 4 months, and 6 months. ]The Fatigue Severity Scale (FSS) consists of nine questions and measures the impact of fatigue.
- McGill Pain Questionnaire Short Form (MPQ-SF) [ Time Frame: Change from baseline in pain at 2 months, 4 months, and 6 months. ]The MPQ-SF contains 15 pain-related words, which can be rated from 0 to 3 (higher=more severe).
- The Patient Health Questionnaire-9 (PHQ-9) [ Time Frame: Change from baseline in mood at 2 months, 4 months, and 6 months. ]The PHQ-9 consists of nine questions (rated from 0 to 3) that correspond to nine diagnostic criteria for major depressive disorder.
- The Self-Reported Habit Index (SRHI) [ Time Frame: Changes from baseline in characteristics of health behaviour at 2 months, 4 months, and 6 months. ]The SRHI is a 12-item scale, rated on a 7-point Likert scale, that measures characteristics of habitual behavior. We will ask participants to rate their strength of habit for three specific activity-related behaviors: sitting during leisure time at home, sitting during usual occupational activities, and walking outside for 10 minutes. A higher score indicates a stronger habit or behavior that is done frequently, automatically, and done without thinking about it.
- Partners in Health Scale [ Time Frame: Baseline, Months 2, 4, and 6 ]The Partners in Health Scale is a 12-item measure designed to assess self-efficacy, knowledge of health conditions and treatment, and self-management behaviors such as adopting a healthy lifestyle.
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): NCT02554474
|Contact: Navi Grewal, MScfirstname.lastname@example.org|
|Contact: Morgan Barber, MHAemail@example.com|
|Canada, British Columbia|
|Arthritis Research Canada||Recruiting|
|Richmond, British Columbia, Canada, V6X 2C7|
|Contact: Navi Grewal, MSc 604-207-4053 firstname.lastname@example.org|
|Contact: Morgan Barber, MHA 604-207-4027 email@example.com|
|Principal Investigator:||Linda Li, PhD||Professor|