OPAM-IA: Using Digital Activity Trackers to Improve Physical Activity in Inflammatory Arthritis
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| ClinicalTrials.gov Identifier: NCT02554474 |
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Recruitment Status :
Completed
First Posted : September 18, 2015
Results First Posted : June 4, 2021
Last Update Posted : June 21, 2022
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Joint Diseases Rheumatoid Arthritis Systemic Lupus Erythematosus | Behavioral: Education, Fitbit/FitViz, physiotherapist counselling. Behavioral: Same intervention with a 9-week 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) |
| Actual Enrollment : | 118 participants |
| Allocation: | Randomized |
| Intervention Model: | Crossover Assignment |
| Masking: | None (Open Label) |
| 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 1, 2017 |
| Actual Primary Completion Date : | August 25, 2019 |
| Actual Study Completion Date : | August 25, 2019 |
| Arm | Intervention/treatment |
|---|---|
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Active Comparator: Immediate Group
Time spent in Moderate/Vigorous Physical Activity (MVPA) was measured with a SenseWear Mini sensor over a 7-day period. The mean time was calculated 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 two minutes below the threshold.
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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. |
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Placebo Comparator: Delay Group
Time spent in sedentary activity was measured with a SenseWear Mini sensor over a 7-day period. The mean daily time spent in sedentary activity was calculated with an energy expenditure of <=1.5 METs, occurring in bouts of >= 20 minutes during waking hours.
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Behavioral: Same intervention with a 9-week delay
The Delayed Intervention Group will receive the same intervention as the Immediate Intervention Group, but with a 9-week delay. |
- Daily Time in Moderate/Vigorous Physical Activity [ Time Frame: Baseline, 9 weeks, 18 weeks, 27 weeks ]Time spent in Moderate/Vigorous Physical Activity (MVPA) was measured with a SenseWear Mini sensor over a 7-day period. The mean time was calculated 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 two minutes below the threshold.
- Time Spent in Sedentary Activity [ Time Frame: Baseline, 9 weeks, 18 weeks, 27 weeks ]Time spent in sedentary activity was measured with a SenseWear Mini sensor over a 7-day period. The mean daily time spent in sedentary activity was calculated with an energy expenditure of <=1.5 METs, occurring in bouts of >= 20 minutes during waking hours.
- Fatigue Severity Scale [ Time Frame: Baseline, 9 weeks, 18 weeks, 27 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.
- McGill Pain Questionnaire Short Form (MPQ-SF) [ Time Frame: Baseline, 9 weeks, 18 weeks, 27 weeks ]The MPQ-SF contains 15 pain-related words, which can be rated from 0 to 3. Range 0 - 45; higher=more severe pain.
- The Patient Health Questionnaire-9 (PHQ-9) [ Time Frame: Baseline, 9 weeks, 18 weeks, 27 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),
- Partners In Health Scale [ Time Frame: Baseline, 9 weeks, 18 weeks, 27 weeks ]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. Range 0-96; higher score = higher perceived confidence and ability in self-care.
- The Self-Reported Habit Index (SRHI) - Sitting at Work Index [ Time Frame: Baseline, 9 weeks, 18 weeks, 27 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.
- The Self-Reported Habit Index (SRHI) - Sitting at Leisure Index [ Time Frame: Baseline, 9 weeks, 18 weeks, 27 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.
- The Self-Reported Habit Index (SRHI) - Walking Index [ Time Frame: Baseline, 9 weeks, 18 weeks, 27 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.
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| Ages Eligible for Study: | 19 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Have a physician confirmed diagnosis of RA or SLE.
- Have an email address and daily access to a computer with internet connection.
- Be able to attend a 1.5-hour education session at Mary Pack Arthritis Centre, Arthritis Research Centre, or a Fraser Health site.
Exclusion Criteria:
- Have previously used any physical activity wearables.
- Face a level of risk by exercising as identified by the Physical Activity Readiness Questionnaire (PAR-Q).
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
| Canada, British Columbia | |
| Arthritis Research Canada | |
| Richmond, British Columbia, Canada, V6X 2C7 | |
| Principal Investigator: | Linda Li, PhD | Professor |
Documents provided by Linda Li, University of British Columbia:
Other Publications:
| Responsible Party: | Linda Li, Professor, University of British Columbia |
| ClinicalTrials.gov Identifier: | NCT02554474 |
| Other Study ID Numbers: |
H15-01843 |
| First Posted: | September 18, 2015 Key Record Dates |
| Results First Posted: | June 4, 2021 |
| Last Update Posted: | June 21, 2022 |
| Last Verified: | May 2022 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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Physical activity Exercise Rheumatoid |
Arthritis Lupus SLE |
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Arthritis Joint Diseases Lupus Erythematosus, Systemic Musculoskeletal Diseases |
Connective Tissue Diseases Autoimmune Diseases Immune System Diseases |