OPAM-IA: Using Digital Activity Trackers to Improve Physical Activity in Inflammatory Arthritis

Rheumatoid Arthritis Clinical Trial

Official title:

Effective of Online Physical Activity Monitoring in Inflammatory Arthritis (OPAM-IA): A New Model of Care

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02554474
• Other study ID #: H15-01843
• Status: Completed
• Phase: N/A
• Start date: January 1, 2017
• Est. completion date: August 25, 2019

Study information

• Verified date: January 2024
• Source: University of British Columbia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Being physically active can reduce pain and fatigue, improve mobility and enhance quality of life in people with arthritis, but adherence to an active lifestyle is poor, with less than half of people with arthritis being active. The primary goal of this randomized controlled trial is to assess the efficacy of a physical activity coaching model to improve physical activity participation and reduce sedentary time in patients with Rheumatoid Arthritis and Systemic Lupus Erythematosus. This model combines the use of a Fitbit Flex (wireless physical activity tracker) paired with a FitViz application, a group education session, and telephone counselling by a physiotherapist.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 118
• Est. completion date: August 25, 2019
• Est. primary completion date: August 25, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Arthritis
• Joint Diseases
• Lupus Erythematosus, Systemic
• Rheumatoid Arthritis
• Systemic Lupus Erythematosus

Intervention

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.
• 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.

Locations

Country	Name	City	State
Canada	Arthritis Research Canada	Richmond	British Columbia

Sponsors (6)

Lead Sponsor	Collaborator
University of British Columbia	Arthritis Research Centre of Canada, Fraser Health, Simon Fraser University, The Arthritis Society, Canada, Vancouver General Hospital

Country where clinical trial is conducted

Canada, 

References & Publications (3)

Leese J, Zhu S, Townsend AF, Backman CL, Nimmon L, Li LC. Ethical issues experienced by persons with rheumatoid arthritis in a wearable-enabled physical activity intervention study. Health Expect. 2022 Aug;25(4):1418-1431. doi: 10.1111/hex.13481. Epub 202 — View Citation

Li LC, Feehan LM, Shaw C, Xie H, Sayre EC, Avina-Zubeita A, Grewal N, Townsend AF, Gromala D, Noonan G, Backman CL. A technology-enabled Counselling program versus a delayed treatment control to support physical activity participation in people with inflammatory arthritis: study protocol for the OPAM-IA randomized controlled trial. BMC Rheumatol. 2017 Nov 28;1:6. doi: 10.1186/s41927-017-0005-4. eCollection 2017. — View Citation

Li LC, Feehan LM, Xie H, Lu N, Shaw C, Gromala D, Avina-Zubieta JA, Koehn C, Hoens AM, English K, Tam J, Therrien S, Townsend AF, Noonan G, Backman CL. Efficacy of a Physical Activity Counseling Program With Use of a Wearable Tracker in People With Inflam — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Daily Time in Moderate/Vigorous Physical Activity	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.	Baseline, 9 weeks, 18 weeks, 27 weeks
Secondary	Time Spent in Sedentary Activity	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.	Baseline, 9 weeks, 18 weeks, 27 weeks
Secondary	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.	Baseline, 9 weeks, 18 weeks, 27 weeks
Secondary	McGill Pain Questionnaire Short Form (MPQ-SF)	The MPQ-SF contains 15 pain-related words, which can be rated from 0 to 3. Range 0 - 45; higher=more severe pain.	Baseline, 9 weeks, 18 weeks, 27 weeks
Secondary	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),	Baseline, 9 weeks, 18 weeks, 27 weeks
Secondary	Partners In Health Scale	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.	Baseline, 9 weeks, 18 weeks, 27 weeks
Secondary	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.	Baseline, 9 weeks, 18 weeks, 27 weeks
Secondary	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.	Baseline, 9 weeks, 18 weeks, 27 weeks
Secondary	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.	Baseline, 9 weeks, 18 weeks, 27 weeks