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

• ClinicalTrials.gov Identifier: NCT02554474
• Recruitment Status: Completed
• First Posted: September 18, 2015
• Results First Posted: June 4, 2021
• Last Update Posted: June 21, 2022
• Sponsor: University of British Columbia
• Collaborators: Simon Fraser University; Arthritis Research Centre of Canada; Vancouver General Hospital; The Arthritis Society, Canada; Fraser Health
• Information provided by (Responsible Party): Linda Li, University of British Columbia

Tracking Information

• First Submitted Date: September 16, 2015
• First Posted Date: September 18, 2015
• Results First Submitted Date: April 17, 2021
• Results First Posted Date: June 4, 2021
• Last Update Posted Date: June 21, 2022
• Actual Study Start Date: January 1, 2017
• Actual Primary Completion Date: August 25, 2019 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: May 10, 2021)

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.

Original Primary Outcome Measures (submitted: September 16, 2015)

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.

Current Secondary Outcome Measures (submitted: May 10, 2021)

• 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.

Original Secondary Outcome Measures (submitted: September 16, 2015)

• 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.
• 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.

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: OPAM-IA: Using Digital Activity Trackers to Improve Physical Activity in Inflammatory Arthritis
• Official Title: Effective of Online Physical Activity Monitoring in Inflammatory Arthritis (OPAM-IA): A New Model of Care
• Brief 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.

Detailed 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.

• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Crossover Assignment; Masking: None (Open Label); Primary Purpose: Supportive Care

Condition

• Joint Diseases
• 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.
• 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.

Study Arms

• 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.
  Intervention: Behavioral: Education, Fitbit/FitViz, physiotherapist counselling.
• 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.
  Intervention: Behavioral: Same intervention with a 9-week delay

Publications *

• 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.
• 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 Inflammatory Arthritis: A Randomized Controlled Trial. Arthritis Care Res (Hoboken). 2020 Dec;72(12):1755-1765. doi: 10.1002/acr.24199.
• 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 2022 Mar 18.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: May 10, 2021): 118
• Original Estimated Enrollment (submitted: September 16, 2015): 120
• Actual Study Completion Date: August 25, 2019
• Actual Primary Completion Date: August 25, 2019 (Final data collection date for primary outcome measure)

Eligibility Criteria

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).

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 19 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Canada

Administrative Information

• NCT Number: NCT02554474
• Other Study ID Numbers: H15-01843
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Linda Li, University of British Columbia
• Original Responsible Party: University of British Columbia
• Current Study Sponsor: University of British Columbia
• Original Study Sponsor: Same as current

Collaborators

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

Investigators

• Principal Investigator: Linda Li, PhD; Professor

• PRS Account: University of British Columbia
• Verification Date: May 2022