We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    nct02554474
Previous Study | Return to List | Next Study

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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:
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

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.

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

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.

Layout table for study information
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
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: 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.
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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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),

  5. 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.

  6. 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.

  7. 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.

  8. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).

Information from the National Library of Medicine

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


Locations
Layout table for location information
Canada, British Columbia
Arthritis Research Canada
Richmond, British Columbia, Canada, V6X 2C7
Sponsors and Collaborators
University of British Columbia
Simon Fraser University
Arthritis Research Centre of Canada
Vancouver General Hospital
The Arthritis Society, Canada
Fraser Health
Investigators
Layout table for investigator information
Principal Investigator: Linda Li, PhD Professor
  Study Documents (Full-Text)

Documents provided by Linda Li, University of British Columbia:
Publications of Results:
Other Publications:
Layout table for additonal information
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

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Linda Li, University of British Columbia:
Physical activity
Exercise
Rheumatoid
Arthritis
Lupus
SLE
Additional relevant MeSH terms:
Layout table for MeSH terms
Arthritis
Joint Diseases
Lupus Erythematosus, Systemic
Musculoskeletal Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases