MONITOR-OA: Using Wearable Activity Trackers to Improve Physical Activity in Knee Osteoarthritis
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|ClinicalTrials.gov Identifier: NCT02315664|
Recruitment Status : Completed
First Posted : December 12, 2014
Last Update Posted : July 14, 2017
|Condition or disease||Intervention/treatment||Phase|
|Knee Osteoarthritis Joint Diseases||Behavioral: Education session, Fitbit Flex, and remote coaching by a PT Behavioral: Same intervention with a 2 month delay||Not Applicable|
This project will address the Research Question: Can a non-intrusive physical activity tracking tool, combined with a group education session and advice from a physiotherapist (PT), increase physical activity in patients with knee osteoarthritis (OA)? The investigators focus on knee OA because it is common (affecting 1 in 10) and can be debilitating. Being physically active improves pain, mobility and quality of life; however, less than half of patients are active. Combining the best evidence in OA care and digital technology, the investigators propose a new model of care for improving physical activity in patients with OA. Our primary objective is to determine whether a model involving 1) a group education session, 2) the use of Fitbit Flex, a commercially available physical activity tracker, and 3) remote coaching by a PT can improve physical activity and reduce sedentary time in patients with knee OA. This model of care is in line with the goal of Mary Pack Arthritis Program (MPAP) to optimize activity independence of OA patients with MPAP's available human resources. 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 OA disease status, and 4) improve in their self-efficacy of OA management, 4) To examine whether individuals in the Intervention Group will show improved cognitive function over the intervention period compared to the control group, and 5) To examine the pre-intervention factors that predict the degree to which individuals in the Intervention Group increase MVPA and reduce sedentary time.
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 :||61 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Single (Outcomes Assessor)|
|Primary Purpose:||Supportive Care|
|Official Title:||Improving Physical Activity Using an Online Monitoring Tool: a New Model of Care for Knee Osteoarthritis|
|Actual Study Start Date :||November 2, 2015|
|Actual Primary Completion Date :||May 17, 2017|
|Actual Study Completion Date :||May 25, 2017|
Experimental: Immediate Intervention Group
Education session, Fitbit Flex, and remote coaching by a PT: These three components of the intervention will be delivered to the participants in Month 1 and 2. At the end of the education session, the PT will help participants set personal activity goals. In Month 1 and 2, participants will use the Fitbit Flex. The PT will review the progress with participants via 20-minute bi-weekly phone calls and progressively modify their activities. In Month 3-6, participants will keep the Fitbit and continue to use it with access to a PT via email as needed. In addition, they will receive a monthly e-newsletter about arthritis research that is not related to physical activity.
Behavioral: Education session, Fitbit Flex, and remote coaching by a PT
Participants will receive a brief education session, use of a commercially available physical activity tracker called Fitbit Flex, and remote counseling by a PT. Intervention will be received immediately.
Experimental: Delayed Intervention Group
Same intervention with a 2 month delay: The Delayed Intervention Group (control group) will receive the same monthly e-newsletter in Months 1-2. The full intervention will be initiated in Month 3 with a brief education session, use of Fitbit Flex, and counseling by a physiotherapist. In Month 4, they will continue the intervention without the PT phone calls. Participants will keep the Fitbit for Month 5-6, and have email access to PT as 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 Months 2, 4, and 6. We will calculate the average daily MVPA accumulated in bouts per day. A bout is defined as > 10 consecutive minutes at the level of 3 or higher METs, with allowance for interruption of up to 1 minute 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.
- Knee Injury and OA Outcome Score (KOOS) [ Time Frame: Change from baseline in knee pain, stiffness, daily activity, sport/recreation, and quality of life at 2 months, 4 months, and 6 months. ]The KOOS consists of five subscales: knee pain, stiffness, daily activity, sports/recreation, and quality of life.
- 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.
- Cognitive Function assessment [ Time Frame: Change from baseline in cognitive functioning at 2 months, 4 months, and 6 months. ]Cognitive functioning will be assessed with computer-based tasks: Kirby tasks, Stroop task, list-sorting task, and picture sequence memory test.
- Montreal Cognitive Assessment (MoCA) [ Time Frame: Baseline ]The MoCA is a one-page 30-point test that assesses the following cognitive domains: visuospatial/executive, naming, memory, attention, language, abstraction, delayed recall, and orientation.
- Community Health Activities Model Program for Seniors (CHAMPS) [ Time Frame: Change from baseline in physical activity at 2 months, 4 months, and 6 months. ]The CHAMPS questionnaire asks participants about their current engagement in 40 different activities including household chores, recreational chores, and leisure and social activities.
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): NCT02315664
|Canada, British Columbia|
|Arthritis Research Canada|
|Richmond, British Columbia, Canada, V6X 2C7|
|Principal Investigator:||Linda Li, PhD||Arthritis Research Canada|