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Trials / Completed

CompletedNCT02315664

MONITOR-OA: Using Wearable Activity Trackers to Improve Physical Activity in Knee Osteoarthritis

Improving Physical Activity Using an Online Monitoring Tool: a New Model of Care for Knee Osteoarthritis

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
61 (actual)
Sponsor
University of British Columbia · Academic / Other
Sex
All
Age
19 Years
Healthy volunteers
Not accepted

Summary

Physical activity is an essential first-line treatment for patients with knee osteoarthritis (OA). However, a 2013 systematic review found only 13% met the activity recommendation of 150 minutes or more per week. The primary goal of this randomized controlled trail is to assess the efficacy of a physical activity counseling model, involving a group education session, the use of Fitbit Flex (a wireless physical activity tracking device), and online/telephone coaching by a physiotherapist (PT), to improve physical activity and reduce sedentary time in patients with knee OA. Engaging in regular physical activity can have the additional benefit of improving cognitive functioning.

Detailed description

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.

Conditions

Interventions

TypeNameDescription
BEHAVIORALEducation session, Fitbit Flex, and remote coaching by a PTParticipants 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.
BEHAVIORALSame intervention with a 2 month delayThe Delayed Intervention Group will receive the same intervention as the Immediate Intervention Group, but with a 2 month delay.

Timeline

Start date
2015-11-02
Primary completion
2017-05-17
Completion
2017-05-25
First posted
2014-12-12
Last updated
2019-10-28
Results posted
2019-10-28

Locations

1 site across 1 country: Canada

Source: ClinicalTrials.gov record NCT02315664. Inclusion in this directory is not an endorsement.

MONITOR-OA: Using Wearable Activity Trackers to Improve Physical Activity in Knee Osteoarthritis (NCT02315664) · Clinical Trials Directory