Trial Outcomes & Findings for MONITOR-OA: Using Wearable Activity Trackers to Improve Physical Activity in Knee Osteoarthritis (NCT NCT02315664)
NCT ID: NCT02315664
Last Updated: 2019-10-28
Results Overview
Participants wore a SenseWear Mini accelerometer for 7 days at baseline, and Months 2, 4, and 6. We calculated the average daily time (minutes) spent in MVPA accumulated in bouts. A bout is defined as 10 or more consecutive minutes at the level of 3 or higher METs, with allowance for interruption of up to 1 minute below the threshold.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
61 participants
Primary outcome timeframe
Baseline; 2 months, 4 months and 6 months from baseline
Results posted on
2019-10-28
Participant Flow
The recruitment period was from February 2015 - October 2016. Recruitment strategies included placing study advertisement material at Community Health Centres and Mary Pack Arthritis Centre. We also had study advertisement disseminated through Arthritis Research Canada website and group collaborators' group newsletters.
After enrollment, participants completed the baseline assessment, and after completion of baseline participants were randomly assigned to the immediate group or the delayed group (ie, control) in 1:1 allocation ratio.
Participant milestones
| Measure |
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.
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.
|
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.
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.
|
|---|---|---|
|
Overall Study
STARTED
|
30
|
31
|
|
Overall Study
COMPLETED
|
29
|
27
|
|
Overall Study
NOT COMPLETED
|
1
|
4
|
Reasons for withdrawal
| Measure |
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.
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.
|
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.
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.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
|
Overall Study
Withdrawal by Subject
|
0
|
3
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Immediate Intervention Group
n=30 Participants
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.
|
Delayed Intervention Group
n=31 Participants
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.
|
Total
n=61 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
61.3 years
STANDARD_DEVIATION 9.4 • n=30 Participants
|
62.1 years
STANDARD_DEVIATION 8.5 • n=31 Participants
|
61.7 years
STANDARD_DEVIATION 8.9 • n=61 Participants
|
|
Sex: Female, Male
Female
|
22 Participants
n=30 Participants
|
28 Participants
n=31 Participants
|
50 Participants
n=61 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=30 Participants
|
3 Participants
n=31 Participants
|
11 Participants
n=61 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Canada
|
30 participants
n=30 Participants
|
31 participants
n=31 Participants
|
61 participants
n=61 Participants
|
|
Marital Status
Married/Common Law
|
19 Participants
n=30 Participants
|
14 Participants
n=31 Participants
|
33 Participants
n=61 Participants
|
|
Marital Status
Separated/Divorced
|
7 Participants
n=30 Participants
|
8 Participants
n=31 Participants
|
15 Participants
n=61 Participants
|
|
Marital Status
Widowed/Never married/Other
|
4 Participants
n=30 Participants
|
9 Participants
n=31 Participants
|
13 Participants
n=61 Participants
|
|
Gross annual household income (CAN$)
≤12,000
|
0 Participants
n=30 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=61 Participants
|
|
Gross annual household income (CAN$)
12,001-24,000
|
1 Participants
n=30 Participants
|
2 Participants
n=31 Participants
|
3 Participants
n=61 Participants
|
|
Gross annual household income (CAN$)
24,001-40,000
|
4 Participants
n=30 Participants
|
2 Participants
n=31 Participants
|
6 Participants
n=61 Participants
|
|
Gross annual household income (CAN$)
40,001-60,000
|
5 Participants
n=30 Participants
|
6 Participants
n=31 Participants
|
11 Participants
n=61 Participants
|
|
Gross annual household income (CAN$)
60,001-80,000
|
9 Participants
n=30 Participants
|
4 Participants
n=31 Participants
|
13 Participants
n=61 Participants
|
|
Gross annual household income (CAN$)
80,001-100,000
|
2 Participants
n=30 Participants
|
3 Participants
n=31 Participants
|
5 Participants
n=61 Participants
|
|
Gross annual household income (CAN$)
>100,000
|
5 Participants
n=30 Participants
|
6 Participants
n=31 Participants
|
11 Participants
n=61 Participants
|
|
Gross annual household income (CAN$)
No answer
|
4 Participants
n=30 Participants
|
8 Participants
n=31 Participants
|
12 Participants
n=61 Participants
|
|
Diagnosed with OA
Yes
|
26 Participants
n=30 Participants
|
26 Participants
n=31 Participants
|
52 Participants
n=61 Participants
|
|
Diagnosed with OA
No, but met the "likely OA" criteria
|
4 Participants
n=30 Participants
|
5 Participants
n=31 Participants
|
9 Participants
n=61 Participants
|
|
In general would you say your health is...
Excellent
|
1 Participants
n=30 Participants
|
0 Participants
n=31 Participants
|
1 Participants
n=61 Participants
|
|
In general would you say your health is...
Very good
|
15 Participants
n=30 Participants
|
14 Participants
n=31 Participants
|
29 Participants
n=61 Participants
|
|
In general would you say your health is...
Good
|
10 Participants
n=30 Participants
|
14 Participants
n=31 Participants
|
24 Participants
n=61 Participants
|
|
In general would you say your health is...
Fair
|
4 Participants
n=30 Participants
|
3 Participants
n=31 Participants
|
7 Participants
n=61 Participants
|
|
In general would you say your health is...
Poor
|
0 Participants
n=30 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=61 Participants
|
|
Compared to one year ago, how would you rate your health in general now?
Much better
|
2 Participants
n=30 Participants
|
2 Participants
n=31 Participants
|
4 Participants
n=61 Participants
|
|
Compared to one year ago, how would you rate your health in general now?
Somewhat better
|
6 Participants
n=30 Participants
|
3 Participants
n=31 Participants
|
9 Participants
n=61 Participants
|
|
Compared to one year ago, how would you rate your health in general now?
About the same
|
12 Participants
n=30 Participants
|
15 Participants
n=31 Participants
|
27 Participants
n=61 Participants
|
|
Compared to one year ago, how would you rate your health in general now?
Somewhat worse
|
10 Participants
n=30 Participants
|
11 Participants
n=31 Participants
|
21 Participants
n=61 Participants
|
|
Compared to one year ago, how would you rate your health in general now?
Much worse
|
0 Participants
n=30 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=61 Participants
|
|
Number of comorbid conditions
|
2.0 Comorbid conditions
n=30 Participants
|
4.0 Comorbid conditions
n=31 Participants
|
3.0 Comorbid conditions
n=61 Participants
|
|
Body mass index
|
29.2 kg/m^2
STANDARD_DEVIATION 5.5 • n=30 Participants
|
29.2 kg/m^2
STANDARD_DEVIATION 4.8 • n=31 Participants
|
29.2 kg/m^2
STANDARD_DEVIATION 5.1 • n=61 Participants
|
PRIMARY outcome
Timeframe: Baseline; 2 months, 4 months and 6 months from baselinePopulation: The number of participants analyzed is the same as the number of participants assigned to each group.
Participants wore a SenseWear Mini accelerometer for 7 days at baseline, and Months 2, 4, and 6. We calculated the average daily time (minutes) spent in MVPA accumulated in bouts. A bout is defined as 10 or more consecutive minutes at the level of 3 or higher METs, with allowance for interruption of up to 1 minute below the threshold.
Outcome measures
| Measure |
Immediate Intervention Group
n=30 Participants
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.
|
Delayed Intervention Group
n=31 Participants
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.
|
|---|---|---|
|
Time Spent in Moderate-to-Vigorous Physical Activity (MVPA)
Baseline
|
62.1 Minutes per day
Standard Deviation 54.6
|
65.3 Minutes per day
Standard Deviation 77.4
|
|
Time Spent in Moderate-to-Vigorous Physical Activity (MVPA)
2 months
|
75.5 Minutes per day
Standard Deviation 54.3
|
50.0 Minutes per day
Standard Deviation 46.8
|
|
Time Spent in Moderate-to-Vigorous Physical Activity (MVPA)
4 months
|
62.6 Minutes per day
Standard Deviation 56.3
|
60.1 Minutes per day
Standard Deviation 76.8
|
|
Time Spent in Moderate-to-Vigorous Physical Activity (MVPA)
6 months
|
65.6 Minutes per day
Standard Deviation 48.5
|
70.7 Minutes per day
Standard Deviation 71.9
|
SECONDARY outcome
Timeframe: Change from baseline in time spent sedentary behaviors at 2 months, 4 months, and 6 months.Population: The number of participants analyzed is the same as the number of participants assigned to each group.
We calculated the average daily time spent with an energy expenditure of 1.5 METs or lower, occurring in bouts of 20 minutes or more during waking hours.
Outcome measures
| Measure |
Immediate Intervention Group
n=30 Participants
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.
|
Delayed Intervention Group
n=31 Participants
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.
|
|---|---|---|
|
Time Spent in Sedentary Behaviors
Baseline
|
464.1 Minutes per day
Standard Deviation 137.7
|
497.4 Minutes per day
Standard Deviation 200.7
|
|
Time Spent in Sedentary Behaviors
2 months
|
437.6 Minutes per day
Standard Deviation 133.9
|
503.0 Minutes per day
Standard Deviation 160.7
|
|
Time Spent in Sedentary Behaviors
4 months
|
505.9 Minutes per day
Standard Deviation 167.2
|
508.9 Minutes per day
Standard Deviation 189
|
|
Time Spent in Sedentary Behaviors
6 months
|
435.8 Minutes per day
Standard Deviation 138.8
|
496.0 Minutes per day
Standard Deviation 179.5
|
SECONDARY outcome
Timeframe: Baseline; 2 months, 4 months and 6 months from baselinePopulation: The number of participants analyzed is the same as the number of participants assigned to each group.
Symptoms were measured by Knee Injury and OA Outcome Score (KOOS). The KOOS measures knee osteoarthritis disease status and consists of five sub-scales: knee pain, stiffness, daily activity, sports/recreation, and quality of life. Scores range from 0 to 100, with higher being better.
Outcome measures
| Measure |
Immediate Intervention Group
n=30 Participants
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.
|
Delayed Intervention Group
n=31 Participants
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.
|
|---|---|---|
|
KOOS - Symptoms
Baseline
|
59.8 score on a scale
Standard Deviation 16.1
|
62.9 score on a scale
Standard Deviation 17.2
|
|
KOOS - Symptoms
2 months
|
62.6 score on a scale
Standard Deviation 15.6
|
61.7 score on a scale
Standard Deviation 14.5
|
|
KOOS - Symptoms
4 months
|
62.4 score on a scale
Standard Deviation 14.7
|
63.4 score on a scale
Standard Deviation 16.7
|
|
KOOS - Symptoms
6 months
|
62.1 score on a scale
Standard Deviation 15.3
|
61.4 score on a scale
Standard Deviation 19.8
|
SECONDARY outcome
Timeframe: Baseline; 2 months, 4 months and 6 months from baselinePopulation: The number of participants analyzed is the same as the number of participants assigned to each group.
Pain was measured by Knee Injury and OA Outcome Score (KOOS). The KOOS measures knee osteoarthritis disease status and consists of five sub-scales: knee pain, stiffness, daily activity, sports/recreation, and quality of life. Scores range from 0 to 100, with higher being better.
Outcome measures
| Measure |
Immediate Intervention Group
n=30 Participants
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.
|
Delayed Intervention Group
n=31 Participants
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.
|
|---|---|---|
|
KOOS - Pain
Baseline
|
66.2 score on a scale
Standard Deviation 17.5
|
65.1 score on a scale
Standard Deviation 17.9
|
|
KOOS - Pain
2 months
|
70.9 score on a scale
Standard Deviation 17
|
64.8 score on a scale
Standard Deviation 14.6
|
|
KOOS - Pain
4 months
|
67.5 score on a scale
Standard Deviation 15.5
|
66.3 score on a scale
Standard Deviation 15.2
|
|
KOOS - Pain
6 months
|
68.6 score on a scale
Standard Deviation 17.5
|
66.2 score on a scale
Standard Deviation 16.4
|
SECONDARY outcome
Timeframe: Baseline; 2 months, 4 months and 6 months from baselinePopulation: The number of participants analyzed is the same as the number of participants assigned to each group.
Activity of Daily Living was measured by Knee Injury and OA Outcome Score (KOOS). The KOOS measures knee osteoarthritis disease status and consists of five sub-scales: knee pain, stiffness, daily activity, sports/recreation, and quality of life. Scores range from 0 to 100, with higher being better.
Outcome measures
| Measure |
Immediate Intervention Group
n=30 Participants
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.
|
Delayed Intervention Group
n=31 Participants
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.
|
|---|---|---|
|
KOOS - Activity of Daily Living
Baseline
|
71.8 score on a scale
Standard Deviation 17.5
|
74.1 score on a scale
Standard Deviation 17.6
|
|
KOOS - Activity of Daily Living
2 months
|
76 score on a scale
Standard Deviation 16.1
|
71 score on a scale
Standard Deviation 16.5
|
|
KOOS - Activity of Daily Living
4 months
|
76.6 score on a scale
Standard Deviation 17.5
|
75.2 score on a scale
Standard Deviation 17.2
|
|
KOOS - Activity of Daily Living
6 months
|
75.1 score on a scale
Standard Deviation 15.9
|
73.9 score on a scale
Standard Deviation 15.8
|
SECONDARY outcome
Timeframe: Baseline; 2 months, 4 months and 6 months from baselinePopulation: The number of participants analyzed is the same as the number of participants assigned to each group.
Sports \& Recreation was measured by Knee Injury and OA Outcome Score (KOOS). The KOOS measures knee osteoarthritis disease status and consists of five sub-scales: knee pain, stiffness, daily activity, sports/recreation, and quality of life. Scores range from 0 to 100, with higher being better.
Outcome measures
| Measure |
Immediate Intervention Group
n=30 Participants
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.
|
Delayed Intervention Group
n=31 Participants
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.
|
|---|---|---|
|
KOOS - Sports & Recreation
Baseline
|
47.3 score on a scale
Standard Deviation 26.6
|
52.7 score on a scale
Standard Deviation 27.7
|
|
KOOS - Sports & Recreation
2 months
|
49.3 score on a scale
Standard Deviation 24.9
|
47 score on a scale
Standard Deviation 23.3
|
|
KOOS - Sports & Recreation
4 months
|
50 score on a scale
Standard Deviation 25.6
|
48.9 score on a scale
Standard Deviation 27.7
|
|
KOOS - Sports & Recreation
6 months
|
50.4 score on a scale
Standard Deviation 26.3
|
49.8 score on a scale
Standard Deviation 29.2
|
SECONDARY outcome
Timeframe: Baseline; 2 months, 4 months and 6 months from baselinePopulation: The number of participants analyzed is the same as the number of participants assigned to each group.
Quality of Life was measured by Knee Injury and OA Outcome Score (KOOS). The KOOS measures knee osteoarthritis disease status and consists of five sub-scales: knee pain, stiffness, daily activity, sports/recreation, and quality of life. Scores range from 0 to 100, with higher being better.
Outcome measures
| Measure |
Immediate Intervention Group
n=30 Participants
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.
|
Delayed Intervention Group
n=31 Participants
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.
|
|---|---|---|
|
KOOS - Quality of Life
Baseline
|
41 score on a scale
Standard Deviation 19.8
|
44.6 score on a scale
Standard Deviation 16.3
|
|
KOOS - Quality of Life
2 months
|
47.2 score on a scale
Standard Deviation 18.9
|
42.4 score on a scale
Standard Deviation 16.8
|
|
KOOS - Quality of Life
4 months
|
45.4 score on a scale
Standard Deviation 17.6
|
47.5 score on a scale
Standard Deviation 13.6
|
|
KOOS - Quality of Life
6 months
|
44.9 score on a scale
Standard Deviation 17.9
|
48.1 score on a scale
Standard Deviation 19.1
|
SECONDARY outcome
Timeframe: Baseline; 2 months, 4 months and 6 months from baselinePopulation: The number of participants analyzed is the same as the number of participants assigned to each group.
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. Scores range from 0 to 96, with lower being better.
Outcome measures
| Measure |
Immediate Intervention Group
n=30 Participants
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.
|
Delayed Intervention Group
n=31 Participants
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.
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Partners in Health Scale
Baseline
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18.4 score on a scale
Standard Deviation 12.6
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20.5 score on a scale
Standard Deviation 12.8
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Partners in Health Scale
2 months
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14.9 score on a scale
Standard Deviation 11.4
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18.3 score on a scale
Standard Deviation 13.7
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Partners in Health Scale
4 months
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14.3 score on a scale
Standard Deviation 10.1
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14.9 score on a scale
Standard Deviation 9.6
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Partners in Health Scale
6 months
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12.9 score on a scale
Standard Deviation 9.2
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13.1 score on a scale
Standard Deviation 9.2
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Adverse Events
Immediate Intervention Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Delayed Intervention Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Linda Li, Professor, University of British Columbia
Arthritis Research Canada
Phone: 604-207-4020
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place