OPAM-IA: Using Digital Activity Trackers to Improve Physical Activity in Inflammatory Arthritis
Sponsor
University of British Columbia (Other)
Overall Status
Completed
CT.gov ID
NCT02554474
Collaborator
Simon Fraser University (Other), Arthritis Research Centre of Canada (Other), Vancouver General Hospital (Other), The Arthritis Society, Canada (Other), Fraser Health (Other)
118
1
2
31.7
3.7
Study Details
Study Description
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 |
|---|---|---|
|
N/A |
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 Design
Study Type:
Interventional
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
:
Jan 1, 2017
Actual Primary Completion Date
:
Aug 25, 2019
Actual Study Completion Date
:
Aug 25, 2019
Arms and Interventions
| 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.
|
Outcome Measures
Primary Outcome Measures
- Daily Time in Moderate/Vigorous Physical Activity [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
- Time Spent in Sedentary Activity [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 [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) [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) [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 [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 [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 [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 [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.
Eligibility Criteria
Criteria
Ages Eligible for Study:
19 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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).
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | 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
- Principal Investigator: Linda Li, PhD, Professor
Study Documents (Full-Text)
More Information
Publications
Responsible Party:
Linda Li,
Professor,
University of British Columbia
ClinicalTrials.gov Identifier:
NCT02554474
Other Study ID Numbers:
- H15-01843
First Posted:
Sep 18, 2015
Last Update Posted:
Jun 21, 2022
Last Verified:
May 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Linda Li,
Professor,
University of British Columbia
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | Recruitment period was 2017-2019. Participants were recruited from the Mary Pack Arthritis Program (Vancouver Coastal Health Authority) and Fraser Health Authority in British Columbia, Canada. Study information was also posted on Facebook, Twitter, Kajiji and Craigslist. |
|---|---|
| Pre-assignment Detail | After completing baseline measures at home, participants were randomized to the Immediate or Delay Group in 1:1 allocation ratio. |
| Arm/Group Title | Immediate Group | Delay Group |
|---|---|---|
| Arm/Group Description | Education, Fitbit/FitViz, physiotherapist counselling. These 3 components will be delivered to the participants in Months 1 and 2. The session will include a short presentation about physical activity in everyday life, an individual goal-setting session with a registered PT, and an orientation to the Fitbit and FitViz app. Participants will use the Fitbit/FitViz. The PT will review the progress with participants via bi-weekly phone calls and progressively modify their activities. In Month 3-6, participants will continue using the Fitbit/FitViz and have access to a PT via email as needed, but no bi-weekly phone calls. 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. | Same intervention with a 2 month delay: The full intervention will be initiated in Month 3 and 4 with a brief education session, use of a Fitbit paired with the FitViz app, and counseling by a PT. In Month 5-6, participants will continue the intervention without the PT phone calls, but will have email access to PT, if 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. |
| Period Title: Overall Study | ||
| STARTED | 59 | 59 |
| COMPLETED | 56 | 57 |
| NOT COMPLETED | 3 | 2 |
Baseline Characteristics
| Arm/Group Title | Immediate Group | Delay Group | Total |
|---|---|---|---|
| Arm/Group Description | Education, Fitbit/FitViz, physiotherapist counselling. These 3 components were delivered to the participants in Weeks 1-8. The session included a short presentation about physical activity in everyday life, an individual goal-setting session with a registered PT, and an orientation to the Fitbit and FitViz app. Participants used a Fitbit and the FitViz app. The PT reviewed the progress with participants via bi-weekly counselling phone calls and progressively modify their activities. In Weeks 9-26, participants continued using the Fitbit and FitViz and had access to a PT via email as needed, but no bi-weekly phone calls. | Same intervention (Education, Fitbit/FitViz, physiotherapist counselling) with a 9-week delay. The full intervention was delivered in Week 10-17. In Weeks 18-26, participants continued using the Fitbit and FitViz and had access to a PT via email as needed, but no bi-weekly phone calls. | Total of all reporting groups |
| Overall Participants | 59 | 59 | 118 |
| Age (years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [years] |
53.5
(14.7)
|
53.1
(12.6)
|
53.3
(13.6)
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
51
86.4%
|
54
91.5%
|
105
89%
|
| Male |
8
13.6%
|
5
8.5%
|
13
11%
|
| Race and Ethnicity Not Collected (Count of Participants) | |||
| Count of Participants [Participants] |
0
0%
|
||
| Race and Ethnicity Not Collected (Count of Participants) | |||
| Count of Participants [Participants] |
0
0%
|
||
| Region of Enrollment (participants) [Number] | |||
| Canada |
59
100%
|
59
100%
|
118
100%
|
| Region of Enrollment (participants) [Number] | |||
| Canada |
59
100%
|
59
100%
|
118
100%
|
| Daily time in moderate/vigorous physical activity (Minutes) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [Minutes] |
37.8
(39.6)
|
31.6
(42.7)
|
34.7
(41.1)
|
| Time in purposeful activity (Minutes) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [Minutes] |
13.0
(20.4)
|
11.2
(24.5)
|
12.1
(22.5)
|
| Daily steps (Steps) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [Steps] |
5900.8
(3214.1)
|
5605.7
(2865.1)
|
5753.2
(3035.2)
|
| Daily sedentary time (Minutes) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [Minutes] |
491.6
(192.5)
|
523.0
(194.4)
|
507.3
(193.3)
|
| McGill Pain Questionnaire (Units on a scale) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [Units on a scale] |
13.3
(10.8)
|
13.9
(9.5)
|
13.6
(10.1)
|
| Fatigue Severity Scale (Units on a scale) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [Units on a scale] |
4.8
(1.4)
|
4.9
(1.3)
|
4.8
(1.3)
|
| Partners in Health (Units on a scale) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [Units on a scale] |
72.8
(11.7)
|
73.5
(12.2)
|
73.1
(11.9)
|
| Patient Health Questionnaire (PHQ-9) (Units on a scale) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [Units on a scale] |
7.6
(5.9)
|
8.1
(5.6)
|
7.8
(5.7)
|
| Self-Reported Habit Index (units on a scale) [Mean (Standard Deviation) ] | |||
| Sitting at work subscale |
4.5
(1.7)
|
4.6
(1.8)
|
4.5
(1.7)
|
| Sitting at leisure subscale |
4.7
(1.4)
|
4.7
(1.3)
|
4.7
(1.3)
|
| Walking subscale |
4.1
(1.8)
|
3.7
(1.6)
|
3.9
(1.7)
|
Outcome Measures
| Title | Daily Time in Moderate/Vigorous Physical Activity |
|---|---|
| Description | 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. |
| Time Frame | Baseline, 9 weeks, 18 weeks, 27 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| 59 participants were randomized into each group. Week 9: Immediate Group - 3 withdrew;1 with missing data. Delay Group - 2 withdrew Week 18: Immediate Group - 3 additional participants withdrew; 2 with missing data. Delay Group - 1 additional participant withdrew. Week 27: Immediate Group - 1 additional participants withdrew, Delay Group - no additional participant withdrew; 6 with missing data. |
| Arm/Group Title | Immediate Group | Delay Group |
|---|---|---|
| Arm/Group Description | Education, Fitbit/FitViz, physiotherapist counselling. These 3 components were delivered to the participants in Weeks 1-8. The session included a short presentation about physical activity in everyday life, an individual goal-setting session with a registered PT, and an orientation to the Fitbit and FitViz app. Participants used a Fitbit and the FitViz app. The PT reviewed the progress with participants via bi-weekly counselling phone calls and progressively modify their activities. In Weeks 9-26, participants continued using the Fitbit and FitViz and had access to a PT via email as needed, but no bi-weekly phone calls. | Same intervention (Education, Fitbit/FitViz, physiotherapist counselling) with a 9-week delay. The full intervention was delivered in Week 10-17. In Weeks 18-26, participants continued using the Fitbit and FitViz and had access to a PT via email as needed, but no bi-weekly phone calls. |
| Measure Participants | 59 | 59 |
| Baseline |
37.8
(39.6)
|
31.6
(42.7)
|
| 9 weeks |
44.7
(41.2)
|
31.6
(32.4)
|
| 18 weeks |
43.2
(48.2)
|
32.8
(36.8)
|
| 27 weeks |
37.8
(38.8)
|
34.0
(36.1)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Immediate Group, Delay Group |
|---|---|---|
| Comments | We performed an intent-to-treat analysis. For the main comparison, we used analysis of covariance (ANCOVA) to estimate an adjusted mean difference comparing time in MVPA at 9 weeks (primary end point) between groups, adjusting for baseline MVPA, diagnosis, and blocking. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Adjusted difference in mean change |
| Estimated Value | 9.4 | |
| Confidence Interval |
(2-Sided) 95% -0.5 to 19.3 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Time Spent in Sedentary Activity |
|---|---|
| Description | 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. |
| Time Frame | Baseline, 9 weeks, 18 weeks, 27 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| 59 participants were randomized into each group. Week 9: Immediate Group - 3 withdrew;1 with missing data. Delay Group - 2 withdrew Week 18: Immediate Group - 3 additional participants withdrew; 2 with missing data. Delay Group - 1 additional participant withdrew. Week 27: Immediate Group - 1 additional participants withdrew, Delay Group - no additional participant withdrew; 6 with missing data. |
| Arm/Group Title | Immediate Group | Delay Group |
|---|---|---|
| Arm/Group Description | Education, Fitbit/FitViz, physiotherapist counselling. These 3 components were delivered to the participants in Weeks 1-8. The session included a short presentation about physical activity in everyday life, an individual goal-setting session with a registered PT, and an orientation to the Fitbit and FitViz app. Participants used a Fitbit and the FitViz app. The PT reviewed the progress with participants via bi-weekly counselling phone calls and progressively modify their activities. In Weeks 9-26, participants continued using the Fitbit and FitViz and had access to a PT via email as needed, but no bi-weekly phone calls. | Same intervention (Education, Fitbit/FitViz, physiotherapist counselling) with a 9-week delay. The full intervention was delivered in Week 10-17. In Weeks 18-26, participants continued using the Fitbit and FitViz and had access to a PT via email as needed, but no bi-weekly phone calls. |
| Measure Participants | 59 | 59 |
| Baseline |
491.6
(192.5)
|
523.0
(194.4)
|
| 9 weeks |
508.4
(203.5)
|
530.0
(180.2)
|
| 18 weeks |
507.8
(195.8)
|
531.4
(165.4)
|
| 27 weeks |
506.8
(179.7)
|
498.0
(155.6)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Immediate Group, Delay Group |
|---|---|---|
| Comments | We performed an intent-to-treat analysis. For the main comparison, we used analysis of covariance (ANCOVA) to estimate an adjusted mean difference comparing sedentary time at 9 weeks (primary end point) between groups, adjusting for baseline sedentary time, diagnosis, and blocking. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Adjusted difference in mean change |
| Estimated Value | -10.4 | |
| Confidence Interval |
(2-Sided) 95% -53.4 to 32.6 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Fatigue Severity Scale |
|---|---|
| Description | 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. |
| Time Frame | Baseline, 9 weeks, 18 weeks, 27 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| 59 participants were randomized into each group. Week 9: Immediate Group - 3 withdrew;1 with missing data. Delay Group - 2 withdrew Week 18: Immediate Group - 3 additional participants withdrew; 2 with missing data. Delay Group - 1 additional participant withdrew. Week 27: Immediate Group - 1 additional participants withdrew, Delay Group - no additional participant withdrew; 6 with missing data. |
| Arm/Group Title | Immediate Group | Delay Group |
|---|---|---|
| Arm/Group Description | Education, Fitbit/FitViz, physiotherapist counselling. These 3 components were delivered to the participants in Weeks 1-8. The session included a short presentation about physical activity in everyday life, an individual goal-setting session with a registered PT, and an orientation to the Fitbit and FitViz app. Participants used a Fitbit and the FitViz app. The PT reviewed the progress with participants via bi-weekly counselling phone calls and progressively modify their activities. In Weeks 9-26, participants continued using the Fitbit and FitViz and had access to a PT via email as needed, but no bi-weekly phone calls. | Same intervention (Education, Fitbit/FitViz, physiotherapist counselling) with a 9-week delay. The full intervention was delivered in Week 10-17. In Weeks 18-26, participants continued using the Fitbit and FitViz and had access to a PT via email as needed, but no bi-weekly phone calls. |
| Measure Participants | 59 | 59 |
| Baseline |
4.8
(1.4)
|
4.9
(1.3)
|
| 9 weeks |
4.5
(1.3)
|
4.9
(1.3)
|
| 18 weeks |
4.8
(1.3)
|
4.6
(1.5)
|
| 27 weeks |
4.5
(1.4)
|
4.7
(1.4)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Immediate Group, Delay Group |
|---|---|---|
| Comments | We performed an intent-to-treat analysis. For the main comparison, we used analysis of covariance (ANCOVA) to estimate an adjusted mean difference comparing time in the Fatigue Severity Scale at 9 weeks (primary end point) between groups, adjusting for baseline fatigue score, diagnosis, and blocking. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Adjusted difference in mean change |
| Estimated Value | -0.31 | |
| Confidence Interval |
(2-Sided) 95% -0.63 to 0.01 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | McGill Pain Questionnaire Short Form (MPQ-SF) |
|---|---|
| Description | The MPQ-SF contains 15 pain-related words, which can be rated from 0 to 3. Range 0 - 45; higher=more severe pain. |
| Time Frame | Baseline, 9 weeks, 18 weeks, 27 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| 59 participants were randomized into each group. Week 9: Immediate Group - 3 withdrew;1 with missing data. Delay Group - 2 withdrew Week 18: Immediate Group - 3 additional participants withdrew; 2 with missing data. Delay Group - 1 additional participant withdrew. Week 27: Immediate Group - 1 additional participants withdrew, Delay Group - no additional participant withdrew; 6 with missing data. |
| Arm/Group Title | Immediate Group | Delay Group |
|---|---|---|
| Arm/Group Description | Education, Fitbit/FitViz, physiotherapist counselling. These 3 components were delivered to the participants in Weeks 1-8. The session included a short presentation about physical activity in everyday life, an individual goal-setting session with a registered PT, and an orientation to the Fitbit and FitViz app. Participants used a Fitbit and the FitViz app. The PT reviewed the progress with participants via bi-weekly counselling phone calls and progressively modify their activities. In Weeks 9-26, participants continued using the Fitbit and FitViz and had access to a PT via email as needed, but no bi-weekly phone calls. | Same intervention (Education, Fitbit/FitViz, physiotherapist counselling) with a 9-week delay. The full intervention was delivered in Week 10-17. In Weeks 18-26, participants continued using the Fitbit and FitViz and had access to a PT via email as needed, but no bi-weekly phone calls. |
| Measure Participants | 59 | 59 |
| Baseline |
13.3
(10.8)
|
13.9
(9.5)
|
| 9 weeks |
10.9
(8.4)
|
14.6
(9.7)
|
| 18 weeks |
10.6
(9.6)
|
12.6
(10.0)
|
| 27 weeks |
11.8
(10.0)
|
11.0
(9.8)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Immediate Group, Delay Group |
|---|---|---|
| Comments | We performed an intent-to-treat analysis. For the main comparison, we used analysis of covariance (ANCOVA) to estimate an adjusted mean difference comparing pain at 9 weeks (primary end point) between groups, adjusting for pain score, diagnosis, and blocking. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Adjusted difference in mean change |
| Estimated Value | -2.45 | |
| Confidence Interval |
(2-Sided) 95% -4.78 to -0.13 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | The Patient Health Questionnaire-9 (PHQ-9) |
|---|---|
| Description | 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), |
| Time Frame | Baseline, 9 weeks, 18 weeks, 27 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| 59 participants were randomized into each group. Week 9: Immediate Group - 3 withdrew;1 with missing data. Delay Group - 2 withdrew Week 18: Immediate Group - 3 additional participants withdrew; 2 with missing data. Delay Group - 1 additional participant withdrew. Week 27: Immediate Group - 1 additional participants withdrew, Delay Group - no additional participant withdrew; 6 with missing data. |
| Arm/Group Title | Immediate Group | Delay Group |
|---|---|---|
| Arm/Group Description | Education, Fitbit/FitViz, physiotherapist counselling. These 3 components were delivered to the participants in Weeks 1-8. The session included a short presentation about physical activity in everyday life, an individual goal-setting session with a registered PT, and an orientation to the Fitbit and FitViz app. Participants used a Fitbit and the FitViz app. The PT reviewed the progress with participants via bi-weekly counselling phone calls and progressively modify their activities. In Weeks 9-26, participants continued using the Fitbit and FitViz and had access to a PT via email as needed, but no bi-weekly phone calls. | Same intervention (Education, Fitbit/FitViz, physiotherapist counselling) with a 9-week delay. The full intervention was delivered in Week 10-17. In Weeks 18-26, participants continued using the Fitbit and FitViz and had access to a PT via email as needed, but no bi-weekly phone calls. |
| Measure Participants | 59 | 59 |
| Baseline |
7.6
(5.9)
|
8.1
(5.6)
|
| 9 weeks |
6.8
(5.6)
|
7.9
(5.7)
|
| 18 weeks |
6.0
(5.0)
|
6.2
(5.4)
|
| 27 weeks |
5.2
(3.8)
|
6.7
(5.9)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Immediate Group, Delay Group |
|---|---|---|
| Comments | We performed an intent-to-treat analysis. For the main comparison, we used analysis of covariance (ANCOVA) to estimate an adjusted mean difference comparing the PHQ-9 scores at 9 weeks (primary end point) between groups, adjusting for baseline score, diagnosis, and blocking. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Adjusted difference in mean change |
| Estimated Value | -0.22 | |
| Confidence Interval |
(2-Sided) 95% -1.78 to 1.35 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Partners In Health Scale |
|---|---|
| Description | 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. |
| Time Frame | Baseline, 9 weeks, 18 weeks, 27 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| 59 participants were randomized into each group. Week 9: Immediate Group - 3 withdrew;1 with missing data. Delay Group - 2 withdrew Week 18: Immediate Group - 3 additional participants withdrew; 2 with missing data. Delay Group - 1 additional participant withdrew. Week 27: Immediate Group - 1 additional participants withdrew, Delay Group - no additional participant withdrew; 6 with missing data. |
| Arm/Group Title | Immediate Group | Delay Group |
|---|---|---|
| Arm/Group Description | Education, Fitbit/FitViz, physiotherapist counselling. These 3 components were delivered to the participants in Weeks 1-8. The session included a short presentation about physical activity in everyday life, an individual goal-setting session with a registered PT, and an orientation to the Fitbit and FitViz app. Participants used a Fitbit and the FitViz app. The PT reviewed the progress with participants via bi-weekly counselling phone calls and progressively modify their activities. In Weeks 9-26, participants continued using the Fitbit and FitViz and had access to a PT via email as needed, but no bi-weekly phone calls. | Same intervention (Education, Fitbit/FitViz, physiotherapist counselling) with a 9-week delay. The full intervention was delivered in Week 10-17. In Weeks 18-26, participants continued using the Fitbit and FitViz and had access to a PT via email as needed, but no bi-weekly phone calls. |
| Measure Participants | 59 | 59 |
| Baseline |
72.8
(11.7)
|
73.5
(12.2)
|
| 9 weeks |
75.5
(12.5)
|
74.6
(11.2)
|
| 18 weeks |
77.7
(11.4)
|
78.7
(10.8)
|
| 27 weeks |
77.9
(12.6)
|
77.4
(10.7)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Immediate Group, Delay Group |
|---|---|---|
| Comments | We performed an intent-to-treat analysis. For the main comparison, we used analysis of covariance (ANCOVA) to estimate an adjusted mean difference comparing the Partners In Health Scale scores at 9 weeks (primary end point) between groups, adjusting for baseline score, diagnosis, and blocking. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Adjusted difference in mean change |
| Estimated Value | 1.58 | |
| Confidence Interval |
(2-Sided) 95% -1.02 to 4.18 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | The Self-Reported Habit Index (SRHI) - Sitting at Work Index |
|---|---|
| Description | 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. |
| Time Frame | Baseline, 9 weeks, 18 weeks, 27 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| 59 participants were randomized into each group. Week 9: Immediate Group - 3 withdrew;1 with missing data. Delay Group - 2 withdrew Week 18: Immediate Group - 3 additional participants withdrew; 2 with missing data. Delay Group - 1 additional participant withdrew. Week 27: Immediate Group - 1 additional participants withdrew, Delay Group - no additional participant withdrew; 6 with missing data. |
| Arm/Group Title | Immediate Group | Delay Group |
|---|---|---|
| Arm/Group Description | Education, Fitbit/FitViz, physiotherapist counselling. These 3 components were delivered to the participants in Weeks 1-8. The session included a short presentation about physical activity in everyday life, an individual goal-setting session with a registered PT, and an orientation to the Fitbit and FitViz app. Participants used a Fitbit and the FitViz app. The PT reviewed the progress with participants via bi-weekly counselling phone calls and progressively modify their activities. In Weeks 9-26, participants continued using the Fitbit and FitViz and had access to a PT via email as needed, but no bi-weekly phone calls. | Same intervention (Education, Fitbit/FitViz, physiotherapist counselling) with a 9-week delay. The full intervention was delivered in Week 10-17. In Weeks 18-26, participants continued using the Fitbit and FitViz and had access to a PT via email as needed, but no bi-weekly phone calls. |
| Measure Participants | 59 | 59 |
| Baseline |
4.5
(1.7)
|
4.6
(1.8)
|
| 9 weeks |
4.3
(1.8)
|
4.7
(1.7)
|
| 18 weeks |
4.6
(1.7)
|
4.6
(1.8)
|
| 27 weeks |
4.4
(1.4)
|
4.6
(1.7)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Immediate Group, Delay Group |
|---|---|---|
| Comments | We performed an intent-to-treat analysis. For the main comparison, analysis of covariance (ANCOVA) was used to estimate an adjusted mean difference comparing the Sitting at Work index scores at 9 weeks (primary end point) between groups, adjusting for baseline score, diagnosis, and blocking. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Adjusted difference in mean change |
| Estimated Value | 0.05 | |
| Confidence Interval |
(2-Sided) 95% -0.05 to 0.16 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | The Self-Reported Habit Index (SRHI) - Sitting at Leisure Index |
|---|---|
| Description | 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. |
| Time Frame | Baseline, 9 weeks, 18 weeks, 27 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| 59 participants were randomized into each group. Week 9: Immediate Group - 3 withdrew;1 with missing data. Delay Group - 2 withdrew Week 18: Immediate Group - 3 additional participants withdrew; 2 with missing data. Delay Group - 1 additional participant withdrew. Week 27: Immediate Group - 1 additional participants withdrew, Delay Group - no additional participant withdrew; 6 with missing data. |
| Arm/Group Title | Immediate Group | Delay Group |
|---|---|---|
| Arm/Group Description | Education, Fitbit/FitViz, physiotherapist counselling. These 3 components were delivered to the participants in Weeks 1-8. The session included a short presentation about physical activity in everyday life, an individual goal-setting session with a registered PT, and an orientation to the Fitbit and FitViz app. Participants used a Fitbit and the FitViz app. The PT reviewed the progress with participants via bi-weekly counselling phone calls and progressively modify their activities. In Weeks 9-26, participants continued using the Fitbit and FitViz and had access to a PT via email as needed, but no bi-weekly phone calls. | Same intervention (Education, Fitbit/FitViz, physiotherapist counselling) with a 9-week delay. The full intervention was delivered in Week 10-17. In Weeks 18-26, participants continued using the Fitbit and FitViz and had access to a PT via email as needed, but no bi-weekly phone calls. |
| Measure Participants | 59 | 59 |
| Baseline |
4.7
(1.4)
|
4.7
(1.3)
|
| 9 weeks |
4.7
(1.3)
|
4.8
(1.4)
|
| 18 weeks |
4.6
(1.3)
|
4.8
(1.2)
|
| 27 weeks |
4.6
(1.3)
|
4.7
(1.4)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Immediate Group, Delay Group |
|---|---|---|
| Comments | We performed an intent-to-treat analysis. For the main comparison, analysis of covariance (ANCOVA) was used to estimate an adjusted mean difference comparing the Sitting at Leisure index scores at 9 weeks (primary end point) between groups, adjusting for baseline score, diagnosis, and blocking. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Adjusted difference in mean change |
| Estimated Value | 0 | |
| Confidence Interval |
(2-Sided) 95% -0.37 to 0.37 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | The Self-Reported Habit Index (SRHI) - Walking Index |
|---|---|
| Description | 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. |
| Time Frame | Baseline, 9 weeks, 18 weeks, 27 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| 59 participants were randomized into each group. Week 9: Immediate Group - 3 withdrew;1 with missing data. Delay Group - 2 withdrew Week 18: Immediate Group - 3 additional participants withdrew; 2 with missing data. Delay Group - 1 additional participant withdrew. Week 27: Immediate Group - 1 additional participants withdrew, Delay Group - no additional participant withdrew; 6 with missing data. |
| Arm/Group Title | Immediate Group | Delay Group |
|---|---|---|
| Arm/Group Description | Education, Fitbit/FitViz, physiotherapist counselling. These 3 components were delivered to the participants in Weeks 1-8. The session included a short presentation about physical activity in everyday life, an individual goal-setting session with a registered PT, and an orientation to the Fitbit and FitViz app. Participants used a Fitbit and the FitViz app. The PT reviewed the progress with participants via bi-weekly counselling phone calls and progressively modify their activities. In Weeks 9-26, participants continued using the Fitbit and FitViz and had access to a PT via email as needed, but no bi-weekly phone calls. | Same intervention (Education, Fitbit/FitViz, physiotherapist counselling) with a 9-week delay. The full intervention was delivered in Week 10-17. In Weeks 18-26, participants continued using the Fitbit and FitViz and had access to a PT via email as needed, but no bi-weekly phone calls. |
| Measure Participants | 59 | 59 |
| Baseline |
4.1
(1.8)
|
3.7
(1.6)
|
| 9 weeks |
4.4
(1.7)
|
3.6
(1.7)
|
| 18 weeks |
4.3
(1.6)
|
4.0
(1.6)
|
| 27 weeks |
4.7
(1.5)
|
4.0
(1.7)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Immediate Group, Delay Group |
|---|---|---|
| Comments | We performed an intent-to-treat analysis. For the main comparison, analysis of covariance (ANCOVA) was used to estimate an adjusted mean difference comparing the Walking index scores at 9 weeks (primary end point) between groups, adjusting for baseline score, diagnosis, and blocking. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Adjusted difference in mean change |
| Estimated Value | 0.54 | |
| Confidence Interval |
(2-Sided) 95% 0.08 to 0.99 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Adverse Events
| Time Frame | 26 weeks | |||
|---|---|---|---|---|
| Adverse Event Reporting Description | Self-reported adverse events were collected, including muscle pain, ligament sprain, or falls while being physically active, were collected. | |||
| Arm/Group Title | Immediate Group | Delay Group | ||
| Arm/Group Description | 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. | 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. | ||
All Cause Mortality |
||||
| Immediate Group | Delay Group | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/59 (0%) | 0/59 (0%) | ||
Serious Adverse Events |
||||
| Immediate Group | Delay Group | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/59 (0%) | 0/59 (0%) | ||
Other (Not Including Serious) Adverse Events |
||||
| Immediate Group | Delay Group | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 13/59 (22%) | 10/59 (16.9%) | ||
| Musculoskeletal and connective tissue disorders | ||||
| Muscle pain | 10/59 (16.9%) | 9/59 (15.3%) | ||
| Ligament sprain | 3/59 (5.1%) | 1/59 (1.7%) | ||
Limitations/Caveats
A limitation is the inclusion of only individuals with rheumatoid arthritis and systemic lupus erythematosus. We focused on these 2 diseases because of feasibility for recruitment in our community. The findings, however, are not generalizable to people with other types of inflammatory arthritis. Furthermore, the results may not be generalizable to men because 89% of the participants were women.
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Dr. Linda Li |
|---|---|
| Organization | University of British Columbia |
| Phone | 604-207-4020 |
| lli@arthritisresearch.ca |
Responsible Party:
Linda Li,
Professor,
University of British Columbia
ClinicalTrials.gov Identifier:
NCT02554474
Other Study ID Numbers:
- H15-01843
First Posted:
Sep 18, 2015
Last Update Posted:
Jun 21, 2022
Last Verified:
May 1, 2022