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

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ClinicalTrials.gov Identifier: NCT02554474

Recruitment Status : Completed

First Posted : September 18, 2015

Results First Posted : June 4, 2021

Last Update Posted : June 21, 2022

View this study on Beta.ClinicalTrials.gov

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

Study Type	Interventional
Study Design	Allocation: Randomized; Intervention Model: Crossover Assignment; Masking: None (Open Label); Primary Purpose: Supportive Care
Conditions	Joint Diseases Rheumatoid Arthritis Systemic Lupus Erythematosus
Interventions	Behavioral: Education, Fitbit/FitViz, physiotherapist counselling. Behavioral: Same intervention with a 9-week delay
Enrollment	118

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 Details	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, physiothe...	Same intervention with a 2 month de...
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 ^[1]	57 ^[1]
Not Completed	3	2
Reason Not Completed
Protocol Violation	1	1
Health issue not related to the study	1	0
Withdrawal by Subject	1	1
[1] Indicates number of participants who completed assessment at the primary endpoint.

Baseline Characteristics

Arm/Group Title		Immediate Group	Delay Group	Total
Arm/Group Description		Education, Fitbit/FitViz, physiothe...	Same intervention (Education, Fitbi...	Total of all reporting groups
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 Number of Baseline Participants		59	59	118
Baseline Analysis Population Description		[Not Specified]
Baseline Analysis Population Description		[Not Specified]
Age, Continuous Mean (Standard Deviation) Unit of measure: Years
	Number Analyzed	59 participants	59 participants	118 participants
		53.5 (14.7)	53.1 (12.6)	53.3 (13.6)
Sex: Female, Male Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	59 participants	59 participants	118 participants
	Female	51 86.4%	54 91.5%	105 89.0%
	Male	8 13.6%	5 8.5%	13 11.0%
Race and Ethnicity Not Collected ^[1] Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	0 participants	0 participants	0 participants
				0
		[1] Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
Race and Ethnicity Not Collected ^[1] Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	0 participants	0 participants	0 participants
				0
		[1] Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
Region of Enrollment Measure Type: Number Unit of measure: Participants
Canada	Number Analyzed	59 participants	59 participants	118 participants
Canada		59	59	118
Region of Enrollment Measure Type: Number Unit of measure: Participants
Canada	Number Analyzed	59 participants	59 participants	118 participants
Canada		59	59	118
Daily time in moderate/vigorous physical activity Mean (Standard Deviation) Unit of measure: Minutes
	Number Analyzed	59 participants	59 participants	118 participants
		37.8 (39.6)	31.6 (42.7)	34.7 (41.1)
Time in purposeful activity Mean (Standard Deviation) Unit of measure: Minutes
	Number Analyzed	59 participants	59 participants	118 participants
		13.0 (20.4)	11.2 (24.5)	12.1 (22.5)
Daily steps Mean (Standard Deviation) Unit of measure: Steps
	Number Analyzed	59 participants	59 participants	118 participants
		5900.8 (3214.1)	5605.7 (2865.1)	5753.2 (3035.2)
Daily sedentary time Mean (Standard Deviation) Unit of measure: Minutes
	Number Analyzed	59 participants	59 participants	118 participants
		491.6 (192.5)	523.0 (194.4)	507.3 (193.3)
McGill Pain Questionnaire ^[1] Mean (Standard Deviation) Unit of measure: Units on a scale
	Number Analyzed	59 participants	59 participants	118 participants
		13.3 (10.8)	13.9 (9.5)	13.6 (10.1)
		[1] Measure Description: McGill Pain Questionnaire (range 0-45; lower score = less severe pain)
Fatigue Severity Scale ^[1] Mean (Standard Deviation) Unit of measure: Units on a scale
	Number Analyzed	59 participants	59 participants	118 participants
		4.8 (1.4)	4.9 (1.3)	4.8 (1.3)
		[1] Measure Description: Fatigue Severity Scale (range 1-7; lower score = less fatigue)
Partners in Health ^[1] Mean (Standard Deviation) Unit of measure: Units on a scale
	Number Analyzed	59 participants	59 participants	118 participants
		72.8 (11.7)	73.5 (12.2)	73.1 (11.9)
		[1] Measure Description: Partners in Health (range 0-96; higher score = higher perceived confidence and ability in self-care)
Patient Health Questionnaire (PHQ-9) ^[1] Mean (Standard Deviation) Unit of measure: Units on a scale
	Number Analyzed	59 participants	59 participants	118 participants
		7.6 (5.9)	8.1 (5.6)	7.8 (5.7)
		[1] Measure Description: PHQ-9; range 0-27; lower score = less depressive symptoms
Self-Reported Habit Index ^[1] Mean (Standard Deviation) Unit of measure: Units on a scale
Sitting at work subscale	Number Analyzed	59 participants	59 participants	118 participants
Sitting at work subscale		4.5 (1.7)	4.6 (1.8)	4.5 (1.7)
Sitting at leisure subscale	Number Analyzed	59 participants	59 participants	118 participants
Sitting at leisure subscale		4.7 (1.4)	4.7 (1.3)	4.7 (1.3)
Walking subscale	Number Analyzed	59 participants	59 participants	118 participants
Walking subscale		4.1 (1.8)	3.7 (1.6)	3.9 (1.7)
		[1] Measure Description: Self-Reported Habit Index (range 1-7; higher score = stronger habit)

Outcome Measures

1.Primary Outcome


Title	Daily Time in Moderate/Vigorous Physical Activity
Description	Time spent in Moderate/Vigorous Physical Activity (MVPA) was measured ...
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, physiothe...	Same intervention (Education, Fitbi...
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.
Overall Number of Participants Analyzed		59	59
Mean (Standard Deviation) Unit of Measure: Minutes
Baseline	Number Analyzed	59 participants	59 participants
Baseline		37.8 (39.6)	31.6 (42.7)
9 weeks	Number Analyzed	55 participants	57 participants
9 weeks		44.7 (41.2)	31.6 (32.4)
18 weeks	Number Analyzed	51 participants	56 participants
18 weeks		43.2 (48.2)	32.8 (36.8)
27 weeks	Number Analyzed	50 participants	52 participants
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	[Not Specified]

Method of Estimation	Estimation Parameter	Adjusted difference in mean change
	Estimated Value	9.4
	Confidence Interval	(2-Sided) 95% -0.5 to 19.3
	Estimation Comments	[Not Specified]

2.Secondary Outcome


Title	Time Spent in Sedentary Activity
Description	Time spent in sedentary activity was measured with a SenseWear Mini se...
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

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, physiothe...	Same intervention (Education, Fitbi...
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.
Overall Number of Participants Analyzed		59	59
Mean (Standard Deviation) Unit of Measure: Minutes
Baseline	Number Analyzed	59 participants	59 participants
Baseline		491.6 (192.5)	523.0 (194.4)
9 weeks	Number Analyzed	55 participants	57 participants
9 weeks		508.4 (203.5)	530.0 (180.2)
18 weeks	Number Analyzed	51 participants	56 participants
18 weeks		507.8 (195.8)	531.4 (165.4)
27 weeks	Number Analyzed	50 participants	52 participants
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	[Not Specified]

Method of Estimation	Estimation Parameter	Adjusted difference in mean change
	Estimated Value	-10.4
	Confidence Interval	(2-Sided) 95% -53.4 to 32.6
	Estimation Comments	[Not Specified]

3.Secondary Outcome


Title	Fatigue Severity Scale
Description	The Fatigue Severity Scale consists of 9 questions and measures the im...
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

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, physiothe...	Same intervention (Education, Fitbi...
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.
Overall Number of Participants Analyzed		59	59
Mean (Standard Deviation) Unit of Measure: score on a scale
Baseline	Number Analyzed	59 participants	59 participants
Baseline		4.8 (1.4)	4.9 (1.3)
9 weeks	Number Analyzed	55 participants	57 participants
9 weeks		4.5 (1.3)	4.9 (1.3)
18 weeks	Number Analyzed	51 participants	56 participants
18 weeks		4.8 (1.3)	4.6 (1.5)
27 weeks	Number Analyzed	50 participants	52 participants
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	[Not Specified]

Method of Estimation	Estimation Parameter	Adjusted difference in mean change
	Estimated Value	-0.31
	Confidence Interval	(2-Sided) 95% -0.63 to 0.01
	Estimation Comments	[Not Specified]

4.Secondary Outcome


Title	McGill Pain Questionnaire Short Form (MPQ-SF)
Description	The MPQ-SF contains 15 pain-related words, which can be rated from 0 t...
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

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, physiothe...	Same intervention (Education, Fitbi...
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.
Overall Number of Participants Analyzed		59	59
Mean (Standard Deviation) Unit of Measure: score on a scale
Baseline	Number Analyzed	59 participants	59 participants
Baseline		13.3 (10.8)	13.9 (9.5)
9 weeks	Number Analyzed	55 participants	57 participants
9 weeks		10.9 (8.4)	14.6 (9.7)
18 weeks	Number Analyzed	51 participants	56 participants
18 weeks		10.6 (9.6)	12.6 (10.0)
27 weeks	Number Analyzed	50 participants	52 participants
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	[Not Specified]

Method of Estimation	Estimation Parameter	Adjusted difference in mean change
	Estimated Value	-2.45
	Confidence Interval	(2-Sided) 95% -4.78 to -0.13
	Estimation Comments	[Not Specified]

5.Secondary Outcome


Title	The Patient Health Questionnaire-9 (PHQ-9)
Description	The PHQ-9 consists of nine questions (rated from 0 to 3) that correspo...
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

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, physiothe...	Same intervention (Education, Fitbi...
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.
Overall Number of Participants Analyzed		59	59
Mean (Standard Deviation) Unit of Measure: score on a scale
Baseline	Number Analyzed	59 participants	59 participants
Baseline		7.6 (5.9)	8.1 (5.6)
9 weeks	Number Analyzed	55 participants	57 participants
9 weeks		6.8 (5.6)	7.9 (5.7)
18 weeks	Number Analyzed	51 participants	56 participants
18 weeks		6.0 (5.0)	6.2 (5.4)
27 weeks	Number Analyzed	50 participants	52 participants
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	[Not Specified]

Method of Estimation	Estimation Parameter	Adjusted difference in mean change
	Estimated Value	-0.22
	Confidence Interval	(2-Sided) 95% -1.78 to 1.35
	Estimation Comments	[Not Specified]

6.Secondary Outcome


Title	Partners In Health Scale
Description	The Partners in Health Scale is a 12-item measure designed to assess s...
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

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, physiothe...	Same intervention (Education, Fitbi...
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.
Overall Number of Participants Analyzed	59	59
Mean (Standard Deviation) Unit of Measure: score on a scale
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	[Not Specified]

Method of Estimation	Estimation Parameter	Adjusted difference in mean change
	Estimated Value	1.58
	Confidence Interval	(2-Sided) 95% -1.02 to 4.18
	Estimation Comments	[Not Specified]

7.Secondary Outcome


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 mea...
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

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, physiothe...	Same intervention (Education, Fitbi...
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.
Overall Number of Participants Analyzed	59	59
Mean (Standard Deviation) Unit of Measure: score on a scale
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	[Not Specified]

Method of Estimation	Estimation Parameter	Adjusted difference in mean change
	Estimated Value	0.05
	Confidence Interval	(2-Sided) 95% -0.05 to 0.16
	Estimation Comments	[Not Specified]

8.Secondary Outcome


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 mea...
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

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, physiothe...	Same intervention (Education, Fitbi...
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.
Overall Number of Participants Analyzed		59	59
Mean (Standard Deviation) Unit of Measure: score on a scale
Baseline	Number Analyzed	59 participants	59 participants
Baseline		4.7 (1.4)	4.7 (1.3)
9 weeks	Number Analyzed	55 participants	57 participants
9 weeks		4.7 (1.3)	4.8 (1.4)
18 weeks	Number Analyzed	51 participants	56 participants
18 weeks		4.6 (1.3)	4.8 (1.2)
27 weeks	Number Analyzed	50 participants	52 participants
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	[Not Specified]

Method of Estimation	Estimation Parameter	Adjusted difference in mean change
	Estimated Value	0
	Confidence Interval	(2-Sided) 95% -0.37 to 0.37
	Estimation Comments	[Not Specified]

9.Secondary Outcome


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 mea...
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

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, physiothe...	Same intervention (Education, Fitbi...
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.
Overall Number of Participants Analyzed		59	59
Mean (Standard Deviation) Unit of Measure: score on a scale
Baseline	Number Analyzed	59 participants	59 participants
Baseline		4.1 (1.8)	3.7 (1.6)
9 weeks	Number Analyzed	55 participants	57 participants
9 weeks		4.4 (1.7)	3.6 (1.7)
18 weeks	Number Analyzed	51 participants	56 participants
18 weeks		4.3 (1.6)	4.0 (1.6)
27 weeks	Number Analyzed	50 participants	52 participants
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	[Not Specified]

Method of Estimation	Estimation Parameter	Adjusted difference in mean change
	Estimated Value	0.54
	Confidence Interval	(2-Sided) 95% 0.08 to 0.99
	Estimation Comments	[Not Specified]

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 Phy...	Time spent in sedentary activity wa...
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 (%)	Affected / at Risk (%)
Total	0/59 (0.00%)	0/59 (0.00%)
Serious Adverse Events Serious Adverse Events
	Immediate Group	Delay Group
	Affected / at Risk (%)	Affected / at Risk (%)
Total	0/59 (0.00%)	0/59 (0.00%)
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	0%
	Immediate Group	Delay Group
	Affected / at Risk (%)	Affected / at Risk (%)
Total	13/59 (22.03%)	10/59 (16.95%)
Musculoskeletal and connective tissue disorders
Muscle pain ^*	10/59 (16.95%)	9/59 (15.25%)
Ligament sprain ^*	3/59 (5.08%)	1/59 (1.69%)
* Indicates events were collected by non-systematic assessment

Limitations and 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

Layout table for Results Point of Contact information

Name/Title:	Dr. Linda Li
Organization:	University of British Columbia
Phone:	604-207-4020
EMail:	lli@arthritisresearch.ca

Publications of Results:

Li LC, Feehan LM, Xie H, Lu N, Shaw C, Gromala D, Avina-Zubieta JA, Koehn C, Hoens AM, English K, Tam J, Therrien S, Townsend AF, Noonan G, Backman CL. Efficacy of a Physical Activity Counseling Program With Use of a Wearable Tracker in People With Inflammatory Arthritis: A Randomized Controlled Trial. Arthritis Care Res (Hoboken). 2020 Dec;72(12):1755-1765. doi: 10.1002/acr.24199.

Leese J, Zhu S, Townsend AF, Backman CL, Nimmon L, Li LC. Ethical issues experienced by persons with rheumatoid arthritis in a wearable-enabled physical activity intervention study. Health Expect. 2022 Aug;25(4):1418-1431. doi: 10.1111/hex.13481. Epub 2022 Mar 18.

Other Publications:

Li LC, Feehan LM, Shaw C, Xie H, Sayre EC, Avina-Zubeita A, Grewal N, Townsend AF, Gromala D, Noonan G, Backman CL. A technology-enabled Counselling program versus a delayed treatment control to support physical activity participation in people with inflammatory arthritis: study protocol for the OPAM-IA randomized controlled trial. BMC Rheumatol. 2017 Nov 28;1:6. doi: 10.1186/s41927-017-0005-4. eCollection 2017.

Layout table for additonal information

Responsible Party:	Linda Li, University of British Columbia
ClinicalTrials.gov Identifier:	NCT02554474
Other Study ID Numbers:	H15-01843
First Submitted:	September 16, 2015
First Posted:	September 18, 2015
Results First Submitted:	April 17, 2021
Results First Posted:	June 4, 2021
Last Update Posted:	June 21, 2022

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