Trial Outcomes & Findings for an On-demand Program to EmpoweR Active Self-management (OPERAS) (NCT NCT03404245)

Last Updated: 2026-02-13

Results Overview

Patient Activation Measure is a 13-item self-reported measure of individuals' confidence in managing chronic diseases. Each item has a 4-point response (1 "strongly disagree"; 4 "strongly agree"), with the aggregate raw score converted to 0-100. Hibbard et al presented a 4-stage activation model derived from the standardized scores: 1) Believing an active role is important (PAM score \<47); 2) Having confidence and knowledge to take action (47.1 - 55.1); 3) Taking action (55.2 - 67); 4) Maintaining healthy behaviours despite setbacks (\> 67.1).

Recruitment status

COMPLETED

Study phase

Target enrollment

132 participants

Primary outcome timeframe

Baseline, 27 weeks, 53 weeks

Results posted on

2026-02-13

Participant Flow

Participants were recruited from rheumatology clinics in Metro Vancouver and through the network of patient groups, including Arthritis Consumer Experts and Arthritis Research Canada's Arthritis Patient Advisory Board. We also posted study information on social media (Facebook, Twitter, Kajiji, and Craigslist) and Arthritis Research Canada's website.

No significant event that occured after participant enrollment, but prior to assignment to participants to an arm.

Participant milestones

Participant milestones
Measure	Immediate Intervention Group The Immediate Intervention Group received an education session on RA management from a registered physical therapist (PT), Fitbit/self-management web app, PT counselling. These 3 components were delivered to the participants in Months 1 and 2. The session included a short presentation about physical activity in everyday life, an individual goal-setting session with a PT, and an orientation to the Fitbit device and the web app. Participants were provided access to a Fitbit and an app account. The PT reviewed physical activity goals with participants via bi-weekly phone calls and progressively modify their activities. In Month 3-6, participants continued using Fitbit and the app and had access to a PT via email as needed, but no phone call. In Months 7-12, participants kept their Fitbit and app account, but did not have access to a PT.	Delayed Intervention Group The Delayed Intervention Group received the same intervention with a 6 month delay: The full intervention was initiated in Month 7 and 8 with a brief education session. Participant also used a Fitbit paired with the self-management web app, and received counseling by a physical therapist (PT). In Month 9-12, participants continued the intervention without the PT phone calls, and had email access to PT, if needed. Same intervention with a 6 month delay: The Delayed Intervention Group will receive the same intervention as the Immediate Intervention Group, but with a 6 month delay.
Baseline STARTED	66	66
Baseline COMPLETED	65	66
Baseline NOT COMPLETED	1	0
Week 27 - Primary Endpoint STARTED	65	66
Week 27 - Primary Endpoint COMPLETED	58	62
Week 27 - Primary Endpoint NOT COMPLETED	7	4
Week 53 - Follow-up STARTED	58	62
Week 53 - Follow-up COMPLETED	55	55
Week 53 - Follow-up NOT COMPLETED	3	7

Reasons for withdrawal

Reasons for withdrawal
Measure	Immediate Intervention Group The Immediate Intervention Group received an education session on RA management from a registered physical therapist (PT), Fitbit/self-management web app, PT counselling. These 3 components were delivered to the participants in Months 1 and 2. The session included a short presentation about physical activity in everyday life, an individual goal-setting session with a PT, and an orientation to the Fitbit device and the web app. Participants were provided access to a Fitbit and an app account. The PT reviewed physical activity goals with participants via bi-weekly phone calls and progressively modify their activities. In Month 3-6, participants continued using Fitbit and the app and had access to a PT via email as needed, but no phone call. In Months 7-12, participants kept their Fitbit and app account, but did not have access to a PT.	Delayed Intervention Group The Delayed Intervention Group received the same intervention with a 6 month delay: The full intervention was initiated in Month 7 and 8 with a brief education session. Participant also used a Fitbit paired with the self-management web app, and received counseling by a physical therapist (PT). In Month 9-12, participants continued the intervention without the PT phone calls, and had email access to PT, if needed. Same intervention with a 6 month delay: The Delayed Intervention Group will receive the same intervention as the Immediate Intervention Group, but with a 6 month delay.
Baseline Erroneously randomized	1	0
Week 27 - Primary Endpoint Withdrawal by Subject	4	3
Week 27 - Primary Endpoint Lost to Follow-up	2	0
Week 27 - Primary Endpoint COVID related reasons	0	1
Week 27 - Primary Endpoint Natural disaster evacuation	1	0
Week 53 - Follow-up Withdrawal by Subject	1	7
Week 53 - Follow-up Moved out of province	1	0
Week 53 - Follow-up Health reason	1	0

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Immediate Intervention Group n=65 Participants The Immediate Intervention Group received an education session on RA management from a registered physical therapist (PT), Fitbit/self-management web app, PT counselling. These 3 components were delivered to the participants in Months 1 and 2. The session included a short presentation about physical activity in everyday life, an individual goal-setting session with a PT, and an orientation to the Fitbit device and the web app. Participants were provided access to a Fitbit and an app account. The PT reviewed physical activity goals with participants via bi-weekly phone calls and progressively modify their activities. In Month 3-6, participants continued using Fitbit and the app and had access to a PT via email as needed, but no phone call. In Months 7-12, participants kept their Fitbit and app account, but did not have access to a PT.	Delayed Intervention Group n=66 Participants The Delayed Intervention Group received the same intervention with a 6 month delay: The full intervention was initiated in Month 7 and 8 with a brief education session. Participant also used a Fitbit paired with the self-management web app, and received counseling by a physical therapist (PT). In Month 9-12, participants continued the intervention without the PT phone calls, and had email access to PT, if needed.	Total n=131 Participants Total of all reporting groups
Age, Continuous	54.8 Years STANDARD_DEVIATION 13.1 • n=65 Participants	56.9 Years STANDARD_DEVIATION 13.2 • n=66 Participants	55.8 Years STANDARD_DEVIATION 13.1 • n=131 Participants
Sex: Female, Male Female	60 Participants n=65 Participants	60 Participants n=66 Participants	120 Participants n=131 Participants
Sex: Female, Male Male	5 Participants n=65 Participants	6 Participants n=66 Participants	11 Participants n=131 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Marital status Married/Common law	44 Participants n=65 Participants	44 Participants n=66 Participants	88 Participants n=131 Participants
Marital status Separated/Divorced	14 Participants n=65 Participants	9 Participants n=66 Participants	23 Participants n=131 Participants
Marital status Widowed/Never married	7 Participants n=65 Participants	13 Participants n=66 Participants	20 Participants n=131 Participants
Gross annual household Income in Canadian dollars $40 000 or under	11 Participants n=65 Participants	11 Participants n=66 Participants	22 Participants n=131 Participants
Gross annual household Income in Canadian dollars $40 001-$80 000	12 Participants n=65 Participants	16 Participants n=66 Participants	28 Participants n=131 Participants
Gross annual household Income in Canadian dollars Over $80 000	37 Participants n=65 Participants	25 Participants n=66 Participants	62 Participants n=131 Participants
Gross annual household Income in Canadian dollars No answer	5 Participants n=65 Participants	14 Participants n=66 Participants	19 Participants n=131 Participants
Disease duration	9.2 Years STANDARD_DEVIATION 10.9 • n=65 Participants	11.7 Years STANDARD_DEVIATION 11.2 • n=66 Participants	10.5 Years STANDARD_DEVIATION 11.0 • n=131 Participants
Body mass index	27.7 kg/m2 STANDARD_DEVIATION 6.8 • n=65 Participants	26.0 kg/m2 STANDARD_DEVIATION 6.0 • n=66 Participants	26.9 kg/m2 STANDARD_DEVIATION 6.4 • n=131 Participants
Experience with health apps Less than 1 year	37 Participants n=65 Participants	36 Participants n=66 Participants	73 Participants n=131 Participants
Experience with health apps 1-3 years	10 Participants n=65 Participants	13 Participants n=66 Participants	23 Participants n=131 Participants
Experience with health apps 4 or more years	11 Participants n=65 Participants	9 Participants n=66 Participants	20 Participants n=131 Participants
Experience with health apps No answer	7 Participants n=65 Participants	8 Participants n=66 Participants	15 Participants n=131 Participants
Level of patient activation assessed by the Patient Activation Measure 1 (score <47)	7 Participants n=65 Participants	4 Participants n=66 Participants	11 Participants n=131 Participants
Level of patient activation assessed by the Patient Activation Measure 2 (47.1-55.1)	7 Participants n=65 Participants	8 Participants n=66 Participants	15 Participants n=131 Participants
Level of patient activation assessed by the Patient Activation Measure 3 (55.2-67)	25 Participants n=65 Participants	17 Participants n=66 Participants	42 Participants n=131 Participants
Level of patient activation assessed by the Patient Activation Measure 4 (>67.1-100)	26 Participants n=65 Participants	37 Participants n=66 Participants	63 Participants n=131 Participants

PRIMARY outcome

Timeframe: Baseline, 27 weeks, 53 weeks

Population: One individual in the Immediate Group revealed that he did not have RA after randomization; hence, 131 were included in the analysis (Immediate: 65, Delayed: 66). Week 27: Immediate Group - 4 withdrew; 2 unable to contact. 1 natural disaster evacuation; Delay Group - 3 withdrew; 1 COVID related reason Week 53.: Immediate Group - 1 withdrew; 1 moved out of province, 1 health reason. Delay Group - 7 additional participant withdrew.

Outcome measures

Outcome measures
Measure	Immediate Intervention Group n=65 Participants The Immediate Intervention Group received an education session on RA management from a registered physical therapist (PT), Fitbit/self-management web app, PT counselling. These 3 components were delivered to the participants in Months 1 and 2. The session included a short presentation about physical activity in everyday life, an individual goal-setting session with a PT, and an orientation to the Fitbit device and the web app. Participants were provided access to a Fitbit and an app account. The PT reviewed physical activity goals with participants via bi-weekly phone calls and progressively modify their activities. In Month 3-6, participants continued using Fitbit and the app and had access to a PT via email as needed, but no phone call. In Months 7-12, participants kept their Fitbit and app account, but did not have access to a PT.	Delayed Intervention Group n=66 Participants The Delayed Intervention Group received the same intervention with a 6 month delay: The full intervention was initiated in Month 7 and 8 with a brief education session. Participant also used a Fitbit paired with the self-management web app, and received counseling by a physical therapist (PT). In Month 9-12, participants continued the intervention without the PT phone calls, and had email access to PT, if needed.
Patient Activation Measure 27 weeks	69.8 score on a scale Standard Deviation 17.2	67.1 score on a scale Standard Deviation 13.5
Patient Activation Measure 53 weeks	67.3 score on a scale Standard Deviation 15.1	72.2 score on a scale Standard Deviation 17.5
Patient Activation Measure Baseline	65.1 score on a scale Standard Deviation 13.7	68.3 score on a scale Standard Deviation 13.9

SECONDARY outcome

Timeframe: Baseline, 27 weeks, 53 weeks

Population: 66 participants were randomized into each group; 1 from the Immediate group were erroneously randomized (no rheumatoid arthritis) Week 27: Immediate Group - 4 withdrew; 2 unable to contact. 1 natural disaster evacuation; Delay Group - 3 withdrew; 1 COVID related reason Week 53.: Immediate Group - 1 withdrew; 1 moved out of province, 1 health reason. Delay Group - 7 additional participant withdrew.

Rheumatoid Arthritis Disease Activity Index consists of: 1) global disease activity; 2) joint tenderness/swelling; 3) pain; 4) morning stiffness; 5) number/severity of painful joints. Score ranges from 0 - 10; lower = better.

Outcome measures

Outcome measures
Measure	Immediate Intervention Group n=65 Participants The Immediate Intervention Group received an education session on RA management from a registered physical therapist (PT), Fitbit/self-management web app, PT counselling. These 3 components were delivered to the participants in Months 1 and 2. The session included a short presentation about physical activity in everyday life, an individual goal-setting session with a PT, and an orientation to the Fitbit device and the web app. Participants were provided access to a Fitbit and an app account. The PT reviewed physical activity goals with participants via bi-weekly phone calls and progressively modify their activities. In Month 3-6, participants continued using Fitbit and the app and had access to a PT via email as needed, but no phone call. In Months 7-12, participants kept their Fitbit and app account, but did not have access to a PT.	Delayed Intervention Group n=66 Participants The Delayed Intervention Group received the same intervention with a 6 month delay: The full intervention was initiated in Month 7 and 8 with a brief education session. Participant also used a Fitbit paired with the self-management web app, and received counseling by a physical therapist (PT). In Month 9-12, participants continued the intervention without the PT phone calls, and had email access to PT, if needed.
Rheumatoid Arthritis Disease Activity Index Baseline	3.6 score on a scale Standard Deviation 1.9	3.7 score on a scale Standard Deviation 1.9
Rheumatoid Arthritis Disease Activity Index 27 weeks	3.0 score on a scale Standard Deviation 2.0	3.6 score on a scale Standard Deviation 1.8
Rheumatoid Arthritis Disease Activity Index 53 weeks	2.8 score on a scale Standard Deviation 2.0	2.8 score on a scale Standard Deviation 1.8

SECONDARY outcome

Timeframe: Baseline, 27 weeks, 52 weeks

The MPQ-SF contains 15 pain-related words, which can be rated from 0 to 3. Range 0 - 45; higher=more severe pain.

Outcome measures

Outcome measures
Measure	Immediate Intervention Group n=65 Participants The Immediate Intervention Group received an education session on RA management from a registered physical therapist (PT), Fitbit/self-management web app, PT counselling. These 3 components were delivered to the participants in Months 1 and 2. The session included a short presentation about physical activity in everyday life, an individual goal-setting session with a PT, and an orientation to the Fitbit device and the web app. Participants were provided access to a Fitbit and an app account. The PT reviewed physical activity goals with participants via bi-weekly phone calls and progressively modify their activities. In Month 3-6, participants continued using Fitbit and the app and had access to a PT via email as needed, but no phone call. In Months 7-12, participants kept their Fitbit and app account, but did not have access to a PT.	Delayed Intervention Group n=66 Participants The Delayed Intervention Group received the same intervention with a 6 month delay: The full intervention was initiated in Month 7 and 8 with a brief education session. Participant also used a Fitbit paired with the self-management web app, and received counseling by a physical therapist (PT). In Month 9-12, participants continued the intervention without the PT phone calls, and had email access to PT, if needed.
McGill Pain Questionnaire Baseline	11.0 score on a scale Standard Deviation 8.2	10.2 score on a scale Standard Deviation 7.5
McGill Pain Questionnaire 27 weeks	9.1 score on a scale Standard Deviation 8.0	10.0 score on a scale Standard Deviation 7.1
McGill Pain Questionnaire 53 weeks	9.2 score on a scale Standard Deviation 7.9	9.5 score on a scale Standard Deviation 8.5

SECONDARY outcome

Timeframe: Baseline, 27 weeks, 53 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.

Outcome measures

Outcome measures
Measure	Immediate Intervention Group n=65 Participants The Immediate Intervention Group received an education session on RA management from a registered physical therapist (PT), Fitbit/self-management web app, PT counselling. These 3 components were delivered to the participants in Months 1 and 2. The session included a short presentation about physical activity in everyday life, an individual goal-setting session with a PT, and an orientation to the Fitbit device and the web app. Participants were provided access to a Fitbit and an app account. The PT reviewed physical activity goals with participants via bi-weekly phone calls and progressively modify their activities. In Month 3-6, participants continued using Fitbit and the app and had access to a PT via email as needed, but no phone call. In Months 7-12, participants kept their Fitbit and app account, but did not have access to a PT.	Delayed Intervention Group n=66 Participants The Delayed Intervention Group received the same intervention with a 6 month delay: The full intervention was initiated in Month 7 and 8 with a brief education session. Participant also used a Fitbit paired with the self-management web app, and received counseling by a physical therapist (PT). In Month 9-12, participants continued the intervention without the PT phone calls, and had email access to PT, if needed.
Fatigue Severity Scale Baseline	4.7 score on a scale Standard Deviation 1.4	4.6 score on a scale Standard Deviation 1.3
Fatigue Severity Scale 27 weeks	4.3 score on a scale Standard Deviation 1.5	4.6 score on a scale Standard Deviation 1.3
Fatigue Severity Scale 53 weeks	4.5 score on a scale Standard Deviation 1.5	4.4 score on a scale Standard Deviation 1.5

SECONDARY outcome

Timeframe: Baseline, 27 weeks, 53 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),

Outcome measures

Outcome measures
Measure	Immediate Intervention Group n=65 Participants The Immediate Intervention Group received an education session on RA management from a registered physical therapist (PT), Fitbit/self-management web app, PT counselling. These 3 components were delivered to the participants in Months 1 and 2. The session included a short presentation about physical activity in everyday life, an individual goal-setting session with a PT, and an orientation to the Fitbit device and the web app. Participants were provided access to a Fitbit and an app account. The PT reviewed physical activity goals with participants via bi-weekly phone calls and progressively modify their activities. In Month 3-6, participants continued using Fitbit and the app and had access to a PT via email as needed, but no phone call. In Months 7-12, participants kept their Fitbit and app account, but did not have access to a PT.	Delayed Intervention Group n=66 Participants The Delayed Intervention Group received the same intervention with a 6 month delay: The full intervention was initiated in Month 7 and 8 with a brief education session. Participant also used a Fitbit paired with the self-management web app, and received counseling by a physical therapist (PT). In Month 9-12, participants continued the intervention without the PT phone calls, and had email access to PT, if needed.
The Patient Health Questionnaire-9 (PHQ-9) Baseline	7.6 score on a scale Standard Deviation 5.6	7.0 score on a scale Standard Deviation 4.9
The Patient Health Questionnaire-9 (PHQ-9) 27 weeks	5.0 score on a scale Standard Deviation 3.8	6.3 score on a scale Standard Deviation 5.3
The Patient Health Questionnaire-9 (PHQ-9) 53 weeks	4.8 score on a scale Standard Deviation 4.0	5.4 score on a scale Standard Deviation 5.0

SECONDARY outcome

Timeframe: Baseline, 27 weeks, 52 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.

Outcome measures

Outcome measures
Measure	Immediate Intervention Group n=65 Participants The Immediate Intervention Group received an education session on RA management from a registered physical therapist (PT), Fitbit/self-management web app, PT counselling. These 3 components were delivered to the participants in Months 1 and 2. The session included a short presentation about physical activity in everyday life, an individual goal-setting session with a PT, and an orientation to the Fitbit device and the web app. Participants were provided access to a Fitbit and an app account. The PT reviewed physical activity goals with participants via bi-weekly phone calls and progressively modify their activities. In Month 3-6, participants continued using Fitbit and the app and had access to a PT via email as needed, but no phone call. In Months 7-12, participants kept their Fitbit and app account, but did not have access to a PT.	Delayed Intervention Group n=66 Participants The Delayed Intervention Group received the same intervention with a 6 month delay: The full intervention was initiated in Month 7 and 8 with a brief education session. Participant also used a Fitbit paired with the self-management web app, and received counseling by a physical therapist (PT). In Month 9-12, participants continued the intervention without the PT phone calls, and had email access to PT, if needed.
The Self-Reported Habit Index (SRHI) - Sitting at Work Index Baseline	4.6 score on a scale Standard Deviation 1.4	4.7 score on a scale Standard Deviation 1.7
The Self-Reported Habit Index (SRHI) - Sitting at Work Index 27 weeks	4.6 score on a scale Standard Deviation 1.4	4.6 score on a scale Standard Deviation 1.6
The Self-Reported Habit Index (SRHI) - Sitting at Work Index 53 weeks	4.5 score on a scale Standard Deviation 1.6	4.6 score on a scale Standard Deviation 1.8

SECONDARY outcome

Timeframe: Baseline, 27 weeks, 52 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.

Outcome measures

Outcome measures
Measure	Immediate Intervention Group n=65 Participants The Immediate Intervention Group received an education session on RA management from a registered physical therapist (PT), Fitbit/self-management web app, PT counselling. These 3 components were delivered to the participants in Months 1 and 2. The session included a short presentation about physical activity in everyday life, an individual goal-setting session with a PT, and an orientation to the Fitbit device and the web app. Participants were provided access to a Fitbit and an app account. The PT reviewed physical activity goals with participants via bi-weekly phone calls and progressively modify their activities. In Month 3-6, participants continued using Fitbit and the app and had access to a PT via email as needed, but no phone call. In Months 7-12, participants kept their Fitbit and app account, but did not have access to a PT.	Delayed Intervention Group n=66 Participants The Delayed Intervention Group received the same intervention with a 6 month delay: The full intervention was initiated in Month 7 and 8 with a brief education session. Participant also used a Fitbit paired with the self-management web app, and received counseling by a physical therapist (PT). In Month 9-12, participants continued the intervention without the PT phone calls, and had email access to PT, if needed.
The Self-Reported Habit Index (SRHI) - Sitting at Leisure Index Baseline	4.5 score on a scale Standard Deviation 1.4	4.6 score on a scale Standard Deviation 1.3
The Self-Reported Habit Index (SRHI) - Sitting at Leisure Index 27 weeks	4.5 score on a scale Standard Deviation 1.1	4.7 score on a scale Standard Deviation 1.5
The Self-Reported Habit Index (SRHI) - Sitting at Leisure Index 53 weeks	4.4 score on a scale Standard Deviation 1.3	4.6 score on a scale Standard Deviation 1.6

SECONDARY outcome

Timeframe: Baseline, 27 weeks, 52 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.

Outcome measures

Outcome measures
Measure	Immediate Intervention Group n=65 Participants The Immediate Intervention Group received an education session on RA management from a registered physical therapist (PT), Fitbit/self-management web app, PT counselling. These 3 components were delivered to the participants in Months 1 and 2. The session included a short presentation about physical activity in everyday life, an individual goal-setting session with a PT, and an orientation to the Fitbit device and the web app. Participants were provided access to a Fitbit and an app account. The PT reviewed physical activity goals with participants via bi-weekly phone calls and progressively modify their activities. In Month 3-6, participants continued using Fitbit and the app and had access to a PT via email as needed, but no phone call. In Months 7-12, participants kept their Fitbit and app account, but did not have access to a PT.	Delayed Intervention Group n=66 Participants The Delayed Intervention Group received the same intervention with a 6 month delay: The full intervention was initiated in Month 7 and 8 with a brief education session. Participant also used a Fitbit paired with the self-management web app, and received counseling by a physical therapist (PT). In Month 9-12, participants continued the intervention without the PT phone calls, and had email access to PT, if needed.
The Self-Reported Habit Index (SRHI) - Walking Index Baseline	4.5 score on a scale Standard Deviation 1.6	4.5 score on a scale Standard Deviation 1.8
The Self-Reported Habit Index (SRHI) - Walking Index 27 weeks	4.6 score on a scale Standard Deviation 1.7	4.3 score on a scale Standard Deviation 1.9
The Self-Reported Habit Index (SRHI) - Walking Index 53 weeks	4.8 score on a scale Standard Deviation 1.6	4.7 score on a scale Standard Deviation 1.7

SECONDARY outcome

Timeframe: Baseline, 27 weeks, 53 weeks

Population: Baseline: Missing in 7 Immediate (I) gp \& 6 Delayed (D) gp due to COVID restrictions Wk 27: I gp - 6 not interested; 4 COVID reasons; 2 moved, 1 lost contact; 1 evacuation; 1 device discomfort; 1 insufficient data D gp - 6 not interested; 8 COVID reason; 1 moved Wk 53: I gp - 10 not interested; 6 COVID reasons; 2 device discomfort; 2 moved; 2 health reasons; 1 evacuation D gp - 7 not interested; 9 COVID reason; 2 device discomfort; 1 moved; 1 health reason

Time spent in Moderate/Vigorous Physical Activity (MVPA) is measured with a SenseWear Mini sensor over a 7-day period. We will calculate the mean time spent 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 one minute below the threshold.

Outcome measures

Outcome measures
Measure	Immediate Intervention Group n=65 Participants The Immediate Intervention Group received an education session on RA management from a registered physical therapist (PT), Fitbit/self-management web app, PT counselling. These 3 components were delivered to the participants in Months 1 and 2. The session included a short presentation about physical activity in everyday life, an individual goal-setting session with a PT, and an orientation to the Fitbit device and the web app. Participants were provided access to a Fitbit and an app account. The PT reviewed physical activity goals with participants via bi-weekly phone calls and progressively modify their activities. In Month 3-6, participants continued using Fitbit and the app and had access to a PT via email as needed, but no phone call. In Months 7-12, participants kept their Fitbit and app account, but did not have access to a PT.	Delayed Intervention Group n=66 Participants The Delayed Intervention Group received the same intervention with a 6 month delay: The full intervention was initiated in Month 7 and 8 with a brief education session. Participant also used a Fitbit paired with the self-management web app, and received counseling by a physical therapist (PT). In Month 9-12, participants continued the intervention without the PT phone calls, and had email access to PT, if needed.
Daily Time in Moderate/Vigorous Physical Activity (MVPA) Baseline	36.8 minutes Standard Deviation 35.9	38.4 minutes Standard Deviation 38.6
Daily Time in Moderate/Vigorous Physical Activity (MVPA) 27 weeks	42.0 minutes Standard Deviation 41.5	45.5 minutes Standard Deviation 54.5
Daily Time in Moderate/Vigorous Physical Activity (MVPA) 53 weeks	42.4 minutes Standard Deviation 44.0	47.8 minutes Standard Deviation 55.8

SECONDARY outcome

Timeframe: Baseline, 27 weeks, 53 weeks

Time spent in sedentary activity is measured with a SenseWear Mini sensor over a 7-day period. We will calculate the mean daily time spent in sedentary activity, with an energy expenditure of \<=1.5 METs, occurring in bouts of \>= 20 minutes during waking hours

Outcome measures

Outcome measures
Measure	Immediate Intervention Group n=65 Participants The Immediate Intervention Group received an education session on RA management from a registered physical therapist (PT), Fitbit/self-management web app, PT counselling. These 3 components were delivered to the participants in Months 1 and 2. The session included a short presentation about physical activity in everyday life, an individual goal-setting session with a PT, and an orientation to the Fitbit device and the web app. Participants were provided access to a Fitbit and an app account. The PT reviewed physical activity goals with participants via bi-weekly phone calls and progressively modify their activities. In Month 3-6, participants continued using Fitbit and the app and had access to a PT via email as needed, but no phone call. In Months 7-12, participants kept their Fitbit and app account, but did not have access to a PT.	Delayed Intervention Group n=66 Participants The Delayed Intervention Group received the same intervention with a 6 month delay: The full intervention was initiated in Month 7 and 8 with a brief education session. Participant also used a Fitbit paired with the self-management web app, and received counseling by a physical therapist (PT). In Month 9-12, participants continued the intervention without the PT phone calls, and had email access to PT, if needed.
Daily Sedentary Time Baseline	514.9 minutes Standard Deviation 176.1	467.8 minutes Standard Deviation 175.2
Daily Sedentary Time 27 weeks	539.8 minutes Standard Deviation 186.9	504.2 minutes Standard Deviation 184.4
Daily Sedentary Time 53 weeks	546.7 minutes Standard Deviation 163.2	504.0 minutes Standard Deviation 164.2

Adverse Events

Immediate Intervention Group

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Delayed Intervention Group

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Immediate Intervention Group n=65 participants at risk The Immediate Intervention Group received an education session on RA management from a registered physical therapist (PT), Fitbit/self-management web app, PT counselling. These 3 components were delivered to the participants in Months 1 and 2. The session included a short presentation about physical activity in everyday life, an individual goal-setting session with a PT, and an orientation to the Fitbit device and the web app. Participants were provided access to a Fitbit and an app account. The PT reviewed physical activity goals with participants via bi-weekly phone calls and progressively modify their activities. In Month 3-6, participants continued using Fitbit and the app and had access to a PT via email as needed, but no phone call. In Months 7-12, participants kept their Fitbit and app account, but did not have access to a PT.	Delayed Intervention Group n=66 participants at risk The Delayed Intervention Group received the same intervention with a 6 month delay: The full intervention was initiated in Month 7 and 8 with a brief education session. Participant also used a Fitbit paired with the self-management web app, and received counseling by a physical therapist (PT). In Month 9-12, participants continued the intervention without the PT phone calls, and had email access to PT, if needed.
Musculoskeletal and connective tissue disorders Muscle pain	1.5% 1/65 • Number of events 1 • 53 weeks Participants reported all serious adverse events, including falls, cardiovascular and musculoskeletal events, to the research coordinator during the study. They also recorded adverse events related to physical activity in the follow-up questionnaires at weeks 27 and 53.	0.00% 0/66 • 53 weeks Participants reported all serious adverse events, including falls, cardiovascular and musculoskeletal events, to the research coordinator during the study. They also recorded adverse events related to physical activity in the follow-up questionnaires at weeks 27 and 53.
Musculoskeletal and connective tissue disorders Falls, unrelated to the intervention	3.1% 2/65 • Number of events 2 • 53 weeks Participants reported all serious adverse events, including falls, cardiovascular and musculoskeletal events, to the research coordinator during the study. They also recorded adverse events related to physical activity in the follow-up questionnaires at weeks 27 and 53.	3.0% 2/66 • Number of events 2 • 53 weeks Participants reported all serious adverse events, including falls, cardiovascular and musculoskeletal events, to the research coordinator during the study. They also recorded adverse events related to physical activity in the follow-up questionnaires at weeks 27 and 53.

Additional Information

Linda Li

University of British Columbia

Phone: 604-207-4020

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place