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| Name | Class |
|---|---|
| Simon Fraser University | OTHER |
| Arthritis Research Centre of Canada | OTHER |
| Vancouver General Hospital | OTHER |
| The Arthritis Society, Canada |
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Self-management is a key component of successful chronic disease management and patients can benefit from learning about how daily activities and treatments relate to their symptoms and health status on an ongoing basis. The primary goal of this randomized controlled trial is to assess the efficacy of an e-health intervention, OPERAS, which includes two components: 1) the use of a newly developed web app to self-monitor symptoms/disease activity and treatment use, and help patients identify when a medical visit or treatment change is needed; 2) remote activity counselling provided by a physiotherapist, with the use of a wearable device (Fitbit) and the app to provide activity level feedback. The app component of OPERAS is hosted by the secure network of Arthritis Research Canada.
Self-management is a fundamental component in arthritis care, however, it is often neglected as most models of arthritis care focus on early access to medical consultation and surgical interventions. Patient self-management refers to the active participation of patients in a variety of activities that contribute to lessening the physical and emotional impact of illnesses. There are several factors attributing to a lack of self-management practice, such as frustration from managing health on a trial-and-error basis, a lack of knowledge to effectively monitor symptoms and disease, and being unsure about how to manage physical activities without aggravating symptoms. The variety of risk factors highlight 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 for patients to be engaged in their care and to stay physically active.
Our primary objective is to assess the efficacy of an e-health intervention, OPERAS, which integrates the Arthritis Health Journal and a Physical Activity Counselling program, to improve self-management ability. Our secondary objectives are to explore the effect of the intervention on disease status and physical activity levels and to assess barriers to implementation and sustainability of the e-health intervention in (rheumatoid arthritis) RA management.
The investigators will use a mixed-methods approach, involving a randomized controlled trial (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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Immediate Intervention Group | Active Comparator | Education, Fitbit/self-management web app, 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 physical therapist (PT), and an orientation to the Fitbit device and the web app. Participants will be provided access to a Fitbit and an app account. The PT will review physical activity goals with participants via bi-weekly phone calls and progressively modify their activities. In Month 3-6, participants will continue using Fitbit and the app and have access to a PT via email as needed, but no phone call. In Months 7-12, participants may keep their Fitbit and app account, but will not have access to a PT. |
|
| Delayed Intervention Group | Placebo Comparator | Same intervention with a 6 month delay: The full intervention will be initiated in Month 7 and 8 with a brief education session, use of a Fitbit paired with the self-management web app, and counseling by a physical therapist (PT). In Month 9-12, participants will continue the intervention without the PT phone calls, but will have email access to PT, if needed. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Education, Fitbit/self-management app, physiotherapist counselling. | Behavioral | Participants will receive a brief education session, use a physical activity tracker Fitbit Flex paired with a self-management app, and remote counseling by a PT. Intervention will be received immediately. |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Activation Measure | 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). | Baseline, 27 weeks, 53 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Rheumatoid Arthritis Disease Activity Index | 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. | Baseline, 27 weeks, 53 weeks |
| McGill Pain Questionnaire |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Linda Li, PhD | Professor | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arthritis Research Canada | Vancouver | British Columbia | V5Y 3P2 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40217417 | Derived | Feehan L, Xie H, Lu N, Li LC. Twenty-four hour physical activity, sedentary behaviour and sleep profiles in adults living with rheumatoid arthritis: a cross-sectional latent class analysis. J Act Sedentary Sleep Behav. 2024 Apr 17;3(1):10. doi: 10.1186/s44167-024-00049-5. | |
| 31829286 | Derived | Tam J, Lacaille D, Liu-Ambrose T, Shaw C, Xie H, Backman CL, Esdaile JM, Miller K, Petrella R, Li LC. Effectiveness of an online self-management tool, OPERAS (an On-demand Program to EmpoweR Active Self-management), for people with rheumatoid arthritis: a research protocol. Trials. 2019 Dec 11;20(1):712. doi: 10.1186/s13063-019-3851-0. |
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No significant event that occured after participant enrollment, but prior to assignment to participants to an arm.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Baseline |
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| Week 27 - Primary Endpoint |
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| Week 53 - Follow-up |
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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).
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Patient Activation Measure | 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). | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 27 weeks, 53 weeks |
|
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Muscle pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Linda Li | University of British Columbia | 604-207-4020 | lli@arthritisresearch.ca |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 22, 2019 | Dec 27, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D007592 | Joint Diseases |
| D001172 | Arthritis, Rheumatoid |
| D009043 | Motor Activity |
| D001168 | Arthritis |
| ID | Term |
|---|---|
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D004522 | Educational Status |
| ID | Term |
|---|---|
| D012959 | Socioeconomic Factors |
| D011154 | Population Characteristics |
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| OTHER |
| Fraser Health | OTHER |
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|
| Same intervention with a 6 month delay | Behavioral | The Delayed Intervention Group will receive the same intervention as the Immediate Intervention Group, but with a 6 month delay. |
|
The MPQ-SF contains 15 pain-related words, which can be rated from 0 to 3. Range 0 - 45; higher=more severe pain. |
| Baseline, 27 weeks, 52 weeks |
| Fatigue Severity Scale | 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. | Baseline, 27 weeks, 53 weeks |
| The Patient Health Questionnaire-9 (PHQ-9) | 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), | Baseline, 27 weeks, 53 weeks |
| The Self-Reported Habit Index (SRHI) - Sitting at Work Index | 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. | Baseline, 27 weeks, 52 weeks |
| The Self-Reported Habit Index (SRHI) - Sitting at Leisure Index | 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. | Baseline, 27 weeks, 52 weeks |
| The Self-Reported Habit Index (SRHI) - Walking Index | 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. | Baseline, 27 weeks, 52 weeks |
| Daily Time in Moderate/Vigorous Physical Activity (MVPA) | 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. | Baseline, 27 weeks, 53 weeks |
| Daily Sedentary Time | 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 | Baseline, 27 weeks, 53 weeks |
| NOT COMPLETED |
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| NOT COMPLETED |
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| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Marital status | Count of Participants | Participants |
|
| Gross annual household Income in Canadian dollars | Count of Participants | Participants |
|
| Disease duration | Mean | Standard Deviation | Years |
|
| Body mass index | Mean | Standard Deviation | kg/m2 |
|
| Experience with health apps | Count of Participants | Participants |
|
| Level of patient activation assessed by the Patient Activation Measure | Count of Participants | Participants |
|
| OG000 | 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. |
| OG001 | 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. |
|
|
|
| Secondary | Rheumatoid Arthritis Disease Activity Index | 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 27 weeks, 53 weeks |
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| Secondary | McGill Pain Questionnaire | The MPQ-SF contains 15 pain-related words, which can be rated from 0 to 3. Range 0 - 45; higher=more severe pain. | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 27 weeks, 52 weeks |
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| Secondary | Fatigue Severity Scale | 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 27 weeks, 53 weeks |
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| Secondary | The Patient Health Questionnaire-9 (PHQ-9) | 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), | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 27 weeks, 53 weeks |
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| Secondary | The Self-Reported Habit Index (SRHI) - Sitting at Work Index | 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 27 weeks, 52 weeks |
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|
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| Secondary | The Self-Reported Habit Index (SRHI) - Sitting at Leisure Index | 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 27 weeks, 52 weeks |
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| Secondary | The Self-Reported Habit Index (SRHI) - Walking Index | 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 27 weeks, 52 weeks |
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| Secondary | Daily Time in Moderate/Vigorous Physical Activity (MVPA) | 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. | 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 | Posted | Mean | Standard Deviation | minutes | Baseline, 27 weeks, 53 weeks |
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| Secondary | Daily Sedentary Time | 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 | 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 | Posted | Mean | Standard Deviation | minutes | Baseline, 27 weeks, 53 weeks |
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| 0 |
| 65 |
| 0 |
| 65 |
| 3 |
| 65 |
| EG001 | 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. | 0 | 66 | 0 | 66 | 2 | 66 |
| Falls, unrelated to the intervention | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D001519 | Behavior |
| Widowed/Never married |
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| Over $80 000 |
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| No answer |
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| 4 or more years |
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| No answer |
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| 3 (55.2-67) |
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| 4 (>67.1-100) |
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| 27 weeks |
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| 53 weeks |
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