Joint Disease, Rheumatoid Arthritis
Conditions
Keywords
Physical Activity, Exercise, Rheumatoid, Arthritis, Self-management, Symptoms
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALEducation, Fitbit/self-management app, physiotherapist counselling.
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.
BEHAVIORALSame 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.
Sponsors
University of British Columbia
Simon Fraser University
Arthritis Research Centre of Canada
Vancouver General Hospital
The Arthritis Society, Canada
Fraser Health
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* a physician confirmed diagnosis of RA * no joint surgery in the past 6 months * no history of acute injury to any joints in the past 6 months * an email address and daily access to a computer or mobile device.
Exclusion criteria
* people who should not be physically active without medical supervision.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient Activation Measure | Baseline, 27 weeks, 53 weeks | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rheumatoid Arthritis Disease Activity Index | Baseline, 27 weeks, 53 weeks | 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. |
| McGill Pain Questionnaire | 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. |
| Fatigue Severity Scale | 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. |
| The Patient Health Questionnaire-9 (PHQ-9) | 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), |
| The Self-Reported Habit Index (SRHI) - Sitting at Work Index | 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. |
| The Self-Reported Habit Index (SRHI) - Sitting at Leisure Index | 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. |
| The Self-Reported Habit Index (SRHI) - Walking Index | 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. |
| Daily Time in Moderate/Vigorous Physical Activity (MVPA) | Baseline, 27 weeks, 53 weeks | 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. |
| Daily Sedentary Time | 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 |
Countries
Canada
Contacts
PRINCIPAL_INVESTIGATORLinda Li, PhD
Professor
Participant flow
Recruitment details
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.
Pre-assignment details
No significant event that occured after participant enrollment, but prior to assignment to participants to an arm.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 56.9 Years STANDARD_DEVIATION 13.2 |
| Body mass index | 26.0 kg/m2 STANDARD_DEVIATION 6 |
| Disease duration | 9.2 Years STANDARD_DEVIATION 10.9 |
| Experience with health apps 1-3 years | 10 Participants |
| Experience with health apps 4 or more years | 9 Participants |
| Experience with health apps Less than 1 year | 37 Participants |
| Experience with health apps No answer | 8 Participants |
| Gross annual household Income in Canadian dollars $40 000 or under | 11 Participants |
| Gross annual household Income in Canadian dollars $40 001-$80 000 | 16 Participants |
| Gross annual household Income in Canadian dollars No answer | 14 Participants |
| Gross annual household Income in Canadian dollars Over $80 000 | 37 Participants |
| Level of patient activation assessed by the Patient Activation Measure 1 (score <47) | 4 Participants |
| Level of patient activation assessed by the Patient Activation Measure 2 (47.1-55.1) | 15 Participants |
| Level of patient activation assessed by the Patient Activation Measure 3 (55.2-67) | 25 Participants |
| Level of patient activation assessed by the Patient Activation Measure 4 (>67.1-100) | 63 Participants |
| Marital status Married/Common law | 44 Participants |
| Marital status Separated/Divorced | 23 Participants |
| Marital status Widowed/Never married | 7 Participants |
| Race and Ethnicity Not Collected | 0 Participants |
| Sex: Female, Male Female | 120 Participants |
| Sex: Female, Male Male | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 65 | 0 / 66 |
| other Total, other adverse events | 3 / 65 | 2 / 66 |
| serious Total, serious adverse events | 0 / 65 | 0 / 66 |
Outcome results
None listed