Clinical trial NCT03404245: an On-demand Program to EmpoweR Active Self-management (OPERAS)
Official title: Empowering Active Self-management of Arthritis: Raising the Bar With OPERAS (an On-demand Program to EmpoweR Active Self-management)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Joint Disease
Rheumatoid Arthritis
Keywords: Physical Activity
Exercise
Rheumatoid
Arthritis
Self-management
Symptoms
Lead sponsor: University of British Columbia
Sponsor class: OTHER
Collaborators: name: Simon Fraser University
name: Arthritis Research Centre of Canada
name: Vancouver General Hospital
name: The Arthritis Society, Canada
name: Fraser Health
First posted: 2018-01-19
Enrollment: 132
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Patient Activation Measure
timeFrame: Baseline
measure: Patient Activation Measure
timeFrame: 6 months
measure: Patient Activation Measure
timeFrame: 12 months
Secondary outcomes:
measure: Rheumatoid Arthritis Disease Activity Index
timeFrame: Baseline
measure: Rheumatoid Arthritis Disease Activity Index
timeFrame: 6 months
measure: Rheumatoid Arthritis Disease Activity Index
timeFrame: 12 months
measure: Daily Moderate/Vigorous Physical Activity time
timeFrame: Baseline
measure: Daily Moderate/Vigorous Physical Activity time
timeFrame: 6 months
measure: Daily Moderate/Vigorous Physical Activity time
timeFrame: 12 months
measure: Daily sedentary time
timeFrame: Baseline
measure: Daily sedentary time
timeFrame: 6 months
measure: Daily sedentary time
timeFrame: 12 months
Other outcomes:
Locations:
city: Richmond
country: Canada
facility: Arthritis Research Canada
state: British Columbia
Study officials:
affiliation: Professor
name: Linda Li, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.