an On-demand Program to EmpoweR Active Self-management (OPERAS) (OPERAS)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03404245|
Recruitment Status : Not yet recruiting
First Posted : January 19, 2018
Last Update Posted : January 4, 2019
|Condition or disease||Intervention/treatment||Phase|
|Joint Disease Rheumatoid Arthritis||Behavioral: Education, Fitbit/self-management app, physiotherapist counselling. Behavioral: Same intervention with a 6 month delay||Not Applicable|
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 RA management.
The investigators will use a mixed-methods approach, involving a 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||134 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Single (Outcomes Assessor)|
|Primary Purpose:||Supportive Care|
|Official Title:||Empowering Active Self-management of Arthritis: Raising the Bar With OPERAS (an On-demand Program to EmpoweR Active Self-management)|
|Estimated Study Start Date :||January 15, 2019|
|Estimated Primary Completion Date :||January 15, 2021|
|Estimated Study Completion Date :||April 15, 2021|
Active Comparator: Immediate Intervention Group
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 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.
Behavioral: Education, 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.
Placebo Comparator: Delayed Intervention Group
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 PT. In Month 9-12, participants will continue the intervention without the PT phone calls, but will have email access to PT, if needed.
Behavioral: 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.
- Self-management ability [ Time Frame: Change from baseline in self-management ability at 6 months and 12 months ]Our primary outcome measure will be self-management ability assessed by the Patient Activation Measure (PAM). PAM is a 13-item self-reported measure of individuals' confidence in managing chronic diseases
- Disease status [ Time Frame: Change from baseline in disease status at 6 months and 12 months ]We will assess disease status through the RA Disease Activity Index (RADAI), which consists of: 1) global disease activity; 2) joint tenderness/swelling; 3) pain; 4) morning stiffness; 5) number/severity of painful joints
- Physical Activity & Sedentary Time [ Time Frame: Change from baseline in physical activity and sedentary time at 6 months and 12 months ]We will also measure physical activity and sedentary time with a SenseWear Mini sensor, in which participants will wear for 7 days at baseline and at the end of Month 6 and 12. We will calculate the average daily MVPA accumulated in bouts per day. A bout is defined as greater than or equal to 10 consecutive minutes at the level of 3 or higher METs, with allowance for interruption of up to 2 minutes below the threshold. We will calculate the average daily time spent with an energy expenditure of 1.5 METs or lower, occurring in bouts of > 20 minutes during waking hours
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03404245
|Contact: Johnathan Tam, BScemail@example.com|
|Contact: Halima Elmi, MPHfirstname.lastname@example.org|
|Canada, British Columbia|
|Arthritis Research Canada||Not yet recruiting|
|Richmond, British Columbia, Canada, V6X 2C7|
|Contact: Johnathan Tam, BSc 604-207-4027 email@example.com|
|Contact: Halima Elmi, MPH 604-207-4053 firstname.lastname@example.org|
|Principal Investigator:||Linda Li, PhD||Professor|