Empowering Active Self-management of Arthritis: Raising the Bar With OPERAS (an On-demand Program to EmpoweR Active Self-management)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 132
- 试验地点
- 1
- 主要终点
- Patient Activation Measure
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •people who should not be physically active without medical supervision.
研究组 & 干预措施
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 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.
干预措施: Same intervention with a 6 month delay (Behavioral)
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 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.
干预措施: Education, Fitbit/self-management app, physiotherapist counselling. (Behavioral)
结局指标
主要结局
Patient Activation Measure
时间窗: 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).
次要结局
- Rheumatoid Arthritis Disease Activity Index(Baseline, 27 weeks, 53 weeks)
- McGill Pain Questionnaire(Baseline, 27 weeks, 52 weeks)
- Fatigue Severity Scale(Baseline, 27 weeks, 53 weeks)
- The Patient Health Questionnaire-9 (PHQ-9)(Baseline, 27 weeks, 53 weeks)
- The Self-Reported Habit Index (SRHI) - Sitting at Work Index(Baseline, 27 weeks, 52 weeks)
- The Self-Reported Habit Index (SRHI) - Sitting at Leisure Index(Baseline, 27 weeks, 52 weeks)
- The Self-Reported Habit Index (SRHI) - Walking Index(Baseline, 27 weeks, 52 weeks)
- Daily Time in Moderate/Vigorous Physical Activity (MVPA)(Baseline, 27 weeks, 53 weeks)
- Daily Sedentary Time(Baseline, 27 weeks, 53 weeks)
研究者
Linda Li
Professor
University of British Columbia