Pilot Randomized Controlled Trial of the RENEW Intervention for Axial Spondyloarthritis
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- attendance at peer health coaching sessions among RENEW intervention participants.
研究概览
简要总结
The researchers are testing a web-based peer-led program to help manage energy and symptoms in people who have axial spondyloarthritis (axSpA). There are 3 main reasons the researchers are doing this study: 1) to test how easy it is for people with spondyloarthritis to use the RENEW program; 2) to assess whether people like the RENEW program and 3) to understand if it helps with symptom management and disease burden.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Investigator, 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
- •Physician-diagnosed axSpA (including non-radiographic axSpA)
- •Have moderate to severe fatigue (average of ≥4/7 on the Fatigue Severity Scale)
- •Access to a computer, tablet, or smartphone with internet connection
- •Ability to speak and read English
- •Willingness to participate in virtual Zoom coaching sessions and complete online assessments
- •Interested in making some changes and trying new ways to improve health and well-being
排除标准
- •Currently enrolled in other clinical trials
- •Currently undergoing structured rehabilitation or psychological treatment for major depressive disorder
- •Significant cognitive impairment that would prevent informed consent or participation
- •Severe psychiatric illness that would contraindicate participation
研究组 & 干预措施
Group 1: RENEW Program
Participants placed in this group will be assigned a peer health coach to help guide them through the RENEW program right away. Peer health coaches are people on the study team with spondyloarthritis.
In addition, approximately 10 to 15 people from this group will be invited to take part in an optional 30-minute interview after the program ends, to share feedback about their experience with RENEW. If invited, participating in this interview is entirely voluntary.
干预措施: RENEW (Other)
Group 2: Waitlist Group
If placed in this group, participants will receive access to the RENEW website at the end of the 12-week study period. At the end of the 12 weeks, participants will be offered the option to have 1 peer health coaching session with a peer health coach.
结局指标
主要结局
attendance at peer health coaching sessions among RENEW intervention participants.
时间窗: across the 12-week period
Assessed using the Goal Attainment Scaling (GAS) method, which measures the extent to which participants achieved their individualized goals
Goal Attainment Scaling (GAS)
时间窗: Weeks 0, 6, 12
Assessed by health coach
Theoretical Framework of Acceptability (TFA) score (RENEW Intervention group)
时间窗: Week 12
12-item measure assessing affective attitude, burden, perceived effectiveness, and self-efficacy. An average of item scores \>4 out of 5 has been established as indicating high acceptability.
Qualitative Interviews (n=10-15 of RENEW Intervention group)
时间窗: Week 12
Acceptability will also be assessed through qualitative interviews with a subset of intervention participants.
次要结局
未报告次要终点
研究者
Susan Murphy
Professor
University of Michigan