Taking Charge of Systemic Sclerosis: Improving Patient Outcomes Through Self-management
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 267
- 试验地点
- 1
- 主要终点
- Change in Managing Symptoms Scale on the PROMIS® Self-efficacy Short Form 8
研究概览
简要总结
This Study is a collaborative project with partners (people with scleroderma and stakeholders) designed to refine an internet program for patients with scleroderma and to compare the internet program to an authoritative educational book (Taking Charge of Systemic Sclerosis [TOSS]). During a 16-week comparative effectiveness 16-week randomized controlled trial, the investigators will recruit up to 250 patients who will be randomized to either TOSS or authoritative book for patients, The Scleroderma Book: A Guide for Patients and Families.
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
- None
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
- •All participants will be residents of the United States
- •Diagnosed with systemic scleroderma,
- •18 years of age
- •Possess basic computer literacy and have access to a computer with Internet and email capabilities
- •Have the ability to communicate in English
排除标准
- •No computer access
- •Inability to communicate in English
研究组 & 干预措施
Internet-based self-management program
Internet-based self-management program Patients randomized to active treatment intervention will be assigned to the Internet program. The site will be accessed via secured website. The modules will be presented 1-2 per week and will be moderated by a researcher with expertise in moderating Discussion Boards.
干预措施: Internet-based self-management program (Other)
Education book group
Educational book group. Participants in the control group will receive a copy of The Scleroderma Book: A Guide for Patients and Families, by Dr. Maureen Mayes.
干预措施: Scleroderma book (Other)
结局指标
主要结局
Change in Managing Symptoms Scale on the PROMIS® Self-efficacy Short Form 8
时间窗: Baseline compared with 16 weeks, 6 months
Managing Symptoms score on the PROMIS® Self-efficacy Short Form 8 consists of 8 items scored from 1 (not at all confident) to 5 (very confident), this provides a raw score. The raw score is translated to a T-Score using a conversion table supplied by the Assessment Center. A score of 50 is the average for the US general population with a standard deviation of 10. Higher scores are indicative of greater ability to manage symptoms.
次要结局
- Change in Quality of Life on the European Quality of Life-5 Dimensions (EQ-5D) Index Scale(Baseline compared with 16 weeks, 6 months)
- Change in Confidence in Self Management on the Patient Activation Measure Scale(Baseline compared with 16 weeks, 6 months)
- Change in Managing Daily Activities Scale on the PROMIS® Self-efficacy Short Form 8(Baseline compared to 16 weeks and 6 months)
- Change in Managing Emotions Scale on the PROMIS® Self-efficacy Short Form 8(Baseline compared to 16 weeks and 6 months)
- Change in Brief Satisfaction on the Satisfaction With Appearance Scale (SWAP) Scale(Baseline compared with 16 weeks, 6 months)
- Change in Managing Medications and Treatment Scale on the PROMIS® Self-efficacy Short Form 8(Baseline compared to 16 weeks and 6 months)
- Change in Managing Social Interactions Scale on the PROMIS® Self-efficacy Short Form 8(Baseline compared to 16 weeks and 6 months)
- Change in Physical Function Scale on the PROMIS® 29 Profile v 2.0 Outcome Measure(Baseline compared to 16 weeks and 6 months)
- Change in Social Role Scale on the PROMIS® 29 Profile v 2.0 Outcome Measure(Baseline compared to 16 weeks and 6 months)
- Change in Anxiety Scale on the PROMIS® 29 Profile v 2.0 Outcome Measure(Baseline compared to 16 weeks and 6 months)
- Change in Depression Scale on the PROMIS® 29 Profile v 2.0 Outcome Measure(Baseline compared to 16 weeks and 6 months)
- Change in Fatigue Scale on the PROMIS® 29 Profile v 2.0 Outcome Measure(Baseline compared to 16 weeks and 6 months)
- Change Pain Interference Scale on the PROMIS® 29 Profile v 2.0 Outcome Measure(Baseline compared to 16 weeks and 6 months)
- Change in Visual Analogue Scale Pain Intensity Scale on the PROMIS® 29 Profile v 2.0 Outcome Measure(Baseline compared to 16 weeks and 6 months)
- Change in Sleep Disturbance Scale on the PROMIS® 29 Profile v 2.0 Outcome Measure(Baseline compared to 16 weeks and 6 months)
研究者
Dinesh Khanna, MD, MS
Dinesh Khanna, MD,MS, PI
University of Michigan