A Pilot Study of the MyVoice:Rheum Decision Aid to Address the Reproductive Health Needs of Women With Rheumatic Diseases
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 4
- 主要终点
- Acceptability of Intervention
研究概览
简要总结
This is a pilot trial to assess feasibility and acceptability of MyVoice:Rheum vs. a patient pamphlet among female patients ages 18-44 (n=40) who receive rheumatology care.
• Hypothesis: MyVoice:Rheum will be feasible and acceptable to patients who receive rheumatology care.
详细描述
The pilot will demonstrate if the MyVoice:Rheum decision aid can be feasibly and acceptably implemented into the rheumatology context and inform operational procedures for a future hybrid effectiveness-implementation trial. Women in the intervention arm will receive the MyVoice:Rheum decision aid (n=30). Women in the control arm (n=9) will receive a widely-accessible paper-based pamphlet about pregnancy, which, similarly to MyVoice:Rheum, targets women with a broad range of rheumatic diseases.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 44 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients must have at least one of four rheumatic diseases diagnosed by a rheumatologist: rheumatoid arthritis (RA), systemic sclerosis (SSc), myositis, Sjogren's syndrome, vasculitis, spondyloarthritis, and systemic lupus erythematosus (SLE).
- •Patients must read and speak in English as a Spanish-language version of the tool has not yet been developed
- •Access to a smart phone, personal computer, or tablet.
排除标准
- •Women who have had prior hysterectomy or sterilization, or are pregnant.
结局指标
主要结局
Acceptability of Intervention
时间窗: T2 (within 24 hours of intervention and appointment)
Acceptability of Intervention Measure (AIM) consist of Four- item measure, Likert scales ranging from 1 (completely disagree) to 5 (completely agree). Score is determined by calculating the mean of scores, with a higher score indicating higher acceptability. We assigned a feasibility threshold of ≥ 3.5 of 5, for which higher scores indicate more positive responses.
Intervention Appropriateness Measure
时间窗: T2 (within 24 hours of intervention and appointment)
The validated Intervention Appropriateness Measure (IAM) consist of Four-item Likert scales ranging from 1 (completely disagree) to 5 (completely agree); we assigned a feasibility threshold of ≥ 3.5 of 5 for IAM scores, for which higher scores indicate more positive responses. Score is determined by calculating the mean, with a higher score indicating greater appropriateness.
System Usability Scale
时间窗: T2 (within 24 hours of intervention and appointment)
Usability was assessed via summary scores from the System Usability Scale (SUS), which consists of a 10-item Likert scale with scores ranging from 0-100; overall score calculated by finding the mean of items on scale. We set a threshold of scores \>80.3 as 'A'/excellent and 68-80.3 as 'B'/very good, consistent with standard rating for the SUS.
次要结局
未报告次要终点
研究者
Mehret Birru Talabi
Assistant Professor of Medicine
University of Pittsburgh