IADAPT-Third Phase
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 676
- 试验地点
- 3
- 主要终点
- Disease Knowledge and Therapeutic Options
研究概览
简要总结
The goal of this research study is to compare a booklet and a DVD for patients with knee osteoarthritis, osteoporosis, or rheumatoid arthritis.
详细描述
If you agree to take part in this study, you will be randomly assigned (as in the flip of a coin) to 1 of 2 study groups:
- Group 1 will watch a DVD and receive a booklet of information about their disease type (knee osteoarthritis, osteoporosis, or rheumatoid arthritis).
- Group 2 will read a booklet about their disease type.
All the materials including the DVD, booklet, and questionnaires will be in English and Spanish. You may choose which language you prefer to use while watching and/or reading the materials.
You will be asked to complete questionnaires before and after watching the DVD or reading the booklet. We will ask you about how the material made you think and feel and how easy or hard the material was to understand.
You will also fill out short questionnaires that include questions about your demographic information, your health, your thoughts about bone/joint disease, how you might choose treatments for bone/joint disease, and how you make treatment decisions. These questionnaires will take up to 45 minutes to complete in the clinic.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Knee Osteoarthritis (OA): (a) age 45 and over (b) prior diagnosis of knee OA (unilateral or bilateral) by a physician.
- •Rheumatoid Arthritis (RA): (a) age 18 and over, (b) compliance with American College of Rheumatology criteria for the diagnosis of RA, (c) and disease duration < or = 10 years
- •Osteoporosis (OP): (a) female gender, (b) age 45 and over, (c) and at least 3 years post-menopausal
- •Adequate cognitive status as determined by the research assistant (see description in "Recruitment Eligibility")
- •Ability to communicate in English or Spanish language without a translator
- •Have access to a telephone
排除标准
- •Hospitalized
- •Patients with RA or knee OA who also have any other connective tissue disease or spondyloarthropathy.
- •Patients with diagnosis of RA and disease duration (>10 years)
- •Patients who do not sign the informed consent
结局指标
主要结局
Disease Knowledge and Therapeutic Options
时间窗: 3 months
Primary analyses performed using repeated measures ANOVA, with group allocation - multimedia patient decision aids (MM-PtDA) vs. Comparative Effectiveness Research Summary Guide (CERSG) as the factor of interest and knowledge as the central outcome measure.
次要结局
未报告次要终点