STrategic Education for Patients Undergoing PAD Surgery (STEPUP Clinical Trial)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 125
- 试验地点
- 2
- 主要终点
- Readiness to change self-care engagement
研究概览
简要总结
This study will test whether, among patients undergoing surgery for peripheral artery disease (PAD), the addition of an online multimedia patient education video to the current education regimen will improve PAD knowledge, activation, and self-care engagement. The study will randomize 150 participants to one of 2 groups: current education regimen vs. current education regiment with video. The primary outcome is stage of self-care engagement. Secondary outcomes are PAD knowledge, self-efficacy, and activation. A subset of participants will also be randomly selected to participate in semi-structured interviews. Study duration for participants is 6 months.
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
- Single (Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient undergoing surgery for PAD in Division of Vascular Surgery at Northwestern Memorial Hospital
排除标准
- •Inability to provide informed consent
- •Inability to complete study protocol
- •Previously viewed the PAD education video
- •Participation in pilot study
结局指标
主要结局
Readiness to change self-care engagement
时间窗: Baseline to six-month follow-up
Change in readiness to change self-care behaviors will be compared between the 2 groups. Readiness to change self-care behavior will be assessed as 1 of 5 stages in the Transtheoretical Model. Change in readiness to change behavior will be calculated as the difference between stages at baseline and six month follow-up (direction and magnitude). Assessment will occur in paper survey.
次要结局
- Activation level(Baseline to six-month follow-up)
- PAD knowledge and beliefs(Baseline to six-month follow-up)
- Self-efficacy(Baseline to six-month follow-up)