iBDecide Pilot Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 2
- 主要终点
- Feasibility of intervention
研究概览
简要总结
A web application decision support tool has been developed for adolescents and young adults (AYAs). The purpose of this pilot trial is to test the web application for adolescent and young adults (AYAs) with Ulcerative Colitis (UC). This research will assess acceptability, feasibility of the decision support intervention for AYA UC patients. Participants will be randomized to usual care or usual care plus the web application prior to an upcoming clinic visit in Gastroenterology. Participants will complete surveys one week after their clinic visit about decision making preferences and, for those in the intervention group, usability and acceptability of the web application.
详细描述
The iBDecide app provides participants with electronic tools to learn more about UC, track symptoms, create a nutrition diary, enter reminders for medication and clinic visits, as well as learn more about treatment options and compare UC medications.
Participants will be provided instructions over the phone or via email to download the iBDecide app on their personal smartphone approximately two weeks prior to the scheduled clinic visit. When possible they will download the app during the consent call and the research staff member will review features of the app with the participant. For those unable to download it while talking on the phone, a follow-up phone call will be scheduled to review the features. During the consenting phone call or at the clinic visit, a time will be scheduled to collect additional information via a brief telephone survey approximately one week after the clinic visit. Participants will be sent emails and an electronic calendar invitation to confirm their scheduled telephone interview.
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
- 14 Years 至 25 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •English speaking patients with Ulcerative Colitis that have an appointment at the CCHMC Gastroenterology clinic
- •14-25 years of age
- •Treatment decision anticipated during clinic
- •Did not participate in usability testing for the iBDecide App
- •Has a smart phone that can download the iBDecide app
排除标准
- •Unable to read or speak English
结局指标
主要结局
Feasibility of intervention
时间窗: At clinic visit
The extent to which this intervention impacts the flow of a clinic appointment, as measured by physician perception of visit length and efficiency.
Acceptability of intervention
时间窗: One week after clinic visit
The extent to which patients and physicians feel the intervention is appropriate and useful. This is measured through adaptations of the System Usability Scale and the decision aid acceptability measure.
次要结局
- Decisional conflict(At clinic visit)
- Perceived Shared Decision making(One week after clinic visit)
- Decision preference congruence(One week after clinic visit)
研究者
Ellen A. Lipstein MD, MPH
Associate Professor
Children's Hospital Medical Center, Cincinnati