Self-Management Assistance for Recommended Treatement (SMART) App Randomized Control Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 2
- 主要终点
- Medication adherence
研究概览
简要总结
The objective of this trial is to test whether a smartphone app, SMART-IBD, is effective in improving medication adherence and self-management skills in adolescents with IBD. The investigators will conduct a randomized control trial to compare a sample of 20 youth (ages 13-17) with IBD using an app that has educational content and medication reminders to 20 youth in an attention control group. The length of the intervention will include one month of baseline adherence data collection, one month of intervention, and one month of post-treatment adherence data collection.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
The study PI, statistician, co-investigators, and all personnel who are involved in endpoint assessments will be blinded. Only study coordinators will have access to the assignment of each participant.
入排标准
- 年龄范围
- 13 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient diagnosed with Crohn's disease, ulcerative colitis, or indeterminate colitis (collectively IBD)
- •Prescribed at least one medication used to treat IBD, regardless of route of administration
- •Access to internet or wi-fi or data plan and access to smartphone
- •English fluency for patient and clinician
排除标准
- •Diagnosis of pervasive developmental disorder in patient or caregiver as determined by medical chart review
- •Diagnosis of serious mental illness (e.g., schizophrenia) in patient or caregiver as determined by medical chart review
研究组 & 干预措施
SMART-IBD
The SMART-IBD app consists of educational content, medication reminders, and weekly app engagement challenges. App users will participate in weekly challenges that focus on topics such as adherence, sleep, and diary usage. Participants in this arm will complete one month of run-in diaries, one month of diaries during intervention, and one month of diaries post-intervention.
干预措施: SMART-IBD (Behavioral)
Attention Control
Participants in this arm will not receive any intervention content. Participants in this arm will complete one month of run-in diaries, one month of diaries during intervention and one month of diaries post-intervention.
结局指标
主要结局
Medication adherence
时间窗: 3 months
Medication adherence will be measured using electronic monitoring of medications indicated being taken in the SMART-IBD app
次要结局
未报告次要终点