Evaluation of the SMART IBD App Digital Therapeutic Tool for Pediatric Inflammatory Bowel Disease
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 70
- 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 35 youth (ages 13-17) with IBD using an app that contains daily symptom diaries, education content, medication reminders, as well as monthly engagement challenges to 35 youth in an attention control group that will complete daily diaries. The length of the intervention will include one month of baseline symptom and adherence collection, a baseline assessment, 5 months of intervention, and a post-treatment assessment.
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 analyses 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
- •Confirmed diagnosis of IBD (Crohn's Disease, ulcerative colitis, or indeterminate colitis)
- •Prescribed at least one daily or weekly medication for treatment of IBD
- •<86% adherence to prescribed medication
- •Access to internet via Wi-Fi or data plan and access to smartphone
- •English fluency for patient and caregiver
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
结局指标
主要结局
Medication adherence
时间窗: 6 months
Medication adherence will be measured by daily responses by participants to prompts in the SMART IBD app regarding whether each dose was taken for each medication. A mean adherence score will be calculated across medications for each participant for the 28 day periods at baseline and post-treatment.
次要结局
- Disease Activity(6 months)
- Sleep Duration(6 months)
- Stress(6 months)