Self-Management Assistance for Recommended Treatment (SMART) Portal
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 87
- 试验地点
- 2
- 主要终点
- Medication adherence
研究概览
简要总结
The purpose of the study is to develop, evaluate, and optimize an interactive website (the SMART portal). The SMART portal will use IBD-specific and general assessments and interventions to reduce the burden of common barriers to treatment adherence and enhance self-management skills. This study aims to build and revise the SMART portal according to feedback and testing from participants.
详细描述
The study consists of three phases for development and evaluation of the SMART portal. Phase 1 is the development of online assessments and intervention components. There will be no participant interaction with the portal during Phase 1. Phase 2 will consist of one, individual interview with patients, caregivers, and clinicians/nurses to interact with a portal prototype and provide feedback. Phase 3 will contain an open trial for patients and caregivers with baseline, 2-6 months interacting with the portal and progressing through applicable intervention components, and post-treatment. Patient test data will also be loaded into the portal during Phase 3 for clinicians/nurses to interact with for 2-6 months. Feedback from all users will be collected at post-treatment for optimization of the portal.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 11 Years 至 18 Years（Child, Adult）
- 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 known as IBD)
- •Patient between 11 and 18 years of age
- •Patient prescribed at least one oral medication used to treat IBD
- •Access to the internet whether public (example, library) or private (example, home, personal)
- •English fluency for patient, caregiver, and clinician/nurse
- •Clinician/nurse currently providing medical treatment to patients diagnosed with IBD through the IBD Center at Cincinnati Children's Hospital Medical Center
排除标准
- •Diagnosis of pervasive developmental disorder in patient or caregiver
- •Diagnosis of serious mental illness (example, schizophrenia) in patient or caregiver
结局指标
主要结局
Medication adherence
时间窗: Phase 3 - Approximately 2-6 months, depending upon progression through portal components
Medication adherence will be measured by pill count data provided by patients or caregivers at baseline and post-treatment during Phase 3. Phase 3 will start approximately in October 2014 and continue through March 2015.
次要结局
- Disease severity(Phase 3 - Approximately 2-6 months, depending upon progression through portal components)
- Health-related quality of life(Phase 3 - Approximately 2-6 months, depending upon progression through portal components)