Self-Management Assistance for Recommended Treatment (SMART)@Home Care
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Medication Adherence
研究概览
简要总结
The proposed research addresses the limitations or lack of a digital platform to provide remote care of medically complex patients. Previous attempts have had poor clinical validity and suffered lack of patient engagement. The study team will deconstruct the previously implemented SMART platforms to create a roadmap, platform, and template to guide clinicians to create new tools.
Results from Phase 1 of this project highlighted the need for connectivity between the SMART@Home app and Bluetooth-enable devices to provide objective disease activity data as well as integration with Epic electronic health record so that providers can use the data to inform treatment planning and decision making. A subsequent pilot user validation trial is also needed to confirm development goals were met. Conducting a pilot user validation trial of the SMART@Home asthma tracker, spirometer, and action plan is the purpose of the next phases of this study.
A beta test the SMART@Home Asthma Tracker and asthma action plan algorithm will take place with approximately 8 participants. Beta testing will have participants record simulated increases in symptoms to ensure appropriate levels of care is communicated via the app. Then, a group of 40 adolescent (ages 12-17) patients with asthma for a 6-month pilot Randomized Control Trial (RCT). Participants will be randomized into either the IMAAP SMART@Home (n=20) or control (n=20) groups following the completion of baseline measures to test the interactive asthma action plan functionality and impact.
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
- Single (Investigator)
入排标准
- 年龄范围
- 12 Years 至 18 Years(Child, Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients diagnosed with a chronic medical condition requiring regular treatment, i.e., asthma
- •Ages 12-18
- •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
研究组 & 干预措施
SMART@Home
Use of the SMART@Home app for medication and symptom tracking, spirometry feedback
干预措施: SMART@Home (Behavioral)
Control
Usual Care
结局指标
主要结局
Medication Adherence
时间窗: 6 months
Monthly adherence will be calculated by comparing doses taken to doses recommended by IMAAP. Participants will also report rescue medication use each month when completing the ACT.
Number of days app used
时间窗: 6 months
Number of diaries completed by participant
次要结局
未报告次要终点
