An Enhanced Home-Based Telemedicine Program Using Remote Examination Devices for Children With Medical Complexity Receiving Comprehensive Care: a Single-Center Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 254
- 试验地点
- 1
- 主要终点
- Number of Days Care Provided in a Medical Setting
研究概览
简要总结
The purpose of this study is to assess if the benefits for children with medical complexity (CMC) receiving comprehensive care (CC) in an enhanced medical home can be further improved by enhanced telemedicine program (ETM) provided during clinic hours using mobile devices to measure temperature and oxygen saturation, auscultate the heart & lungs, and view the skin, throat, and tympanic membranes in the home.
研究设计
- 研究类型
- 干预性
- 分配方式
- 随机
- 干预模型
- 平行分组
- 主要目的
- 诊断
- 盲法
- 开放（无盲法）
入排标准
- 年龄范围
- — 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- Greater than or equal to 2 hospitalizations or greater than or equal to 1 ICU admission in the year before joining the comprehensive care program
- Greater than 50 percent estimated risk of hospitalization without our care as judged by the medical director
排除标准
- Major heart disease
- Mitochondrial disorders
- Active cancer
- Do-Not-Resuscitate (DNR) order
- Patients receiving compassionate care
研究组 & 干预措施
Comprehensive care (CC) program
干预措施: Comprehensive care (CC) program (Other)
Comprehensive care (CC) program augmented with enhanced telemedicine (ETM)
干预措施: Comprehensive care (CC) program (Other)
Comprehensive care (CC) program augmented with enhanced telemedicine (ETM)
干预措施: Enhanced telemedicine (ETM) (Device)
方案终点
主要结局
Number of Days Care Provided in a Medical Setting
时间窗: end of study(about 24 months)
Total Number of Episodes of Serious Illnesses (Causing Death, Pediatric ICU Admission, and Hospital Stay > 7d).
时间窗: end of study(about 24 months)
次要结局
- Cost Effectiveness of ETM(end of study(about 24 months))
- Number of Hospital Admissions Due to All-Cause Infections(end of study(about 24 months))
- Average Numbers of Clinic Visits(end of study(about 24 months))
- Average Total Number of Emergency Department Visits(end of study(about 24 months))
- Average Number of Hospital Days(end of study(about 24 months))
- Average Number of Pediatric Intensive Care Unit (PICU) Days(end of study(about 24 months))
- Total Number of Deaths(end of study(about 24 months))
- Parent Ratings of Care Assessed Using the Consumer Assessment of Healthcare Providers and Systems Survey(end of study(about 24 months))
试验结果
结果已于 2026-08-14 在 ClinicalTrials.gov 公示。 在 ClinicalTrials.gov 查看
受试者流程
入组 254 人 · 完成 208 人
主要终点
Number of Days Care Provided in a Medical Setting
days · Full Range · 时间窗: end of study(about 24 months)
| Comprehensive Care (CC) Program （n=124） | Comprehensive Care (CC) Program Augmented With Enhanced Telemedicine (ETM) （n=130） |
|---|---|
| 23.3 (0–62) | 25.9 (0–111) |
Total Number of Episodes of Serious Illnesses (Causing Death, Pediatric ICU Admission, and Hospital Stay > 7d).
number of episodes · 时间窗: end of study(about 24 months)
| Comprehensive Care (CC) Program （n=124） | Comprehensive Care (CC) Program Augmented With Enhanced Telemedicine (ETM) （n=130） |
|---|---|
| 41 | 118 |
其他终点（8）
Cost Effectiveness of ETM
时间窗: end of study(about 24 months)
该终点未公示数据。
Data were not collected or analyzed for this outcome because cost data could not be obtained from the hospital and no cost information was available for participants. The study protocol was not amended to reflect this collective team decision. Data collection and analysis for this outcome measure will not be conducted in the future. Therefore, no participants were measured or analyzed for this outcome measure.
Number of Hospital Admissions Due to All-Cause Infections
hospital admissions · Full Range · 时间窗: end of study(about 24 months)
| Comprehensive Care (CC) Program （n=124） | Comprehensive Care (CC) Program Augmented With Enhanced Telemedicine (ETM) （n=130） |
|---|---|
| 2.431 (0–51) | 2.453 (0–53) |
Average Numbers of Clinic Visits
clinic visits · Full Range · 时间窗: end of study(about 24 months)
| Comprehensive Care (CC) Program （n=124） | Comprehensive Care (CC) Program Augmented With Enhanced Telemedicine (ETM) （n=130） |
|---|---|
| 6.89 (1–51) | 7.15 (1–40) |
Average Total Number of Emergency Department Visits
emergency department visit · Full Range · 时间窗: end of study(about 24 months)
| Comprehensive Care (CC) Program （n=124） | Comprehensive Care (CC) Program Augmented With Enhanced Telemedicine (ETM) （n=130） |
|---|---|
| 2.28 (0–23) | 2.8 (0–23) |
Average Number of Hospital Days
days · Full Range · 时间窗: end of study(about 24 months)
| Comprehensive Care (CC) Program （n=124） | Comprehensive Care (CC) Program Augmented With Enhanced Telemedicine (ETM) （n=130） |
|---|---|
| 14.79 (0–62) | 16.34 (0–110) |
Average Number of Pediatric Intensive Care Unit (PICU) Days
days · Full Range · 时间窗: end of study(about 24 months)
| Comprehensive Care (CC) Program （n=124） | Comprehensive Care (CC) Program Augmented With Enhanced Telemedicine (ETM) （n=130） |
|---|---|
| 5.169 (0–61) | 8.362 (0–88) |
Total Number of Deaths
Participants · 时间窗: end of study(about 24 months)
| Comprehensive Care (CC) Program （n=124） | Comprehensive Care (CC) Program Augmented With Enhanced Telemedicine (ETM) （n=130） |
|---|---|
| 3 | 6 |
Parent Ratings of Care Assessed Using the Consumer Assessment of Healthcare Providers and Systems Survey
时间窗: end of study(about 24 months)
该终点未公示数据。
Data were not collected for this outcome measure because the study survey was not administered. Therefore, no data were available for any participants. This outcome measure will not be collected in the future. The study protocol was not amended to reflect this.
安全性
| 组别 | 严重不良事件 | 死亡 |
|---|---|---|
| Comprehensive Care (CC) Program | 0 / 124 | 3 / 124 |
| Comprehensive Care (CC) Program Augmented With Enhanced Telemedicine (ETM) | 0 / 130 | 6 / 130 |
数值为申办方在 ClinicalTrials.gov 公示的原始数据，未经重新计算；括号内为公示的离散度（如 95% 置信区间）。
研究者
研究点 (1)
标识符
- NCT 编号
- NCT05408143
- 其他研究编号
- HSC-MS-21-0829, 5 UA6MC31101-05-00
日期
- 首次提交
- (4年前)
- 首次发布
- (4年前)
- 主要完成日期
- (2年前)
- 研究完成日期
- (2年前)
- 最近核实
- (3个月前)
- 最近更新
- (上个月)
监管与共享
- FDA 监管药物
- 否
- FDA 监管器械
- 是
- 个体参与者数据共享计划
- 否
- 是否有结果
- 是