Randomized, Controlled Evaluation of Health Partner mHealth for Total Joint Replacement at Penn Medicine Princeton Medical Center
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 127
- 试验地点
- 2
- 主要终点
- Care Path Behavioral Assessment (CPBA), Pre-surgery
研究概览
简要总结
This is a prospective, single-center, randomized, comparative, controlled study. Penn Medicine Princeton Medical Center will enroll a total of 296 subjects (18 years or older) who are electing to have total knee or hip replacement surgery. Subjects will be randomized to either the treatment group (Health Partner alongside standard care) or the control group (standard care alone). Health Partner is a combination of a mobile application and a web-based portal. The primary objective is to compare care plan adherence (pre- and post-surgery) for Health Partner vs. control subjects. Secondary objectives include evaluating all-cause medical resource utilization, communication with health care provider, well-being, fear of surgery, confidence in recovery from surgery, sleep, and patient satisfaction for 90 days post-surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Care Path Behavioral Assessment (CPBA), Pre-surgery
时间窗: Early post-operative (day after surgery to 6 weeks post-surgery)
Survey assesses degree of subject adherence with pre-surgical activities
Care Path Behavioral Assessment (CPBA), Post-surgery
时间窗: Late post-operative (11-13 weeks post-surgery)
Survey assesses degree of subject adherence with post-surgical activities
次要结局
- Medical Resource Utilization(Late post-operative (11-13 weeks post-surgery))
- Confidence in Recovery (1-item)(Baseline (-6 to -3 weeks pre-surgery), pre-operative (-3 weeks to day before surgery), early post-operative (day after surgery to 6 weeks post-surgery))
- Fear of Surgery (1-item)(Baseline (-6 to -3 weeks pre-surgery), pre-operative (-3 weeks to the day before surgery), early post-operative (day after surgery to 6 weeks post-surgery))
- Adherence (MOS Patient Adherence)(Early post-operative (day after surgery to 6 weeks post-surgery) and late post-operative (11-13 weeks post-surgery))
- Well-being (MQLI)(Baseline (-6 to -3 weeks pre-surgery), pre-operative (-3 weeks to day before surgery), early post-operative (day after surgery to 6 weeks post-surgery), and late post-operative (11-13 weeks post-surgery))
- Well-being (PHCS-WB)(Baseline (-6 to -3 weeks pre-surgery), pre-operative (-3 weeks to day before surgery), early post-operative (day after surgery to 6 weeks post-surgery), and late post-operative (11-13 weeks post-surgery))
- Sleep (MOS Sleep Scale)(Baseline (-6 to -3 weeks pre-surgery), pre-operative (-3 weeks to day before surgery), early post-operative (day after surgery to 6 weeks post-surgery), and late post-operative (11-13 weeks post-surgery))
- Sleep (2-items)(Baseline (-6 to -3 weeks pre-surgery), pre-operative (-3 weeks to day before surgery), early post-operative (day after surgery to 6 weeks post-surgery), and late post-operative (11-13 weeks post-surgery))
- Communication (STAR-P)(Baseline (-6 to -3 weeks pre-surgery), pre-operative (-3 weeks to day before surgery), early post-operative (day after surgery to 6 weeks post-surgery), and late post-operative (11-13 weeks post-surgery))
- Communication (1-item)(Baseline (-6 to -3 weeks pre-surgery), pre-operative (-3 weeks to day before surgery), early post-operative (day after surgery to 6 weeks post-surgery), and late post-operative (11-13 weeks post-surgery))