A Mixed Methods Randomized, Controlled Evaluation of Health Partner mHealth for Total Joint Replacement at Providence Health & Services
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 79
- 试验地点
- 6
- 主要终点
- Care Path Behavioral Assessment (CPBA), Post-surgery
研究概览
简要总结
This is a prospective, mixed methods, multi-center, randomized, comparative, controlled study. Providence Health & Services 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 an iPhone or iPod Touch Operating System mobile application and a health care provider 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. To evaluate the behavioral factors associated with care path adherence using a qualitative interview method.To evaluate the usability and preferences of patients in their interaction with the intervention using a qualitative interview method, for product development.
The total planned study duration is approximately 1 year and 7 months.
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
- •Subject is 18 or older at the time of consent.
- •Subject must be identified by their PH & S provider as needing elective unilateral TKA or THA.
- •Subject is willing to give voluntary, written informed consent to participate in this Study prior to the scheduled TKA or THA surgery.
- •Subject authorizes the transfer of his/her information to the Sponsor and Business Associate.
- •Subject must have a valid e-mail address and willing to access their inbox on a regular basis.
- •Subject must possess an iPhone/iPad/iPod Touch with operating iOS 9.0 or later and be willing to use and access digital materials from a mobile app.
- •Subject must be able to comprehend and comply with the requirements of the Study.
- •Subject must be able to speak, read and understand English fluently.
排除标准
- •Subject is not able to follow the standard of care (e.g. due to allergies) and would require special care or circumstances.
- •Subject scheduled to have TKA or THA sooner than 4 weeks from the time they enrolled in the study.
- •Subject is undergoing a revision to a previous surgery.
- •Subject is undergoing TKA or THA following traumatic injury (i.e. fracture).
- •Subject is expected to need another lower limb joint replacement (hip/knee) prior to completing this Study.
- •Subject is a repeat patient and was enrolled in the study previously.
- •Subject has had prior experience with the Health Partner companion app.
- •Subject is currently involved in any personal injury litigation, medical-legal or worker's compensation claims.
- •Subject, in the opinion of the sub-investigator is a drug or alcohol abuser (in the last 5 years) or has a psychological disorder that could affect his/her ability to complete patient reported questionnaires or be compliant with follow-up requirements.
- •Subject was diagnosed and is taking prescription medications to treat a muscular disorder that limits mobility due to severe stiffness and pain such as fibromyalgia or polymyalgia.
- •Subject has a significant neurological or musculoskeletal disorder(s) or disease that may adversely affect gait or weight bearing activities (e.g., muscular dystrophy, multiple sclerosis, Charcot disease).
结局指标
主要结局
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
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
次要结局
- Medical Resource Utilization(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))
- Well-being (PHS-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))
- Fear of Surgery (1-item)(Baseline (-6 to -3 weeks pre-surgery), pre-operative (-3 weeks to day before 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))
- Adherence (MOS Patient Adherence)(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 (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))
- Qualitative Interview(Group 1: 1-7 days pre-surgery, Group 2: 7-10 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))