Health Partner Evaluation at Princeton
- Conditions
- Total Knee Arthroplasty; Total Hip Arthroplasty
- Interventions
- Behavioral: Health PartnerBehavioral: Standard Care
- Registration Number
- NCT03386786
- Lead Sponsor
- DePuy Orthopaedics
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 127
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intervention (Health Partner) Health Partner The mobile health (mHealth) product, Health Partner for Knees and Hips (Health Partner), is a combination of a mobile application (app) and a web-based portal. Control Standard Care Patients randomized to Control will receive pre-printed brochures that outline the steps of the care plan for unilateral TKA and THA, as per standard care provided to any unilateral TJA patient receiving care at Princeton Healthcare System (PHCS).
- Primary Outcome Measures
Name Time Method Care Path Behavioral Assessment (CPBA), Pre-surgery 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 Late post-operative (11-13 weeks post-surgery) Survey assesses degree of subject adherence with post-surgical activities
- Secondary Outcome Measures
Name Time Method Medical Resource Utilization Late post-operative (11-13 weeks post-surgery) Seven questions to evaluate the number and duration of encounters with the healthcare system after 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) One question to gauge subject's confidence in their recovery after surgery on a five-point Likert scale
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) One question to gauge degree to which subject is fearful of surgery on a five-point Likert scale
Adherence (MOS Patient Adherence) Early post-operative (day after surgery to 6 weeks post-surgery) and late post-operative (11-13 weeks post-surgery) The Medical Outcomes Study (MOS) Patient Adherence is a 5-item questionnaire gauging subject self-reported ability to follow doctors' suggestions and the frequency of subject adherence
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) The Multi-Cultural Quality of Life Index (MQLI) asks respondents to rank ten different areas of their life \[self-care and independent functioning, occupational functioning, social-emotional support, community and service support, interpersonal functioning, global perception of quality of life, physical well-being, personal fulfillment, psychological/emotional well-being, and spiritual fulfillment\] on a 10-point Likert scale
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) The Public Health Surveillance Well-Being Scale (PHCS-WB) comprises 10-items gauging self-reported mental, physical, and social components of well-being
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) The Medical Outcomes Study (MOS) Sleep Scale is a 12-item instrument intended to gauge extent and nature of sleep disturbances
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) Two questions to assess whether subjects had 7-9 hours of restful sleep per night
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) The STAR-P is a 12-item instrument to gauge subject's perceptions of clinical communication
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) One question to assess the frequency of subject's communication with their provider
Trial Locations
- Locations (1)
Penn Medicine Princeton Medical Center
🇺🇸Plainsboro, New Jersey, United States