Health Partner Evaluation at Princeton

Study Overview
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Brief Summary
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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.

Official Title
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Randomized, Controlled Evaluation of Health Partner mHealth for Total Joint Replacement at Penn Medicine Princeton Medical Center

Conditions
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Total Knee Arthroplasty; Total Hip Arthroplasty

Intervention / Treatment
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* Behavioral: Health Partner
* Behavioral: Standard Care


Participation Criteria
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Eligibility Criteria
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Subjects meeting all the following specific criteria will be considered for participation in the study: Subject is 18 years or older at the time of consent. Subject must be identified by their provider as needing elective unilateral TKA or THA. Subject must have a valid e-mail address and willing to access their inbox on a regular basis. Subject must possess a smartphone/device capable of downloading the current version of the Health Partner mobile app and be willing to access and use digital materials for this project. 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. Subject is willing to give voluntary, written informed consent to participate in this service evaluation and authorize the transfer of his/her information to the Sponsor and Business Associate. Subjects will be excluded from participation in the study if they meet any of the following criteria: Subject is not able to follow the standard of care and would require special care or circumstances. Subject scheduled to have TKA or THA less than or equal to 2 weeks (14 days) from the time they are 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 service evaluation. 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 their healthcare provider, 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).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention (Health Partner)<br>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. | Behavioral: Health Partner<br>* Health Partner is a combination of a mobile application and a web-based portal.<br>* Other names: mHealth;|
| Other: Control<br>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). | Behavioral: Standard Care<br>* 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).<br>* Other names: Control;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Care Path Behavioral Assessment (CPBA), Pre-surgery | Survey assesses degree of subject adherence with pre-surgical activities | Early post-operative (day after surgery to 6 weeks post-surgery) | 
| Care Path Behavioral Assessment (CPBA), Post-surgery | Survey assesses degree of subject adherence with post-surgical activities | Late post-operative (11-13 weeks post-surgery) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Medical Resource Utilization | Seven questions to evaluate the number and duration of encounters with the healthcare system after surgery | Late post-operative (11-13 weeks post-surgery) | 
| Confidence in Recovery (1-item) | One question to gauge subject's confidence in their recovery after surgery on a five-point Likert 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) | 
| Fear of Surgery (1-item) | One question to gauge degree to which subject is fearful of surgery on a five-point Likert scale | 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) | 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 | Early post-operative (day after surgery to 6 weeks post-surgery) and late post-operative (11-13 weeks post-surgery) | 
| Well-being (MQLI) | 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 | 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) | The Public Health Surveillance Well-Being Scale (PHCS-WB) comprises 10-items gauging self-reported mental, physical, and social components of well-being | 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) | The Medical Outcomes Study (MOS) Sleep Scale is a 12-item instrument intended to gauge extent and nature of sleep disturbances | 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) | Two questions to assess whether subjects had 7-9 hours of restful sleep per night | 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) | The STAR-P is a 12-item instrument to gauge subject's perceptions of clinical communication | 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) | One question to assess the frequency of subject's communication with their provider | 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Total Knee Arthroplasty, Total Hip Arthroplasty, Total Knee Replacement, Total Hip Replacement, Hospital Care Plan, mHealth