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Business decision to close study due to slow enrollment.
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| Name | Class |
|---|---|
| Johnson & Johnson Health and Wellness Solutions, Inc. | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention (Health Partner) | Experimental | 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. |
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| Control | Other | 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). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Health Partner | Behavioral | Health Partner is a combination of a mobile application and a web-based portal. |
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| 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) |
| 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) |
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Subjects meeting all the following specific criteria will be considered for participation in the study:
Subjects will be excluded from participation in the study if they meet any of the following criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Juliet Puorro, MSN, BN | Penn Medicine Princeton Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Penn Medicine Princeton Medical Center | Plainsboro | New Jersey | 08536 | United States |
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| ID | Term |
|---|---|
| D017216 | Telemedicine |
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D003695 | Delivery of Health Care |
| D010346 | Patient Care Management |
| D006298 | Health Services Administration |
| D019984 | Quality Indicators, Health Care |
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| Standard Care | Behavioral | 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). |
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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) |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |