Health Partner Evaluation at Providence
NCT03443284 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 79
Last updated 2020-01-02
Summary
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.
Conditions
- Total Knee Arthroplasty; Total Hip Arthroplasty
Interventions
- BEHAVIORAL
-
Health Partner
Health Partner is a combination of an iPhone or iPod Touch Operating System mobile application and a health care provider portal.
- BEHAVIORAL
-
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 Providence Health \& Services.
Sponsors & Collaborators
-
Johnson & Johnson Health and Wellness Solutions, Inc.
collaborator INDUSTRY -
DePuy Orthopaedics
lead INDUSTRY
Principal Investigators
-
Thomas Croy, MD · Providence Newberg Medical Center
-
Arnold Peterson, MD · Providence Sacred Heart/Holy Family
Study Design
- Allocation
- RANDOMIZED
- Purpose
- SUPPORTIVE_CARE
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2018-12-11
- Primary Completion
- 2019-12-17
- Completion
- 2019-12-17
Countries
- United States
Study Locations
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