Health Partner Evaluation at Princeton

Total Knee Arthroplasty; Total Hip Arthroplasty Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03386786
• Other study ID #: DSJ_2017_01
• Status: Terminated
• Phase: N/A
• Start date: June 30, 2017
• Est. completion date: December 11, 2019

Study information

• Verified date: December 2019
• Source: DePuy Orthopaedics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 127
• Est. completion date: December 11, 2019
• Est. primary completion date: December 11, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Subjects meeting all the following specific criteria will be considered for participation in the study:

1. Subject is 18 years or older at the time of consent.

2. Subject must be identified by their provider as needing elective unilateral TKA or THA.

3. Subject must have a valid e-mail address and willing to access their inbox on a regular basis.

4. 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.

5. Subject must be able to comprehend and comply with the requirements of the study.

6. Subject must be able to speak, read and understand English fluently.

7. 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:

1. Subject is not able to follow the standard of care and would require special care or circumstances.

2. 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.

3. Subject is undergoing a revision to a previous surgery.

4. Subject is undergoing TKA or THA following traumatic injury (i.e. fracture).

5. Subject is expected to need another lower limb joint replacement (hip/knee) prior to completing this service evaluation.

6. Subject is a repeat patient and was enrolled in the study previously.

7. Subject has had prior experience with the Health Partner companion app.

8. Subject is currently involved in any personal injury litigation, medical-legal or worker's compensation claims.

9. 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.

10. 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.

11. 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).

Related Conditions & MeSH terms

• Total Knee Arthroplasty; Total Hip Arthroplasty

Intervention

Behavioral:
• Health Partner
Health Partner is a combination of a mobile application and a web-based portal.
• 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).

Locations

Country	Name	City	State
United States	Penn Medicine Princeton Medical Center	Plainsboro	New Jersey

Sponsors (2)

Lead Sponsor	Collaborator
DePuy Orthopaedics	Johnson & Johnson Health and Wellness Solutions, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)