Health Partner Evaluation at Princeton

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

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.

Study Overview

• Status: Terminated
• Conditions: Total Knee Arthroplasty; Total Hip Arthroplasty
• Intervention / Treatment: Behavioral: Health Partner; Behavioral: Standard Care

• Study Type: Interventional
• Enrollment (Actual): 127
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • Plainsboro, New Jersey, United States, 08536
      • Penn Medicine Princeton Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention (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.	Behavioral: Health Partner; Health Partner is a combination of a mobile application and a web-based portal.; Other Names: mHealth
Other: Control; 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; 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).; Other Names: Control

What is the study measuring?

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)
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)
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 (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)
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 (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)
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)

Collaborators and Investigators

• Sponsor: DePuy Orthopaedics
• Collaborators: Johnson & Johnson Health and Wellness Solutions, Inc.
• Investigators: Principal Investigator: Juliet Puorro, MSN, BN, Penn Medicine Princeton Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): June 30, 2017
• Primary Completion (Actual): December 11, 2019
• Study Completion (Actual): December 11, 2019

Study Registration Dates

• First Submitted: October 2, 2017
• First Submitted That Met QC Criteria: December 21, 2017
• First Posted (Actual): December 29, 2017

Study Record Updates

• Last Update Posted (Actual): January 2, 2020
• Last Update Submitted That Met QC Criteria: December 30, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Keywords: mHealth; Total Knee Arthroplasty; Total Hip Arthroplasty; Total Knee Replacement; Total Hip Replacement; Hospital Care Plan
• Other Study ID Numbers: DSJ_2017_01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No