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Health Partner Evaluation at Princeton

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ClinicalTrials.gov Identifier: NCT03386786
Recruitment Status : Recruiting
First Posted : December 29, 2017
Last Update Posted : August 15, 2018
Sponsor:
Collaborator:
Johnson & Johnson Health and Wellness Solutions, Inc.
Information provided by (Responsible Party):
DePuy Orthopaedics

Brief 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. The total planned study duration is approximately 1 year and 7 months.

Condition or disease Intervention/treatment Phase
Total Knee Arthroplasty; Total Hip Arthroplasty Behavioral: Health Partner Behavioral: Standard Care Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 296 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Randomized, Controlled Evaluation of Health Partner mHealth for Total Joint Replacement at Penn Medicine Princeton Medical Center
Actual Study Start Date : June 30, 2017
Estimated Primary Completion Date : January 31, 2019
Estimated Study Completion Date : January 31, 2019

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 Name: mHealth

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 Name: Control




Primary Outcome Measures :
  1. Care Path Behavioral Assessment (CPBA), Pre-surgery [ Time Frame: Early post-operative (day after surgery to 6 weeks post-surgery) ]
    Survey assesses degree of subject adherence with pre-surgical activities

  2. Care Path Behavioral Assessment (CPBA), Post-surgery [ Time Frame: Late post-operative (11-13 weeks post-surgery) ]
    Survey assesses degree of subject adherence with post-surgical activities


Secondary Outcome Measures :
  1. Medical Resource Utilization [ Time Frame: Late post-operative (11-13 weeks post-surgery) ]
    Seven questions to evaluate the number and duration of encounters with the healthcare system after surgery

  2. Confidence in Recovery (1-item) [ Time Frame: 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) ]
    One question to gauge subject's confidence in their recovery after surgery on a five-point Likert scale

  3. Fear of Surgery (1-item) [ Time Frame: 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) ]
    One question to gauge degree to which subject is fearful of surgery on a five-point Likert scale

  4. Adherence (MOS Patient Adherence) [ Time Frame: Early post-operative (day after surgery to 6 weeks post-surgery) and late post-operative (11-13 weeks post-surgery) ]
    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

  5. Well-being (MQLI) [ Time Frame: 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) ]
    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

  6. Well-being (PHCS-WB) [ Time Frame: 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) ]
    The Public Health Surveillance Well-Being Scale (PHCS-WB) comprises 10-items gauging self-reported mental, physical, and social components of well-being

  7. Sleep (MOS Sleep Scale) [ Time Frame: 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) ]
    The Medical Outcomes Study (MOS) Sleep Scale is a 12-item instrument intended to gauge extent and nature of sleep disturbances

  8. Sleep (2-items) [ Time Frame: 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) ]
    Two questions to assess whether subjects had 7-9 hours of restful sleep per night

  9. Communication (STAR-P) [ Time Frame: 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) ]
    The STAR-P is a 12-item instrument to gauge subject's perceptions of clinical communication

  10. Communication (1-item) [ Time Frame: 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) ]
    One question to assess the frequency of subject's communication with their provider



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 3 weeks (21 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 the sub-investigator 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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03386786


Contacts
Contact: Juliet Puorro, MSN, RN (609) 853-8806 jpuorro@princetonhcs.org
Contact: Elizabeth Shokoff (609) 853-7954 eshokoff@princetonhcs.org

Locations
United States, New Jersey
Penn Medicine Princeton Medical Center Recruiting
Plainsboro, New Jersey, United States, 08536
Sponsors and Collaborators
DePuy Orthopaedics
Johnson & Johnson Health and Wellness Solutions, Inc.
Investigators
Principal Investigator: Juliet Puorro, MSN, BN Penn Medicine Princeton Medical Center

Responsible Party: DePuy Orthopaedics
ClinicalTrials.gov Identifier: NCT03386786     History of Changes
Other Study ID Numbers: DSJ_2017_01
First Posted: December 29, 2017    Key Record Dates
Last Update Posted: August 15, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by DePuy Orthopaedics:
Total Knee Arthroplasty
Total Hip Arthroplasty
Total Knee Replacement
Total Hip Replacement
Hospital Care Plan
mHealth