Health Partner Evaluation at Princeton

NCT ID: NCT03386786

Last Updated: 2020-01-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

127 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-06-30

Study Completion Date

2019-12-11

Brief Summary

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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.

Detailed Description

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Conditions

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Total Knee Arthroplasty; Total Hip Arthroplasty

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Health Partner

Intervention Type BEHAVIORAL

Health Partner is a combination of a mobile application and a web-based portal.

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).

Group Type OTHER

Standard Care

Intervention Type 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).

Interventions

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Health Partner

Health Partner is a combination of a mobile application and a web-based portal.

Intervention Type 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).

Intervention Type BEHAVIORAL

Other Intervention Names

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mHealth Control

Eligibility Criteria

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Exclusion 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).
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Johnson & Johnson Health and Wellness Solutions, Inc.

INDUSTRY

Sponsor Role collaborator

DePuy Orthopaedics

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Juliet Puorro, MSN, BN

Role: PRINCIPAL_INVESTIGATOR

Penn Medicine Princeton Medical Center

Locations

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Penn Medicine Princeton Medical Center

Plainsboro, New Jersey, United States

Site Status

Countries

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United States

Other Identifiers

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DSJ_2017_01

Identifier Type: -

Identifier Source: org_study_id

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