Health Partner Evaluation at Princeton

Description

This is a prospective, single-center, randomized, comparative, controlled study. Princeton HealthCare System 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. The total planned study duration is approximately 1 year and 7 months.

Study Start Date

June, 30 2017

Estimated Completion Date

January 2019

Interventions

  • Behavioral: Health Partner
  • Behavioral: Standard Care

Study ID

DePuy Orthopaedics -- DSJ_2017_01

Status

Unknown

Trial ID

NCT03386786

Study Type

Interventional

Trial Phase

N/A

Enrollment Quota

296

Sponsor

DePuy Orthopaedics

Subjects meeting all the following specific criteria will be considered for participation in the study: 1. Subject is 18 or older at the time of consent. 2. Subject must be identified by their PHCS provider as needing elective unilateral TJR. 3. Subject must be approved by their insurance provider for unilateral TJR or willing to pay for costs out-of-pocket. 4. Subject must have a valid e-mail address and willing to access their inbox on a regular basis. 5. Subject must possess an iPhone/iPod Touch with operating iOS 9.0 or later and be willing to use and access digital materials from a mobile app. 6. Subject must be able to comprehend and comply with the requirements of the study. 7. Subject must be able to speak, read and understand English fluently. 8. 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. 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 (e.g. due to allergies) and would require special care or circumstances. 2. Subject is undergoing a revision to a previous surgery. 3. Subject is undergoing TJR following traumatic injury (i.e. fracture). 4. Subject is expected to need another lower limb joint replacement (hip/knee) prior to completing this service evaluation. 5. Subject is currently involved in any personal injury litigation, medical-legal or worker's compensation claims. 6. 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. 7. 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. 8. 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).

Gender

All

Ages

18 Years and older

Accepts Healthy Volunteers

No

Study Locations and Contact Information (1)

Study Location Distance Name Phone Email
Princeton HealthCare System - Plainsboro, New Jersey 92.8 miles None None None

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