Health Partner Evaluation at Providence

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

79 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-12-11

Study Completion Date

2019-12-17

Brief Summary

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This is a prospective, mixed methods, multi-center, randomized, comparative, controlled study. Providence Health \& Services 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. To evaluate the behavioral factors associated with care path adherence using a qualitative interview method.To evaluate the usability and preferences of patients in their interaction with the intervention using a qualitative interview method, for product development.

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

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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 an iPhone or iPod Touch Operating System (iOS) mobile application (app) and a health care provider (HCP) portal.

Group Type EXPERIMENTAL

Health Partner

Intervention Type BEHAVIORAL

Health Partner is a combination of an iPhone or iPod Touch Operating System mobile application and a health care provider 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 Providence Health \& Services.

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 Providence Health \& Services.

Interventions

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Health Partner

Health Partner is a combination of an iPhone or iPod Touch Operating System mobile application and a health care provider 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 Providence Health \& Services.

Intervention Type BEHAVIORAL

Other Intervention Names

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mHealth Control

Eligibility Criteria

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Inclusion Criteria

* Subject is 18 or older at the time of consent.
* Subject must be identified by their PH \& S provider as needing elective unilateral TKA or THA.
* Subject is willing to give voluntary, written informed consent to participate in this Study prior to the scheduled TKA or THA surgery.
* Subject authorizes the transfer of his/her information to the Sponsor and Business Associate.
* Subject must have a valid e-mail address and willing to access their inbox on a regular basis.
* Subject must possess an iPhone/iPad/iPod Touch with operating iOS 9.0 or later and be willing to use and access digital materials from a mobile app.
* Subject must be able to comprehend and comply with the requirements of the Study.
* Subject must be able to speak, read and understand English fluently.

Exclusion Criteria

* Subject is not able to follow the standard of care (e.g. due to allergies) and would require special care or circumstances.
* Subject scheduled to have TKA or THA sooner than 4 weeks from the time they enrolled in the study.
* Subject is undergoing a revision to a previous surgery.
* Subject is undergoing TKA or THA following traumatic injury (i.e. fracture).
* Subject is expected to need another lower limb joint replacement (hip/knee) prior to completing this Study.
* Subject is a repeat patient and was enrolled in the study previously.
* Subject has had prior experience with the Health Partner companion app.
* Subject is currently involved in any personal injury litigation, medical-legal or worker's compensation claims.
* 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.
* 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.
* 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