Health Partner Evaluation at Providence

Status:	Recruiting
Healthy:	No
Age Range:	18 - Any
Updated:	3/30/2019
Start Date:	December 11, 2018
End Date:	July 31, 2020
Contact:	Christie Rice
Email:	Christie.Rice@providence.org
Phone:	503-215-4297

A Mixed Methods Randomized, Controlled Evaluation of Health Partner mHealth for Total Joint Replacement at Providence Health & Services

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.

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).

We found this trial at

sites

Providence Newberg Medical Center

1001 Providence Dr
Newberg, Oregon 97132

(503) 537-1555