Clinical trial NCT03443284: Health Partner Evaluation at Providence
Official title: A Mixed Methods Randomized, Controlled Evaluation of Health Partner mHealth for Total Joint Replacement at Providence Health & Services
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Total Knee Arthroplasty; Total Hip Arthroplasty
Keywords: Total Knee Arthroplasty
Total Hip Arthroplasty
Total Knee Replacement
Total Hip Replacement
Hospital Care Plan
mHealth
Lead sponsor: DePuy Orthopaedics
Sponsor class: INDUSTRY
Collaborators: name: Johnson & Johnson Health and Wellness Solutions, Inc.
First posted: 2018-02-23
Enrollment: 79
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.


Eligibility criteria: 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).

Primary outcomes:
measure: Care Path Behavioral Assessment (CPBA) Pre-surgery
timeFrame: Early post-operative (day after surgery to 6 weeks post-surgery)
measure: Care Path Behavioral Assessment (CPBA), Post-surgery
timeFrame: Late post-operative (11-13 weeks post surgery)
Secondary outcomes:
measure: Medical Resource Utilization
timeFrame: Late post-operative (11-13 weeks post-surgery)
measure: Confidence in Recovery (1-item)
timeFrame: 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)
measure: Fear of Surgery (1-item)
timeFrame: Baseline (-6 to -3 weeks pre-surgery), pre-operative (-3 weeks to day before surgery)
measure: Adherence (MOS Patient Adherence)
timeFrame: 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)
measure: Well-being (MQLI)
timeFrame: 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)
measure: Well-being (PHS-WB)
timeFrame: 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)
measure: Sleep (MOS Sleep Scale)
timeFrame: 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)
measure: Sleep (2-items)
timeFrame: 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)
measure: Communication (1-item)
timeFrame: 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)
measure: Qualitative Interview
timeFrame: Group 1: 1-7 days pre-surgery, Group 2: 7-10 weeks post-surgery
Other outcomes:
Locations:
city: Newberg
country: United States
facility: Providence Newberg Medical Center
state: Oregon
city: Spokane
country: United States
facility: Providence Sacred Heart Hospital
state: Washington
city: Spokane
country: United States
facility: Providence Holy Family Hospital
state: Washington
Study officials:
affiliation: Providence Newberg Medical Center
name: Thomas Croy, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Providence Sacred Heart/Holy Family
name: Arnold Peterson, MD
role: PRINCIPAL_INVESTIGATOR
References: