Health Partner Evaluation at Providence

NCT03443284 | Terminated

• 1 other identifier: DSJ-2017-06
• Study Type: interventional
• Target: 79
• Locations: 1 country
• Sites: 3

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.

Conditions

Total Knee Arthroplasty; Total Hip Arthroplasty

Keywords

Total Knee Arthroplasty; Total Hip Arthroplasty; Total Knee Replacement; Total Hip Replacement; Hospital Care Plan; mHealth

Outcome Measures

Primary Outcomes (2)

• Care Path Behavioral Assessment (CPBA) Pre-surgery

  Survey assesses degree of subject adherence with pre-surgical activities

  Early post-operative (day after surgery to 6 weeks post-surgery)

• Care Path Behavioral Assessment (CPBA), Post-surgery

  Survey assesses degree of subject adherence with post-surgical activities

  Late post-operative (11-13 weeks post surgery)

Secondary Outcomes (10)

• Medical Resource Utilization

  Late post-operative (11-13 weeks post-surgery)

• Confidence in Recovery (1-item)

  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)

• Fear of Surgery (1-item)

  Baseline (-6 to -3 weeks pre-surgery), pre-operative (-3 weeks to day before surgery)

• Adherence (MOS Patient Adherence)

  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)

• Well-being (MQLI)

  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)

Study Arms (2)

Intervention (Health Partner)

EXPERIMENTAL

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.

Behavioral: Health Partner

Control

OTHER

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.

Behavioral: Standard Care

Interventions

Health Partner BEHAVIORAL

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

Also known as: mHealth

Intervention (Health Partner)

Standard Care 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.

Also known as: Control

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• DePuy Orthopaedics: lead
• Johnson & Johnson Health and Wellness Solutions, Inc.: collaborator

Study Sites (3)

Providence Newberg Medical Center

Newberg, Oregon, 97132, United States

Location

Providence Sacred Heart Hospital

Spokane, Washington, 99204, United States

Location

Providence Holy Family Hospital

Spokane, Washington, 99208, United States

Location

MeSH Terms

Interventions

Telemedicine; Standard of Care

Intervention Hierarchy (Ancestors)

Delivery of Health Care; Patient Care Management; Health Services Administration; Quality Indicators, Health Care; Quality of Health Care; Health Care Quality, Access, and Evaluation

Study Officials

• Thomas Croy, MD

  Providence Newberg Medical Center

  PRINCIPAL INVESTIGATOR

• Arnold Peterson, MD

  Providence Sacred Heart/Holy Family

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 31, 2018
• First Posted: February 23, 2018
• Study Start: December 11, 2018
• Primary Completion: December 17, 2019
• Study Completion: December 17, 2019
• Last Updated: January 2, 2020

Record last verified: 2019-12

Locations

US (3)