- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03443284
Health Partner Evaluation at Providence
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.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Oregon
-
Newberg, Oregon, United States, 97132
- Providence Newberg Medical Center
-
-
Washington
-
Spokane, Washington, United States, 99208
- Providence Holy Family Hospital
-
Spokane, Washington, United States, 99204
- Providence Sacred Heart Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: SUPPORTIVE_CARE
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: 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.
|
Health Partner is a combination of an iPhone or iPod Touch Operating System mobile application and a health care provider portal.
Other Names:
|
OTHER: 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.
|
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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Care Path Behavioral Assessment (CPBA) Pre-surgery
Time Frame: Early post-operative (day after surgery to 6 weeks post-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
Time Frame: Late post-operative (11-13 weeks post surgery)
|
Survey assesses degree of subject adherence with post-surgical activities
|
Late post-operative (11-13 weeks post surgery)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Medical Resource Utilization
Time Frame: Late post-operative (11-13 weeks post-surgery)
|
Seven questions to evaluate the number and duration of encounters with the healthcare system after surgery
|
Late post-operative (11-13 weeks post-surgery)
|
Confidence in Recovery (1-item)
Time Frame: 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)
|
One question to guage subject's confidence in their recovery after surgery on a five-point Likert scale (ranging from Strongly disagree to Strongly sgree)
|
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)
Time Frame: Baseline (-6 to -3 weeks pre-surgery), pre-operative (-3 weeks to day before surgery)
|
One question to guage degree to which subject is fearful of surgery on a five-point Likert scale (ranging from Strongly disagree to Strongly sgree)
|
Baseline (-6 to -3 weeks pre-surgery), pre-operative (-3 weeks to day before surgery)
|
Adherence (MOS Patient Adherence)
Time Frame: 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)
|
The Medical Outcomes Study (MOS) Patient Adherence is a 5-item questionnaire (ranging from "None of the time" to "All of the time") guaging subject self-reported ability to follow doctors' suggestions and the frequency of subject adherence.
To score general adherence, the responses are averaged together after reversing items 1 and 3.
|
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)
Time Frame: 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)
|
The Multi-Cultural Quality of Life Index (MQLI) asks respondents to rank ten different areas of their life [self-care and independent functioning, occupational functioning, social-emotional support, community and service support, interpersonal functioning, global perception of quality of life, physical well-being, personal fulfillment, psychological/emotional well-being, and spiritual fulfillment] on a 10-point Likert scale
|
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)
|
Well-being (PHS-WB)
Time Frame: 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)
|
The Public Health Surveillance Well-Being Scale (PHS-WB) comprises 10-items guaging self-reported mental, physical, and social components of well-being.
Response options for 6 of the items are on a 5-point Likert-type scale.
The responses options range from "strongly disagree" to "strongly agree," "none of the time" to "all of the time," and "poor" to "excellent."
Three of the items are based on a 10-point Likert-type scale.
Response options for the 10-point items range from "very dissatisfied" to "very satisfied."
One item assesses energy/vitality over the past 30 day.
The responses for that item ranged from 0 to 30.
A score for the PHS-WB scale was created by summing the 10 items for each respondent.
|
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)
|
Sleep (MOS Sleep Scale)
Time Frame: 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)
|
The MOS Sleep Scale is a 12-item instrument, which measures multiple facets of sleep.
The MOS Sleep Scale yields a sleep problems index and six scale scores: sleep disturbance (have trouble falling asleep, how long to fall asleep, sleep was not quiet, awaken during your sleep time, and have trouble falling asleep again), sleep adequacy (get enough sleep to feel rested upon waking in the morning and get amount of sleep needed), daytime somnolence (drowsy during day, have trouble staying awake during the day, and take naps), snoring, awaken short of breath or with headache, and quantity of sleep.
Quantity of sleep is scored as the average hours slept per night.
The other scales and problems index are scored on a range from 0 to 100 with higher scores indicating more of the concept being measured.
|
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)
|
Sleep (2-items)
Time Frame: 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)
|
Two questions to assess whether subjects had 7-9 hours of restful sleep per night
|
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)
|
Communication (1-item)
Time Frame: 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)
|
One question to assess the frequency of subject's communication with their provider
|
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)
|
Qualitative Interview
Time Frame: Group 1: 1-7 days pre-surgery, Group 2: 7-10 weeks post-surgery
|
A qualitative interview to evaluate the behavioral factors associated with care path adherence and to evaluate the usability and preferences of patients in their interaction with the intervention, for product development.
|
Group 1: 1-7 days pre-surgery, Group 2: 7-10 weeks post-surgery
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Thomas Croy, MD, Providence Newberg Medical Center
- Principal Investigator: Arnold Peterson, MD, Providence Sacred Heart/Holy Family
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- DSJ-2017-06
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Total Knee Arthroplasty; Total Hip Arthroplasty
-
DePuy OrthopaedicsJohnson & Johnson Health and Wellness Solutions, Inc.TerminatedTotal Knee Arthroplasty; Total Hip ArthroplastyUnited States
-
Northern Orthopaedic Division, DenmarkCompletedTotal Knee Arthroplasty | Total Hip ArthroplastyDenmark
-
James A. KeeneyRecruitingPrimary Total Hip Arthroplasty | Primary Total Knee ArthroplastyUnited States
-
Desert Orthopedic Center Medical Research FoundationBaxter Healthcare CorporationUnknownTotal Knee Arthroplasty | Arthroplasty, Replacement, HipUnited States
-
Northwell HealthNext Science TMNot yet recruitingTotal Knee Arthroplasty | Total Hip ArthroplastyUnited States
-
Kootenai HealthCompletedTotal Hip and Knee Arthroplasty
-
Centre hospitalier de l'Université de Montréal...CompletedTotal Hip or Knee ArthroplastyCanada
-
Central DuPage HospitalUnknownInfected Total Hip or Knee ArthroplastyUnited States
-
Limacorporate S.p.aRecruitingTotal Knee Arthroplasty | Revision Total Knee ArthroplastyUnited Kingdom, Portugal, Slovakia
-
Sunnybrook Health Sciences CentreRecruitingAseptic Revision Total Hip Arthroplasty | Total Knee Arthroplasty With Exchange of at Least One Prosthetic ComponentCanada
Clinical Trials on Health Partner
-
Hunter College of City University of New YorkRecruitingHIV InfectionsUnited States
-
DePuy OrthopaedicsJohnson & Johnson Health and Wellness Solutions, Inc.TerminatedTotal Knee Arthroplasty; Total Hip ArthroplastyUnited States
-
University of WashingtonNational Institute of Allergy and Infectious Diseases (NIAID); Washington State...CompletedGonorrhea | Chlamydia Trachomatis | Neisseria GonorrhoeaeUnited States
-
Boston Medical CenterAgency for Healthcare Research and Quality (AHRQ)CompletedPreventive Care | Medication ManagementUnited States
-
Johns Hopkins UniversityNational Institute of Nursing Research (NINR)Completed
-
University of MiamiNational Institute of Neurological Disorders and Stroke (NINDS)CompletedChronic Fatigue SyndromeUnited States
-
National Institute on Drug Dependence, ChinaMan Wellness Center, Beijing, ChinaNot yet recruitingSexually Transmitted Diseases | HIV/AIDS | Prevention
-
University of WashingtonUniversity of Nairobi; Kenya Ministry of HealthCompleted
-
Centers for Disease Control and PreventionTulane UniversityCompletedUrethritis | Trichomonas VaginalisUnited States