Health Partner Evaluation at Providence

Study Overview
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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.

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

Conditions
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Total Knee Arthroplasty; Total Hip Arthroplasty

Intervention / Treatment
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* Behavioral: Health Partner
* Behavioral: Standard Care


Participation Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention (Health Partner)<br>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<br>* Health Partner is a combination of an iPhone or iPod Touch Operating System mobile application and a health care provider portal.<br>* Other names: mHealth;|
| Other: Control<br>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<br>* 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.<br>* Other names: Control;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Medical Resource Utilization | 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Total Knee Arthroplasty, Total Hip Arthroplasty, Total Knee Replacement, Total Hip Replacement, Hospital Care Plan, mHealth