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Business decision to close study due to low and slow enrollment.
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| Name | Class |
|---|---|
| Johnson & Johnson Health and Wellness Solutions, Inc. | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Health Partner | Behavioral | Health Partner is a combination of an iPhone or iPod Touch Operating System mobile application and a health care provider portal. |
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| 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) |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Thomas Croy, MD | Providence Newberg Medical Center | Principal Investigator |
| Arnold Peterson, MD | Providence Sacred Heart/Holy Family | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Providence Newberg Medical Center | Newberg | Oregon | 97132 | United States | ||
| Providence Sacred Heart Hospital |
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| ID | Term |
|---|---|
| D017216 | Telemedicine |
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D003695 | Delivery of Health Care |
| D010346 | Patient Care Management |
| D006298 | Health Services Administration |
| D019984 | Quality Indicators, Health Care |
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| 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. |
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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 |
| Spokane |
| Washington |
| 99204 |
| United States |
| Providence Holy Family Hospital | Spokane | Washington | 99208 | United States |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |