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| Name | Class |
|---|---|
| Reflexion Health, Inc. | INDUSTRY |
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The goals of this research study are the following:
This study will compare the effects on health service use costs of tele-rehabilitation-supported physical therapy versus traditional home and/or clinic-based physical therapy following total knee replacement (TKR) surgery. It will also examine standard post-surgical clinical measures to confirm non-inferiority of outcomes between groups. A total of 300 patients will receive standard pre- and post-surgical medical care from their healthcare providers, and be randomized to receive pre-surgery rehabilitation exercises ("pre-hab") and post-discharge physical therapy provided via either a home-based tele-rehabilitation platform (intervention group, n=150) or home-health and clinic-based physical therapy regimen (control group, n=150). Data will be collected by sites at enrollment, baseline, hospital discharge, and 6 weeks following surgery. Patients will complete telephone surveys regarding their health and knee function at baseline, 6 weeks, and 3 months after surgery. Patients will also keep a diary from hospital discharge through 3 months documenting healthcare utilization and progress toward a personal recovery goal. Diary information will be collected over the phone concurrently with administration of the 6-week and 3-month surveys. The episode for analysis will be from surgery through 3 months post-discharge, in alignment with the Centers for Medicare and Medicaid Services Comprehensive Care for Joint Replacement (CJR) bundled payment model. Physical risks or benefits to patients for participating in this study are as expected from standard pre- and post-surgical physical therapy associated with total knee replacement surgery. The low risk of loss of confidentiality for all subjects will be minimized using appropriate safeguards.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Virtual physical therapy | Other | Virtual physical therapy rehabilitation program (VERA) used in the home with care planning and remote support and monitoring by physical therapists |
|
| Traditional physical therapy | Other | No intervention. Standard home health physical therapy and/or outpatient clinic physical therapy as prescribed. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Virtual physical therapy rehabilitation program | Device | Virtual Exercise Rehabilitation Assistant (VERA), a virtual physical therapy delivery system installed in patient's home |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cost Difference in US Dollars | Difference in total health service use costs at 12-weeks postoperative between patients who receive tele-rehab-supported PT versus traditional home and/or clinic-based PT for TKR. | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Knee Injury and Osteoarthritis Outcome Score (KOOS) | Survey regarding health [Knee Injury and Osteoarthritis Outcome Score (KOOS)] for pain, symptoms, activities of daily living, function in sports and recreation, and knee-related quality of life (QOL) at 6 weeks and 12 weeks, scored from 0 to 100. Higher score indicates better outcomes. | 6 weeks and 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Knee Injury and Osteoarthritis Outcome Score (KOOS) Sub-domain Scores | Scores in KOOS sub-domains of pain, symptoms, activities of daily living (ADL), sports and recreation, and quality of life (QOL). Each sub-domain score can be normalized to values ranging from 0 to 100. Higher scores denote better outcomes. | 6 weeks and 12 weeks |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Janet Bettger, ScD | Duke Clinical Research Institute, Duke Dept of Orthopaedic Surgery | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of North Carolina Orhthopedics | Chapel Hill | North Carolina | 27514 | United States | ||
| Duke Orthopaedics |
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| ID | Title | Description |
|---|---|---|
| FG000 | Virtual Physical Therapy | Virtual physical therapy rehabilitation program (VERA) used in the home with care planning and remote support and monitoring by physical therapists Virtual physical therapy rehabilitation program: Virtual Exercise Rehabilitation Assistant (VERA), a virtual physical therapy delivery system installed in patient's home |
| FG001 | Traditional Physical Therapy | No intervention. Standard home health physical therapy and/or outpatient clinic physical therapy as prescribed. No intervention: Traditional physical therapy delivered in clinic or via home-health visits |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Enrolled patients excluding those found to be ineligible after enrollment and prior to surgery
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| ID | Title | Description |
|---|---|---|
| BG000 | Virtual Physical Therapy | Virtual physical therapy rehabilitation program (VERA) used in the home with care planning and remote support and monitoring by physical therapists Virtual physical therapy rehabilitation program: Virtual Exercise Rehabilitation Assistant (VERA), a virtual physical therapy delivery system installed in patient's home |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Cost Difference in US Dollars | Difference in total health service use costs at 12-weeks postoperative between patients who receive tele-rehab-supported PT versus traditional home and/or clinic-based PT for TKR. | Patients randomized and receiving eligible surgery, and completing the study through 12 weeks post surgery. | Posted | Median | Inter-Quartile Range | US Dollars | 12 weeks |
|
Mortality at discharge from surgical hospitalization.
Mortality was assessed at hospital discharge only, using available medical records. No other adverse events were assessed since this was a study of cost savings between marketed virtual physical therapy assistant and traditional clinic/home-health-based physical therapy.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Virtual Physical Therapy | Virtual physical therapy rehabilitation program (VERA) used in the home with care planning and remote support and monitoring by physical therapists Virtual physical therapy rehabilitation program: Virtual Exercise Rehabilitation Assistant (VERA), a virtual physical therapy delivery system installed in patient's home |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Janet Bettger, ScD | Duke Clinical Research Institute | 919-613-0379 | janet.bettger@duke.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 2, 2017 | Apr 11, 2019 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 8, 2018 | Apr 11, 2019 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Aug 17, 2016 | Apr 11, 2019 | ICF_002.pdf |
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| No intervention | Other | Traditional physical therapy delivered in clinic or via home-health visits |
|
| Range of Motion | Knee range of motion [lower (extension) and upper range of motion (flexion)] at 6 weeks | 6 weeks |
| 10-meter Gait Speed | Gait speed 6 weeks after surgery | 6 weeks |
| Pain Score | Non-inferiority safety endpoint: pain score at 12 weeks. Measured on scale from 0 to 10, with 0 being no pain and 10 being worst pain imaginable. | 12 weeks |
| Report of Falls | Any fall reported between hospital discharge and 12-week follow-up (yes/no) | 12 weeks |
| Re-hospitalization | Re-hospitalizations since hospital discharge (total count) | 12 weeks |
| Physical Activity |
Physical activity (duration of moderate exercise in total minutes per week) |
| 6 weeks and 12 weeks |
| Return to Work | Return to work (yes, modified schedule, or no) for those who stopped working prior to surgery | 6 weeks and 12 weeks |
| Patient-Reported Outcomes Measurement Information System (PROMIS) - Mental Health (MH) Score | PROMIS mental health score at 12 weeks, on a scale of 0 to 20 with higher scores indicating better mental health. | 12 weeks |
| Patient-Reported Outcomes Measurement Information System (PROMIS) - Physical Health (PH) Score | PROMIS physical health score at 12 weeks, on a scale of 0 to 20, with higher scores indicating better physical health. | 12 weeks |
| Satisfaction With Physical Function | Score on Satisfaction with Physical Function questionnaire through 12 weeks after surgery, on a scale of 0 to 6, with 6 being higher satisfaction. | 12 weeks |
| Satisfaction With Tele-rehab Platform | Satisfaction with tele-rehab platform, on scale of 0 to 10, with 10 being highly satisfied. | 12 weeks |
| Durham |
| North Carolina |
| 27705 |
| United States |
| Greensboro Orthopedics | Greensboro | North Carolina | 27408 | United States |
| Raleigh Orthopaedics | Raleigh | North Carolina | 27612 | United States |
| BG001 |
| Traditional Physical Therapy |
No intervention. Standard home health physical therapy and/or outpatient clinic physical therapy as prescribed. No intervention: Traditional physical therapy delivered in clinic or via home-health visits |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| RAPT Score | Standardized Risk Assessment and Prediction Tool (RAPT) used to predict likely discharge destination in patients undergoing elective hip or knee replacement. Scores range from 1-12. Score < 6 indicates likely discharge to inpatient rehab; these patients were not eligible for enrollment. Score of 6 or higher indicates likely discharge to home, with or without supportive services such as home health. | Mean | Standard Deviation | units on a scale |
|
| Traditional Physical Therapy |
No intervention. Standard home health physical therapy and/or outpatient clinic physical therapy as prescribed. No intervention: Traditional physical therapy delivered in clinic or via home-health visits |
|
|
| Secondary | Knee Injury and Osteoarthritis Outcome Score (KOOS) | Survey regarding health [Knee Injury and Osteoarthritis Outcome Score (KOOS)] for pain, symptoms, activities of daily living, function in sports and recreation, and knee-related quality of life (QOL) at 6 weeks and 12 weeks, scored from 0 to 100. Higher score indicates better outcomes. | Patients randomized and receiving eligible surgery, completing study through 12 weeks, and providing complete responses to survey questions | Posted | Mean | Standard Deviation | score on a scale | 6 weeks and 12 weeks |
|
|
|
| Secondary | Range of Motion | Knee range of motion [lower (extension) and upper range of motion (flexion)] at 6 weeks | Patients randomized and receiving eligible surgery, completing study through 12 weeks, and having range of motion measured at specified time point. | Posted | Mean | Standard Deviation | degrees from parallel to floor | 6 weeks |
|
|
|
| Secondary | 10-meter Gait Speed | Gait speed 6 weeks after surgery | Patients randomized and receiving eligible surgery, completing study through 12 weeks, and having gait speed measured. | Posted | Mean | Standard Deviation | minutes | 6 weeks |
|
|
|
| Secondary | Pain Score | Non-inferiority safety endpoint: pain score at 12 weeks. Measured on scale from 0 to 10, with 0 being no pain and 10 being worst pain imaginable. | Patients randomized and receiving eligible surgery, completing study through 12 weeks, and responding to survey question regarding pain. | Posted | Mean | Standard Deviation | score on a scale | 12 weeks |
|
|
|
| Secondary | Report of Falls | Any fall reported between hospital discharge and 12-week follow-up (yes/no) | Patients randomized and receiving eligible surgery, completing study through 12 weeks, and answering survey question regarding falls. | Posted | Number | percentage of patients | 12 weeks |
|
|
|
| Secondary | Re-hospitalization | Re-hospitalizations since hospital discharge (total count) | Patients randomized and receiving eligible surgery, completing study through 12 weeks, and providing complete responses to survey questions. | Posted | Mean | Standard Deviation | number of rehospitalizations per patient | 12 weeks |
|
|
|
| Other Pre-specified | Knee Injury and Osteoarthritis Outcome Score (KOOS) Sub-domain Scores | Scores in KOOS sub-domains of pain, symptoms, activities of daily living (ADL), sports and recreation, and quality of life (QOL). Each sub-domain score can be normalized to values ranging from 0 to 100. Higher scores denote better outcomes. | Patients randomized and receiving eligible surgery, completing study through 12 weeks, and providing complete responses to survey questions. | Posted | Mean | Standard Deviation | score on a scale | 6 weeks and 12 weeks |
|
|
|
| Other Pre-specified | Physical Activity | Physical activity (duration of moderate exercise in total minutes per week) | Patients randomized and receiving eligible surgery, completing study through 12 weeks, and providing complete responses to survey questions. | Posted | Median | Inter-Quartile Range | minutes per week | 6 weeks and 12 weeks |
|
|
|
| Other Pre-specified | Return to Work | Return to work (yes, modified schedule, or no) for those who stopped working prior to surgery | Patients randomized and receiving eligible surgery, completing study through 12 weeks, and providing complete responses to survey questions. | Posted | Count of Participants | Participants | 6 weeks and 12 weeks |
|
|
|
| Other Pre-specified | Patient-Reported Outcomes Measurement Information System (PROMIS) - Mental Health (MH) Score | PROMIS mental health score at 12 weeks, on a scale of 0 to 20 with higher scores indicating better mental health. | Patients randomized and receiving eligible surgery, completing study through 12 weeks, and providing complete responses to survey questions. | Posted | Mean | Standard Deviation | score on a scale | 12 weeks |
|
|
|
| Other Pre-specified | Patient-Reported Outcomes Measurement Information System (PROMIS) - Physical Health (PH) Score | PROMIS physical health score at 12 weeks, on a scale of 0 to 20, with higher scores indicating better physical health. | Patients randomized and receiving eligible surgery, completing study through 12 weeks, and providing complete responses to survey questions. | Posted | Mean | Standard Deviation | score on a scale | 12 weeks |
|
|
|
| Other Pre-specified | Satisfaction With Physical Function | Score on Satisfaction with Physical Function questionnaire through 12 weeks after surgery, on a scale of 0 to 6, with 6 being higher satisfaction. | Patients randomized and receiving eligible surgery, completing study through 12 weeks, and providing complete responses to survey questions. | Posted | Mean | Standard Deviation | score on a scale | 12 weeks |
|
|
|
| Other Pre-specified | Satisfaction With Tele-rehab Platform | Satisfaction with tele-rehab platform, on scale of 0 to 10, with 10 being highly satisfied. | Patients randomized and receiving eligible surgery, completing study through 12 weeks, using the virtual platform at least once, and providing response to survey question. | Posted | Number | percentage of participants | 12 weeks |
|
|
|
| 0 |
| 143 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Traditional Physical Therapy | No intervention. Standard home health physical therapy and/or outpatient clinic physical therapy as prescribed. No intervention: Traditional physical therapy delivered in clinic or via home-health visits | 0 | 144 | 0 | 0 | 0 | 0 |
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| Function/Daily Living (6 weeks) |
|
| Sports/Recreation (6 weeks) |
|
| Quality of Life (6 weeks) |
|
| Pain (12 weeks) |
|
| Symptoms (12 weeks) |
|
| Function/Daily Living (12 weeks) |
|
| Sports/Recreation (12 weeks) |
|
| Quality of Life (12 weeks) |
|
| No |
|
| Not recorded |
|
| 12 weeks |
|
| Title | Measurements |
|---|---|
|