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| ID | Type | Description | Link |
|---|---|---|---|
| 5R01MH099011-02 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
| National Institute of Mental Health (NIMH) | NIH |
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The purpose of this study is to provide evidence that Enhanced Medical Rehabilitation is an effective treatment for older adults after disabling medical events.
The intervention involves physical and occupational therapy for patients who have been admitted to a skilled nursing facility for therapy following a disabling medical event.
Participants in this study will be randomly assigned to receive either Enhanced or standard of care therapy, meaning they will either receive their PT (Physical Therapy)& OT(Occupational Therapy) from therapists who have been specially trained in the study intervention or from therapists with normal training. Participants will be assessed at baseline, 30, 60, and 90 days after baseline, and at the date of their discharge from the skilled nursing facility.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard of Care Rehabilitation | Active Comparator |
| |
| Enhanced Medical Rehabilitation | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Enhanced Medical Rehabilitation | Behavioral | Daily PT/OT provided by therapists trained in Enhanced Medical Rehabilitation. This training focuses on improved communication, patient engagement, and intensity. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Barthel Index Score | Barthel Index scores range from 0 to 100, with higher scores indicating greater levels of function. | Baseline and Discharge, an average of 24 days. |
| Measure | Description | Time Frame |
|---|---|---|
| Gait Speed (Determined by 4 or 10 Meter Walk Test) | Meters walked per second. | Discharge, an average of 24 days after baseline. |
| Distance Ambulated in 6-Minute Walk Test | Feet walked during 6 minute interval. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Eric Lenze, MD | Washington University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Barnes-Jewish Extended Care | St Louis | Missouri | 63105 | United States | ||
| Washington University School of Medicine |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27689608 | Background | Bland MD, Birkenmeier RL, Barco P, Lenard E, Lang CE, Lenze EJ. Enhanced Medical Rehabilitation: Effectiveness of a clinical training model. NeuroRehabilitation. 2016 Oct 14;39(4):481-498. doi: 10.3233/NRE-161380. | |
| 34131093 | Derived | Ercal B, Rodebaugh TL, Bland MD, Barco P, Lenard E, Lang CE, Miller JP, Yingling M, Lenze EJ. Executive Function Moderates Functional Outcomes of Engagement Strategies During Rehabilitation in Older Adults. Am J Phys Med Rehabil. 2021 Jul 1;100(7):635-642. doi: 10.1097/PHM.0000000000001739. |
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Participants were recruited from 2 skilled nursing facilities in the St. Louis, Missouri metropolitan area from July 29, 2014 through March 22, 2018.
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| ID | Title | Description |
|---|---|---|
| FG000 | Standard of Care Rehabilitation | Standard of Care Rehabilitation: Daily PT/OT provided by therapists not trained in the treatment intervention. |
| FG001 | Enhanced Medical Rehabilitation | Enhanced Medical Rehabilitation: Daily PT/OT provided by therapists trained in Enhanced Medical Rehabilitation. This training focuses on improved communication, patient engagement, and intensity. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Standard of Care Rehabilitation | Standard of Care Rehabilitation: Daily PT/OT provided by therapists not trained in the treatment intervention. |
| BG001 | Enhanced Medical Rehabilitation |
| 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 | Change in Barthel Index Score | Barthel Index scores range from 0 to 100, with higher scores indicating greater levels of function. | One Standard of Care participant did not have a baseline Barthel completed. Otherwise, all other 228 participants were included in the analysis. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline and Discharge, an average of 24 days. |
|
90 days
All cause mortality was tracked for 90 days.
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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 | Standard of Care Rehabilitation | Standard of Care Rehabilitation: Daily PT/OT provided by therapists not trained in the treatment intervention. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| all cause mortality | General disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Emily Lenard | Washington University | 314-747-5706 | lenarde@wustl.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | May 29, 2019 | Jun 9, 2020 | SAP_000.pdf |
| Prot | Yes | No | No | Study Protocol | Jan 18, 2018 | Jun 23, 2020 | Prot_001.pdf |
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| ID | Term |
|---|---|
| D003863 | Depression |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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| Standard of Care Rehabilitation | Behavioral | Daily PT/OT provided by therapists not trained in the treatment intervention. |
|
| Discharge, an average of 24 days after baseline. |
| Self-reported Barthel Index | Barthel Index scores range from 0 to 100, with higher scores indicating greater levels of function. Conducted as a self-report at timepoints where patient was not in an institutional setting. | 30, 60, and 90 Days Post Admission to the SNF |
| Discharge Disposition | Number of participants discharged from skilled nursing facility to home | Discharge, an average of 24 days after baseline. |
| Rehospitalizations | Assesses whether the participant was readmitted to the hospital. | Days 30, 60, and 90 post admission to a SNF as well as at Discharge |
| St Louis |
| Missouri |
| 63110 |
| United States |
| Alexian Brothers Sherbrooke Village | St Louis | Missouri | 63125 | United States |
| 31365113 | Derived | Lenze EJ, Lenard E, Bland M, Barco P, Miller JP, Yingling M, Lang CE, Morrow-Howell N, Baum CM, Binder EF, Rodebaugh TL. Effect of Enhanced Medical Rehabilitation on Functional Recovery in Older Adults Receiving Skilled Nursing Care After Acute Rehabilitation: A Randomized Clinical Trial. JAMA Netw Open. 2019 Jul 3;2(7):e198199. doi: 10.1001/jamanetworkopen.2019.8199. |
| Lost to Follow-up |
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| Physician Decision |
|
Enhanced Medical Rehabilitation: Daily PT/OT provided by therapists trained in Enhanced Medical Rehabilitation. This training focuses on improved communication, patient engagement, and intensity.
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Impairment Type | Participants' medical conditions were rated by organ system using the Cumulative Illness Rating Scale for Geriatrics (CIRS-G). Participants with extremely severe impairment (CIRSG item score of 4) are tabulated below. Some participants had extremely severe impairment in more than one category. | Count of Participants | Participants |
|
| MADRS Score | The Montgomery-Asberg Depression Rating Scale (MADRS) is a measurement of depressive symptom severity. Scores can range from 0-60 with higher scores indicating more depressive symptoms. | Mean | Standard Deviation | units on a scale |
|
| Short Blessed Test Score | The Short Blessed Test is a measure of cognitive impairment. It is a brief assessment of orientation, registration, and attention. Scores range from 0-28. Higher scores indicate worse impairment, with scores of 5-9 consistent with mild cognitive impairment and scores of at least 10 consistent with dementia. | Mean | Standard Deviation | units on a scale |
|
| Barthel Index Total Score (Premorbid) | The Barthel Index is an instrument that measures a person's ability to perform 10 basic activities of daily living or mobility items, with a scale range between 0 and 100 (higher scores indicate better function). | Mean | Standard Deviation | units on a scale |
|
| Barthel Index Total Score (Admission) | The Barthel Index is an instrument that measures a person's ability to perform 10 basic activities of daily living or mobility items, with a scale range between 0 and 100 (higher scores indicate better function). | Mean | Standard Deviation | units on a scale |
|
| CIRS-G Score | The Cumulative Illness Rating Scale for Geriatrics (CIRS-G) is used to quantify chronic illness burden from the medical records. Higher scores indicate greater burden. | Mean | Standard Deviation | units on a scale |
|
|
|
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| Secondary | Gait Speed (Determined by 4 or 10 Meter Walk Test) | Meters walked per second. | All participants with a gait speed at discharge were included in the analysis. | Posted | Median | Inter-Quartile Range | meters per second | Discharge, an average of 24 days after baseline. |
|
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|
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| Secondary | Distance Ambulated in 6-Minute Walk Test | Feet walked during 6 minute interval. | All participants able to perform a 6-minute walk at discharge were included in the analysis. | Posted | Median | Inter-Quartile Range | feet | Discharge, an average of 24 days after baseline. |
|
|
|
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| Secondary | Self-reported Barthel Index | Barthel Index scores range from 0 to 100, with higher scores indicating greater levels of function. Conducted as a self-report at timepoints where patient was not in an institutional setting. | Any participant with data at either 30 days, 60 days, 90 days, or at discharge were included in the analyses. | Posted | Mean | Standard Error | score on a scale | 30, 60, and 90 Days Post Admission to the SNF |
|
|
|
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| Secondary | Discharge Disposition | Number of participants discharged from skilled nursing facility to home | Any participant with a discharge disposition of either 'to home' or 'to institution' were included in the analysis. | Posted | Count of Participants | Participants | Discharge, an average of 24 days after baseline. |
|
|
|
|
| Secondary | Rehospitalizations | Assesses whether the participant was readmitted to the hospital. | Any participant with at least one re-hospitalization at day 30, day 60, day 90 or at discharge was included in the analysis. | Posted | Count of Participants | Participants | Days 30, 60, and 90 post admission to a SNF as well as at Discharge |
|
|
|
|
| 6 |
| 115 |
| 6 |
| 115 |
| 0 |
| 115 |
| EG001 | Enhanced Medical Rehabilitation | Enhanced Medical Rehabilitation: Daily PT/OT provided by therapists trained in Enhanced Medical Rehabilitation. This training focuses on improved communication, patient engagement, and intensity. | 11 | 114 | 11 | 114 | 0 | 114 |
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| Day 90 |
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