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| ID | Type | Description | Link |
|---|---|---|---|
| R21TW009746 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Fogarty International Center of the National Institute of Health | NIH |
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Traumatic brain injury (TBI) patients in Latin America experience high levels of disability and extremely poor functional outcomes, and their informal caregivers play a key role in their rehabilitation and care. To improve TBI rehabilitation through stronger informal caregiving, the proposed study will develop and evaluate an evidence--based and culturally sensitive Transition Assistance Program for informal caregivers of patients with TBI in Latin America during the patient's transition from hospital to home. This study will generate findings that can provide empirically supported guidance to clinicians regarding the provision of culturally tailored rehabilitation services for TBI caregivers in Latin America and in the U.S.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | Experimental Transition Assistance Program |
|
| Control | No Intervention | Control |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transition Assistance Program | Behavioral |
|
| Measure | Description | Time Frame |
|---|---|---|
| Zarit Burden Interview | 22-item measure of caregiver self-reported burden. Response options for each item range from 0-4, and total scores range from 0-88, with higher scores indicating greater self-reported burden. Only total scores are reported here. | 2 months post-hospital discharge |
| Measure | Description | Time Frame |
|---|---|---|
| Exemplary Care Scale-Provide Subscale | 4-item measure of the patient's report of the quality of care they receive from their caregiver. Response options for each item range from 1-4, and total scores range from 4-16, with higher scores indicating a higher quality of informal care received. Only Provide subscale scores of the Exemplary Care Scale are reported here. | 2 months post-hospital discharge |
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TBI Patient Inclusion Criteria:
Caregiver Inclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Paul B. Perrin, Ph.D. | Virginia Commonwealth University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pontificia Universidad Javeriana Cali | Cali | 0000 | Colombia | |||
| Universidad Sur Colombiana |
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| ID | Title | Description |
|---|---|---|
| FG000 | Transition Assistance Program | Group receiving the 5-session behavioral treatment from a clinician |
| FG001 | Control | Group receiving the standard of care at the rehabilitation facility |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Transition Assistance Program | Group receiving the 5-session behavioral treatment from a clinician |
| BG001 | Control | Group receiving the standard of care at the rehabilitation facility |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Zarit Burden Interview | 22-item measure of caregiver self-reported burden. Response options for each item range from 0-4, and total scores range from 0-88, with higher scores indicating greater self-reported burden. Only total scores are reported here. | Data are from caregivers only, hence not the full sample. | Posted | Mean | Standard Deviation | units on a scale | 2 months post-hospital discharge |
|
4-month data collection window
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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 | Transition Assistance Program | Group receiving the 5-session behavioral treatment from a clinician |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Paul Perrin | Virginia Commonwealth University | 8048273894 | pperrin@vcu.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 6, 2014 | Aug 15, 2017 | SAP_000.pdf |
| Prot | Yes | No | No | Study Protocol | May 6, 2014 | Aug 21, 2017 | Prot_001.pdf |
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| ID | Term |
|---|---|
| D000070642 | Brain Injuries, Traumatic |
| D001930 | Brain Injuries |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D006259 | Craniocerebral Trauma |
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| Neiva |
| 0000 |
| Colombia |
| National Institute of Neurology and Neurosurgery | Mexico City | 14269 | Mexico |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | Years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
|
|
| Secondary | Exemplary Care Scale-Provide Subscale | 4-item measure of the patient's report of the quality of care they receive from their caregiver. Response options for each item range from 1-4, and total scores range from 4-16, with higher scores indicating a higher quality of informal care received. Only Provide subscale scores of the Exemplary Care Scale are reported here. | This is patient-report only at post-test, hence it does not use the full sample. | Posted | Mean | Standard Deviation | units on a scale | 2 months post-hospital discharge |
|
|
|
| 0 |
| 125 |
| 0 |
| 125 |
| 0 |
| 125 |
| EG001 | Control | Group receiving the standard of care at the rehabilitation facility | 0 | 125 | 0 | 125 | 0 | 125 |
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| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |