Traumatic Brain Injury
Conditions
Keywords
Brain Injuries, Caregivers, Intervention Studies, Latin America
Brief summary
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.
Interventions
BEHAVIORALTransition Assistance Program
Sponsors
Fogarty International Center of the National Institute of Health
Virginia Commonwealth University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Caregiver)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
TBI Patient Inclusion Criteria: * Will be discharged home and not to a nursing home * Give permission for their caregiver to participate * Sign an informed consent * Have the ability to communicate over the phone for data collection * Are between 18-60 years of age Caregiver Inclusion Criteria * Have a telephone in the home or cellular phone and are able to talk on the phone * Sign an informed consent * Score at least a 13 on a health literacy screening tool * Are between 18-85 years of age
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Zarit Burden Interview | 2 months post-hospital discharge | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Exemplary Care Scale-Provide Subscale | 2 months post-hospital discharge | 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. |
Countries
Colombia, Mexico
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Transition Assistance Program Group receiving the 5-session behavioral treatment from a clinician | 125 |
| Control Group receiving the standard of care at the rehabilitation facility | 125 |
| Total | 250 |
Baseline characteristics
| Characteristic | Transition Assistance Program | Control | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 5 Participants | 6 Participants | 11 Participants |
| Age, Categorical Between 18 and 65 years | 120 Participants | 119 Participants | 239 Participants |
| Age, Continuous | 37 Years STANDARD_DEVIATION 14 | 39 Years STANDARD_DEVIATION 13 | 38 Years STANDARD_DEVIATION 14 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 125 Participants | 125 Participants | 250 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment Colombia | 44 participants | 44 participants | 88 participants |
| Region of Enrollment Mexico | 81 participants | 81 participants | 162 participants |
| Sex: Female, Male Female | 61 Participants | 63 Participants | 124 Participants |
| Sex: Female, Male Male | 64 Participants | 62 Participants | 126 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 125 | 0 / 125 |
| other Total, other adverse events | 0 / 125 | 0 / 125 |
| serious Total, serious adverse events | 0 / 125 | 0 / 125 |
Outcome results
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.
Time frame: 2 months post-hospital discharge
Population: Data are from caregivers only, hence not the full sample.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Transition Assistance Program | Zarit Burden Interview | 23.41 units on a scale | Standard Deviation 16.5 |
| Control | Zarit Burden Interview | 26.48 units on a scale | Standard Deviation 19.71 |
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.
Time frame: 2 months post-hospital discharge
Population: This is patient-report only at post-test, hence it does not use the full sample.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Transition Assistance Program | Exemplary Care Scale-Provide Subscale | 14.23 units on a scale | Standard Deviation 2.89 |
| Control | Exemplary Care Scale-Provide Subscale | 14.07 units on a scale | Standard Deviation 2.64 |