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Trial Outcomes & Findings for A Culturally Sensitive Intervention for TBI Caregivers in Latin America (NCT NCT02207803)

NCT ID: NCT02207803

Last Updated: 2017-10-18

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

250 participants

Primary outcome timeframe

2 months post-hospital discharge

Results posted on

2017-10-18

Participant Flow

Participant milestones

Participant milestones
Measure
Transition Assistance Program
Group receiving the 5-session behavioral treatment from a clinician
Control
Group receiving the standard of care at the rehabilitation facility
Overall Study
STARTED
125
125
Overall Study
COMPLETED
110
108
Overall Study
NOT COMPLETED
15
17

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Culturally Sensitive Intervention for TBI Caregivers in Latin America

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Transition Assistance Program
n=125 Participants
Group receiving the 5-session behavioral treatment from a clinician
Control
n=125 Participants
Group receiving the standard of care at the rehabilitation facility
Total
n=250 Participants
Total of all reporting groups
Age, Categorical
<=18 years
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Age, Categorical
Between 18 and 65 years
120 Participants
n=5 Participants
119 Participants
n=7 Participants
239 Participants
n=5 Participants
Age, Categorical
>=65 years
5 Participants
n=5 Participants
6 Participants
n=7 Participants
11 Participants
n=5 Participants
Age, Continuous
37 Years
STANDARD_DEVIATION 14 • n=5 Participants
39 Years
STANDARD_DEVIATION 13 • n=7 Participants
38 Years
STANDARD_DEVIATION 14 • n=5 Participants
Sex: Female, Male
Female
61 Participants
n=5 Participants
63 Participants
n=7 Participants
124 Participants
n=5 Participants
Sex: Female, Male
Male
64 Participants
n=5 Participants
62 Participants
n=7 Participants
126 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
125 Participants
n=5 Participants
125 Participants
n=7 Participants
250 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Region of Enrollment
Colombia
44 participants
n=5 Participants
44 participants
n=7 Participants
88 participants
n=5 Participants
Region of Enrollment
Mexico
81 participants
n=5 Participants
81 participants
n=7 Participants
162 participants
n=5 Participants

PRIMARY outcome

Timeframe: 2 months post-hospital discharge

Population: Data are from caregivers only, hence not the full sample.

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.

Outcome measures

Outcome measures
Measure
Transition Assistance Program
n=56 Participants
Group receiving the 5-session behavioral treatment from a clinician
Control
n=56 Participants
Group receiving the standard of care at the rehabilitation facility
Zarit Burden Interview
23.41 units on a scale
Standard Deviation 16.50
26.48 units on a scale
Standard Deviation 19.71

SECONDARY outcome

Timeframe: 2 months post-hospital discharge

Population: This is patient-report only at post-test, hence it does not use the full sample.

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.

Outcome measures

Outcome measures
Measure
Transition Assistance Program
n=56 Participants
Group receiving the 5-session behavioral treatment from a clinician
Control
n=56 Participants
Group receiving the standard of care at the rehabilitation facility
Exemplary Care Scale-Provide Subscale
14.23 units on a scale
Standard Deviation 2.89
14.07 units on a scale
Standard Deviation 2.64

Adverse Events

Transition Assistance Program

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Control

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Paul Perrin

Virginia Commonwealth University

Phone: 8048273894

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place