Problem Solving for Caregivers of Persons With Brain Injury
Primary Purpose
Traumatic Brain Injury
Status
Unknown status
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Problem Solving intervention
Sponsored by
About this trial
This is an interventional educational/counseling/training trial for Traumatic Brain Injury focused on measuring Emotional outcomes, health outcomes, traumatic brain injury, caregiving
Eligibility Criteria
Inclusion Criteria: Minimum age of 19 years Brain injury diagnosis at least 6 mos in-house non-paid caregiver of person with brain injury functional literacy caregiver willing to discuss abuse issues Exclusion Criteria: -
Sites / Locations
- University of Alabama at BirminghamRecruiting
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00164645
First Posted
September 12, 2005
Last Updated
April 26, 2006
Sponsor
Centers for Disease Control and Prevention
1. Study Identification
Unique Protocol Identification Number
NCT00164645
Brief Title
Problem Solving for Caregivers of Persons With Brain Injury
Official Title
Problem Solving for Caregivers of Patients With Traumatic Brain Injury
Study Type
Interventional
2. Study Status
Record Verification Date
September 2005
Overall Recruitment Status
Unknown status
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Centers for Disease Control and Prevention
4. Oversight
5. Study Description
Brief Summary
Family caregivers of persons with traumatic brain injury (TBI) have long-term demands that tax their coping abilities and adversely affect their health and well-being. This project will test the effectiveness of a problem-solving training program tailored to the unique needs of family caregivers of persons with TBI. Over a 3-year period, family caregivers and their care recipients will be recruited and randomly assigned to a problem-solving intervention group (n=40 dyads) or a control group (n=40 dyads). Participants in the problem-solving intervention group will receive four face-to-face problem-solving training sessions and monthly telephone problem-solving sessions over the course of 1 year. Control group participants will receive a handbook of educational materials and a staff member will contact each control group participant monthly by telephone to review these materials and other informational needs. No problem-solving training will be provided to control participants throughout the year.
Caregivers and care recipients will be assessed at four points during their participation: at the initial assessment, at 4 months, at 8 months, and at the completion of the 1-year participation period. All evaluations will be conducted in the participants' homes. Measures of problem-solving ability, caregiver burden, and adjustment (depression, health, satisfaction with life) will be collected. Structural equation modeling and other regression/inferential analyses will be used to determine the effects of problem solving on caregiver adjustment over time after taking into account care recipient adjustment and caregiver ethnicity. This project will: (1) demonstrate how specified physical and emotional outcomes of caregivers and care recipients are related to caregiver problem-solving abilities and how these relationships vary as a function of time; (2) evaluate the effectiveness of a community-based, problem-solving intervention that will be delivered to caregivers; and (3) identify caregivers and care recipients with TBI who are at risk for adverse emotional and health outcomes.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Traumatic Brain Injury
Keywords
Emotional outcomes, health outcomes, traumatic brain injury, caregiving
7. Study Design
Primary Purpose
Educational/Counseling/Training
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
Single
Allocation
Randomized
8. Arms, Groups, and Interventions
Intervention Type
Behavioral
Intervention Name(s)
Problem Solving intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Eligibility Criteria
Inclusion Criteria:
Minimum age of 19 years Brain injury diagnosis at least 6 mos in-house non-paid caregiver of person with brain injury functional literacy caregiver willing to discuss abuse issues
Exclusion Criteria:
-
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Patricia Rivera, PhD
Phone
205-934-3464
Email
rivera@uab.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Timothy R Elliot, PhD, ABPP
Organizational Affiliation
University of Alabama at Birmingham
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Patricia Rivera, PhD
Phone
205-934-3463
Email
rivera@uab.edu
12. IPD Sharing Statement
Links:
URL
http://www.uab.edu/CaregiverProjects
Description
Related Info
Learn more about this trial
Problem Solving for Caregivers of Persons With Brain Injury
We'll reach out to this number within 24 hrs