Ignite Creation Date:
2024-05-05 @ 11:53 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00164645
Status:
UNKNOWN
Last Update Posted:
2006-04-27
First Post:
2005-09-12
Brief Title:
Problem Solving for Caregivers of Persons With Brain Injury
Sponsor:
Centers for Disease Control and Prevention
Organization:
Centers for Disease Control and Prevention
Study Overview
Official Title:
Problem Solving for Caregivers of Patients With Traumatic Brain Injury
Status:
UNKNOWN
Status Verified Date:
2005-09
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 n40 dyads or a control group n40 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 regressioninferential 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
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 regressioninferential 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None