Telephone Intervention for Caregivers of Persons With Traumatic Brain Injury

Phase 2

Completed

• Conditions: Brain Injuries
• Interventions: Behavioral: Problem-solving, education based telephone counseling; Other: No Intervention

• Registration Number: NCT00692575
• Lead Sponsor: University of Washington

Brief Summary

This study seeks to determine if problem-based telephone counseling improves quality of life and emotional well-being for caregivers of persons with moderate to severe traumatic brain injury (TBI).

Detailed Description

Caregivers and patients with TBI are recruited from the acute medical and inpatient rehabilitation units at Harborview Medical Center and the University of Washington Medical Center in Seattle, WA. After informed consent is obtained, information is gathered from the caregiver about his/her living situation, support systems, and the nature of the caregiving relationship. Additional information is gathered from the person with TBI about how he/she is doing cognitively, socially, and emotionally. Prior to discharge home, caregivers are randomly selected to receive either standard care (typical support and/or resources) or standard care plus problem-based telephone counseling.

The telephone follow-up group receives a telephone call from a caregiver support specialist at 2, 4, 6, 8, 10, 12, 14, and 16 weeks after discharge of the patient with TBI home with the option of two additional calls. During those calls, the caregiver support specialist provides training on problem-solving skills along with education on topics of interest to caregivers of persons with TBI.

An outcome assessment is done at 6 months and 1 year after discharge home.

Study Timeline

• Study Start: 2008-06
• Study First Submitted: 2008-06-03
• Study First Submitted QC: 2008-06-03
• Study First Posted: 2008-06-06
• Primary Completion: 2012-09
• Study Completion: 2013-04
• Status Verified: 2014-04
• Last Update Submitted: 2014-04-10
• Last Update Posted: 2014-04-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 153

Inclusion Criteria

• Family member or other person having a long-term relationship (at least one year) with person with TBI admitted to hospital and discharged home from acute care, inpatient rehabilitation, and/or skilled nursing facility within 7 months of date of injury.
• Sufficient English to permit communication without an interpreter.

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Exclusion Criteria

• Lack of a telephone.
• Lack of a permanent home address.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1: Experimental	Problem-solving, education based telephone counseling	Problem-solving, education based telephone counseling.
2: No intervention	No Intervention	Standard of care control group

Primary Outcome Measures

Name	Time	Method
Composite measure based on the Bakas Caregiving Outcomes Scale and the Brief Symptom Inventory	6 mos and 1 year post discharge home

Secondary Outcome Measures

Name	Time	Method
Brief Symptom Inventory (person with TBI)	6 mos post discharge home
Caregiver resource utilization	6 mos and 1 year post discharge home
Caregiver community participation as measured by the PART-O	6 mos and 1 year post discharge home
Caregiver employment	6 mos and 1 year post discharge home
Perceived Quality of Life (person with TBI)	6 mos post discharge home

Trial Locations

Locations (1)

University of Washington; 🇺🇸 Seattle, Washington, United States