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Clinical Trials/NCT00692575
NCT00692575
Completed
Phase 2

Modular Scheduled Telephone Intervention for Caregivers of Persons With Traumatic Brain Injury: A Randomized Controlled Trial

University of Washington1 site in 1 country153 target enrollmentJune 2008
ConditionsBrain Injuries

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Brain Injuries
Sponsor
University of Washington
Enrollment
153
Locations
1
Primary Endpoint
Composite measure based on the Bakas Caregiving Outcomes Scale and the Brief Symptom Inventory
Status
Completed
Last Updated
12 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 2008
End Date
April 2013
Last Updated
12 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Janet Powell

Associate Professor

University of Washington

Eligibility Criteria

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.

Exclusion Criteria

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

Outcomes

Primary Outcomes

Composite measure based on the Bakas Caregiving Outcomes Scale and the Brief Symptom Inventory

Time Frame: 6 mos and 1 year post discharge home

Secondary Outcomes

  • 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)

Study Sites (1)

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