Telephone Intervention for Caregivers of Persons With Traumatic Brain Injury

This study has been completed.
Sponsor:
Collaborator:
U.S. Department of Education
Information provided by (Responsible Party):
Janet Powell, University of Washington
ClinicalTrials.gov Identifier:
NCT00692575
First received: June 3, 2008
Last updated: April 10, 2014
Last verified: April 2014
  Purpose

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).


Condition Intervention Phase
Brain Injuries
Behavioral: Problem-solving, education based telephone counseling
Other: No Intervention
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Modular Scheduled Telephone Intervention for Caregivers of Persons With Traumatic Brain Injury: A Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by University of Washington:

Primary Outcome Measures:
  • Composite measure based on the Bakas Caregiving Outcomes Scale and the Brief Symptom Inventory [ Time Frame: 6 mos and 1 year post discharge home ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Caregiver community participation as measured by the PART-O [ Time Frame: 6 mos and 1 year post discharge home ] [ Designated as safety issue: No ]
  • Caregiver employment [ Time Frame: 6 mos and 1 year post discharge home ] [ Designated as safety issue: No ]
  • Caregiver resource utilization [ Time Frame: 6 mos and 1 year post discharge home ] [ Designated as safety issue: No ]
  • Perceived Quality of Life (person with TBI) [ Time Frame: 6 mos post discharge home ] [ Designated as safety issue: No ]
  • Brief Symptom Inventory (person with TBI) [ Time Frame: 6 mos post discharge home ] [ Designated as safety issue: No ]

Enrollment: 153
Study Start Date: June 2008
Study Completion Date: April 2013
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1: Experimental
Problem-solving, education based telephone counseling.
Behavioral: Problem-solving, education based telephone counseling
Caregivers are contacted every 2 weeks for 16-20 weeks after discharge of TBI survivor home. A caregiver support specialist provides telephone counseling based on a problem-solving, educational model.
Sham Comparator: 2: No intervention
Standard of care control group
Other: No Intervention
The control group will receive standard of care, i.e., typical resources and/or supports offered to caregivers of persons with TBI.
Other Name: Standard of care

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.

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00692575

Locations
United States, Washington
University of Washington
Seattle, Washington, United States, 98195
Sponsors and Collaborators
University of Washington
U.S. Department of Education
Investigators
Principal Investigator: Janet M. Powell, PhD University of Washington
Study Director: Kathleen R. Bell, MD University of Washington
  More Information

No publications provided

Responsible Party: Janet Powell, Associate Professor, University of Washington
ClinicalTrials.gov Identifier: NCT00692575     History of Changes
Other Study ID Numbers: 33690-J, NIDRR grant # H133A070032
Study First Received: June 3, 2008
Last Updated: April 10, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Washington:
Brain Injuries, Traumatic
Caregivers

Additional relevant MeSH terms:
Brain Injuries
Wounds and Injuries
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System

ClinicalTrials.gov processed this record on April 16, 2014