Telephone Intervention for Caregivers of Persons With Traumatic Brain Injury - Full Text View

Sponsors and Collaborators:	University of Washington Department of Education
Information provided by:	University of Washington
ClinicalTrials.gov Identifier:	NCT00692575

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-based telephone counseling Other: No Intervention	Phase II

MedlinePlus related topics: Caregivers Traumatic Brain Injury

U.S. FDA Resources

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

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 inpatient rehabilitation discharge ] [ 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 inpatient rehabilitation discharge ] [ Designated as safety issue: No ]
Caregiver employment [ Time Frame: 6 mos and 1 year post inpatient rehabilitation discharge ] [ Designated as safety issue: No ]
Caregiver resource utilization [ Time Frame: 6 mos and 1 year post inpatient rehabilitation discharge ] [ Designated as safety issue: No ]
Perceived Quality of Life (person with TBI) [ Time Frame: 6 mos post inpatient rehabilitation discharge ] [ Designated as safety issue: No ]
Brief Symptom Inventory (person with TBI) [ Time Frame: 6 mos post inpatient rehabilitation discharge ] [ Designated as safety issue: No ]

Estimated Enrollment:	180
Study Start Date:	June 2008
Estimated Study Completion Date:	September 2012
Estimated Primary Completion Date:	April 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental: Experimental Problem-solving based telephone counseling.	Behavioral: Problem-based telephone counseling Caregivers are contacted every 2 weeks for 8-10 weeks after discharge of TBI survivor from hospital inpatient rehabilitation unit. A research care mentor provides telephone counseling based on a problem-solving, educational model.
2: No intervention: Sham Comparator 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.

Detailed Description:

Caregivers and patients with TBI are recruited from the 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 from inpatient rehabilitation, 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 research care mentor 2, 4, 6, 8, 10, 12, 14, and 16 weeks after discharge of the patient with TBI from inpatient rehabilitation. During those calls, the research care mentor 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 rehabilitation discharge.

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
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 receiving inpatient rehabilitation services for the first time since injury.
Sufficient English to permit communication without an interpreter.

Exclusion Criteria:

Lack of a telephone.
Lack of a permanent home address.
Person with TBI transferring to inpatient rehabilitation from sub acute care facility more than 4 months after date of initial injury

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00692575

Contacts

Contact: Aaron Scrol, MA

206-731-5196

ascrol@u.washington.edu

Locations

United States, Washington
University of Washington	Recruiting
Seattle, Washington, United States, 98195
Contact: Aaron Scrol, MA 206-731-5196 ascrol@u.washington.edu
Principal Investigator: Janet M. Powell, PhD

Sponsors and Collaborators

University of Washington

Department of Education

Investigators

Principal Investigator:	Janet M. Powell, PhD	University of Washington
Study Director:	Kathleen R. Bell, MD	University of Washington

More Information

Responsible Party:	University of Washington ( Janet M. Powell, PhD, Associate Professor )
Study ID Numbers:	33690 J, NIDRR grant # H133A070032
Study First Received:	June 3, 2008
Last Updated:	June 3, 2008
ClinicalTrials.gov Identifier:	NCT00692575
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Washington:

Brain Injuries, Traumatic
Caregivers

Study placed in the following topic categories:

Craniocerebral Trauma
Wounds and Injuries
Disorders of Environmental Origin
Central Nervous System Diseases

Trauma, Nervous System
Brain Diseases
Brain Injuries

Additional relevant MeSH terms:

Nervous System Diseases

ClinicalTrials.gov processed this record on January 16, 2009