Telephone Intervention for Caregivers of Persons With Traumatic Brain Injury

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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).

Condition or disease	Intervention/treatment	Phase
Brain Injuries	Behavioral: Problem-solving, education based telephone counseling; Other: No Intervention	Phase 2

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 Design

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	153 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Single (Outcomes Assessor)
Primary Purpose:	Treatment
Official Title:	Modular Scheduled Telephone Intervention for Caregivers of Persons With Traumatic Brain Injury: A Randomized Controlled Trial
Study Start Date :	June 2008
Actual Primary Completion Date :	September 2012
Actual Study Completion Date :	April 2013

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
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

Outcome Measures

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. 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 Outcome Measures :

1. Caregiver community participation as measured by the PART-O [ Time Frame: 6 mos and 1 year post discharge home ]
2. Caregiver employment [ Time Frame: 6 mos and 1 year post discharge home ]
3. Caregiver resource utilization [ Time Frame: 6 mos and 1 year post discharge home ]
4. Perceived Quality of Life (person with TBI) [ Time Frame: 6 mos post discharge home ]
5. Brief Symptom Inventory (person with TBI) [ Time Frame: 6 mos post discharge home ]

Eligibility Criteria

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	16 Years and older (Child, Adult, Senior)
Sexes Eligible for Study:	All
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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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 ( Other Grant/Funding Number: NIDRR )
First Posted:	June 6, 2008
Last Update Posted:	April 14, 2014
Last Verified:	April 2014

Keywords provided by Janet Powell, University of Washington:

Brain Injuries, Traumatic; Caregivers

Additional relevant MeSH terms:

Wounds and Injuries; Brain Injuries; Brain Injuries, Traumatic; Brain Diseases	Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System