Telephone Intervention for Caregivers of Persons With Traumatic Brain Injury

Brain Injuries Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00692575
• Other study ID #: 33690-J
• Secondary ID: NIDRR grant # H1
• Status: Completed
• Phase: Phase 2
• First received: June 3, 2008
• Last updated: April 10, 2014
• Start date: June 2008
• Est. completion date: April 2013

Study information

• Verified date: April 2014
• Source: University of Washington
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 153
• Est. completion date: April 2013
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Brain Injuries

Intervention

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.

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.

Locations

Country	Name	City	State
United States	University of Washington	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
University of Washington	U.S. Department of Education

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Composite measure based on the Bakas Caregiving Outcomes Scale and the Brief Symptom Inventory		6 mos and 1 year post discharge home	No
Secondary	Caregiver community participation as measured by the PART-O		6 mos and 1 year post discharge home	No
Secondary	Caregiver employment		6 mos and 1 year post discharge home	No
Secondary	Caregiver resource utilization		6 mos and 1 year post discharge home	No
Secondary	Perceived Quality of Life (person with TBI)		6 mos post discharge home	No
Secondary	Brief Symptom Inventory (person with TBI)		6 mos post discharge home	No