Telephone Intervention for Caregivers of Persons With Traumatic Brain Injury

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

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).

Study Overview

• Status: Completed
• Conditions: Brain Injuries
• Intervention / Treatment: Behavioral: Problem-solving, education based telephone counseling; Other: No Intervention

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 Type: Interventional
• Enrollment (Actual): 153
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Washington
    • Seattle, Washington, United States, 98195
      • University of Washington

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: Standard of care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Composite measure based on the Bakas Caregiving Outcomes Scale and the Brief Symptom Inventory	6 mos and 1 year post discharge home

Secondary Outcome Measures

Outcome Measure	Time Frame
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
Caregiver resource utilization	6 mos and 1 year post discharge home
Perceived Quality of Life (person with TBI)	6 mos post discharge home
Brief Symptom Inventory (person with TBI)	6 mos post discharge home

Collaborators and Investigators

• Sponsor: University of Washington
• Collaborators: U.S. Department of Education
• Investigators: Principal Investigator: Janet M. Powell, PhD, University of Washington; Study Director: Kathleen R. Bell, MD, University of Washington

Publications and helpful links

General Publications

• Powell JM, Wise EK, Brockway JA, Fraser R, Temkin N, Bell KR. Characteristics and Concerns of Caregivers of Adults With Traumatic Brain Injury. J Head Trauma Rehabil. 2017 Jan/Feb;32(1):E33-E41. doi: 10.1097/HTR.0000000000000219.
• Powell JM, Fraser R, Brockway JA, Temkin N, Bell KR. A Telehealth Approach to Caregiver Self-Management Following Traumatic Brain Injury: A Randomized Controlled Trial. J Head Trauma Rehabil. 2016 May-Jun;31(3):180-90. doi: 10.1097/HTR.0000000000000167.

Study record dates

Study Major Dates

• Study Start: June 1, 2008
• Primary Completion (Actual): September 1, 2012
• Study Completion (Actual): April 1, 2013

Study Registration Dates

• First Submitted: June 3, 2008
• First Submitted That Met QC Criteria: June 3, 2008
• First Posted (Estimate): June 6, 2008

Study Record Updates

• Last Update Posted (Estimate): April 14, 2014
• Last Update Submitted That Met QC Criteria: April 10, 2014
• Last Verified: April 1, 2014

More Information

Terms related to this study

• Keywords: Caregivers; Brain Injuries, Traumatic
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Brain Injuries; Wounds and Injuries; Brain Injuries, Traumatic
• Other Study ID Numbers: 33690-J; NIDRR grant # H133A070032 (Other Grant/Funding Number: NIDRR)