Telephone Intervention for Caregivers of Persons With Traumatic Brain Injury
Primary Purpose
Brain Injuries
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Problem-solving, education based telephone counseling
No Intervention
Sponsored by
About this trial
This is an interventional treatment trial for Brain Injuries focused on measuring Brain Injuries, Traumatic, Caregivers
Eligibility 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.
Sites / Locations
- University of Washington
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
1: Experimental
2: No intervention
Arm Description
Problem-solving, education based telephone counseling.
Standard of care control group
Outcomes
Primary Outcome Measures
Composite measure based on the Bakas Caregiving Outcomes Scale and the Brief Symptom Inventory
Secondary Outcome Measures
Caregiver community participation as measured by the PART-O
Caregiver employment
Caregiver resource utilization
Perceived Quality of Life (person with TBI)
Brief Symptom Inventory (person with TBI)
Full Information
NCT ID
NCT00692575
First Posted
June 3, 2008
Last Updated
April 10, 2014
Sponsor
University of Washington
Collaborators
U.S. Department of Education
1. Study Identification
Unique Protocol Identification Number
NCT00692575
Brief Title
Telephone Intervention for Caregivers of Persons With Traumatic Brain Injury
Official Title
Modular Scheduled Telephone Intervention for Caregivers of Persons With Traumatic Brain Injury: A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
April 2014
Overall Recruitment Status
Completed
Study Start Date
June 2008 (undefined)
Primary Completion Date
September 2012 (Actual)
Study Completion Date
April 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Washington
Collaborators
U.S. Department of Education
4. Oversight
Data Monitoring Committee
No
5. Study Description
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).
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain Injuries
Keywords
Brain Injuries, Traumatic, Caregivers
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
153 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1: Experimental
Arm Type
Experimental
Arm Description
Problem-solving, education based telephone counseling.
Arm Title
2: No intervention
Arm Type
Sham Comparator
Arm Description
Standard of care control group
Intervention Type
Behavioral
Intervention Name(s)
Problem-solving, education based telephone counseling
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
No Intervention
Other Intervention Name(s)
Standard of care
Intervention Description
The control group will receive standard of care, i.e., typical resources and/or supports offered to caregivers of persons with TBI.
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Caregiver community participation as measured by the PART-O
Time Frame
6 mos and 1 year post discharge home
Title
Caregiver employment
Time Frame
6 mos and 1 year post discharge home
Title
Caregiver resource utilization
Time Frame
6 mos and 1 year post discharge home
Title
Perceived Quality of Life (person with TBI)
Time Frame
6 mos post discharge home
Title
Brief Symptom Inventory (person with TBI)
Time Frame
6 mos post discharge home
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Janet M. Powell, PhD
Organizational Affiliation
University of Washington
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Kathleen R. Bell, MD
Organizational Affiliation
University of Washington
Official's Role
Study Director
Facility Information:
Facility Name
University of Washington
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
27022956
Citation
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.
Results Reference
derived
PubMed Identifier
26394294
Citation
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.
Results Reference
derived
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Telephone Intervention for Caregivers of Persons With Traumatic Brain Injury
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