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Telephone Intervention for Caregivers of Persons With Traumatic Brain Injury

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ClinicalTrials.gov Identifier: NCT00692575
Recruitment Status : Completed
First Posted : June 6, 2008
Last Update Posted : April 14, 2014
Sponsor:
Collaborator:
U.S. Department of Education
Information provided by (Responsible Party):
Janet Powell, University of Washington

June 3, 2008
June 6, 2008
April 14, 2014
June 2008
September 2012   (Final data collection date for primary outcome measure)
Composite measure based on the Bakas Caregiving Outcomes Scale and the Brief Symptom Inventory [ Time Frame: 6 mos and 1 year post discharge home ]
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 ]
Complete list of historical versions of study NCT00692575 on ClinicalTrials.gov Archive Site
  • Caregiver community participation as measured by the PART-O [ Time Frame: 6 mos and 1 year post discharge home ]
  • Caregiver employment [ Time Frame: 6 mos and 1 year post discharge home ]
  • Caregiver resource utilization [ Time Frame: 6 mos and 1 year post discharge home ]
  • Perceived Quality of Life (person with TBI) [ Time Frame: 6 mos post discharge home ]
  • Brief Symptom Inventory (person with TBI) [ Time Frame: 6 mos post discharge home ]
  • Caregiver community participation as measured by the PART-O [ Time Frame: 6 mos and 1 year post inpatient rehabilitation discharge ]
  • Caregiver employment [ Time Frame: 6 mos and 1 year post inpatient rehabilitation discharge ]
  • Caregiver resource utilization [ Time Frame: 6 mos and 1 year post inpatient rehabilitation discharge ]
  • Perceived Quality of Life (person with TBI) [ Time Frame: 6 mos post inpatient rehabilitation discharge ]
  • Brief Symptom Inventory (person with TBI) [ Time Frame: 6 mos post inpatient rehabilitation discharge ]
Not Provided
Not Provided
 
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).

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.

Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Brain Injuries
  • 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.
    Other Name: Standard of care
  • Experimental: 1: Experimental
    Problem-solving, education based telephone counseling.
    Intervention: Behavioral: Problem-solving, education based telephone counseling
  • Sham Comparator: 2: No intervention
    Standard of care control group
    Intervention: Other: No Intervention
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
153
180
April 2013
September 2012   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
16 Years and older   (Child, Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00692575
33690-J
NIDRR grant # H133A070032 ( Other Grant/Funding Number: NIDRR )
No
Not Provided
Not Provided
Janet Powell, University of Washington
University of Washington
U.S. Department of Education
Principal Investigator: Janet M. Powell, PhD University of Washington
Study Director: Kathleen R. Bell, MD University of Washington
University of Washington
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP