Clinical trial NCT00692575: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Brain Injuries
Keywords: Brain Injuries, Traumatic
Caregivers
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: U.S. Department of Education
First posted: 2008-06-06
Enrollment: 153
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Composite measure based on the Bakas Caregiving Outcomes Scale and the Brief Symptom Inventory
timeFrame: 6 mos and 1 year post discharge home
Secondary outcomes:
measure: Caregiver community participation as measured by the PART-O
timeFrame: 6 mos and 1 year post discharge home
measure: Caregiver employment
timeFrame: 6 mos and 1 year post discharge home
measure: Caregiver resource utilization
timeFrame: 6 mos and 1 year post discharge home
measure: Perceived Quality of Life (person with TBI)
timeFrame: 6 mos post discharge home
measure: Brief Symptom Inventory (person with TBI)
timeFrame: 6 mos post discharge home
Other outcomes:
Locations:
city: Seattle
country: United States
facility: University of Washington
state: Washington
Study officials:
affiliation: University of Washington
name: Janet M. Powell, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Washington
name: Kathleen R. Bell, MD
role: STUDY_DIRECTOR
References:
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.
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.