Telephone Intervention for Caregivers of Persons With Traumatic Brain Injury

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Brain Injuries

Intervention / Treatment
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* Behavioral: Problem-solving, education based telephone counseling
* Other: No Intervention


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1: Experimental<br>Problem-solving, education based telephone counseling. | Behavioral: Problem-solving, education based telephone counseling<br>* 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.<br>|
| Sham Comparator: 2: No intervention<br>Standard of care control group | Other: No Intervention<br>* The control group will receive standard of care, i.e., typical resources and/or supports offered to caregivers of persons with TBI.<br>* Other names: Standard of care;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Brain Injuries, Traumatic, Caregivers