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Completed

NCT Number: NCT00692575

Telephone Intervention for Caregivers of Persons With Traumatic Brain Injury

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).

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Key information

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of Washington

Seattle, Washington, 98195, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Problem-solving, education based telephone counseling

Behavioral

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.

No intervention

Other

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

Primary outcomes

  1. 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 outcomes

  1. Caregiver community participation as measured by the PART-O

    Time frame: 6 mos and 1 year post discharge home

  2. Caregiver employment

    Time frame: 6 mos and 1 year post discharge home

  3. Caregiver resource utilization

    Time frame: 6 mos and 1 year post discharge home

  4. Perceived Quality of Life (person with TBI)

    Time frame: 6 mos post discharge home

  5. Brief Symptom Inventory (person with TBI)

    Time frame: 6 mos post discharge home

Sponsors and collaborators

Lead sponsor

University of Washington

Other

Collaborators

  • U.S. Department of Education

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2012
Study completion
2013
First posted
Jun 6, 2008
Registry last updated
Apr 14, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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