Telephone Intervention for Caregivers of Persons With Traumatic Brain Injury
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| ClinicalTrials.gov Identifier: NCT00692575 |
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Recruitment Status :
Completed
First Posted : June 6, 2008
Last Update Posted : April 14, 2014
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Brain Injuries | Behavioral: Problem-solving, education based telephone counseling Other: No Intervention | Phase 2 |
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.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 153 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Single (Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | Modular Scheduled Telephone Intervention for Caregivers of Persons With Traumatic Brain Injury: A Randomized Controlled Trial |
| Study Start Date : | June 2008 |
| Actual Primary Completion Date : | September 2012 |
| Actual Study Completion Date : | April 2013 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: 1: Experimental
Problem-solving, education based telephone counseling.
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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. |
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Sham Comparator: 2: No intervention
Standard of care control group
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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 |
- Composite measure based on the Bakas Caregiving Outcomes Scale and the Brief Symptom Inventory [ Time Frame: 6 mos and 1 year post discharge home ]
- 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 ]
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| Ages Eligible for Study: | 16 Years and older (Child, Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00692575
| United States, Washington | |
| University of Washington | |
| Seattle, Washington, United States, 98195 | |
| Principal Investigator: | Janet M. Powell, PhD | University of Washington | |
| Study Director: | Kathleen R. Bell, MD | University of Washington |
| Responsible Party: | Janet Powell, Associate Professor, University of Washington |
| ClinicalTrials.gov Identifier: | NCT00692575 History of Changes |
| Other Study ID Numbers: |
33690-J NIDRR grant # H133A070032 ( Other Grant/Funding Number: NIDRR ) |
| First Posted: | June 6, 2008 Key Record Dates |
| Last Update Posted: | April 14, 2014 |
| Last Verified: | April 2014 |
Keywords provided by Janet Powell, University of Washington:
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Brain Injuries, Traumatic Caregivers |
Additional relevant MeSH terms:
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Wounds and Injuries Brain Injuries Brain Injuries, Traumatic Brain Diseases |
Central Nervous System Diseases Nervous System Diseases Craniocerebral Trauma Trauma, Nervous System |