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| Sponsored by: |
National Institute of Child Health and Human Development (NICHD) |
| Information provided by: | National Institute of Child Health and Human Development (NICHD) |
| ClinicalTrials.gov Identifier: | NCT00006447 |
Purpose
This randomized trial tested a 6 month intervention of computer network vs a control group (standard care) to improve quality of life and health status for traumatic brain injury (TBI) patients and their caregivers. The network, termed the Trauma Recovery Support System (TRSS), consisted of a central computer system connected via modem to a personal computer in the caregiver's home. Users could access via the Internet special modules and communication services to help them cope with their new roles as caregivers and with accompanying social isolation. These modules were an on-line discussion group, an "ask an expert questions" function, a database of previously asked questions with answers, a database of community resources, and a reference library.
| Condition | Intervention | Phase |
|
Traumatic Brain Injuries |
Procedure: Social Support |
Phase II |
| MedlinePlus related topics: | Caregivers Head and Brain Injuries Injuries Wounds |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Active Control, Single Group Assignment, Efficacy Study |
| Estimated Enrollment: | 64 |
| Study Start Date: | September 1997 |
| Estimated Study Completion Date: | August 2000 |
Traumatic brain injury (TBI) has long-term and often devastating impacts on a family. The spouse or partner caring for an individual with TBI experiences significant emotional distress, and psychological and physical morbidity. Clinical experience indicates that patients with strong family support progress further than those without family involvement. There is strong evidence that support provided to caregivers improves their well being, as well as that of the care recipient. The trial was designed to lessen her morbidity, improve her support for the TBI partner, and improve recovery of the TBI person.
The effectiveness of a newly developed Trauma Recovery Support System (TRSS) was evaluated using a randomized controlled experimental design. Sixty-four patient/caregiver pairs were recruited, and those (randomly) assigned to the experimental group received access to the centralized TRSS via a personal computer in their homes including access via Internet to special modules and communication services to help them cope with their new roles as caregivers and with accompanying social isolation. Modules consist of an on-line discussion group, an "ask an expert questions" function, a database of previously asked questions with answers, a database of community resources, and a reference library. Controls received standard care. All participants (experimental and control) were interviewed at 0, 3, and 6 months from time of patient discharge, initially in person and later by phone to evaluate the status of the caregiver (quality of life and health status) and TBI patient recovery. Sociodemographic and other background data was collected.
Eligibility
| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations More Information
Click here for more information about the National Institute of Child Health and Human Development research.
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| Study ID Numbers: | NICHD-0106, 5R01 HD36075-02 |
| First Received: | November 4, 2000 |
| Last Updated: | February 21, 2007 |
| ClinicalTrials.gov Identifier: | NCT00006447 |
| Health Authority: | United States: Federal Government |
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