Supporting Traumatic Brain Injury (TBI) Caregivers

Traumatic Brain Injuries Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00006447
• Other study ID #: NICHD-0106
• Secondary ID: 5R01HD036075-02
• Status: Completed
• Phase: Phase 2
• First received: November 4, 2000
• Last updated: September 23, 2016
• Start date: September 1997

Study information

• Verified date: May 2011
• Source: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. primary completion date: August 2002
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Male/female pairs (both at least 18 years of age), where male is recovering from traumatic brain injury (Ranchos Los Amigos Scale class of 1-8) and female spouse/partner is the caregiver

Exclusion Criteria:

• Caregiver (female) not able to read and write English well enough to answer review's questions

• Patients cared for by children, siblings or parents (as opposed to spouse/partner)

• Patients discharged to locations other than home

• Female patients with male caregivers

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Brain Injuries
• Traumatic Brain Injuries
• Wounds and Injuries

Intervention

Procedure:
• Social Support

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

External Links

•   Click here for more information about the National Institute of Child Health and Human Development research.