Supporting Traumatic Brain Injury (TBI) Caregivers

This study has been withdrawn prior to enrollment.
(Study terminated/withdrawn)
Sponsor:
Information provided by:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier:
NCT00006447
First received: November 4, 2000
Last updated: May 20, 2011
Last verified: May 2011
  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 2

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

Resource links provided by NLM:


Further study details as provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):

Estimated Enrollment: 64
Study Start Date: September 1997
Estimated Study Completion Date: August 2000
Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00006447

Sponsors and Collaborators
Investigators
Investigator: Armando James Rotondi University of Pittsburgh, Dept of Anesthesiology & CCM
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00006447     History of Changes
Other Study ID Numbers: NICHD-0106, 5R01 HD36075-02
Study First Received: November 4, 2000
Last Updated: May 20, 2011
Health Authority: United States: Federal Government

Keywords provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):
Brain Injuries
Trauma
Caregivers
Burden and Dependency
Rehabilitation
Support, social
Information System
Information Resources (PT)
Disability, persons with

Additional relevant MeSH terms:
Brain Injuries
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries

ClinicalTrials.gov processed this record on September 15, 2014