Viewing Study NCT00006447



Ignite Creation Date: 2024-05-05 @ 11:20 AM
Last Modification Date: 2024-10-26 @ 9:05 AM
Study NCT ID: NCT00006447
Status: COMPLETED
Last Update Posted: 2016-09-26
First Post: 2000-11-04

Brief Title: Supporting Traumatic Brain Injury TBI Caregivers
Sponsor: Eunice Kennedy Shriver National Institute of Child Health and Human Development NICHD
Organization: Eunice Kennedy Shriver National Institute of Child Health and Human Development NICHD

Study Overview

Official Title: None
Status: COMPLETED
Status Verified Date: 2011-05
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief 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 caregivers 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
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 patientcaregiver 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

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None
Secondary IDs
Secondary ID Type Domain Link
5R01HD036075-02 NIH None httpsreporternihgovquickSearch5R01HD036075-02