Supporting Traumatic Brain Injury (TBI) Caregivers
2 other identifiers
interventional
64
0 countries
N/A
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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 1997
CompletedFirst Submitted
Initial submission to the registry
November 4, 2000
CompletedFirst Posted
Study publicly available on registry
November 6, 2000
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2002
CompletedSeptember 26, 2016
May 1, 2011
4.9 years
November 4, 2000
September 23, 2016
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
Armando James Rotondi
University of Pittsburgh, Dept of Anesthesiology & CCM
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- NIH
Study Record Dates
First Submitted
November 4, 2000
First Posted
November 6, 2000
Study Start
September 1, 1997
Primary Completion
August 1, 2002
Last Updated
September 26, 2016
Record last verified: 2011-05