NCT00006447

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

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at P50-P75 for phase_2

Status
completed

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

Completed
3.2 years until next milestone

First Submitted

Initial submission to the registry

November 4, 2000

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 6, 2000

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2002

Completed
Last Updated

September 26, 2016

Status Verified

May 1, 2011

Enrollment Period

4.9 years

First QC Date

November 4, 2000

Last Update Submit

September 23, 2016

Conditions

Keywords

Brain InjuriesTraumaCaregiversBurden and DependencyRehabilitationSupport, socialInformation SystemInformation Resources (PT)Disability, persons with

Interventions

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

Brain Injuries, TraumaticBrain InjuriesWounds and Injuries

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous System

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