NCT05993312

Brief Summary

The aim of this study is to describe the quality of life of CT patients in our study, at least 6 months after the occurrence of the trauma. This assessment is related to the patient's degree of sequelae, using the GOSE scale.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2023

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2023

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 7, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 15, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2023

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2024

Completed
Last Updated

August 15, 2023

Status Verified

August 1, 2023

Enrollment Period

6 months

First QC Date

August 7, 2023

Last Update Submit

August 7, 2023

Conditions

All Adult Patients Admitted to theHMPIT ICU for Management of Head Trauma

Outcome Measures

Primary Outcomes (1)

  • quality of life in patients with BI / The short form12 SF12 questionnaire

    To describe the relationship between distant sequelae of trauma assessed by the GOSE scale and quality of life in patients with BI.

    6 month

Study Arms (1)

A bras actif

Other: quality of life

Interventions

quality of lifeOTHER

To describe the relationship between distant sequelae of trauma assessed by the GOSE scale and quality of life

A bras actif

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Collection of patients: medical data from the ICU medical record. Data collection of quality of life : outpatient clinic: the interview will be conducted by telephone. If number phone patient cannot be reached, the questionnaire will be sent by post to the patient's address

You may qualify if:

  • All adult patients (age 18 or over) admitted to the HMPIT intensive care unit for management of head trauma (isolated or as part of a polytrauma).

You may not qualify if:

  • Patients lost to follow-up after discharge. Incomplete ICU medical records. Patients or their families who refused to participate in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Military Hospital of Tunis

Tunis, Montfleury, 1008, Tunisia

RECRUITING

Service de réanimation

Tunis, Montfleury, 1008, Tunisia

RECRUITING

MeSH Terms

Interventions

Quality of Life

Intervention Hierarchy (Ancestors)

Health StatusDemographyEpidemiologic MeasurementsPublic HealthEnvironment and Public Health

Study Officials

  • Aicha N REBAI

    hopital militaire de TUNIS

    STUDY CHAIR

Central Study Contacts

Aicha REBAI, FR

CONTACT

21671391133aicha.rebai@fmt.utm.tn

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Target Duration
6 Months
Sponsor Type
NETWORK
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
DR Aicha REBAI

Study Record Dates

First Submitted

August 7, 2023

First Posted

August 15, 2023

Study Start

June 1, 2023

Primary Completion

November 30, 2023

Study Completion

December 30, 2024

Last Updated

August 15, 2023

Record last verified: 2023-08

Locations

TU(2)