NCT02305303

Brief Summary

Treatment of severe trauma patients includes intensive cares. Both trauma and intensive care may lead to a post-traumatic stress disorder‬ and then to a decreased quality of life. Diaries may improve the frequency and the intensity of PTSD. Aim of investigator is to assess if diaries may improve quality of life after a severe trauma.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
226

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2014

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

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

First Submitted

Initial submission to the registry

September 9, 2014

Completed
2 months until next milestone

Study Start

First participant enrolled

November 9, 2014

Completed
23 days until next milestone

First Posted

Study publicly available on registry

December 2, 2014

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 8, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 8, 2017

Completed
Last Updated

October 26, 2021

Status Verified

October 1, 2021

Enrollment Period

3 years

First QC Date

September 9, 2014

Last Update Submit

October 18, 2021

Conditions

Post-traumatic Stress Disorder

Keywords

Quality of lifepost-traumatic stress disordertrauma

Outcome Measures

Primary Outcomes (1)

  • Quality of life

    To assess the quality of life (QoL), investigator will use the WHO Quality of Life questionnaire Brief Version (WHOQOL- Bref) in its french-language version. exploring four dimensions (physical, psychological, social and environmental).

    12 months after the trauma

Secondary Outcomes (3)

  • post-traumatic stress disorder (PTSD)

    12 months after the trauma

  • predictive factors of decrease in QoL after severe trauma

    12 months after the trauma

  • patients' expectations

    12 months after the trauma

Study Arms (2)

Diary

EXPERIMENTAL

Use of diary

Procedure: Diary

Without Diary

NO INTERVENTION

Interventions

DiaryPROCEDURE

A diary written prospectively during the ICU stay by the staff and relatives

Diary

Eligibility Criteria

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

You may qualify if:

  • all patients over 18
  • with severe trauma (Injury Severity Score (ISS) \> 15)
  • admitted in our trauma centered and hospitalized in intensive care unit for more than 48 h

You may not qualify if:

  • non-French language fluent patients
  • Patients with dementia
  • Hospitalization in intensive care unit less than
  • opposition to data utilization

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Département d'Anesthésie-Réanimation Groupe Hospitalier Pitié Salpêtrière

Paris, 75013, France

Location

MeSH Terms

Conditions

Stress Disorders, Post-TraumaticWounds and Injuries

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Study Officials

  • Marie Benazzour, Nurse

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 9, 2014

First Posted

December 2, 2014

Study Start

November 9, 2014

Primary Completion

November 8, 2017

Study Completion

November 8, 2017

Last Updated

October 26, 2021

Record last verified: 2021-10

Locations

FR(1)