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Impact of an ICU Diary on the Well-being of Patients and Families. A Prospective Multicenter Mixed Study (ICU-diary)

F

Fondation Hôpital Saint-Joseph

Status

Completed

Conditions

Stress Disorders Post Traumatic

Treatments

Other: ICU diary

Study type

Interventional

Funder types

Other

Identifiers

NCT02519725
ICU DIARY

Details and patient eligibility

About

The purpose of this study is to assess the influence of an ICU diary implemented during the ICU stay on the psychological well-being of patients and families after ICU discharge.

Full description

Implementation of an ICU diary in a randomized design in 36 ICUs in France The ICU diary contains entries from staff and families or relatives

Quantitative description of psychological well-being of the patients and families or relatives are evaluated 3 months after ICU discharge

Qualitative evaluation of how the patient uses the diary is scheduled by a phone interview 6 months after ICU discharge.

An amendment of the ethic committee permitted to increase in 2016/02 both the number of eligible patients to 700 and the number of centers.

Enrollment

715 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Patients with his family admitted in an ICU and mechanically ventilated more than 48 hours

Exclusion criteria

  • Patients without families admitted in an ICU and mechanically ventilated more than 48 hours
  • Patients or families not fluent in French
  • Patients moribund
  • Patients with a neurologic or psychiatric disease responsible for admission or pre-existing before the ICU admission
  • Patients admitted after a cardiac arrest
  • Deaf and mute patients

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

715 participants in 2 patient groups

With diary
Active Comparator group
Description:
a ICU diary is open by staff for the patient and his relatives during the ICU stay
Treatment:
Other: ICU diary
Without diary
No Intervention group
Description:
No diary is open during the ICU stay

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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