NCT05288140

Brief Summary

Randomized clinical trial that aims to evaluate the impact of the use of a diary in patients and relatives of patients admitted to an ICU in relation to usual practice in terms of health-related quality of life, the post-traumatic stress and anxiety/depression at 2, 6 and 12 months after ICU discharge.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
240

participants targeted

Target at P75+ for not_applicable

Timeline
8mo left

Started Jan 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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 Progress87%
Jan 2022Dec 2026

Study Start

First participant enrolled

January 1, 2022

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 1, 2022

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 21, 2022

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Expected
Last Updated

March 27, 2024

Status Verified

March 1, 2024

Enrollment Period

4 years

First QC Date

February 1, 2022

Last Update Submit

March 26, 2024

Conditions

Diary (Blank Journal)Intensive Care UnitPatientFamilyPICSStressAnxietyDepressionQuality of Life

Outcome Measures

Primary Outcomes (9)

  • Hospital Anxiety and Depression Scale (HADS)

    questionnaries, range of 0-21 for either anxiety and depression subscores. Higher scores corresponding to worse outcomes. 0-7 normal; 8-10 borderline abnormal; 11-21 sever symptoms of anxiety or depressin.

    2 months

  • Hospital Anxiety and Depression Scale (HADS)

    questionnaries, range of 0-21 for either anxiety and depression subscores. Higher scores corresponding to worse outcomes. 0-7 normal; 8-10 borderline abnormal; 11-21 sever symptoms of anxiety or depressin.

    6 months

  • Hospital Anxiety and Depression Scale (HADS)

    questionnaries, range of 0-21 for either anxiety and depression subscores. Higher scores corresponding to worse outcomes. 0-7 normal; 8-10 borderline abnormal; 11-21 sever symptoms of anxiety or depressin.

    12 months

  • SF-36 Health Survey

    questionnaries to measure quality of life. 36 items. from 0 to 100, with 100 being the best health

    2 months

  • SF-36 Health Survey

    questionnaries to measure quality of life. 36 items. from 0 to 100, with 100 being the best health

    6 months

  • SF-36 Health Survey

    questionnaries to measure quality of life. 36 items. from 0 to 100, with 100 being the best health

    12 months

  • Revised Impact of Event Scales (IES-R)

    questionnaries; measuring areas of hyperarousal, avoidance, and intrusion as subscales. Total score ranges from 0-88, higher score associated with worse PTSD symptoms. 1-22 mild PTSD,;22 signal clinically significant PTSD symptoms.

    2 months

  • Revised Impact of Event Scales (IES-R)

    questionnaries; measuring areas of hyperarousal, avoidance, and intrusion as subscales. Total score ranges from 0-88, higher score associated with worse PTSD symptoms. 1-22 mild PTSD,;22 signal clinically significant PTSD symptoms.

    6 months

  • Revised Impact of Event Scales (IES-R)

    questionnaries; measuring areas of hyperarousal, avoidance, and intrusion as subscales. Total score ranges from 0-88, higher score associated with worse PTSD symptoms. 1-22 mild PTSD,;22 signal clinically significant PTSD symptoms.

    12 months

Study Arms (2)

usual ICU practice

NO INTERVENTION

The patient's evolution is reported verbally to the family.

ICU diary

EXPERIMENTAL

Made a diary

Other: use of diary

Interventions

use of diaryOTHER

a diary is made for the experimental group where the events and events during the period of sedation and intubation are explained

ICU diary

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • admitted intensive care unit
  • sedated and mechanically ventilated for 24hours
  • signed consent
  • not language barrier
  • willingness to attend follow-up visits

You may not qualify if:

  • verbal manifestation of psychiatric, mental or cognitive antecedents
  • who do not coluntarily agree to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidad de Barcelona

Barcelona, 08185, Spain

RECRUITING

Related Publications (1)

  • Munoz-Rey P, Romero-Garcia M, Angles-Sabate I, Ausio-Dot A, Alonso-Fernandez S, Alcala-Jimenez I, Huertas-Zurriaga A, Tur-Rubio C, Delgado-Hito P. Efficacy of the intensive care unit diary: a mixed-method study protocol. BMC Nurs. 2026 Jan 19. doi: 10.1186/s12912-026-04300-z. Online ahead of print.

    PMID: 41555387DERIVED

MeSH Terms

Conditions

Anxiety DisordersDepression

Condition Hierarchy (Ancestors)

Mental DisordersBehavioral SymptomsBehavior

Central Study Contacts

Pilar Muñoz Rey

CONTACT

639534904mpmunozr.germanstrias@gencat.cat

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: A control group and an experimental group
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

February 1, 2022

First Posted

March 21, 2022

Study Start

January 1, 2022

Primary Completion

December 31, 2025

Study Completion (Estimated)

December 31, 2026

Last Updated

March 27, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)