QUADERN: Efficacy of the Use of Diaries in Intensive Care Units

Sponsor

University of Barcelona (Other)

Overall Status

Recruiting

CT.gov ID

NCT05288140

Collaborator

(none)

240

Enrollment

Location

Arms

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Diary (Blank Journal) Intensive Care Unit Patient Family PICS Stress Anxiety Depression Quality of Life	Other: use of diary	N/A

Detailed Description

Randomized, parallel, open, non-blinded, multicenter clinical trial, with an experimental group (diary) and a control group (usual practice), to compare the effect produced on quality of life by post-traumatic stress and anxiety/depression of patients and relatives, whether or not they have access to a diary during the stay in the unit. Three validated scales will be used at three different times. 120 cases per group, carrying out a preliminary pilot test. Data analysis according to IBM SPSS v.24 to describe and compare both groups.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

240 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

A control group and an experimental groupA control group and an experimental group

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Prevention

Official Title:

Efficacy of the Use of Diaries in Intensive Care Units

Actual Study Start Date :

Jan 1, 2022

Anticipated Primary Completion Date :

Dec 31, 2023

Anticipated Study Completion Date :

Dec 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: usual ICU practice The patient's evolution is reported verbally to the family.
Experimental: ICU diary Made a diary	Other: use of diary a diary is made for the experimental group where the events and events during the period of sedation and intubation are explained

Arm

Intervention/Treatment

No Intervention: usual ICU practice

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

Experimental: ICU diary

Made a diary

Other: use of diary

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

Outcome Measures

Primary Outcome Measures

Hospital Anxiety and Depression Scale (HADS) [2 months]
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.
Hospital Anxiety and Depression Scale (HADS) [6 months]
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.
Hospital Anxiety and Depression Scale (HADS) [12 months]
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.
SF-36 Health Survey [2 months]
questionnaries to measure quality of life. 36 items. from 0 to 100, with 100 being the best health
SF-36 Health Survey [6 months]
questionnaries to measure quality of life. 36 items. from 0 to 100, with 100 being the best health
SF-36 Health Survey [12 months]
questionnaries to measure quality of life. 36 items. from 0 to 100, with 100 being the best health
Revised Impact of Event Scales (IES-R) [2 months]
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.
Revised Impact of Event Scales (IES-R) [6 months]
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.
Revised Impact of Event Scales (IES-R) [12 months]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 100 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Universidad de Barcelona	Barcelona		Spain	08185

Sponsors and Collaborators

University of Barcelona

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Pilar Muñoz Rey, principal investigator, University of Barcelona

ClinicalTrials.gov Identifier:

NCT05288140

Other Study ID Numbers:

PI-18-138

First Posted:

Mar 21, 2022

Last Update Posted:

Mar 21, 2022

Last Verified:

Mar 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Mar 21, 2022