Efficacy of the Use of Diaries in Intensive Care Units

Depression Clinical Trial

— QUADERN  

Official title:

Efficacy of the Use of Diaries in Intensive Care Units

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05288140
• Other study ID #: PI-18-138
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2022
• Est. completion date: December 31, 2026

Study information

• Verified date: March 2024
• Source: University of Barcelona
• Contact: Pilar Muñoz Rey
• Phone: 639534904
• Email: mpmunozr.germanstrias[@]gencat.cat
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 240
• Est. completion date: December 31, 2026
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Anxiety
• Depression
• Family
• Intensive Care Unit
• Patient
• PICS
• Quality of Life
• Stress

Intervention

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

Locations

Country	Name	City	State
Spain	Universidad de Barcelona	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
University of Barcelona

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	SF-36 Health Survey	questionnaries to measure quality of life. 36 items. from 0 to 100, with 100 being the best health	2 months
Primary	SF-36 Health Survey	questionnaries to measure quality of life. 36 items. from 0 to 100, with 100 being the best health	6 months
Primary	SF-36 Health Survey	questionnaries to measure quality of life. 36 items. from 0 to 100, with 100 being the best health	12 months
Primary	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
Primary	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
Primary	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