Universidad de Barcelona
Barcelona, 08185, Spain
Location status: Recruiting
Recruiting
NCT Number: NCT05288140
Efficacy of the Use of Diaries in Intensive Care Units
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.
Recruiting
Interested in participating?
Request InfoKey information
Conditions
Age range
18 year–100 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
About this study
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.
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
use of diary
Othera diary is made for the experimental group where the events and events during the period of sedation and intubation are explained
Primary outcomes
-
Hospital Anxiety and Depression Scale (HADS)
Time frame: 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)
Time frame: 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)
Time frame: 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
Time frame: 2 months
questionnaries to measure quality of life. 36 items. from 0 to 100, with 100 being the best health
-
SF-36 Health Survey
Time frame: 6 months
questionnaries to measure quality of life. 36 items. from 0 to 100, with 100 being the best health
-
SF-36 Health Survey
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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.
Study contacts
Contact information is provided by the study sponsor or research team.
Sponsors and collaborators
Lead sponsor
University of Barcelona
Other
Registry information
Acronym: QUADERN
Important dates
- Study start
- 2022
- Primary completion
- 2025
- Study completion
- 2026
- First posted
- Mar 21, 2022
- Registry last updated
- Mar 27, 2024
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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