Efficacy of the Use of Diaries in Intensive Care Units (QUADERN)

University of Barcelona

Status: Enrolling

Conditions: PICS; Quality of Life; Family; Patient; Intensive Care Unit; Depression; Anxiety; Diary (Blank Journal); Stress

Treatments: Other: use of diary

Study type: Interventional

Funder types: Other

Identifiers

NCT05288140

PI-18-138

Details and patient eligibility

About

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.

Full 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.

Enrollment: 240 estimated patients

Sex: All

Ages: 18 to 100 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

240 participants in 2 patient groups

usual ICU practice

No Intervention group

Description:

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

ICU diary

Experimental group

Description:

Made a diary

Treatment:

Other: use of diary