ICU Diaries and Its Effects After the Unit Discharge

NCT04163497 | Unknown DMC

• 1 other identifier: 3.011.427
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

Brief Summary

The preparation of ICU Diary, conducted by the Hospital care team towards the patient, has been suggested as an effective and low-cost strategy to enhance the patient's experience in the intensive care unit, as well as to prevent anxiety, depression and Posttraumatic Stress Disorder (PTSD). New-found researches in Brazilian ICUs indicates the pervasiveness of these symptoms in patients who have been hospitalized in the unit, however, there are no randomized trials that evaluate the impact of Diaries in the Brazilian context. The aim is to explore the effects of providing an ICU Diary in the symptoms of anxiety, depression and PTSD within patients who were hospitalized in the unit. Refers to a randomized controlled trial that is being conducted in two ICUs in a general-purpose hospital in Porto Alegre, Brazil.

Conditions

Post Intensive Care Unit Syndrome; Intensive Care Unit Syndrome; PTSD; Anxiety Symptoms; Depressive Symptoms

Outcome Measures

Primary Outcomes (3)

• Posttraumatic Stress Disorder (PTSD)

  number of patients with PTSD assessed by Posttraumatic Stress Disorder Checklist (PCL-5) - PCL-5 A 20-item selfreport measure designed to assess the DSM-5 symptoms of PTSD. Responders are asked to rate how bothered they have been by each item in the past month on a 5-point Likert scale ranging from 0-4. A provisional PTSD diagnosis can be made by treating each item rated as 2 = "Moderately" or higher as a symptom endorsed, then following the DSM-5 diagnostic rule which requires at least: 1 Criterion B item (questions 1-5), 1 Criterion C item (questions 6-7), 2 Criterion D items (questions 8-14), 2 Criterion E items (questions 15-20). According the authors, a PCL-5 cut-point of 33 it's a reasonable value to use for provisional PTSD diagnosis.

  1 week after ICU discharge

• Posttraumatic Stress Disorder (PTSD)

  number of patients with PTSD assessed by Posttraumatic Stress Disorder Checklist (PCL-5) - PCL-5 A 20-item selfreport measure designed to assess the DSM-5 symptoms of PTSD. Responders are asked to rate how bothered they have been by each item in the past month on a 5-point Likert scale ranging from 0-4. A provisional PTSD diagnosis can be made by treating each item rated as 2 = "Moderately" or higher as a symptom endorsed, then following the DSM-5 diagnostic rule which requires at least: 1 Criterion B item (questions 1-5), 1 Criterion C item (questions 6-7), 2 Criterion D items (questions 8-14), 2 Criterion E items (questions 15-20). According the authors, a PCL-5 cut-point of 33 it's a reasonable value to use for provisional PTSD diagnosis.

  1 month after ICU discharge

• Posttraumatic Stress Disorder (PTSD)

  number of patients with PTSD assessed by Posttraumatic Stress Disorder Checklist (PCL-5) - PCL-5 A 20-item selfreport measure designed to assess the DSM-5 symptoms of PTSD. Responders are asked to rate how bothered they have been by each item in the past month on a 5-point Likert scale ranging from 0-4. A provisional PTSD diagnosis can be made by treating each item rated as 2 = "Moderately" or higher as a symptom endorsed, then following the DSM-5 diagnostic rule which requires at least: 1 Criterion B item (questions 1-5), 1 Criterion C item (questions 6-7), 2 Criterion D items (questions 8-14), 2 Criterion E items (questions 15-20). According the authors, a PCL-5 cut-point of 33 it's a reasonable value to use for provisional PTSD diagnosis.

  3 months after ICU discharge

Secondary Outcomes (2)

• Anxiety

  1 week, 1 month and 3 months after ICU discharge

• Depression

  1 week, 1 month and 3 months after ICU discharge

Study Arms (2)

Diary reading

EXPERIMENTAL

Device: ICU Diaries

No diary reading

NO INTERVENTION

Interventions

ICU Diaries DEVICE

To explore the effects of providing an ICU Diary in the symptoms of anxiety, depression and PTSD within patients who were hospitalized in the unit.

Diary reading

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Will be included in this study ICU patients, older than 18 years old who are on mechanical ventilation, whose family members accept the participation by signing the consent form.

You may not qualify if:

• remain in the ICU for less than 72 hours;
• require mechanical ventilation for less than 24 hours;
• have limiting neurological symptoms (such as previous dementia);
• have a diagnosis of PTSD prior to hospitalization;
• have severe cognitive impairment at ICU discharge;
• not participate in all stages of the study, or whose outcome is death.

Sponsors & Collaborators

• Hospital Ernesto Dornelles: lead

Study Sites (1)

Juliana Mara Stormovski de Andrade

Porto Alegre, Rio Grande do Sul, 90160091, Brazil

RECRUITING

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Anxiety Disorders; Depression

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Central Study Contacts

Juliana Andrade

CONTACT

+55 51 993094059; diariouti@gmail.com

Bárbara Rech

CONTACT

+55 51 984148510; barbara.rech@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The finaly analysis, by the statistician will be masking.
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 31, 2019
• First Posted: November 14, 2019
• Study Start: July 22, 2019
• Primary Completion: March 9, 2020
• Study Completion: September 9, 2020
• Last Updated: November 14, 2019

Record last verified: 2019-11

Locations

BR (1)