ICU Diaries and Its Effects After the Unit Discharge

NCT ID: NCT04163497

Last Updated: 2019-11-14

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 102 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-07-22
• Study Completion Date: 2020-09-09

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.

Detailed Description

The Diaries will be filled voluntarily by the professionals who provide the patient care - psychologists, nutritionists, nursing technicians, nurses, physicians and physiotherapists. In addition, the patient's family members who wish to participate and collaborate with the Diaries may ask anyone on the team to assist them. The Diaries will be available at the bedside and may be filled with objective and subjective data on the patient's clinical condition and daily evolution, as well as remarkable events. Examples of entries possibilities are messages, pictures, drawings, photographs, thoughts, sayings, and wishes. Photographic records aim to provide the patient memories of the environment and of his advances in treatment. They will be attached to the Diary only if the patient wishes.

The predicted sample is composed of 102 intensive care patients, aged above 18 years old, that require mechanical ventilation and remained in the ICU more than 72 hours.

All patients who meet the inclusion criteria will have their Diary drawn up by the team and will be randomized one week after discharge from the ICU. All patients will have their memory assessed at 1 week deadline after critical care discharge, and at this moment, the intervention patients will receive their ICU Diary along with psychological support. One month after the ICU discharge, all the patients will be evaluated by phone and checked in symptoms of depression, anxiety and Posttraumatic Stress Disorder (PSTD).

The final assessment of the development of the symptoms will be at the deadline of 3 months.The patients in the control group will be invited to withdraw their Diary after the end of the survey. In case of readmission in the ICU, in a period less than 72h of discharge, the Diary used will be reactivated. In cases of death, the researchers will offer the responsible parent the opportunity to receive the Diary. During this period, the Diaries will be stored by the researchers confidentially, in a previously defined location.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Diary reading

Group Type: EXPERIMENTAL

ICU Diaries

Intervention Type: 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.

No diary reading

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

ICU Diaries

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospital Ernesto Dornelles

OTHER

Sponsor Role: lead

Responsible Party

Juliana Mara Stormovski de Andrade

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Juliana Mara Stormovski de Andrade

Porto Alegre, Rio Grande do Sul, Brazil

Site Status: RECRUITING

Countries

Brazil

Central Contacts

Juliana Andrade

Role: CONTACT

diariouti@gmail.com

+55 51 993094059

Bárbara Rech

Role: CONTACT

barbara.rech@gmail.com

+55 51 984148510

Facility Contacts

Juliana Mara Andrade

Role: primary

jstorma@hotmail.com

5551984148510

Other Identifiers

3.011.427

Identifier Type: -

Identifier Source: org_study_id