Post Intensive Care Unit SyndromeNCT04163497
ICU Diaries and Its Effects After the Unit Discharge
A study testing ICU Diaries in people with Post Intensive Care Unit Syndrome and Intensive Care Unit Syndrome, run by Hospital Ernesto Dornelles at 1 site in Brazil.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post Intensive Care Unit Syndrome, Intensive Care Unit Syndrome, PTSD
- What is being tested?
- ICU Diaries
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 1 siteBrazil
- Study dates
- 22 Jul 2019to 9 Sep 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Juliana Mara Stormovski de Andrade
Porto Alegre, Rio Grande do Sul, 90160091
Juliana Mara Andrade, 5551984148510, jstorma@hotmail.com
About this study
Official title: Patient Experience: ICU Diaries and Its Effects After the Unit Discharge
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.
Read the 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
- Being tested
- ICU Diaries
- Medical subject headings
- Stress Disorders, Post-Traumatic, Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ICU DiariesDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Diary reading | Experimental | Not described Receives: Device: ICU Diaries |
| No diary reading | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 3 months after ICU discharge
Secondary outcomes (2)
Anxiety
number of patients with anxiety symptoms assessed by Hospital Anxiety and Depression Scale (HADS) - A self-assesment scale composed of 14 items rated on a 4-point Likert scale ranging from 0 to 3, with 5 of the 14 items reversed scored. Items from each of the 7-item anxiety and depression subscales are summed to give total subscale scores ranging from 0 to 21, with higher scores indicating higher levels of anxiety and depression.The cutoff points suggested by the authors were adopted: no anxiety from 0 to 8, with anxiety ≥ 9; no depression from 0 to 8, with depression ≥ 9.
Measured: 1 week, 1 month and 3 months after ICU discharge
Depression
number of patients with depression symptoms assessed by Hospital Anxiety and Depression Scale (HADS) - A self-assesment scale composed of 14 items rated on a 4-point Likert scale ranging from 0 to 3, with 5 of the 14 items reversed scored. Items from each of the 7-item anxiety and depression subscales are summed to give total subscale scores ranging from 0 to 21, with higher scores indicating higher levels of anxiety and depression.The cutoff points suggested by the authors were adopted: no anxiety from 0 to 8, with anxiety ≥ 9; no depression from 0 to 8, with depression ≥ 9.
Measured: 1 week, 1 month and 3 months after ICU discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2019
- Study start22 Jul 2019
- Primary completion9 Mar 2020 (estimated)
- Study completion9 Sep 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Intensive Care Unit SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 102 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Ernesto Dornelles
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Juliana Mara Stormovski de Andrade, Hospital Ernesto Dornelles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04163497
- Sponsor's protocol ID
- 3.011.427
- Status last verified
- Nov 2019
- First submitted
- 31 Jul 2019
- Last updated
- 14 Nov 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Experience: ICU Diaries and Its Effects After the Unit Discharge
- ClinicalTrials.gov ID
- NCT04163497
- Acronym / sponsor ID
- 3.011.427
- Conditions
- Post Intensive Care Unit Syndrome, Intensive Care Unit Syndrome, PTSD, Anxiety Symptoms, Depressive Symptoms
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 102 participants (estimated)
- Lead sponsor
- Hospital Ernesto DornellesUniversity, hospital or other
- Study start
- 22 Jul 2019 (actual)
- Primary completion
- 9 Mar 2020 (estimated)
- Study completion
- 9 Sep 2020 (estimated)
- First posted
- 14 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Diary reading | Experimental | Device: ICU Diaries |
| No diary reading | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ICU DiariesTo explore the effects of providing an ICU Diary in the symptoms of anxiety, depression and PTSD within patients who were hospitalized in the unit. | Device | Diary reading |
Primary outcome
Posttraumatic Stress Disorder (PTSD)
Time frame: 1 week after ICU discharge
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.
Posttraumatic Stress Disorder (PTSD)
Time frame: 1 month after ICU discharge
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.
Posttraumatic Stress Disorder (PTSD)
Time frame: 3 months after ICU discharge
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.
2 secondary outcomes
Anxiety
Time frame: 1 week, 1 month and 3 months after ICU discharge
Depression
Time frame: 1 week, 1 month and 3 months after ICU discharge
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2019.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ICU Diaries in people with Post Intensive Care Unit Syndrome and Intensive Care Unit Syndrome, run by Hospital Ernesto Dornelles at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Juliana Andrade (+55 51 993094059, diariouti@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Posttraumatic Stress Disorder (PTSD) (time frame: 1 week after ICU discharge). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2019.