Acute Stress DisorderGASA-CIRNCT03812458
GASA-CIR Trail (Guidance and the Symptoms of Acute Stress and Anxiety in Critically Ill Patients Relatives in Intensive Care Unit)
A study testing website and brochure in people with Acute Stress Disorder and Anxiety, run by Federal University of Rio Grande do Sul at 1 site in Brazil.
Trial summary
A randomized clinical trial 1:1 among relatives of patients admitted to an intensive care unit, the intervention group will be composed by family members who receive a printed brochure and will be encouraged to visit a website detailed information and plain language about the ICU environment and the critically ill… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Acute Stress Disorder, Anxiety, Depression
- What is being tested?
- website and brochure
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 190 participants
- Where
- 1 siteBrazil
- Study dates
- 10 Dec 2019to 10 Dec 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- For patient, with more than 18 years old, who ICU admission exceeding 48 hours;
- For Patient's Family Members: familiar close to a patient hospitalized in the ICU (spouse, father, mother, son, daughter, grandmother, brother, sister, uncle, aunt, cousin);
Who cannot join
- For Patient's Family Members: communication difficulty (illiteracy, not speaking Portuguese, deafness or mutism). Some other family member of the patient has already been included in the study. Refusal to sign the term of free and clarified consent.
Trial locations and contacts
1 site in 1 country.
Hospital Moinhos de Vento - ICU contact
Brazil1 site, 1 recruiting
- Recruiting
Hospital Moinhos de Vento
Porto Alegre, Rio Grande do Sul, 90035902
Vitoria Machado, vitoriahomemmachado@gmail.com
About this study
Official title: Impact of the Guidance, Through Website and Brochure, in the Symptoms of Acute Stress and Anxiety in Relatives of Critically Ill Paciente in Intensive Care Unit: Randomized Clinical Trial
A randomized clinical trial 1:1 among relatives of patients admitted to an intensive care unit, the intervention group will be composed by family members who receive a printed brochure and will be encouraged to visit a website detailed information and plain language about the ICU environment and the critically ill patient characteristics. The primary outcome will be the impact of orientations on symptoms of post-traumatic stress, assessed by the IES-R scale. Secondary outcome measures will include symptoms of anxiety and depression at the end of 7 days and after 3 months of follow-up by the HADS scales, the degree of satisfaction of the relatives, through the FS-ICU scale, as well as the association of resilience, through the CD-RISC scale, with the symptoms of anxiety and depression.
Read the detailed description
The hospitalization of one family member may be responsible for the generation of anxiety and depression, especially if the patient environment for the intensive care unit (ICU). The orientation of family members, through website and brochure, seems to have effect of reducing these symptoms, however, there is a shortage of studies capable of such conduct. The focus of this study will be to evaluate the impact of family guidance in reducing symptoms of depression, acute stress and anxiety displayed by them, in addition to verifying the association between resilience.
A randomized clinical trial 1:1 among relatives of patients admitted to an intensive care unit, the randomization will be in blocks of different sizes and stratified according to the educational level of the familiar. Intervention group will be composed by family members who receive a printed brochure and will be encouraged to visit a website detailed information and plain language about the ICU environment (treatments, care, alarms, multidisciplinary team) and the critically ill patient characteristics (organic dysfunction, prognosis, palliative care, organ dysfunction). The family, of the control group, will not receive the printed brochure and are not encouraged to visit the website. After hospitalization of the patient in the ICU, the research team will have up to 48 hrs to evaluate the eligibility criteria of the next of kin of this patient. Primary outcome will be the impact of orientations on symptoms of post-traumatic stress, assessed by the IES-R scale. Secondary outcome measures will include symptoms of anxiety and depression at the end of 7 days and after 3 months of follow-up by the HADS scale, the degree of satisfaction of the relatives, through the FS-ICU scale, as well as the association of resilience, through the CD-RISC scale, with the symptoms of anxiety and depression The study will occur with families of patients admitted to the ICUs of Hospital Moinhos de Vento and Hospital Ernesto Dornelles. We will collect characteristics related to demographic, social, educational features, levels of resilience, religiosity and prior history of mood disorder, anxiety disorder or post-traumatic stress disorder, length of ICU stay, SAPS III, and ICU and hospital outcomes.
- Conditions
- Acute Stress Disorder, Anxiety, Depression
- Being tested
- website and brochure
- Keywords
- resilience, anxiety, acute stress, relatives, critical ill patients
- Medical subject headings
- Stress Disorders, Traumatic, Acute, Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
website and brochureBehavioural
website and brochure
| Study group | Role | What they receive |
|---|---|---|
| Guidance | Experimental | The intervention group will consist of the relatives who will receive a printed brochure and are encouraged to visit a website with detailed information and with simple language regarding the ICU environment (treatments, care, alarms, multidisciplinary team) and the characteristics of critically ill patients (organ dysfunction, prognosis, palliative care, organ dysfunction). Receives: Behavioral: website and brochure |
| Control | No intervention | The families who will not receive the brochure and are not encouraged to visit the website. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute stress in critically ill relatives.
Using the Impact of Events Scale-Revised. The scale contains 22 questions. It evaluates the subjective distress caused by traumatic events. Items are rated on a 5-point scale, ranging from 0 (nothing) to 4 (extremely). The total score ranges from 0 to 88. A score greater than 33 identifies individuals with symptoms of acute stress disorder.
Measured: After 7 days from enrollment in ICU.
Secondary outcomes (4)
Satisfaction of the relatives of patients admitted to the ICU: FS-ICU scale
Using the FS-ICU scale. The Family Satisfaction in the Intensive Care Unit (FS-ICU) questionnaire measures family satisfaction with care in the intensive care unit. The score ranges 0-100, with higher scores indicating greater satisfaction.
Measured: After 7 days from enrollment in ICU.
Symptoms of post-traumatic stress.
Assessed by the Impact of Events Scale-Revised (IES-R). The scale contains 22 questions. It evaluates the subjective distress caused by traumatic events. Items are rated on a 5-point scale, ranging from 0 (nothing) to 4 (extremely). The total score ranges from 0 to 88. A score greater than 33 identifies individuals with symptoms of acute stress disorder.
Measured: 3 months from enrollment in ICU.
Symptoms of anxiety and depression
Using the HADS scale. The questionnaire is composed of 14 questions. The total score ranges from 0 to 42. Score greater than 8 in subgroup, or a total score greater than 16, identify patients with anxiety and depression symptoms.
Measured: 3 months from enrollment in ICU.
Symptoms of anxiety and depression
Using the HADS scale. The questionnaire is composed of 14 questions. The total score ranges from 0 to 42. Score greater than 8 in subgroup, or a total score greater than 16, identify patients with anxiety and depression symptoms.
Measured: After 7 days from enrollment in ICU.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2019
- Study start10 Dec 2019
- Primary completion2 Mar 2020 (estimated)
- Study completion10 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Stress DisorderStudies 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
- Parallel groups
- Model description
- Parallel multicentric randomized clinical trial
- Masking
- None (open label)
- Enrolment
- 190 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federal University of Rio Grande do Sul
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Moinhos de Vento, Ministry of Health, Brazil
- Responsible party
- Principal investigator, Vitória Homem Machado, Federal University of Rio Grande do Sul
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03812458
- Sponsor's protocol ID
- acute stress,anxiety
- Acronym
- GASA-CIR
- Status last verified
- Jan 2020
- First submitted
- 5 Nov 2018
- Last updated
- 13 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of the Guidance, Through Website and Brochure, in the Symptoms of Acute Stress and Anxiety in Relatives of Critically Ill Paciente in Intensive Care Unit: Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03812458
- Acronym / sponsor ID
- GASA-CIR / acute stress,anxiety
- Conditions
- Acute Stress Disorder, Anxiety, Depression
- Keywords
- resilience, anxiety, acute stress, relatives, critical ill patients
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 190 participants (estimated)
- Lead sponsor
- Federal University of Rio Grande do SulUniversity, hospital or other
- Collaborators
- Hospital Moinhos de Vento, Ministry of Health, Brazil
- Study start
- 10 Dec 2019 (actual)
- Primary completion
- 2 Mar 2020 (estimated)
- Study completion
- 10 Dec 2020 (estimated)
- First posted
- 23 Jan 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.
A randomized clinical trial 1:1 among relatives of patients admitted to an intensive care unit, the intervention group will be composed by family members who receive a printed brochure and will be encouraged to visit a website detailed information and plain language about the ICU environment and the critically ill patient characteristics. The primary outcome will be the impact of orientations on symptoms of post-traumatic stress, assessed by the IES-R scale. Secondary outcome measures will include symptoms of anxiety and depression at the end of 7 days and after 3 months of follow-up by the HADS scales, the degree of satisfaction of the relatives, through the FS-ICU scale, as well as the association of resilience, through the CD-RISC scale, with the symptoms of anxiety and depression.
Detailed description
The hospitalization of one family member may be responsible for the generation of anxiety and depression, especially if the patient environment for the intensive care unit (ICU). The orientation of family members, through website and brochure, seems to have effect of reducing these symptoms, however, there is a shortage of studies capable of such conduct. The focus of this study will be to evaluate the impact of family guidance in reducing symptoms of depression, acute stress and anxiety displayed by them, in addition to verifying the association between resilience.
A randomized clinical trial 1:1 among relatives of patients admitted to an intensive care unit, the randomization will be in blocks of different sizes and stratified according to the educational level of the familiar. Intervention group will be composed by family members who receive a printed brochure and will be encouraged to visit a website detailed information and plain language about the ICU environment (treatments, care, alarms, multidisciplinary team) and the critically ill patient characteristics (organic dysfunction, prognosis, palliative care, organ dysfunction). The family, of the control group, will not receive the printed brochure and are not encouraged to visit the website. After hospitalization of the patient in the ICU, the research team will have up to 48 hrs to evaluate the eligibility criteria of the next of kin of this patient. Primary outcome will be the impact of orientations on symptoms of post-traumatic stress, assessed by the IES-R scale. Secondary outcome measures will include symptoms of anxiety and depression at the end of 7 days and after 3 months of follow-up by the HADS scale, the degree of satisfaction of the relatives, through the FS-ICU scale, as well as the association of resilience, through the CD-RISC scale, with the symptoms of anxiety and depression The study will occur with families of patients admitted to the ICUs of Hospital Moinhos de Vento and Hospital Ernesto Dornelles. We will collect characteristics related to demographic, social, educational features, levels of resilience, religiosity and prior history of mood disorder, anxiety disorder or post-traumatic stress disorder, length of ICU stay, SAPS III, and ICU and hospital outcomes.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Parallel multicentric randomized clinical trial
| Arm | Type | Receives |
|---|---|---|
| Guidance | Experimental | Behavioral: website and brochureThe intervention group will consist of the relatives who will receive a printed brochure and are encouraged to visit a website with detailed information and with simple language regarding the ICU environment (treatments, care, alarms, multidisciplinary team) and the characteristics of critically ill patients (organ dysfunction, prognosis, palliative care, organ dysfunction). |
| Control | No intervention | –The families who will not receive the brochure and are not encouraged to visit the website. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- For patient, with more than 18 years old, who ICU admission exceeding 48 hours;
- For Patient's Family Members: familiar close to a patient hospitalized in the ICU (spouse, father, mother, son, daughter, grandmother, brother, sister, uncle, aunt, cousin);
Key exclusion criteria (1 listed)
- For Patient's Family Members: communication difficulty (illiteracy, not speaking Portuguese, deafness or mutism). Some other family member of the patient has already been included in the study. Refusal to sign the term of free and clarified consent.
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 |
|---|---|---|
| website and brochurewebsite and brochure | Behavioural | Guidance |
Primary outcome
Acute stress in critically ill relatives.
Time frame: After 7 days from enrollment in ICU.
Using the Impact of Events Scale-Revised. The scale contains 22 questions. It evaluates the subjective distress caused by traumatic events. Items are rated on a 5-point scale, ranging from 0 (nothing) to 4 (extremely). The total score ranges from 0 to 88. A score greater than 33 identifies individuals with symptoms of acute stress disorder.
4 secondary outcomes
Satisfaction of the relatives of patients admitted to the ICU: FS-ICU scale
Time frame: After 7 days from enrollment in ICU.
Symptoms of post-traumatic stress.
Time frame: 3 months from enrollment in ICU.
Symptoms of anxiety and depression
Time frame: 3 months from enrollment in ICU.
Symptoms of anxiety and depression
Time frame: After 7 days from enrollment in ICU.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2020.
- Individual participant dataSharing planned: No
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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.
Hospital Moinhos de Vento - ICU contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing website and brochure in people with Acute Stress Disorder and Anxiety, run by Federal University of Rio Grande do Sul 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 2 inclusion and 1 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 13 Jan 2020. 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 Vitória Homem Machado (55 51 991022093, vitoriahomemmachado@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acute stress in critically ill relatives. (time frame: After 7 days from enrollment in ICU.). 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 13 Jan 2020.