GASA-CIR Trail (Guidance and the Symptoms of Acute Stress and Anxiety in Critically Ill Patients Relatives in Intensive Care Unit) (GASA-CIR)

• ClinicalTrials.gov Identifier: NCT03812458
• Recruitment Status: Unknown
• First Posted: January 23, 2019
• Last Update Posted: January 13, 2020
• Sponsor: Federal University of Rio Grande do Sul
• Collaborators: Hospital Moinhos de Vento; Ministry of Health, Brazil
• Information provided by (Responsible Party): Vitória Homem Machado, Federal University of Rio Grande do Sul

Study Description

Brief 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 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.

Condition or disease	Intervention/treatment	Phase
Acute Stress Disorder; Anxiety; Depression	Behavioral: website and brochure	Not Applicable

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

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 190 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Parallel multicentric randomized clinical trial
• Masking: None (Open Label)
• Primary Purpose: Prevention
• 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
• Actual Study Start Date: December 10, 2019
• Estimated Primary Completion Date: March 2, 2020
• Estimated Study Completion Date: December 10, 2020

Arms and Interventions

Arm	Intervention/treatment
Experimental: Guidance; 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).	Behavioral: website and brochure; website and brochure
No Intervention: Control; The families who will not receive the brochure and are not encouraged to visit the website.

Outcome Measures

Primary Outcome Measures :

1. 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.

Secondary Outcome Measures :

1. Satisfaction of the relatives of patients admitted to the ICU: FS-ICU scale [ Time Frame: After 7 days from enrollment in ICU. ]
   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.
2. Symptoms of post-traumatic stress. [ Time Frame: 3 months from enrollment in ICU. ]
   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.
3. Symptoms of anxiety and depression [ Time Frame: 3 months from enrollment in ICU. ]
   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.
4. Symptoms of anxiety and depression [ Time Frame: After 7 days from enrollment in ICU. ]
   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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

Inclusion Criteria:

• 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);

Exclusion Criteria:

- 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.

Contacts and Locations

Contacts

Contact: Vitória Homem Machado; 55 51 991022093; vitoriahomemmachado@gmail.com

Contact: Hospital Moinhos de Vento - ICU; 55 51 33143434

Locations

Brazil

Hospital Moinhos de Vento; Recruiting

Porto Alegre, Rio Grande Do Sul, Brazil, 90035902

Contact: Vitoria Machado vitoriahomemmachado@gmail.com

Sponsors and Collaborators

Federal University of Rio Grande do Sul

Hospital Moinhos de Vento

Ministry of Health, Brazil

More Information

• Responsible Party: Vitória Homem Machado, Principal Investigator, Federal University of Rio Grande do Sul
• ClinicalTrials.gov Identifier: NCT03812458
• Other Study ID Numbers: acute stress,anxiety
• First Posted: January 23, 2019
• Last Update Posted: January 13, 2020
• Last Verified: January 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Vitória Homem Machado, Federal University of Rio Grande do Sul:

resilience; anxiety; acute stress; relatives; critical ill patients

Additional relevant MeSH terms:

Anxiety Disorders; Stress Disorders, Traumatic, Acute; Mental Disorders; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders