Clinical trial NCT03812458: GASA-CIR Trail (Guidance and the Symptoms of Acute Stress and Anxiety in Critically Ill Patients Relatives in Intensive Care Unit)
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Acute Stress Disorder
Anxiety
Depression
Keywords: resilience
anxiety
acute stress
relatives
critical ill patients
Lead sponsor: Federal University of Rio Grande do Sul
Sponsor class: OTHER
Collaborators: name: Hospital Moinhos de Vento
name: Ministry of Health, Brazil
First posted: 2019-01-23
Enrollment: 190
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel multicentric randomized clinical trial
Primary purpose: PREVENTION

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.

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.

Eligibility 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.

Primary outcomes:
measure: Acute stress in critically ill relatives.
timeFrame: After 7 days from enrollment in ICU.
Secondary outcomes:
measure: Satisfaction of the relatives of patients admitted to the ICU: FS-ICU scale
timeFrame: After 7 days from enrollment in ICU.
measure: Symptoms of post-traumatic stress.
timeFrame: 3 months from enrollment in ICU.
measure: Symptoms of anxiety and depression
timeFrame: 3 months from enrollment in ICU.
measure: Symptoms of anxiety and depression
timeFrame: After 7 days from enrollment in ICU.
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: Hospital Moinhos de Vento
state: Rio Grande Do Sul
Study officials:
References: