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

NCT03812458 | Unknown

• 1 other identifier: acute stress,anxiety
• Study Type: interventional
• Target: 190
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Stress Disorder; Anxiety; Depression

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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.

  After 7 days from enrollment in ICU.

Secondary Outcomes (4)

• Satisfaction of the relatives of patients admitted to the ICU: FS-ICU scale

  After 7 days from enrollment in ICU.

• Symptoms of post-traumatic stress.

  3 months from enrollment in ICU.

• Symptoms of anxiety and depression

  3 months from enrollment in ICU.

• Symptoms of anxiety and depression

  After 7 days from enrollment in ICU.

Study Arms (2)

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).

Behavioral: website and brochure

Control

NO INTERVENTION

The families who will not receive the brochure and are not encouraged to visit the website.

Interventions

website and brochure BEHAVIORAL

website and brochure

Guidance

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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);

You may not qualify if:

• \- 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.

Sponsors & Collaborators

• Federal University of Rio Grande do Sul: lead
• Hospital Moinhos de Vento: collaborator
• Ministry of Health, Brazil: collaborator

Study Sites (1)

Hospital Moinhos de Vento

Porto Alegre, Rio Grande do Sul, 90035902, Brazil

RECRUITING

MeSH Terms

Conditions

Stress Disorders, Traumatic, Acute; Anxiety Disorders; Depression

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Central Study Contacts

Vitória Homem Machado

CONTACT

55 51 991022093; vitoriahomemmachado@gmail.com

Hospital Moinhos de Vento - ICU

CONTACT

55 51 33143434

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Parallel multicentric randomized clinical trial

Study Record Dates

• First Submitted: November 5, 2018
• First Posted: January 23, 2019
• Study Start: December 10, 2019
• Primary Completion: March 2, 2020
• Study Completion: December 10, 2020
• Last Updated: January 13, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)