Anxiety and Depression in Relatives of Critically Ill Patients: Spouses Versus Other Close Relatives

NCT01589575 | Completed

• 2 other identifiers: LOCAL/2012/CR-032012-A00501-42
• Study Type: observational
• Target: 208
• Locations: 1 country
• Sites: 1

Brief Summary

The main objective of this study is to compare the rate of reported anxiety / depression (HADS \>= 8) among spouses and other family members in ICU patients.

Conditions

Stress Disorders, Post-Traumatic; Anxiety; Depression

Keywords

Intensive Care Unit

Outcome Measures

Primary Outcomes (1)

• Presence/absence of a score >= 8 on the Hospital Anxiety and Depression Scale Questionnaire

  3 months after the patients is discharged from the ICU unit

Secondary Outcomes (7)

• * Presence/absence of a score >= 8 on the Hospital Anxiety and Depression Scale Questionnaire

  4-6 days after the admission of a patient to the ICU

• VAS score for satisfaction concerning the communication of information concerning the patient currently in the ICU

  During the ICU stay (days 1 to 28)

• Number of interviews

  During the ICU stay (days 1 to 28)

• Mean interview duration (minutes)

  During the ICU stay (days 1 to 28)

• Edmonton Symptom Assessment Scale Score

  4-6 days after the admission of a patient to the ICU

Study Arms (2)

Spouses

This group of relatives includes the spouses of ICU patients (over 16 years of age and intubated and under ventilation for at least 48 hours) meeting stated inclusion criteria.

Other relatives

This group of relatives includes the non-spouse relatives of ICU patients (over 16 years of age and intubated and under ventilation for at least 48 hours) meeting stated inclusion criteria.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population includes relatives of patients admitted to intensive care (over the age of 16 years and intubated and ventilated for at least 48 hours). The study population mainly inclused spouses, parents, children, and siblings of patients in intensive care.

You may qualify if:

• The relative must have given his/her informed and signed consent
• The relative must be insured or beneficiary of a health insurance plan
• The relative must be available for 3 months of follow-up

You may not qualify if:

• The relative is under judicial protection, under tutorship or curatorship
• The relative refuses to sign the consent
• It is impossible to correctly inform the relative

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nīmes: lead

Study Sites (1)

CHU de Nîmes - Hôpital Universitaire Carémeau

Nîmes, 30029, France

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Anxiety Disorders; Depression

Condition Hierarchy (Ancestors)

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

Study Officials

• Claire Roger, MD

  Centre Hospitalier Universitaire de Nîmes

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 30, 2012
• First Posted: May 2, 2012
• Study Start: September 1, 2012
• Primary Completion: January 1, 2015
• Study Completion: January 1, 2015
• Last Updated: March 31, 2015

Record last verified: 2015-03

Locations

FR (1)