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Impact of Information Strategy Based on Booklet on Anxiety in Family in ICU

Impact of the Deliverance and Use of a Written Detailed Information Brochure on Anxiety Felt by the Family Members of Patients Admitted in Intensive Care Unit

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01365377
Acronym
FAMILLE
Enrollment
180
Registered
2011-06-03
Start date
2011-04-30
Completion date
2013-04-30
Last updated
2011-06-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anxiety, Depression, Post-traumatic Stress Disorders

Keywords

Anxiety, Depression, Post-traumatic stress disorders, Quality of life, Family, ICU

Brief summary

Anxiety and depression are symptoms frequently met in ICU patients and relatives. Risk factors are known: disease severity, age, gender. Another risk factor is lack of information from the medical staff and nurses. Anxiety and depression can be measured by the Hospital Anxiety and Depression Scale (HADS). Other scales are used in the psychiatric field : the Impact Event Score - Revisited (IES-R) is relevant to detect Post-Traumatic Stress Disorder (PTSD), The Short Form Health Survey (SF-36) is an assessment of life quality. In the following study, the investigators will evaluate the impact of a brochure as complement of oral information on Anxiety developed by relatives and family of ICU patients. The medical and surgical ICU is composed by two different units (different medical and nurse team, different location in the same hospital) of 12 beds on one side, 14 beds on the other side. During a year, in the first unit, the investigators will use the booklet as support and complement of oral information : booklet arm. The information process will be as usual in the other unit : control arm. During the second year, the booklet will be used in the second unit while the first unit will return to the usual oral information (cross-over). For each included patient, one relative or family member is pointed to be the referring family member or referent. This referent receives the HADS questionnaire at Day 3 after admission, at day of discharge if the patient is alive, at one month after discharge. The IES-R questionnaire is delivered at discharge of the living patient and at day 30. The SF-36 questionnaire is given to the referent and the living patient at day 30. The day 30 questionnaires are send by mail at the referent address.

Interventions

OTHERbooklet deliverance and use in the process of daily information

The brochure shows with text and pictures the day-living of the ICU ; Medical and para-medical staff and organization, the devices, complications and treatment

Sponsors

Groupe Hospitalier Pitie-Salpetriere
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* All patients admitted in ICU whose previsible length of stay is over 3 days.

Exclusion criteria

* Admitted patient without organ failure * Family member or patient who can't speak and/or read French * Family who didn't show off within the first week of hospitalization

Design outcomes

Primary

MeasureTime frameDescription
Decreased of the Anxiety Score of 20% in the brochure arm from admission to discharge of ICU.One year per armWe hope to see the anxiety score decreasing between day of admission and day of discharge in the patient's relative who received the brocure.

Secondary

MeasureTime frameDescription
Decreased of Depression Scoring on the HADStwo yearsWe hope to see a decreasing of the Depression Score, which is part of the Hospital Anxiety and Depression Scale, in the group of patient's relatives receiving the booklet.
Diagnostic and following of Post-traumatic stress disorderTwo yearsWe hope to see a decreasing of the score in the Impact Event Score (Revisited)in the group of patient's relatives receiving the booklet, showing a less risk of PTSD.
Assessment of quality of life in patients and relativesTwo yearsA month after ICU discharge, we use the Short-Form 36 to assess quality of life of the surviving patients and their relative.

Countries

France

Contacts

Primary ContactJean-Jacques ROUBY, MD, PhD
chunghi.do@psl.aphp.fr033-142177305

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026