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

Depression Clinical Trial

— FAMILLE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01365377
• Other study ID #: FAMILLE-JJR-2
• Status: Recruiting
• Phase: N/A
• First received: May 31, 2011
• Last updated: June 2, 2011
• Start date: April 2011
• Est. completion date: April 2013

Study information

• Verified date: April 2011
• Source: Groupe Hospitalier Pitie-Salpetriere
• Contact: Jean-Jacques ROUBY, MD, PhD
• Phone: 033-142177305
• Email: chunghi.do[@]psl.aphp.fr
• Is FDA regulated: No
• Health authority: France : Ministère de la Santé et des Sports
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 180
• Est. completion date: April 2013
• Est. primary completion date: April 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders
• Depression
• Post-traumatic Stress Disorders
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

Other:
• booklet 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

Locations

Country	Name	City	State
France	Intensive Care Unit, Groupe Hospitalier Pitie-Salpetriere	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Groupe Hospitalier Pitie-Salpetriere

Country where clinical trial is conducted

France, 

References & Publications (2)

Azoulay E, Pochard F, Kentish-Barnes N, Chevret S, Aboab J, Adrie C, Annane D, Bleichner G, Bollaert PE, Darmon M, Fassier T, Galliot R, Garrouste-Orgeas M, Goulenok C, Goldgran-Toledano D, Hayon J, Jourdain M, Kaidomar M, Laplace C, Larché J, Liotier J, Papazian L, Poisson C, Reignier J, Saidi F, Schlemmer B; FAMIREA Study Group. Risk of post-traumatic stress symptoms in family members of intensive care unit patients. Am J Respir Crit Care Med. 2005 May 1;171(9):987-94. Epub 2005 Jan 21. — View Citation

Jackson JC, Hart RP, Gordon SM, Shintani A, Truman B, May L, Ely EW. Six-month neuropsychological outcome of medical intensive care unit patients. Crit Care Med. 2003 Apr;31(4):1226-34. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Decreased of the Anxiety Score of 20% in the "brochure arm" from admission to discharge of ICU.	We hope to see the anxiety score decreasing between day of admission and day of discharge in the patient's relative who received the brocure.	One year per arm	No
Secondary	Decreased of Depression Scoring on the HADS	We 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.	two years	No
Secondary	Diagnostic and following of Post-traumatic stress disorder	We 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.	Two years	No
Secondary	Assessment of quality of life in patients and relatives	A month after ICU discharge, we use the Short-Form 36 to assess quality of life of the surviving patients and their relative.	Two years	No