Impact of Information Strategy Based on Booklet on Anxiety in Family in ICU (FAMILLE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01365377
Recruitment Status : Unknown
Verified April 2011 by Groupe Hospitalier Pitie-Salpetriere.
Recruitment status was:  Recruiting
First Posted : June 3, 2011
Last Update Posted : June 3, 2011
Information provided by:
Groupe Hospitalier Pitie-Salpetriere

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.

Condition or disease Intervention/treatment Phase
Anxiety Depression Post-traumatic Stress Disorders Other: booklet deliverance and use in the process of daily information Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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
Study Start Date : April 2011
Estimated Primary Completion Date : April 2012
Estimated Study Completion Date : April 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arm Intervention/treatment
Experimental: Booklet
Referent member of the family is designated to receive a written detailed information on Critical care.
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
Other Name: Brochure

No Intervention: No booklet
daily information to the family is given as usual.

Primary Outcome Measures :
  1. Decreased of the Anxiety Score of 20% in the "brochure arm" from admission to discharge of ICU. [ Time Frame: One year per arm ]
    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.

Secondary Outcome Measures :
  1. Decreased of Depression Scoring on the HADS [ Time Frame: two years ]
    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.

  2. Diagnostic and following of Post-traumatic stress disorder [ Time Frame: Two years ]
    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.

  3. Assessment of quality of life in patients and relatives [ Time Frame: Two years ]
    A month after ICU discharge, we use the Short-Form 36 to assess quality of life of the surviving patients and their relative.

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01365377

Contact: Jean-Jacques ROUBY, MD, PhD 033-142177305

Intensive Care Unit, Groupe Hospitalier Pitie-Salpetriere Recruiting
Paris, France, 75013
Principal Investigator: Jean-Jacques ROUBY, MD, PhD         
Sponsors and Collaborators
Groupe Hospitalier Pitie-Salpetriere

Responsible Party: Jean-Jacques ROUBY, MD, PhD, Groupe Hospitalier Pitie-Salpetriere Identifier: NCT01365377     History of Changes
Other Study ID Numbers: FAMILLE-JJR-2
First Posted: June 3, 2011    Key Record Dates
Last Update Posted: June 3, 2011
Last Verified: April 2011

Keywords provided by Groupe Hospitalier Pitie-Salpetriere:
Post-traumatic stress disorders
Quality of life

Additional relevant MeSH terms:
Anxiety Disorders
Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Behavioral Symptoms
Mental Disorders
Trauma and Stressor Related Disorders