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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2011 by Groupe Hospitalier Pitie-Salpetriere.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Groupe Hospitalier Pitie-Salpetriere
ClinicalTrials.gov Identifier:
NCT01365377
First received: May 31, 2011
Last updated: June 2, 2011
Last verified: April 2011
  Purpose

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 Intervention
Anxiety
Depression
Post-traumatic Stress Disorders
Other: booklet deliverance and use in the process of daily information

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Groupe Hospitalier Pitie-Salpetriere:

Primary Outcome Measures:
  • Decreased of the Anxiety Score of 20% in the "brochure arm" from admission to discharge of ICU. [ Time Frame: One year per arm ] [ Designated as safety issue: No ]
    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:
  • Decreased of Depression Scoring on the HADS [ Time Frame: two years ] [ Designated as safety issue: No ]
    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.

  • Diagnostic and following of Post-traumatic stress disorder [ Time Frame: Two years ] [ Designated as safety issue: No ]
    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.

  • Assessment of quality of life in patients and relatives [ Time Frame: Two years ] [ Designated as safety issue: No ]
    A month after ICU discharge, we use the Short-Form 36 to assess quality of life of the surviving patients and their relative.


Estimated Enrollment: 180
Study Start Date: April 2011
Estimated Study Completion Date: April 2013
Estimated Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01365377

Contacts
Contact: Jean-Jacques ROUBY, MD, PhD 033-142177305 chunghi.do@psl.aphp.fr

Locations
France
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
  More Information

Publications:
Responsible Party: Jean-Jacques ROUBY, MD, PhD, Groupe Hospitalier Pitie-Salpetriere
ClinicalTrials.gov Identifier: NCT01365377     History of Changes
Other Study ID Numbers: FAMILLE-JJR-2
Study First Received: May 31, 2011
Last Updated: June 2, 2011
Health Authority: France : Ministère de la Santé et des Sports

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

Additional relevant MeSH terms:
Anxiety Disorders
Depression
Depressive Disorder
Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Behavioral Symptoms
Mental Disorders
Mood Disorders

ClinicalTrials.gov processed this record on November 20, 2014