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

Primary Purpose

Anxiety, Depression, Post-traumatic Stress Disorders

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
booklet deliverance and use in the process of daily information
Sponsored by
Groupe Hospitalier Pitie-Salpetriere
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Anxiety focused on measuring Anxiety, Depression, Post-traumatic stress disorders, Quality of life, Family, ICU

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Intensive Care Unit, Groupe Hospitalier Pitie-SalpetriereRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Booklet

No booklet

Arm Description

Referent member of the family is designated to receive a written detailed information on Critical care.

daily information to the family is given as usual.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.

Full Information

First Posted
May 31, 2011
Last Updated
June 2, 2011
Sponsor
Groupe Hospitalier Pitie-Salpetriere
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1. Study Identification

Unique Protocol Identification Number
NCT01365377
Brief Title
Impact of Information Strategy Based on Booklet on Anxiety in Family in ICU
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2011
Overall Recruitment Status
Unknown status
Study Start Date
April 2011 (undefined)
Primary Completion Date
April 2012 (Anticipated)
Study Completion Date
April 2013 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Groupe Hospitalier Pitie-Salpetriere

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety, Depression, Post-traumatic Stress Disorders
Keywords
Anxiety, Depression, Post-traumatic stress disorders, Quality of life, Family, ICU

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
180 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Booklet
Arm Type
Experimental
Arm Description
Referent member of the family is designated to receive a written detailed information on Critical care.
Arm Title
No booklet
Arm Type
No Intervention
Arm Description
daily information to the family is given as usual.
Intervention Type
Other
Intervention Name(s)
booklet deliverance and use in the process of daily information
Other Intervention Name(s)
Brochure
Intervention Description
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
Primary Outcome Measure Information:
Title
Decreased of the Anxiety Score of 20% in the "brochure arm" from admission to discharge of ICU.
Description
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.
Time Frame
One year per arm
Secondary Outcome Measure Information:
Title
Decreased of Depression Scoring on the HADS
Description
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.
Time Frame
two years
Title
Diagnostic and following of Post-traumatic stress disorder
Description
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.
Time Frame
Two years
Title
Assessment of quality of life in patients and relatives
Description
A month after ICU discharge, we use the Short-Form 36 to assess quality of life of the surviving patients and their relative.
Time Frame
Two years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jean-Jacques ROUBY, MD, PhD
Phone
033-142177305
Email
chunghi.do@psl.aphp.fr
Facility Information:
Facility Name
Intensive Care Unit, Groupe Hospitalier Pitie-Salpetriere
City
Paris
ZIP/Postal Code
75013
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jean-Jacques ROUBY, MD, PhD

12. IPD Sharing Statement

Citations:
PubMed Identifier
15665319
Citation
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, Larche 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. doi: 10.1164/rccm.200409-1295OC. Epub 2005 Jan 21.
Results Reference
background
PubMed Identifier
12682497
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. doi: 10.1097/01.CCM.0000059996.30263.94.
Results Reference
background

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

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