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

NCT ID: NCT01365377

Last Updated: 2011-06-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

180 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-04-30

Study Completion Date

2013-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Anxiety Depression Post-traumatic Stress Disorders

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Booklet

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

Group Type EXPERIMENTAL

booklet deliverance and use in the process of daily information

Intervention Type OTHER

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

No booklet

daily information to the family is given as usual.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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

Intervention Type OTHER

Other Intervention Names

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Brochure

Eligibility Criteria

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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
Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Groupe Hospitalier Pitie-Salpetriere

OTHER

Sponsor Role lead

Responsible Party

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Groupe Hospitalier Pitie-Salpetriere

Locations

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Intensive Care Unit, Groupe Hospitalier Pitie-Salpetriere

Paris, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Jean-Jacques ROUBY, MD, PhD

Role: CONTACT

033-142177305

References

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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.

Reference Type BACKGROUND
PMID: 15665319 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12682497 (View on PubMed)

Other Identifiers

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FAMILLE-JJR-2

Identifier Type: -

Identifier Source: org_study_id

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