Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Improve the Quality of Life After a Hospitalization in Critical Care (AQVAR)

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.
ClinicalTrials.gov Identifier: NCT02762409
Recruitment Status : Completed
First Posted : May 5, 2016
Last Update Posted : July 24, 2017
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier of Chartres

Brief Summary:
Demonstrate that the IPREA3 program (Study: Impact of Multicomponent Intervention to Reduce Perceived Discomforts of the patients in intensive care) reducing discomforts perceived by the patients of intensive care, implemented at the level of the whole intensive care unit, reduce the incidence of the depressive symptoms one year after intensive care exit.

Condition or disease Intervention/treatment
Depression Depression Symptoms Other: experimental Other: control

  Show Detailed Description

Layout table for study information
Study Type : Observational [Patient Registry]
Actual Enrollment : 1006 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 1 Year
Official Title: Improve the Quality of Life After a Hospitalization in Critical Care Thanks to a Program of Prevention of Discomforts Perceived by the Patients of Critical Care Base on Targeted Measures
Actual Study Start Date : October 1, 2015
Actual Primary Completion Date : October 31, 2016
Actual Study Completion Date : December 31, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Critical Care

Group/Cohort Intervention/treatment
patients exposed
Patients exposed will be estimated in the study IPREA3 corresponding to surviving individuals of a hospitalization in intensive care in a department having set up the program of reduction of the discomforts collected by the patients of intensive care during a minimal period of 5 months. The program is so defined as factor of exposure and supposed protector of development of anxio-depressive disorders.These patients will have been included in the study IPREA3 in 17 centers of the interventional group of the study IPREA3 during the months of April, 2015 and October, 2015, and in 17 centers of the group control some study IPREA3 during October 2015
Other: experimental
corresponding to surviving individuals of a hospitalization in intensive care in a department having set up the program of reduction of the discomforts collected by the patients of intensive care during a minimal period of 5 months. The program is so defined as factor of exposure and supposed protector of development of anxio-depressive disorders.These patients will have been included in the study IPREA3 in 17 centers of the interventional group of the study IPREA3 during the months of April, 2015 and October, 2015

patients non exposed
The patients "not exposed" in the supposed factor protector of development of anxio-depressive disorders will be constituted by the patients estimated in the study IPREA3 corresponding to surviving individuals of a hospitalization in intensive care in a department having never operated the program of reduction of the discomforts collected by the patients of intensive care. These patients will have been included in the study IPREA3 in 17 centers of the group control some study IPREA3 during October 2014 and April, 2015 and in 17 centers of the interventional group during October 2014
Other: control
The patients "not exposed" in the supposed factor protector of development of anxio-depressive disorders will be constituted by the patients estimated in the study IPREA3 corresponding to surviving individuals of a hospitalization in intensive care in a department having never operated the program of reduction of the discomforts collected by the patients of intensive care. These patients will have been included in the study IPREA3 in 17 centers of the group control some study IPREA3 during October 2014 and April, 2015




Primary Outcome Measures :
  1. Improve the reduction of depressive symptoms [ Time Frame: up to 52 weeks of the hospitalization ]
    A score 8 (maximal score of 21) allows to hold the presence of clinically significant depressive symptoms.


Secondary Outcome Measures :
  1. Score of the sub-scale A of the questionnaire HAD-S ( Hospital and Anxiety Depression Scale) [ Time Frame: up to 52 weeks of the hospitalization ]

    Allowing to estimate the presence of anxious symptoms. Score of the sub-scale A of the questionnaire HAD-S one year after the exit of intensive care allowing to estimate the presence of anxious symptoms. A score 8 (maximal score of 21) allows to hold the presence of clinically significant anxious symptoms.

    The scale HAD contains 14 highly-rated items from 0 to 3. Seven questions relate to the anxiety ( total A) and seven others in the depressive dimension (total D), so allowing the obtaining of two scores, the maximal note of wich for each of them is 21.


  2. Score IES-R ( impact of Events Scale-Revised) [ Time Frame: up to 52 weeks of the hospitalization ]
    Allowing to detect a risk of state of post traumatic stress.

  3. Questionnaire EQ-5D [ Time Frame: up to 52 weeks of the hospitalization ]
    Indicators of quality of life estimated by questionnaires EQ-5D

  4. Describe quality of life [ Time Frame: up to 52 weeks of the hospitalization ]
    Return home, taken by a professional activity, an existence of a psychiatric or psychological follow up, and a regular consumption of psychotropics

  5. Duration of hospitalization [ Time Frame: Consecutive to the hospitalization in intensive care ]
    Informations are in the medical bases statistic of each hospital


Biospecimen Retention:   None Retained
The calculation of the number of necessary subjects is realized from the main criterion and bases on the proportion of presenting subjects of the clinically significant depressive symptoms in 1 year of their hospitalization in intensive care, estimated from it under scale D of the score HAD-S.The proposal of the subject waited for the patient presenting this profile was on the works available in particular on the general review of DAVYDOW and AL


Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All the patients included in the study AQVAR will be patients included before in the study IPREA3 for whom the IPREA3 questionnary of measure of the discomforts collected by the patients will be informed (available score for each of the items establishing the questionnaire IPREA3). The inclusion of the patients in the study AQVAR will be made the day of the intensive care exit.
Criteria

Inclusion Criteria:

The same criteria of the IPREA3 study

  • Taken out alive of intensive care
  • Hospitalization in intensive care extending at least over three calendar days.

Exclusion Criteria:

  • Deaths in intensive care
  • Age 18-year-old inferior
  • Under guardianship patient
  • Incompatible situation with the administration of the IPREA questionnaire at the exit of intensive care: presence of neuropsychic disorders, language barrier, transfer under mechanical ventilation, taken out of intensive care in urgency
  • Patient refused to participate in the study IPREA3
  • Patient refused to participate in the study AQVAR

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 ClinicalTrials.gov identifier (NCT number): NCT02762409


Locations
Layout table for location information
France
C.H. de Chartres
Chartres, France, 28018
CHU Beaujon APHP
Clichy, France, 92110
CH Douai
Douai, France, 59507
CH La Rochelle
La Rochelle, France, 17022
CH Le Puy en Velay
Le Puy en Velay, France, 43000
CH Lens
Lens, France, 62300
CHU Edouard Herriot
Lyon, France, 69003
CHU Saint Louis APHP
Paris, France, 75010
CHU Cochin APHP
Paris, France, 75014
CHU NHC
Strasbourg, France, 67000
CHU Hautepierre
Strasbourg, France, 67100
CH Troyes
Troyes, France, 10000
Sponsors and Collaborators
Centre Hospitalier of Chartres
Investigators
Layout table for investigator information
Principal Investigator: Pierre KALFON, PhD CH CHARTRES

Additional Information:

Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Centre Hospitalier of Chartres
ClinicalTrials.gov Identifier: NCT02762409     History of Changes
Other Study ID Numbers: PREPS-15-15-0183
First Posted: May 5, 2016    Key Record Dates
Last Update Posted: July 24, 2017
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Centre Hospitalier of Chartres:
critical care
reduction of depression syndrome
anxiety
quality of life
post traumatic stress
discomforts

Additional relevant MeSH terms:
Layout table for MeSH terms
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders