Improve the Quality of Life After a Hospitalization in Critical Care

NCT02762409 | Completed DMC

• 1 other identifier: PREPS-15-15-0183
• Study Type: observational
• Target: 1,006
• Locations: 1 country
• Sites: 12

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.

Conditions

Depression; Depression Symptoms

Keywords

critical care; reduction of depression syndrome; anxiety; quality of life; post traumatic stress; discomforts

Outcome Measures

Primary Outcomes (1)

• Improve the reduction of depressive symptoms

  A score 8 (maximal score of 21) allows to hold the presence of clinically significant depressive symptoms.

  up to 52 weeks of the hospitalization

Secondary Outcomes (5)

• Score of the sub-scale A of the questionnaire HAD-S ( Hospital and Anxiety Depression Scale)

  up to 52 weeks of the hospitalization

• Score IES-R ( impact of Events Scale-Revised)

  up to 52 weeks of the hospitalization

• Questionnaire EQ-5D

  up to 52 weeks of the hospitalization

• Describe quality of life

  up to 52 weeks of the hospitalization

• Duration of hospitalization

  Consecutive to the hospitalization in intensive care

Study Arms (2)

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

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

Interventions

experimental OTHER

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 exposed

control OTHER

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

patients non exposed

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• The same criteria of the IPREA3 study
• Taken out alive of intensive care
• Hospitalization in intensive care extending at least over three calendar days.

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier of Chartres: lead

Study Sites (12)

C.H. de Chartres

Chartres, 28018, France

Location

CHU Beaujon APHP

Clichy, 92110, France

Location

CH Douai

Douai, 59507, France

Location

CH La Rochelle

La Rochelle, 17022, France

Location

CH Le Puy en Velay

Le Puy-en-Velay, 43000, France

Location

CH Lens

Lens, 62300, France

Location

CHU Edouard Herriot

Lyon, 69003, France

Location

CHU Saint Louis APHP

Paris, 75010, France

Location

CHU Cochin APHP

Paris, 75014, France

Location

CHU NHC

Strasbourg, 67000, France

Location

CHU Hautepierre

Strasbourg, 67100, France

Location

CH Troyes

Troyes, 10000, France

Location

Related Publications (6)

• Griffiths J, Fortune G, Barber V, Young JD. The prevalence of post traumatic stress disorder in survivors of ICU treatment: a systematic review. Intensive Care Med. 2007 Sep;33(9):1506-18. doi: 10.1007/s00134-007-0730-z. Epub 2007 Jun 9.

  PMID: 17558490 RESULT

• Pandharipande PP, Girard TD, Ely EW. Long-term cognitive impairment after critical illness. N Engl J Med. 2014 Jan 9;370(2):185-6. doi: 10.1056/NEJMc1313886. No abstract available.

  PMID: 24401069 RESULT

• Davydow DS, Hough CL, Zatzick D, Katon WJ. Psychiatric symptoms and acute care service utilization over the course of the year following medical-surgical ICU admission: a longitudinal investigation*. Crit Care Med. 2014 Dec;42(12):2473-81. doi: 10.1097/CCM.0000000000000527.

  PMID: 25083985 RESULT

• Davydow DS, Zatzick D, Hough CL, Katon WJ. A longitudinal investigation of posttraumatic stress and depressive symptoms over the course of the year following medical-surgical intensive care unit admission. Gen Hosp Psychiatry. 2013 May-Jun;35(3):226-32. doi: 10.1016/j.genhosppsych.2012.12.005. Epub 2013 Jan 28.

  PMID: 23369507 RESULT

• Kalfon P, Mimoz O, Auquier P, Loundou A, Gauzit R, Lepape A, Laurens J, Garrigues B, Pottecher T, Malledant Y. Development and validation of a questionnaire for quantitative assessment of perceived discomforts in critically ill patients. Intensive Care Med. 2010 Oct;36(10):1751-1758. doi: 10.1007/s00134-010-1902-9. Epub 2010 May 26.

  PMID: 20502874 RESULT

• Kalfon P, Alessandrini M, Boucekine M, Renoult S, Geantot MA, Deparis-Dusautois S, Berric A, Collange O, Floccard B, Mimoz O, Julien A, Robert R, Audibert J, Renault A, Follin A, Thevenin D, Revel N, Venot M, Patrigeon RG, Signouret T, Fromentin M, Sharshar T, Vigne C, Pottecher J, Levrat Q, Sossou A, Garrouste-Orgeas M, Quenot JP, Boulle C, Azoulay E, Baumstarck K, Auquier P; IPREA-AQVAR Study Group. Tailored multicomponent program for discomfort reduction in critically ill patients may decrease post-traumatic stress disorder in general ICU survivors at 1 year. Intensive Care Med. 2019 Feb;45(2):223-235. doi: 10.1007/s00134-018-05511-y. Epub 2019 Jan 30.

  PMID: 30701294 DERIVED

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

MeSH Terms

Conditions

Depression; Anxiety Disorders

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders

Study Officials

• Pierre KALFON, PhD

  CH CHARTRES

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 18, 2016
• First Posted: May 5, 2016
• Study Start: October 1, 2015
• Primary Completion: October 31, 2016
• Study Completion: December 31, 2016
• Last Updated: July 24, 2017

Record last verified: 2016-08

Data Sharing

• IPD Sharing: Will not share

Locations

FR (12)