Study in Intensive Care Follow-up Programme in Improving Long-term Outcomes of ICU Survivors

NCT01796509 | Completed DMC

• 1 other identifier: P100147
• Study Type: interventional
• Target: 545
• Locations: 1 country
• Sites: 1

Brief Summary

Study Hypothesis: Critical illness is associated with long-term medical and psychological sequelae that can impact the professional and private life. The purpose of the present multicenter randomized controlled trial is to assess whether or not a medical, psychological and social follow-up improves quality of life of critically ill patients at one year after their discharge from intensive care unit (ICU). Primary Purpose: Death or severe alteration of quality of life assessed with help of EQ5D questionnaire at one year after ICU discharge.

Conditions

Quality of Life; Post ICU Discharge

Keywords

Quality of life,; Sequela disorders,; Socio-professional impact,; Anxiety, depression,; Post traumatic stress disorder,; ICU acquired paresis.

Outcome Measures

Primary Outcomes (1)

• Death or severe alteration of quality of life assessed after ICU discharge

  Death or severe alteration of quality of life assessed with help of EQ5D questionnaire at one year after ICU discharge.

  1 year

Secondary Outcomes (4)

• Assessment of life quality in Medical domain

  1 year

• Assessment in psychological domain

  1 year

• Assessment in social domain

  1 year

• Assessment in economical cost

  1 year

Study Arms (2)

multidisciplinary follow-up

EXPERIMENTAL

Other: Medical, psychological, social

no follow-up

NO INTERVENTION

Interventions

Medical, psychological, social OTHER

After having given his consent, the patient filled auto questionnaire, and then randomized either in follow up arm (i.e. intervention group) or in no follow up arm (i.e. control group). In the follow up arm, medical, psychological and social consultation will be planned within the first seven days after inclusion, and then 3, 6, 12 months. During medical consultation a general examination will be performed, muscle strength, cognitive function, functional disabilities will be assessed with help of MRC, MMS. During psychological consultation, anxiety and depression will be assessed with the help of HAD, IES. The psychologist will also have a free interview. During social consultation personal and professional reinsertion will be assessed.

multidisciplinary follow-up

Eligibility Criteria

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

You may qualify if:

• Men and women older than 18
• Living in an area near the hospital
• Hospitalized in the ICU medical surgical hospitals in this study.
• Who required mechanical ventilation more than 3 days
• Having a life expectancy greater than one year (Mc Cabe score \>2, absence of metastatic cancer)
• Having a general practitioner identified
• Is affiliated to a social health care
• And who have given their written informed consent

You may not qualify if:

• Patients hospitalized in ICU in the previous year
• Patients followed for a preexisting myopathy
• The burn patients, patients with brain injury (Glasgow initial \<8) or trauma
• Patients hospitalized for suicide or self-induced poisoning
• Patients with psychiatric disorders
• Patients with ore dementia
• Pregnant women
• Patients who do not speak fluently French
• Patients with guardianship
• Homeless patients
• No having a general practitioner identified

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Hôpital Raymond Poincaré

Garches, Île-de-France Region, 92380, France

Location

Related Publications (1)

• Friedman D, Grimaldi L, Cariou A, Aegerter P, Gaudry S, Ben Salah A, Oueslati H, Megarbane B, Meunier-Beillard N, Quenot JP, Schwebel C, Jacob L, Robin Lagandre S, Kalfon P, Sonneville R, Siami S, Mazeraud A, Sharshar T. Impact of a Postintensive Care Unit Multidisciplinary Follow-up on the Quality of Life (SUIVI-REA): Protocol for a Multicenter Randomized Controlled Trial. JMIR Res Protoc. 2022 May 9;11(5):e30496. doi: 10.2196/30496.

  PMID: 35532996 DERIVED

MeSH Terms

Conditions

Anxiety Disorders; Depression; Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Mental Disorders; Behavioral Symptoms; Behavior; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders

Study Officials

• Tarek Sharshar, MD, PHD

  ICU, Hôpital Raymond Poincaré

  STUDY DIRECTOR

• Diane Friedman, MD

  ICU, Hôpital Raymond Poincaré

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 13, 2013
• First Posted: February 21, 2013
• Study Start: December 1, 2012
• Primary Completion: September 1, 2018
• Study Completion: March 11, 2020
• Last Updated: January 5, 2022

Record last verified: 2021-02

Locations

FR (1)