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

Multicenter Randomised, Controlled Trial of a Intensive Care Follow -up Programme in Improving Long-term Outcomes of ICU Survivors

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01796509
Acronym
SUIVI-REA
Enrollment
545
Registered
2013-02-21
Start date
2012-12-31
Completion date
2020-03-11
Last updated
2022-01-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Post ICU Discharge, Quality of Life

Keywords

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

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.

Detailed description

Critically ill patients who had required at least 3 days of mechanical ventilation and who consented to participate will be randomized at time of ICU discharge in either follow-up or not follow-up arm. The medical, psychological and social follow-up consists of multidisciplinary consultation at time of ICU discharge (i.e. inclusion), at three, six and 12 months afterward. Patients of the non follow-up group will be seen only at one year. Medical consultation will be focused on evaluation of pre-existing co-morbidities, detection of new ones and of physical disorders related to critical illness (i.e. ICU-acquired paresis, pain, functional disability, cognitive dysfunction…). Psychological assessment will be focused on detection of anxiety, depression and post-traumatic stress syndrome. Social follow-up will assess the social need of the patient in the professional and private domains. Each assessment will be standardized by using validated or appropriate scores. At the end of each multidisciplinary consultation, a report will be sent to the patient and his general practitioner. When necessary, a consultation with a specialist will be organized. At one year, an observer blinded from randomization will call all the patients to assess their quality of life with help of EQ5D questionnaire. Economical cost of multidisciplinary follow-up will be assessed. To our knowledge, there is no follow-up studies that have combined a medical, psychological and social cares. For instance, the PracTical study has not evidenced an improvement of quality of life in patients who had beneficiated from nurse consultations at 3 and 9 months.

Interventions

OTHERMedical, psychological, social

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.

Sponsors

Assistance Publique - Hôpitaux de Paris
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Death or severe alteration of quality of life assessed after ICU discharge1 yearDeath or severe alteration of quality of life assessed with help of EQ5D questionnaire at one year after ICU discharge.

Secondary

MeasureTime frameDescription
Assessment of life quality in Medical domain1 yearICU-acquired paresis assessed with help of MRC sum score, Functional disabilities assessed with help of Barthel and IADL scales, Cognitive dysfunctions assessed with help of MMS score, Pain, Comorbidities (Hypertension, etc…).
Assessment in psychological domain1 yearAnxiety assessed with help of HAD scale, Depression assessed with help of HAD scale Post-traumatic stress syndrome assessed with help of IES scale.
Assessment in social domain1 yearSocial reinsertion with help of RNLI scale.
Assessment in economical cost1 yearNumber of hospitalization,number of outpatient consultation and prescription of new treatment will be assessed within 1 year.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 13, 2026