CompletedNot Applicable

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

France545 participantsStarted 2012-12

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: 1 year

Trial details

NCT IDNCT01796509

SponsorAssistance Publique - Hôpitaux de Paris

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2018-09

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