Clinical trial NCT05527678: 5 Years Quality of Life and Early Mobilization in ICU
Official title: Assessment of Quality of Life in Patients Who Participated in the Promorea 1 Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Quality of Life
ICU Acquired Weakness
Morality
Keywords: ICU
Quality of life
Medical research council sum score
Mortality
early mobilization
Lead sponsor: Centre Hospitalier Régional d'Orléans
Sponsor class: OTHER
First posted: 2022-09-02
Enrollment: 138
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients who participated in the PROMOREA 1 study, whose vital status is "alive" at least 5 years after their discharge from the ICU (INSEE file, MatchID search engine, https://deces.matchid.io/search?fuzzy=false), will be recontacted by mail at the last known address and by phone at the last known number if they do not answer the mail.

Brief summary: In a study published in 2018 the research team had collected the Medical Research Council score (MRCs) at Intensive Care Unit (ICU) discharge.

The investigators would like to be able to examine, if the preliminary results obtained by in 2020 by Van Aerde's team are confirmed in their cohort.

The investigators hypothesize that patients with an MRCs less than or equal to 55 at discharge from the ICU, have a higher mortality rate than those with a score greater than 55.

The investigators would also like to examine whether or not an MRCs score ≤ 55 is associated with a difference in quality of life and autonomy, after 5 and more years post ICU.

Detailed description: Study design Prospective, observational study.

1. Research of vital status
2. Completion of two questionnaires (Short Form-36 and Katz Index of Independence in Activities of Daily Living), to assess quality of life and level of autonomy in activities of daily living, either by telephone or completed directly by hand by the patient from his place of residence.

Eligibility criteria: Inclusion Criteria:

* Have participated in the Promorea1 study
* Alive at the time the questionnaires were sent

Exclusion Criteria:

* Opposition to the use of vital status data
* Extra-national patient not on the national registry

Primary outcomes:
measure: 5 years mortality
timeFrame: Before sending questionnaires
Secondary outcomes:
measure: Medical Outcomes Study 36-item Short-Form Health Survey
timeFrame: through study completion, an average of 6 months
measure: Katz Index of Independence in Activities of Daily Living questionnaire
timeFrame: through study completion, an average of 6 months
Other outcomes:
Locations:
city: Orléans
country: France
facility: Centre Hospitalier Régional d'Orléans
state: Centre Val De Loire
Study officials:
affiliation: Centre Hospitalier Régional d'Orléans
name: Guillaume FOSSAT, Pt Msc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ware JE Jr, Sherbourne CD. The MOS 36-item short-form health survey (SF-36). I. Conceptual framework and item selection. Med Care. 1992 Jun;30(6):473-83.
citation: Fossat G, Baudin F, Courtes L, Bobet S, Dupont A, Bretagnol A, Benzekri-Lefevre D, Kamel T, Muller G, Bercault N, Barbier F, Runge I, Nay MA, Skarzynski M, Mathonnet A, Boulain T. Effect of In-Bed Leg Cycling and Electrical Stimulation of the Quadriceps on Global Muscle Strength in Critically Ill Adults: A Randomized Clinical Trial. JAMA. 2018 Jul 24;320(4):368-378. doi: 10.1001/jama.2018.9592.
citation: Van Aerde N, Meersseman P, Debaveye Y, Wilmer A, Gunst J, Casaer MP, Bruyninckx F, Wouters PJ, Gosselink R, Van den Berghe G, Hermans G. Five-year impact of ICU-acquired neuromuscular complications: a prospective, observational study. Intensive Care Med. 2020 Jun;46(6):1184-1193. doi: 10.1007/s00134-020-05927-5. Epub 2020 Jan 22.