NCT05527678

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
138

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 30, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 2, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

October 28, 2022

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 2, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 2, 2023

Completed
Last Updated

May 17, 2023

Status Verified

May 1, 2023

Enrollment Period

6 months

First QC Date

August 30, 2022

Last Update Submit

May 16, 2023

Conditions

Quality of LifeICU Acquired WeaknessMorality

Keywords

ICUQuality of lifeMedical research council sum scoreMortalityearly mobilization

Outcome Measures

Primary Outcomes (1)

  • 5 years mortality

    Vital status

    Before sending questionnaires

Secondary Outcomes (2)

  • Medical Outcomes Study 36-item Short-Form Health Survey

    through study completion, an average of 6 months

  • Katz Index of Independence in Activities of Daily Living questionnaire

    through study completion, an average of 6 months

Study Arms (1)

5 years ICU survivors

Survivors 5 years after ICU and who participated in the Promorea1 study will be contacted to assess their quality of life.

Other: Questionnaires

Interventions

QuestionnairesOTHER

Written or by phone

5 years ICU survivors

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Hospitalier Régional d'Orléans

Orléans, Centre-Val de Loire, 45067, France

Location

Related Publications (3)

  • 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.

    PMID: 1593914RESULT

  • 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.

    PMID: 30043066RESULT

  • 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.

    PMID: 31970446RESULT

MeSH Terms

Interventions

Surveys and Questionnaires

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Guillaume FOSSAT, Pt Msc

    Centre Hospitalier Régional d'Orléans

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 30, 2022

First Posted

September 2, 2022

Study Start

October 28, 2022

Primary Completion

May 2, 2023

Study Completion

May 2, 2023

Last Updated

May 17, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)