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Completed

NCT Number: NCT05527678

5 Years Quality of Life and Early Mobilization in ICU

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.

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Key information

Conditions

Quality of Life ICU Acquired Weakness Morality

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Centre Hospitalier Régional d'Orléans

Orléans, Centre-Val de Loire, 45067, France

About this study

Study design Prospective, observational study.

  • Research of vital status
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

questionnaires

Other

Written or by phone

Primary outcomes

  1. 5 years mortality

    Time frame: Before sending questionnaires

    Vital status

Secondary outcomes

  1. Medical Outcomes Study 36-item Short-Form Health Survey

    Time frame: through study completion, an average of 6 months

    The 36-Item Short Form Survey (SF-36) is an oft-used, well-researched, self-reported measure of health. It stems from a study called the Medical Outcomes Study.

    It comprises 36 questions which cover eight domains of health.

    The recommended scoring system for the SF-36 is a weighted Likert system for each item. Items in the subscales are summed to obtain a summary score for each subscale or dimension. Each of the 8 summary scores is linearly transformed on a scale from 0 (negative to health) to 100 (favorable to health) to obtain a score for each subscale.

  2. Katz Index of Independence in Activities of Daily Living questionnaire

    Time frame: through study completion, an average of 6 months

    The Katz Index of Independence in Activities of Daily Living, commonly referred to as the Katz ADL, is the most appropriate instrument to assess functional status as a measurement of the client's ability to perform activities of daily living independently. Clinicians typically use the tool to detect problems in performing activities of daily living and to plan care accordingly. The Index ranks adequacy of performance in the six functions of bathing, dressing, toileting, transferring, continence, and feeding. Clients are scored yes/no for independence in each of the six functions.

    A score of 6 indicates full function, 4 indicates moderate impairment, and 2 or less indicates severe functional impairment.

    The instrument is most effectively used among older adults in a variety of care settings, when baseline measurements, taken when the client is well, are compared to periodic or subsequent measures.

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Régional d'Orléans

Other

Registry information

Official study title

Assessment of Quality of Life in Patients Who Participated in the Promorea 1 Study

Acronym: Promorea-qol

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Sep 2, 2022
Registry last updated
May 17, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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