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5 Years Quality of Life and Early Mobilization in ICU

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05527678
Acronym
Promorea-qol
Enrollment
138
Registered
2022-09-02
Start date
2022-10-28
Completion date
2023-05-02
Last updated
2023-05-17

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

Conditions

ICU Acquired Weakness, Morality, Quality of Life

Keywords

ICU, Quality of life, Medical research council sum score, Mortality, early mobilization

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.

Interventions

OTHERQuestionnaires

Written or by phone

Sponsors

Centre Hospitalier Régional d'Orléans
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

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

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

Design outcomes

Primary

MeasureTime frameDescription
5 years mortalityBefore sending questionnairesVital status

Secondary

MeasureTime frameDescription
Medical Outcomes Study 36-item Short-Form Health Surveythrough study completion, an average of 6 monthsThe 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.
Katz Index of Independence in Activities of Daily Living questionnairethrough study completion, an average of 6 monthsThe 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.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026