Quality of Life Clinical Trial
— Promorea-qolOfficial title:
Assessment of Quality of Life in Patients Who Participated in the Promorea 1 Study
NCT number | NCT05527678 |
Other study ID # | CHRO-2022-02 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | October 28, 2022 |
Est. completion date | May 2, 2023 |
Verified date | May 2023 |
Source | Centre Hospitalier Régional d'Orléans |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 138 |
Est. completion date | May 2, 2023 |
Est. primary completion date | May 2, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
France | Centre Hospitalier Régional d'Orléans | Orléans | Centre Val De Loire |
Lead Sponsor | Collaborator |
---|---|
Centre Hospitalier Régional d'Orléans |
France,
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 o — View 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. — View 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 5 years mortality | Vital status | Before sending questionnaires | |
Secondary | Medical Outcomes Study 36-item Short-Form Health Survey | 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. |
through study completion, an average of 6 months | |
Secondary | Katz Index of Independence in Activities of Daily Living questionnaire | 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. |
through study completion, an average of 6 months |
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