5 Years Quality of Life and Early Mobilization in ICU

Quality of Life Clinical Trial

— Promorea-qol  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05527678
• Other study ID #: CHRO-2022-02
• Status: Completed
• Start date: October 28, 2022
• Est. completion date: May 2, 2023

Study information

• Verified date: May 2023
• Source: Centre Hospitalier Régional d'Orléans
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• ICU Acquired Weakness
• Morality
• Quality of Life

Intervention

Other:
• Questionnaires
Written or by phone

Locations

Country	Name	City	State
France	Centre Hospitalier Régional d'Orléans	Orléans	Centre Val De Loire

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Régional d'Orléans

Country where clinical trial is conducted

France, 

References & Publications (3)

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

Outcome

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