Hôtel Dieu Hospital
Paris, 75004, France
NCT Number: NCT05532904
After an acute episode of COVID-19, many patients experience persistent or recurrent symptoms with substantial impairment of their quality of life. The most common symptoms are fatigue, dyspnea, cognitive impairment and pain, but symptoms of all types have been reported. The heterogeneity of symptoms and their potential pathophysiology makes individualized and multidisciplinary management essential.
The primary objective of this study is to evaluate the change in quality of life at 6 months in patients with persistent symptoms after an acute episode of COVID-19 after 6 weeks of personalized multidisciplinary outpatient management versus usual care.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Paris, 75004, France
After an acute episode of COVID-19, many patients experience persistent or recurrent symptoms with substantial impairment of their quality of life. The most common symptoms are fatigue, dyspnea, cognitive impairment, and pain, but symptoms of all types have been reported. The heterogeneity of symptoms and their potential pathophysiology makes individualized and multidisciplinary management essential.
The primary objective is to evaluate the change in quality of life at 6 months in patients with persistent symptoms after an acute episode of COVID-19 after 6 weeks of personalized multidisciplinary outpatient management versus usual care. The secondary objectives are to evaluate the evolution of the quality of life at 3 months, the evolution of the main persistent symptoms (fatigue, dyspnea, cognitive complaints, pain), the patients' satisfaction, the predictive and explanatory factors of the evolution.
This is a prospective randomized open-label study in two parallel arms: personalized multidisciplinary outpatient intervention versus usual care (waiting list). This 6-week program of care will include:
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
This 6-week program of care will include:
Time frame: at 6 Months
SF-12 global score - 12-item Short Form Survey (SF-12) is a general health questionnaire. Two summary scores are reported from the SF-12 - a mental component score (MCS-12) and a physical component score (PCS-12)
Time frame: at 3 Months
SF-12 global score - 12-item Short Form Survey (SF-12) is a general health questionnaireTwo summary scores are reported from the SF-12 - a mental component score (MCS-12) and a physical component score (PCS-12)
Time frame: at 3 months, 6 months
Pichot's scale global score - may vary between 0 and 32. A score above 22 reveals excessive fatigue
Time frame: at 3 months, 6 months
Borg scale (0 min-10 max)
Time frame: at 3 months, 6 months
Mac Nair & Kahn (1983) cognitive difficulties questionnaire, French GRECO consensus version
Time frame: at 3 months, 6 months
Numerical rating scale - from 0 (no pain) to 10 (the maximum imaginable pain)
Time frame: at 3 months, 6 months
Ad hoc questionnaire
Time frame: at inclusion, 3 months, 6 months
Global physical activity questionnaire (GPAQ) score
Time frame: at inclusion, 3 months, 6 months
Difference between estimated and measured heart rate (HR) at the end of the walking test
Time frame: at inclusion, 3 months, 6 months
% weight loss
Time frame: at inclusion, 3 months, 6 months
BMI
Time frame: at inclusion, 3 months, 6 months
Blood albumin
Time frame: at inclusion, 3 months, 6 months
Nutritional risk index
Time frame: at inclusion, 3 months, 6 months
SSD-12 global score- may vary between 0 and 48 points - Each of the three psychological sub-criteria of DSM-5 somatic symptom disorder (cognitive, affective, behavioral) is measured by four items with all item scores ranging between 0 and 4 (0 = never, 1 = rarely, 2 = sometimes, 3 = often, 4 = very often) Ratings are summed up to make a simple sum score
Assistance Publique - Hôpitaux de Paris
Other
Evaluation and Comparison of Multidisciplinary Day-hospital Versus Waiting List Management of Persistent Symptoms After an Acute Episode of COVID-19
Acronym: ECHAP-COVID
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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