Clinical trial NCT04451694: Nutritional Follow up After Hospital Discharge for Coronavirus Disease-19
Official title: Nutritional Follow up After Hospital Discharge for Coronavirus Disease-19
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Covid-19
Keywords: nutritional status
malnutrition
diet intervention
sarcopenia
muscle strength
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2020-06-30
Enrollment: 800
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: complete survey, about 800 patients. No sample List of patients discharged from COVID Units

Brief summary: Coronavirus infection is responsible for muscle wasting (sarcopenia), especially during prolonged stays in intensive care. Sarcopenia, in its functional aspect also seems major in patients hospitalized for this infection, in non-ICU unit. Weight loss also appears to be significant, despite a prevalence of overweight and obesity in severe forms. Undernutrition in the obese patient is also possible (undernourished obese and sarcopenia obesity). Anosmia and dysgeusia participate in undernutrition by reducing energy intake. The rehabilitation of these patients requires nutritional support (increased protein intake) associated with progressive retraining to physical activity.

An early and proactive management procedure within Coronavirus disease-19 units has been implemented in conjunction with the Transversal Nutrition Unit (TNU). This nutritional care must be continued after discharge. Follow-up by teleconsultation or telephone consultation is put in place after the patient's discharge Primary Objective: Evaluation of nutritional status at the time of admission and discharge and home follow-up in outgoing patients from Coronavirus disease-19 Units Secondary objectives: Description of the evolution of food intake, diversity of food and coverage of needs Evaluation of the muscular strength of the wrist (by grip test in hospital) and on the arms and legs after return home (visual analog scale) Evolution of anosmia and dysgeusia (at the time of hospital admission, at the time of hospital discharge and at home) Level of physical training before infection (IPAQ) Description of the general state of health measured by the performance index - world health organization scale Description of nutritional prescriptions Description of the prevention measures and incidence of Inappropriate Refeeding Syndrome (IRS) Care needs assessments


Eligibility criteria: Inclusion Criteria:

* Covid positive (RT-PCR)

Exclusion Criteria:

* Unable to answer questions by telephone or teleconsultation directly or through a relative, minors under 16 years of age

Primary outcomes:
measure: nutritional evaluation
timeFrame: before Covid, at hospital discharge and between 7 and 45 days after discharge
measure: nutritional evaluation
timeFrame: before Covid, at at the time of hospital admission, at the time of hospital discharge and between 7 and 45 days after discharge
Secondary outcomes:
measure: muscle strenght
timeFrame: at the time of hospital admission and at the time of hospital discharge
measure: food intake
timeFrame: at the time of hospital admission, at the time of hospital discharge
measure: food intake
timeFrame: between 7 and 45 days after discharge
measure: muscle strenght
timeFrame: between 7 and 45 days after discharge
measure: biological nutritional status
timeFrame: at the time of hospital admission, at the time of hospital discharge
measure: anosmia
timeFrame: at the time of hospital admission, at the time of hospital discharge and between 7 and 45 days after discharge
Other outcomes:
Locations:
city: VANDOEUVRE LES Nancy
country: France
facility: Quilliot
Study officials:
References:
citation: Quilliot D, Gerard M, Bonsack O, Malgras A, Vaillant MF, Di Patrizio P, Jaussaud R, Ziegler O, Nguyen-Thi PL. Impact of severe SARS-CoV-2 infection on nutritional status and subjective functional loss in a prospective cohort of COVID-19 survivors. BMJ Open. 2021 Jul 14;11(7):e048948. doi: 10.1136/bmjopen-2021-048948.