NCT04365816

Brief Summary

Describe the main clinical features impacting the food intake, and therefore the nutritional status of a population infected by a coronavirus.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
403

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 24, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 28, 2020

Completed
2 days until next milestone

Study Start

First participant enrolled

April 30, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 10, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 10, 2020

Completed
Last Updated

July 28, 2020

Status Verified

July 1, 2020

Enrollment Period

2 months

First QC Date

April 24, 2020

Last Update Submit

July 24, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • Evaluation of food intake at 1 month after discharge from hospital for COVID

    Self assessment on the SEFI (Self-Evaluation of Food Intake) scale at one month after hospital discharge: 0 corresponds to the worsen score (no ingesta) and 10 corresponds to the best (same ingesta than before the disease)

    one month after hospital discharge

Secondary Outcomes (6)

  • Weight variation during the infection

    one month after hospital discharge

  • Clinical signs limiting food intake

    one month after hospital discharge

  • Factors limiting food intake

    one month after hospital discharge

  • Implemented nutritional strategy

    one month after hospital discharge

  • Pre-existing chronic disorders

    one month after hospital discharge

  • +1 more secondary outcomes

Study Arms (7)

Prospective cohort University Hospital, Grenoble

Semi-structured survey administered on the phone, once, one month after discharge from hospital. The interview will not be recorded.

Other: Interview

Prospective cohort University Hospital, Toulouse

Semi-structured survey administered on the phone, once, one month after discharge from hospital. The interview will not be recorded.

Other: Interview

Prospective cohort University Hospital, Nancy

Semi-structured survey administered on the phone, once, one month after discharge from hospital. The interview will not be recorded.

Other: Interview

Prospective cohort University Hospital, Rennes

Semi-structured survey administered on the phone, once, one month after discharge from hospital. The interview will not be recorded.

Other: Interview

Prospective cohort Hospices Civils de Lyon

Semi-structured survey administered on the phone, once, one month after discharge from hospital. The interview will not be recorded.

Other: Interview

Prospective cohort Assistance Publique Hôpitaux de Paris

Semi-structured survey administered on the phone, once, one month after discharge from hospital. The interview will not be recorded.

Other: Interview

Prospective cohort University Hospital, Rouen

Semi-structured survey administered on the phone, once, one month after discharge from hospital. The interview will not be recorded.

Other: Interview

Interventions

A survey was created, aiming to collect information about prior history of chronic disease, the Self-Evaluation of Food Intake, dysregulations (anosmia, ageusia...), anthropometric data, food data during and after hospitalisation, healthcare consumption since the discharge from hospital

Prospective cohort Assistance Publique Hôpitaux de ParisProspective cohort Hospices Civils de LyonProspective cohort University Hospital, GrenobleProspective cohort University Hospital, NancyProspective cohort University Hospital, RennesProspective cohort University Hospital, RouenProspective cohort University Hospital, Toulouse

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients will be recruited after they are discharged from Hospital Covid Units

You may qualify if:

  • days or more after discharge from hospital for Covid-19
  • Patient received information about the trial and gave his/her consent
  • Patient capable of answering the phone (alone or with some help)

You may not qualify if:

  • Patient diseased
  • impossibility to collect information from the patient or one of his/her relatives
  • Patient protected by the French Public Health Code (art. L1121-5 à L1121-8)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Marie-France VAILLANT

Grenoble, 38043, France

Location

MeSH Terms

Conditions

COVID-19

Interventions

Interviews as Topic

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Marie-France VAILLANT, PhD

    Centre Hospitalier Universitaire Grenoble Alpes

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 24, 2020

First Posted

April 28, 2020

Study Start

April 30, 2020

Primary Completion

July 10, 2020

Study Completion

July 10, 2020

Last Updated

July 28, 2020

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will not share

Locations