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Personalized Dietary Advice 3 Months After Discharge From Hospitalization in Geriatrics: Effect on Nutritional Status According to Coronavirus Disease 2019 (COVID-19) Status (Positive or Negative) During Hospitalization (COVINUT)

G

Gérond'if

Status

Completed

Conditions

Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2)

Treatments

Behavioral: Post-hospitalization nutritional monitoring

Study type

Interventional

Funder types

Other

Identifiers

NCT04933929
2020-A02168-31

Details and patient eligibility

About

The principal aim of this interventional, multicentre study is to compare the impact of a follow-up by monthly telephone dietetic consultations, started 3 months after discharge from hospital, for a period of 3 months, on the energy intake in patients elderly people recently hospitalized for Coronavirus disease 2019 (Covid-19), Coronavirus disease Positive group "Covid (+)", or not, Coronavirus disease Negative group"Covid (-)".

The main outcome measure is to compare the total energy intake at 6 months, after 3 months of dietary consultations, between Coronavirus disease Positive group "Covid (+)" and Coronavirus disease negative group "Covid (-)".

Full description

This study consists of nutritional monitoring after hospitalization, carried out by dieticians. Consultations are done remotely, by phone only.

Eligible subjects are included, either upon discharge from hospital or within 3 months (at the latest) following their hospitalization.

135 subjects will be included, 50% will be included in Coronavirus disease Positive group "Covid (+)" and 50% in the Coronavirus desease negative group "Covid (-)" .

The following data will be collected

  • At Inclusion (D0): Average length of hospital stay, medical diagnoses, severity of hospital stay, autonomy and dependency scores, albumin and body mass index (BMI).
  • At M3, M4, M5 and M6: Dietary monitoring data, patient's vital status and dependency scores.

Enrollment

34 patients

Sex

All

Ages

75+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Patient hospitalized or having been hospitalized in acute geriatrics
  • Living at home 3 months after hospitalization in acute geriatrics
  • Having a good understanding of the French language
  • Being able to understand the study information and participate in telephone follow-up
  • Having read the information notice and agreeing to participate in the study
  • For the Covid (+) group: hospitalized for Covid-19 (diagnostic confirmation by positive RT-PCR)
  • For the Covid group (-): hospitalized for any other reason (negative RT-PCR)

Exclusion criteria

  • Patient refusing to participate in the study
  • Subject to a legal protection measure (curatorship, guardianship or safeguard of justice)
  • With cognitive impairment making it impossible to understand the study protocol and express consent.

Trial design

Primary purpose

Supportive Care

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

34 participants in 2 patient groups

Coronavirus disease Positive group "Covid (+)"
Experimental group
Description:
Positive PCR test.
Treatment:
Behavioral: Post-hospitalization nutritional monitoring
Coronavirus disease Negative group "Covid (-)"
Active Comparator group
Description:
Negative PCR test.
Treatment:
Behavioral: Post-hospitalization nutritional monitoring

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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