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)

February 13, 2023 updated by: Gérond'if

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

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 (-)".

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

34

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • IIe-de-France
      • Paris, IIe-de-France, France, 75018
        • Geriatric Department, Bichat, Beaujon and Bretonneau hospitals

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

75 years and older (OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Coronavirus disease Positive group "Covid (+)"
Positive PCR test.
Behavioral: Post-hospitalization nutritional monitoring
Post-hospitalization nutritional monitoring, carried out by dieticians from Saveurs & Vie. Consultations are done remotely, by phone only. Dietitians have gained experience in home nutritional monitoring of elderly people over the phone during the first wave of Coronavirus disease 2019 (COVID-19) .
ACTIVE_COMPARATOR: Coronavirus disease Negative group "Covid (-)"
Negative PCR test.
Behavioral: Post-hospitalization nutritional monitoring
Post-hospitalization nutritional monitoring, carried out by dieticians from Saveurs & Vie. Consultations are done remotely, by phone only. Dietitians have gained experience in home nutritional monitoring of elderly people over the phone during the first wave of Coronavirus disease 2019 (COVID-19) .

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparison of total energy requirements, after 3 months of dietary consultations, between Covid (+) and Covid (-) groups.
Time Frame: 6 months

A 30 to 40 minute telephone survey by a dietitian, with:

  • the reminder of food intake over 24 hours, estimation of the weight of each food and quantification in kcal / day and grams of protein / day.
  • This assessment of food intake will be followed by nutritional advice adapted to the severity of undernutrition, spontaneous food intake, the subject's tastes and dislikes, and the possibilities of preparing the necessary dishes and textures.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessment of the degree of patient dependence according "Index of Independence in Activities of Daily Living" KATZ scale
Time Frame: At inclusion
This is a measurement of the subject's ability to perform activities of daily living independently without including minimum and maximum values
At inclusion
Assessment of patient's level of dependence through an appreciation of instrumental activities of daily living according Lawton scale
Time Frame: At inclusion
Assessment of older people: Self-maintaining and instrumental activities of daily living without including minimum and maximum values
At inclusion
Comparison of weight variation by measuring the Body Mass Index (BMI)
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gérond'if

Investigators

  • Study Chair: Agathe RAYNAUD-SIMON, MD PhD, Geriatric Department, Bichat, Beaujon and Bretonneau hospitals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

July 27, 2020

Primary Completion (ACTUAL)

April 22, 2021

Study Completion (ACTUAL)

July 1, 2021

Study Registration Dates

First Submitted

May 24, 2021

First Submitted That Met QC Criteria

June 21, 2021

First Posted (ACTUAL)

June 22, 2021

Study Record Updates

Last Update Posted (ESTIMATE)

February 14, 2023

Last Update Submitted That Met QC Criteria

February 13, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020-A02168-31

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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