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

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

— COVINUT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04933929
• Other study ID #: 2020-A02168-31
• Status: Completed
• Phase: N/A
• Start date: July 27, 2020
• Est. completion date: July 1, 2021

Study information

• Verified date: February 2023
• Source: Gérond'if
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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 (-)".

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: July 1, 2021
• Est. primary completion date: April 22, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 75 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Coronavirus Infections
• COVID-19
• Severe Acute Respiratory Syndrome
• Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2)
• Syndrome

Intervention

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) .

Locations

Country	Name	City	State
France	Geriatric Department, Bichat, Beaujon and Bretonneau hospitals	Paris	IIe-de-France

Sponsors (1)

Lead Sponsor	Collaborator
Gérond'if

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparison of total energy requirements, after 3 months of dietary consultations, between Covid (+) and Covid (-) groups.	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	Assessment of the degree of patient dependence according "Index of Independence in Activities of Daily Living" KATZ scale	This is a measurement of the subject's ability to perform activities of daily living independently without including minimum and maximum values	At inclusion
Secondary	Assessment of patient's level of dependence through an appreciation of instrumental activities of daily living according Lawton scale	Assessment of older people: Self-maintaining and instrumental activities of daily living without including minimum and maximum values	At inclusion
Secondary	Comparison of weight variation by measuring the Body Mass Index (BMI)		6 months