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

NCT04933929 | Completed

• 1 other identifier: 2020-A02168-31
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief 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 (-)".

Conditions

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

Keywords

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)-positive patients; Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)-negative patients; Coronavirus disease 2019 (COVID-19)

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Assessment of the degree of patient dependence according "Index of Independence in Activities of Daily Living" KATZ scale

  At inclusion

• Assessment of patient's level of dependence through an appreciation of instrumental activities of daily living according Lawton scale

  At inclusion

• Comparison of weight variation by measuring the Body Mass Index (BMI)

  6 months

Study Arms (2)

Coronavirus disease Positive group "Covid (+)"

EXPERIMENTAL

Positive PCR test.

Behavioral: Post-hospitalization nutritional monitoring

Coronavirus disease Negative group "Covid (-)"

ACTIVE COMPARATOR

Negative PCR test.

Behavioral: Post-hospitalization nutritional monitoring

Interventions

Post-hospitalization nutritional monitoring BEHAVIORAL

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) .

Coronavirus disease Negative group "Covid (-)"; Coronavirus disease Positive group "Covid (+)"

Eligibility Criteria

• Age: 75 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Gérond'if: lead

Study Sites (1)

Geriatric Department, Bichat, Beaujon and Bretonneau hospitals

Paris, IIe-de-France, 75018, France

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Agathe RAYNAUD-SIMON, MD PhD

  Geriatric Department, Bichat, Beaujon and Bretonneau hospitals

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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) .

Study Record Dates

• First Submitted: May 24, 2021
• First Posted: June 22, 2021
• Study Start: July 27, 2020
• Primary Completion: April 22, 2021
• Study Completion: July 1, 2021
• Last Updated: February 14, 2023

Record last verified: 2023-02

Locations

FR (1)