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Completed

NCT Number: NCT04933929

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 (-)".

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Key information

Conditions

Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

75 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Geriatric Department, Bichat, Beaujon and Bretonneau hospitals

Paris, IIe-de-France, 75018, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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) .

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

  2. 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

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

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Gérond'if

Other

Registry information

Acronym: COVINUT

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jun 22, 2021
Registry last updated
Feb 14, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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