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

NCT ID: NCT04933929

Last Updated: 2023-02-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-07-27

Study Completion Date

2021-07-01

Brief Summary

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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 (-)".

Detailed Description

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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.

Conditions

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

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Coronavirus disease Positive group "Covid (+)"

Positive PCR test.

Group Type EXPERIMENTAL

Post-hospitalization nutritional monitoring

Intervention Type 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 (-)"

Negative PCR test.

Group Type ACTIVE_COMPARATOR

Post-hospitalization nutritional monitoring

Intervention Type 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) .

Interventions

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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) .

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Gérond'if

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Agathe RAYNAUD-SIMON, MD PhD

Role: STUDY_CHAIR

Geriatric Department, Bichat, Beaujon and Bretonneau hospitals

Locations

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Geriatric Department, Bichat, Beaujon and Bretonneau hospitals

Paris, IIe-de-France, France

Site Status

Countries

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France

Other Identifiers

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2020-A02168-31

Identifier Type: -

Identifier Source: org_study_id

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