Clinical trial 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
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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)
Lead sponsor: Gérond'if
Sponsor class: OTHER
First posted: 2021-06-22
Enrollment: 34
Sex: ALL
Minimum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 purpose: SUPPORTIVE_CARE

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 (-)".

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Comparison of total energy requirements, after 3 months of dietary consultations, between Covid (+) and Covid (-) groups.
timeFrame: 6 months
Secondary outcomes:
measure: Assessment of the degree of patient dependence according "Index of Independence in Activities of Daily Living" KATZ scale
timeFrame: At inclusion
measure: Assessment of patient's level of dependence through an appreciation of instrumental activities of daily living according Lawton scale
timeFrame: At inclusion
measure: Comparison of weight variation by measuring the Body Mass Index (BMI)
timeFrame: 6 months
Other outcomes:
Locations:
city: Paris
country: France
facility: Geriatric Department, Bichat, Beaujon and Bretonneau hospitals
state: IIe-de-France
Study officials:
affiliation: Geriatric Department, Bichat, Beaujon and Bretonneau hospitals
name: Agathe RAYNAUD-SIMON, MD PhD
role: STUDY_CHAIR
References: