Back to resultsPersonalized 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 (COVINUT)
Primary Purpose
Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2)
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Post-hospitalization nutritional monitoring
Sponsored by
About this trial
This is an interventional supportive care trial for Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) focused on measuring 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)
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.
Sites / Locations
- Geriatric Department, Bichat, Beaujon and Bretonneau hospitals
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Coronavirus disease Positive group "Covid (+)"
Coronavirus disease Negative group "Covid (-)"
Arm Description
Positive PCR test.
Negative PCR test.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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
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
Comparison of weight variation by measuring the Body Mass Index (BMI)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04933929
Brief 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
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
July 27, 2020 (Actual)
Primary Completion Date
April 22, 2021 (Actual)
Study Completion Date
July 1, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Gérond'if
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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)
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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) .
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
34 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Coronavirus disease Positive group "Covid (+)"
Arm Type
Experimental
Arm Description
Positive PCR test.
Arm Title
Coronavirus disease Negative group "Covid (-)"
Arm Type
Active Comparator
Arm Description
Negative PCR test.
Intervention Type
Behavioral
Intervention Name(s)
Post-hospitalization nutritional monitoring
Intervention 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 Outcome Measure Information:
Title
Comparison of total energy requirements, after 3 months of dietary consultations, between Covid (+) and Covid (-) groups.
Description
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.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Assessment of the degree of patient dependence according "Index of Independence in Activities of Daily Living" KATZ scale
Description
This is a measurement of the subject's ability to perform activities of daily living independently without including minimum and maximum values
Time Frame
At inclusion
Title
Assessment of patient's level of dependence through an appreciation of instrumental activities of daily living according Lawton scale
Description
Assessment of older people: Self-maintaining and instrumental activities of daily living without including minimum and maximum values
Time Frame
At inclusion
Title
Comparison of weight variation by measuring the Body Mass Index (BMI)
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Agathe RAYNAUD-SIMON, MD PhD
Organizational Affiliation
Geriatric Department, Bichat, Beaujon and Bretonneau hospitals
Official's Role
Study Chair
Facility Information:
Facility Name
Geriatric Department, Bichat, Beaujon and Bretonneau hospitals
City
Paris
State/Province
IIe-de-France
ZIP/Postal Code
75018
Country
France
12. IPD Sharing Statement
Learn more about this trial
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
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