Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2)COVINUTNCT04933929
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
A study testing Post-hospitalization nutritional monitoring in people with Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2), run by Gérond'if at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 75 years and older
- Conditions the study is for
- Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2)
- What is being tested?
- Post-hospitalization nutritional monitoring
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteFrance
- Study dates
- 27 Jul 2020to 1 Jul 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 75 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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)
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
France1 site
Geriatric Department, Bichat, Beaujon and Bretonneau hospitals
Paris, IIe-de-France, 75018
About this study
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
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 (-)".
Read the 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.
- Being tested
- Post-hospitalization nutritional monitoring
- 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)
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Post-hospitalization nutritional monitoringBehavioural
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 group | Role | What they receive |
|---|---|---|
| Coronavirus disease Positive group "Covid (+)" | Experimental | Positive PCR test. Receives: Behavioral: Post-hospitalization nutritional monitoring |
| Coronavirus disease Negative group "Covid (-)" | Active comparator | Negative PCR test. Receives: Behavioral: Post-hospitalization nutritional monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (3)
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
Measured: At inclusion
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
Measured: At inclusion
Comparison of weight variation by measuring the Body Mass Index (BMI)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2021
- Study start27 Jul 2020
- Primary completion22 Apr 2021
- Study completion1 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gérond'if
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Agathe RAYNAUD-SIMON, MD PhD, Study chair, Geriatric Department, Bichat, Beaujon and Bretonneau hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04933929
- Sponsor's protocol ID
- 2020-A02168-31
- Acronym
- COVINUT
- Status last verified
- Feb 2023
- First submitted
- 24 May 2021
- Last updated
- 14 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04933929
- Acronym / sponsor ID
- COVINUT / 2020-A02168-31
- 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)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Gérond'ifUniversity, hospital or other
- Study start
- 27 Jul 2020 (actual)
- Primary completion
- 22 Apr 2021 (actual)
- Study completion
- 1 Jul 2021 (actual)
- First posted
- 22 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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) .
| Arm | Type | Receives |
|---|---|---|
| Coronavirus disease Positive group "Covid (+)" | Experimental | Behavioral: Post-hospitalization nutritional monitoringPositive PCR test. |
| Coronavirus disease Negative group "Covid (-)" | Active comparator | Behavioral: Post-hospitalization nutritional monitoringNegative PCR test. |
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Post-hospitalization nutritional monitoringPost-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) . | Behavioural | Coronavirus disease Negative group "Covid (-)", Coronavirus disease Positive group "Covid (+)" |
Primary outcome
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.
3 secondary outcomes
Assessment of the degree of patient dependence according "Index of Independence in Activities of Daily Living" KATZ scale
Time frame: At inclusion
Assessment of patient's level of dependence through an appreciation of instrumental activities of daily living according Lawton scale
Time frame: At inclusion
Comparison of weight variation by measuring the Body Mass Index (BMI)
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Agathe RAYNAUD-SIMON, MD PhD study chair
Geriatric Department, Bichat, Beaujon and Bretonneau hospitals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Post-hospitalization nutritional monitoring in people with Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2), run by Gérond'if at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of total energy requirements, after 3 months of dietary consultations, between Covid (+) and Covid (-) groups. (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Feb 2023.