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Chronic Heart Failure (CHF)NUTRICOEURNCT02892747

Dietetics Education Focused on Malnutrition Prevention

A study testing Educational Program in people with Chronic Heart Failure (CHF), run by Assistance Publique - Hôpitaux de Paris at 1 site in France.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The intervention tested in this research project aims to reduce the unplanned hospitalizations in CHF patients by preventing the malnutrition using a personalized dietetic education program. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Chronic Heart Failure (CHF)
What is being tested?
Educational Program
Could I receive a placebo?
No, everyone receives an active treatment
How many people
295 participants
Where
1 siteFrance
Study dates
Sep 2016to Nov 2020
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients aged 18 years old and over.
  • Patients with Chronic Heart Failure regardless of its severity stage: stage I to IV according to the New York Heart Association Classification (NYHC), and its age.
  • Patients having at least a cardiac failure on the last two years.
  • BMI ≥ 18,5 (≥ 21 if Age ≥ 70 years).
  • Patients with a prescription of dietary salt restriction, regardless of the amount of salt recommended.
  • Patients benefiting from the Patient Therapeutic Education Program (ICARE) focusing on managing sodium intake.
  • Patients informed of the study, and have given their oral non opposition.
  • Patients insured by a social security.

Who cannot join

  • Severe comorbidity (outside the CHF) affecting the prognosis at 3 months
  • Living in nursing homes or in housing home where it is difficult to manage their feed.

Trial locations and contacts

1 site in 1 country.

Véronique BENEDYGA, Nutritionist contact

(0)1 49 81 22 32 ext. +33

veronique.benedyga@aphp.fr

France1 site, 1 recruiting

  • Henri Mondor Hospital

    Créteil, 94010

    Laetitia GREGOIRE, (0)1 49 81 41 64 ext. +33, Laetitia.gregoire@aphp.fr

    Aroua ZRIBI, (0)1 49 81 47 87 ext. +33, aroua.zribi@aphp.fr

    Recruiting

Other trials in France

About this study

Official title: Impact of Dietetics Education Focused on Prevention of Malnutrition, on Reducing Morbidity and Improving Life Quality of Patients With Chronic Heart Failure (CHF): A Randomized Controlled Multicenter Clinical Trial

The intervention tested in this research project aims to reduce the unplanned hospitalizations in CHF patients by preventing the malnutrition using a personalized dietetic education program. This new program provides concrete solutions to patients by offering balanced menu ideas, adapted to their tastes and social-cultural habits, and a panel of recipes easy to make, inexpensive and tasty (despite the lack of salt). This new educational program should improve the dietary behavior of patients and reinforce the importance of dietary guidance in support of the CHF.

Read the detailed description

Context: The Chronic Heart Failure (CHF) is a major public health problem in terms of frequency, mortality and costs. The care integrates a low-salt diet to reduce fluid retention and cardiac decompensation. A large observational study (ODIN) shows the effectiveness of the Patient's Therapeutic Education program (PTE which provides learning management sodium intake by the intervention of a dietician, I-CARE) on reducing mortality. But prognosis of CHF remains serious leading to many hospitalizations. The nutritional status of patients with CHF is threatened by inadequate energy intake in connection with the low sodium diet and the rest energetic cost (REC). Malnutrition increases the risk of hospitalization because it causes an immune deficiency responsible for infections, bones weakness and impaired cognitive function.

Hypotheses: The investigators postulate that an educational diet focusing on prevention of malnutrition would reduce morbidity and improve quality of life for patients with CHF. For this, the investigators propose a new educational method: adding a personalized program monitoring energy and protein intake in addition to managing sodium intake, notably by offering personalized menu ideas and recipes.

Main objective: Demonstrate that a dietetic education program involving the prevention of malnutrition and managing sodium intake is more effective than the usual dietetic education (based only on management of sodium intake) on the frequency of unplanned hospitalizations (all causes ) at 6 months in CHF patients.

Secondary Objectives: Demonstrate the superiority of the dietetic education program involving the prevention of malnutrition and managing sodium intake over the usual dietetic education, by improving the nutritional status, the quality of life, the survival, the adherence to dietary recommendations and the reduction of hospitalizations for cardiac decompensation, the burden associated with low sodium diet and the costs.

Being tested
Educational Program
Keywords
Chronic Heart Failure (CHF), Dietetics education, Malnutrition
Medical subject headings
Malnutrition

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Educational ProgramBehavioural

Study groups in NCT02892747
Study groupRoleWhat they receive
Educational Program for prevention of malnutritionExperimentalIn addition to the usual nutritional assessment, the patients in the experimental arm benefit of a personalized educational program for prevention of malnutrition. This program aims to monitor energy and protein intake in addition to managing sodium intake, notably by offering personalized menu ideas and recipes.
Receives: Behavioral: Educational Program
ControlNo interventionIn the control arm, patients are followed-up by the cardiologist and the nutritionist, and did not benefit of the personalized educational program for prevention of malnutrition.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The number, duration, reason of hospitalization will be reported in a tracking booklet that will be given to the patient the day of his/her inclusion

    Measured: 6 months after randomization

Secondary outcomes (9)

  1. Sodium intake will be evaluated by dietary survey on 24-hour recall and also by a rich-salt food frequency questionnaire

    Measured: 8th day, 1 month, 2 months, 3 months, 4 months, 5 months and 6 months

  2. Protein supply (g / day) will be assessed by dietary survey on 24-hour recall and also by a food frequency questionnaire.

    Measured: 8th day, 1 month, 2 months, 3 months, 4 months, 5 months and 6 months

  3. Energy intake (Kcal/day)will be assessed by dietary survey on 24-hour recall and also by a food frequency questionnaire.

    Measured: 8th day, 1 month, 2 months, 3 months, 4 months, 5 months and 6 months

  4. EuroQol five dimensions questionnaire (EQ-5D)

    Measured: 6 months after randomization

  5. Minnesota Living With Heart Failure Questionnaire (MLHFQ)

    Measured: 6 months after randomization

  6. Questionnaire "burden of diet"

    Measured: 6 months after randomization

  7. The compliance of dietary recommendations will be assessed by a tracking booklet in which food dietary recommendations will be reported

    Measured: 8th day, 1 month, 2 months, 3 months, 4 months, 5 months and 6 months

  8. The unplanned hospitalizations frequency for cardiac decompensation

    Measured: 6 months after randomization

  9. Death (cardiac cause included)

    Measured: 8th day, 1 month, 2 months, 3 months, 4 months, 5 months and 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Sep 2016 (estimated)
  2. Study startSep 2016
  3. Primary completionNov 2020 (estimated)
  4. Study completionNov 2020 (estimated)

Resources

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
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
295 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02892747
Sponsor's protocol ID
K140703
Acronym
NUTRICOEUR
Status last verified
Nov 2020
First submitted
31 Jul 2016
Last updated
20 Nov 2020
Results posted
No
Data monitoring committee
No

Publications

  • Nicol SM, Carroll DL, Homeyer CM, Zamagni CM. The identification of malnutrition in heart failure patients. Eur J Cardiovasc Nurs. 2002 Jun;1(2):139-47. doi: 10.1016/s1474-5151(02)00005-1.

    PubMed 14622767

  • Arcand J, Floras V, Ahmed M, Al-Hesayen A, Ivanov J, Allard JP, Newton GE. Nutritional inadequacies in patients with stable heart failure. J Am Diet Assoc. 2009 Nov;109(11):1909-13. doi: 10.1016/j.jada.2009.08.011.

    PubMed 19857633

  • Curtis JP, Selter JG, Wang Y, Rathore SS, Jovin IS, Jadbabaie F, Kosiborod M, Portnay EL, Sokol SI, Bader F, Krumholz HM. The obesity paradox: body mass index and outcomes in patients with heart failure. Arch Intern Med. 2005 Jan 10;165(1):55-61. doi: 10.1001/archinte.165.1.55.

    PubMed 15642875

  • Beck CA, Shah S. Research on health-related quality of life and cardiac conditions. Home Healthc Nurse. 2012 Jan;30(1):54-60. doi: 10.1097/NHH.0b013e31823aa740.

    PubMed 22173621

  • Ferrante D, Varini S, Macchia A, Soifer S, Badra R, Nul D, Grancelli H, Doval H; GESICA Investigators. Long-term results after a telephone intervention in chronic heart failure: DIAL (Randomized Trial of Phone Intervention in Chronic Heart Failure) follow-up. J Am Coll Cardiol. 2010 Jul 27;56(5):372-8. doi: 10.1016/j.jacc.2010.03.049.

    PubMed 20650358

Questions about this trial

What is this clinical trial studying?

A study testing Educational Program in people with Chronic Heart Failure (CHF), run by Assistance Publique - Hôpitaux de Paris 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 8 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 20 Nov 2020. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Véronique BENEDYGA, Nutritionist ((0)1 49 81 22 32 ext. +33, veronique.benedyga@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The number, duration, reason of hospitalization will be reported in a tracking booklet that will be given to the patient the day of his/her inclusion (time frame: 6 months after randomization). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02892747, which also lists 5 linked publications.

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 20 Nov 2020.

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