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Dietetics Education Focused on Malnutrition Prevention (NUTRICOEUR)

Primary Purpose

Chronic Heart Failure (CHF)

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Educational Program
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Chronic Heart Failure (CHF) focused on measuring Chronic Heart Failure (CHF), Dietetics education, Malnutrition

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Sites / Locations

  • Henri Mondor HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Educational Program for prevention of malnutrition

Control

Arm Description

In 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.

In 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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Sodium intake will be evaluated by dietary survey on 24-hour recall and also by a rich-salt food frequency questionnaire
Protein supply (g / day) will be assessed by dietary survey on 24-hour recall and also by a food frequency questionnaire.
Energy intake (Kcal/day)will be assessed by dietary survey on 24-hour recall and also by a food frequency questionnaire.
EuroQol five dimensions questionnaire (EQ-5D)
Minnesota Living With Heart Failure Questionnaire (MLHFQ)
Questionnaire "burden of diet"
The compliance of dietary recommendations will be assessed by a tracking booklet in which food dietary recommendations will be reported
The unplanned hospitalizations frequency for cardiac decompensation
Death (cardiac cause included)

Full Information

First Posted
July 31, 2016
Last Updated
November 19, 2020
Sponsor
Assistance Publique - Hôpitaux de Paris
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1. Study Identification

Unique Protocol Identification Number
NCT02892747
Brief Title
Dietetics Education Focused on Malnutrition Prevention
Acronym
NUTRICOEUR
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Unknown status
Study Start Date
September 2016 (undefined)
Primary Completion Date
November 2020 (Anticipated)
Study Completion Date
November 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Heart Failure (CHF)
Keywords
Chronic Heart Failure (CHF), Dietetics education, Malnutrition

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
295 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Educational Program for prevention of malnutrition
Arm Type
Experimental
Arm Description
In 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.
Arm Title
Control
Arm Type
No Intervention
Arm Description
In 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.
Intervention Type
Behavioral
Intervention Name(s)
Educational Program
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
Sodium intake will be evaluated by dietary survey on 24-hour recall and also by a rich-salt food frequency questionnaire
Time Frame
8th day, 1 month, 2 months, 3 months, 4 months, 5 months and 6 months
Title
Protein supply (g / day) will be assessed by dietary survey on 24-hour recall and also by a food frequency questionnaire.
Time Frame
8th day, 1 month, 2 months, 3 months, 4 months, 5 months and 6 months
Title
Energy intake (Kcal/day)will be assessed by dietary survey on 24-hour recall and also by a food frequency questionnaire.
Time Frame
8th day, 1 month, 2 months, 3 months, 4 months, 5 months and 6 months
Title
EuroQol five dimensions questionnaire (EQ-5D)
Time Frame
6 months after randomization
Title
Minnesota Living With Heart Failure Questionnaire (MLHFQ)
Time Frame
6 months after randomization
Title
Questionnaire "burden of diet"
Time Frame
6 months after randomization
Title
The compliance of dietary recommendations will be assessed by a tracking booklet in which food dietary recommendations will be reported
Time Frame
8th day, 1 month, 2 months, 3 months, 4 months, 5 months and 6 months
Title
The unplanned hospitalizations frequency for cardiac decompensation
Time Frame
6 months after randomization
Title
Death (cardiac cause included)
Time Frame
8th day, 1 month, 2 months, 3 months, 4 months, 5 months and 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Véronique BENEDYGA, Nutritionist
Phone
(0)1 49 81 22 32
Ext
+33
Email
veronique.benedyga@aphp.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Véronique BENEDYGA, Nutritionist
Organizational Affiliation
Assistance Publique - Hôpitaux de Paris
Official's Role
Principal Investigator
Facility Information:
Facility Name
Henri Mondor Hospital
City
Creteil
ZIP/Postal Code
94010
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Laetitia GREGOIRE
Phone
(0)1 49 81 41 64
Ext
+33
Email
Laetitia.gregoire@aphp.fr
First Name & Middle Initial & Last Name & Degree
Aroua ZRIBI
Phone
(0)1 49 81 47 87
Ext
+33
Email
aroua.zribi@aphp.fr

12. IPD Sharing Statement

Citations:
PubMed Identifier
14622767
Citation
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.
Results Reference
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PubMed Identifier
19857633
Citation
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.
Results Reference
background
PubMed Identifier
15642875
Citation
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. Erratum In: Arch Intern Med. 2008 Mar 24;168(6):567.
Results Reference
background
PubMed Identifier
22173621
Citation
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.
Results Reference
background
PubMed Identifier
20650358
Citation
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.
Results Reference
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Dietetics Education Focused on Malnutrition Prevention

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