Dietetics Education Focused on Malnutrition Prevention

Chronic Heart Failure (CHF) Clinical Trial

— 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02892747
• Other study ID #: K140703
• Status: Recruiting
• Phase: N/A
• Start date: September 2016
• Est. completion date: November 2020

Study information

• Verified date: November 2020
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Véronique BENEDYGA, Nutritionist
• Phone: (0)1 49 81 22 32
• Email: veronique.benedyga[@]aphp.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 295
• Est. completion date: November 2020
• Est. primary completion date: November 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Heart Failure (CHF)
• Heart Failure
• Malnutrition

Intervention

Behavioral:
• Educational Program

Locations

Country	Name	City	State
France	Henri Mondor Hospital	Creteil

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

References & Publications (5)

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. — View 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. — View 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. Erratum in: Arch Intern Med. 2008 Mar 24;168(6):567. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		6 months after randomization
Secondary	Sodium intake will be evaluated by dietary survey on 24-hour recall and also by a rich-salt food frequency questionnaire		8th day, 1 month, 2 months, 3 months, 4 months, 5 months and 6 months
Secondary	Protein supply (g / day) will be assessed by dietary survey on 24-hour recall and also by a food frequency questionnaire.		8th day, 1 month, 2 months, 3 months, 4 months, 5 months and 6 months
Secondary	Energy intake (Kcal/day)will be assessed by dietary survey on 24-hour recall and also by a food frequency questionnaire.		8th day, 1 month, 2 months, 3 months, 4 months, 5 months and 6 months
Secondary	EuroQol five dimensions questionnaire (EQ-5D)		6 months after randomization
Secondary	Minnesota Living With Heart Failure Questionnaire (MLHFQ)		6 months after randomization
Secondary	Questionnaire "burden of diet"		6 months after randomization
Secondary	The compliance of dietary recommendations will be assessed by a tracking booklet in which food dietary recommendations will be reported		8th day, 1 month, 2 months, 3 months, 4 months, 5 months and 6 months
Secondary	The unplanned hospitalizations frequency for cardiac decompensation		6 months after randomization
Secondary	Death (cardiac cause included)		8th day, 1 month, 2 months, 3 months, 4 months, 5 months and 6 months