An interventional study of Self-Care Behavior in Chronic Heart Failure and Nutrition, sponsored by National Taiwan University Hospital. Completed at 1 site in Taiwan. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2021-02-02.
Sponsored by National Taiwan University Hospital · Not applicable, Interventional, and Supportive care
This study recruited patients diagnosed with heart failure by cardiologists and cardiac outpatients whose cardiac functions were graded from 1 to 4 according to the New York Heart Association as the study participants. The participants were provided active nutrition intervention including diet optimization,specific recommendations and nutritional supplement prescriptions in cases in which nutritional goals were not reached.In addition, this study offered advice by referencing lifestyle change advice provided by the American Heart Association for patients with heart failure.
The Mini Nutritional Assessment Short-Form was used to assess malnutrition indicator values. The participant water, nutrient (i.e., carbohydrates, protein, and fat), and calorie intake data were collected using their recollection of their dietary intake and food intake frequency over a 24-hour dietary recall. The amount of fluid and sodium administered was provided according to the cardiac function grades indicated by the New York Heart Association.In addition, dietary assessments and nutritional advice were offered on the basis of the patients' conditions (i.e., age, activity, and comorbidity).
Finally, instrumental activities of daily living, EQ-5D (an instrument for measuring quality of life), grip performance, and 6-minute walk test data were utilized to analyze the changes in the participants before and after intervention, identifying the correlation between using nutrition education as an intervention measure and improvement in the participants' nutritional status, quality of life, and self-care behavior.
Malnutrition may be caused by decreased nutrient intake or absorption, inflammation, or other disease-related mechanisms. Malnutrition resulting from disease or injury may be caused by decreased food intake or varying degrees of acute or chronic inflammation, which alters body composit ion and prompts a decline in biological functions. The effects of decreased food intake induced by an inflammatory reaction are related to the malnourishment resulted from anorexia, changes in metabolism, increased resting energy expenditure, and increased muscle catabolism. Changes in body composition are characterized by a decrease in any muscle mass marker (excluding fat mass, muscle mass index, or body cell mass). Therefore, malnutrition is associated with clinical results of clinical malfunction.
The primary objectives of heart failure treatment include preventing the need for hospitalization, increasing the survival rate, and improving health status. Patient symptoms, bodily functions, and health status are also referred to as health-related quality of life (HRQoL). The EuroQol-5D (EQ-5D) is used to assess the quality of life of patients undergoing cardiac rehabilitation. This assessment uses 5 aspects, namely mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, to assess patient health status.
Cardiopulmonary exercise testing (CPET) is the gold standard method for evaluating the motor ability of patients with chronic heart failure (CHF), yet is not extensively used. A more commonly used and simpler method is the 6-minute walk test, which measures the distance traveled by walking for 6 minutes. Changes in this value correlate to quality of life. This test is used to investigate the ability to perform daily activities and intensity of exercise in patients with mild to moderate CHF.
Muscle strength is a key indicator for assessing patients with sarcopenia because decreased muscle strength is considered a crucial element in diagnosing muscle reduction. For circumstances in which muscle mass is difficult to assess, muscle strength, such as handgrip strength, can serve as a standard assessment of muscle functions.
Exercise training is considered a valid method for stabilizing patients with heart failure. One study reported that the self-management intervention of a patient with heart failure notably decreased the occurrence of hospitalization and hospital readmission related to heart failure as well as all-cause mortality.
The present study determines the effectiveness of nutrition intervention in routine medical treatment for improving the nutrition and quality of care among patients with heart failure.
This study does not involve drugs, medical technology, or medical equipment.
5,701 studies on the registry are indexed under Heart Failure; 1,220 are open to participants now.
This study's enrollment of 95 is above the median of 72 across 3,736 interventional studies indexed under Heart Failure.
Browse Heart Failure studies →National Taiwan University Hospital is the lead sponsor of 2,563 studies on the registry; 569 are open to participants now.
Of its 11 completed or terminated interventional studies of FDA-regulated products, 2 (18%) have results posted.
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Exclusion Criteria:
Behavioral: Self-Care Behavior
Limitations on liquid and sodium intake will be established in accordance with the NYHA functional classification, and patients will be provided with dietary assessments and nutrition advice according to personal characteristics such as age, physical activity level, and comorbidities. Additionally, suggestions on lifestyle changes were provided by referring to the advice for patients with heart failure from the American Heart Association.
Mini Nutritional Assessment Short-Form
Assess malnutrition indicator values. Nutrition status evaluated by the MNA correlates with energy and nutrient intakes as well as anthropometrics, hematologic, and biological nutrition parameters. MNA has 4 sections: anthropometrics (BMI, weight loss, arm and calf circumference), general assessment (lifestyle, medication, mobility, presence of depression or dementia), dietary assessment (number of meals, food and fluid intake, autonomy of feeding), and subjective assessment (self-perception of health and nutrition). The maximum score for the MNA-SF is 14, with scores ≥12 indicating satisfactory nutrition status and ≤11 indicating a risk of malnutrition.
Time frame: Change from Baseline Mini Nutritional Assessment Short-Form on months 0, 3 at 6 months(Do higher values represent a better outcome).
Instrumental Activities of Daily Living
Instrumental Activities of Daily Living Heath-related quality of life. IADL Scale was developed to assess more complex activities (termed "instrumental activities of daily living") necessary for functioning in community settings (e.g., shopping, cooking, managing finances). The capacity to handle these complex functions normally is lost before basic "activities of daily living" (e.g., eating, bathing, toileting) which are measured by ADL scales. Therefore, assessing IADLS may identify incipient decline in older adults or other individuals who are otherwise capable and healthy. It contains 8 items that are rated with a summary score from 0 (low functioning) to 8 (high functioning). This scale can be administered through an interview or by a written questionnaire.
Time frame: Change from Baseline Instrumental Activities of Daily Living on months 0, 3 at 6 months.
EuroQol-5D
Assess the quality of life of patients undergoing cardiac rehabilitation. the generic EuroQol fivedimensional questionnaire (EQ-5D) instrument are commonly referred to as value sets; an important distinction lies in whether the valuations are elicited from individuals with experience of the health state (experience-based values) or from individuals from the general population to whom the health states are described (hypothetical values). * 100 means the best health you can imagine. * 0 means the worst health you can imagine.
Time frame: Change from Baseline EuroQol-5D on months 0, 3 at 6 months(Do higher values represent a better outcome).
Handgrip strength
Assessment of muscle functions. Measured by dynamometer, before and after intervention. We will compare the statistical properties of between baseline and after 0, 3 at 6 months intervention.
Time frame: Change from Baseline Handgrip strength on months 0, 3 at 6 months.
6-Minute walk test
Changes in this value correlate to quality of life
Time frame: Change from Baseline 6-Minute walk test on months 0, 3 at 6 months(Do higher values represent a better outcome).
Energy intake
Energy intake (Kcal/day)will be assessed by dietary survey on 24-hour recall.
Time frame: Change from Baseline Energy intake on months 0, 3 at 6 months.
Carbohydrate intake
Carbohydrate intake (g / day) will be assessed by dietary survey on 24-hour recall.
Time frame: Change from Baseline Carbohydrate intake on months 0, 3 at 6 months.
Protein intake
Protein intake (g / day) will be assessed by dietary survey on 24-hour recall.
Time frame: Change from Baseline Protein intake on months 0, 3 at 6 months.
Fat intake
Fat intake (g / day) will be assessed by dietary survey on 24-hour recall.
Time frame: Change from Baseline Fat intake on months 0, 3 at 6 months.
Sodium intake
Sodium intake (gm / day) will be evaluated by dietary survey on 24-hour recall.
Time frame: Change from Baseline Sodium intake on months 0, 3 at 6 months.
Water intake
Water intake (ml / day) will be evaluated by dietary survey on 24-hour recall.
Time frame: Change from Baseline Water intake on months 0, 3 at 6 months.
Plan to share: No — De-identified individual participant data for all primary and secondary outcome meaurses will be made available
This study is completed, as verified in Dec 2020. You cannot join it, but the record below documents what was studied.
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