Chronic Heart FailureNCT03845309
Nutritional Interventions in Chronic Heart Failure
A study testing Self-Care Behavior in people with Chronic Heart Failure and Nutrition, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Chronic Heart Failure, Nutrition
- What is being tested?
- Self-Care Behavior
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 95 participants
- Where
- 1 siteTaiwan
- Study dates
- 19 Feb 2019to 13 Dec 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients diagnosed with CHF by a cardiologist. Clinical patients with the functional classification of NYHA FcI-NYHA FcⅣ according to the New York Heart Association (NYHA).
- Adults aged 20 years or older who are conscious, have normal cognitive function, can walk without assistance, and do not require breathing aids. Additionally, participants must be able to answer questionnaires in Mandarin Chinese or Taiwanese, either orally or in writing.
- Patients who have agreed to participate in the study by completing a consent form.
Who cannot join
- Patients with an expected survival period of less than 6 months because of a disease not related to CHF
- Long-term bed-bound patients
- Patients with no potential for rehabilitation because of decline in functions of neural or musculoskeletal systems
- Patients with severe disorders of consciousness or cognitive disorders or those with mental illness
- Patients who require breathing aids for an extended period of time
- Patients with end-stage severe CHF who have been diagnosed by doctors as unable to recover within a short period
Show all 10Show fewer
- Patients who are scheduled to undergo coronary artery bypass surgery or a heart valve surgery within 1 month
- Patients who are on hemodialysis or are awaiting a kidney transplant
- Patients with severe pulmonary diseases who require long-term home oxygen therapy
- Patients who themselves decline to participate or who have a family member who objects to their participation.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Department of Internal Medicine, National Taiwan Univeristy Hospital Yun-Lin branch
Douliu, Yunlin County, 640
About this study
Official title: The Effect of Using Nutrition Education as an Intervention Measure on Elevating the Nutritional Status, Quality of Life, and Self-Care Behavior of Patients With Chronic Heart Failure
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.
Read the detailed description
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.
- Conditions
- Chronic Heart Failure, Nutrition
- Being tested
- Self-Care Behavior
- Keywords
- Heart failure, Nutritional intervention, Quality of Life, Self-Care Behavior
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-Care BehaviorBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Nutritional intervention for CHF | Experimental | Not described Receives: Behavioral: Self-Care Behavior |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: Change from Baseline 6-Minute walk test on months 0, 3 at 6 months(Do higher values represent a better outcome).
Secondary outcomes (6)
Energy intake
Energy intake (Kcal/day)will be assessed by dietary survey on 24-hour recall.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Change from Baseline Water intake on months 0, 3 at 6 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2019
- Study start19 Feb 2019
- Primary completion13 Dec 2020
- Study completion13 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (30)Papers the sponsor has linked to this study.
- Other trials for Chronic Heart FailureStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 95 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jien-Jiun Chen, MD, Principal investigator, National Taiwan University HospitalFeng-Ching Liao, BS, Principal investigator, National Taiwan University HospitalSheng Nan Chang, PhD, Principal investigator, National Taiwan University HospitalShao-Chi Yang, MD, Principal investigator, National Taiwan University HospitalChih-Neng Hsu, MD, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03845309
- Sponsor's protocol ID
- 201810039RINA
- Status last verified
- Dec 2020
- First submitted
- 8 Jan 2019
- Last updated
- 2 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: De-identified individual participant data for all primary and secondary outcome meaurses will be made available
Publications
Abshire M, Xu J, Baptiste D, Almansa JR, Xu J, Cummings A, Andrews MJ, Dennison Himmelfarb C. Nutritional Interventions in Heart Failure: A Systematic Review of the Literature. J Card Fail. 2015 Dec;21(12):989-99. doi: 10.1016/j.cardfail.2015.10.004. Epub 2015 Oct 23.
PubMed 26525961Jensen GL, Mirtallo J, Compher C, Dhaliwal R, Forbes A, Grijalba RF, Hardy G, Kondrup J, Labadarios D, Nyulasi I, Castillo Pineda JC, Waitzberg D; International Consensus Guideline Committee. Adult starvation and disease-related malnutrition: a proposal for etiology-based diagnosis in the clinical practice setting from the International Consensus Guideline Committee. JPEN J Parenter Enteral Nutr. 2010 Mar-Apr;34(2):156-9. doi: 10.1177/0148607110361910.
PubMed 20375423Anthony PS. Nutrition screening tools for hospitalized patients. Nutr Clin Pract. 2008 Aug-Sep;23(4):373-82. doi: 10.1177/0884533608321130.
PubMed 18682588Cederholm T, Barazzoni R, Austin P, Ballmer P, Biolo G, Bischoff SC, Compher C, Correia I, Higashiguchi T, Holst M, Jensen GL, Malone A, Muscaritoli M, Nyulasi I, Pirlich M, Rothenberg E, Schindler K, Schneider SM, de van der Schueren MA, Sieber C, Valentini L, Yu JC, Van Gossum A, Singer P. ESPEN guidelines on definitions and terminology of clinical nutrition. Clin Nutr. 2017 Feb;36(1):49-64. doi: 10.1016/j.clnu.2016.09.004. Epub 2016 Sep 14.
PubMed 27642056Soeters PB, Reijven PL, van Bokhorst-de van der Schueren MA, Schols JM, Halfens RJ, Meijers JM, van Gemert WG. A rational approach to nutritional assessment. Clin Nutr. 2008 Oct;27(5):706-16. doi: 10.1016/j.clnu.2008.07.009. Epub 2008 Sep 9.
PubMed 18783855Cederholm T, Jensen GL, Correia MITD, Gonzalez MC, Fukushima R, Higashiguchi T, Baptista G, Barazzoni R, Blaauw R, Coats A, Crivelli A, Evans DC, Gramlich L, Fuchs-Tarlovsky V, Keller H, Llido L, Malone A, Mogensen KM, Morley JE, Muscaritoli M, Nyulasi I, Pirlich M, Pisprasert V, de van der Schueren MAE, Siltharm S, Singer P, Tappenden K, Velasco N, Waitzberg D, Yamwong P, Yu J, Van Gossum A, Compher C; GLIM Core Leadership Committee; GLIM Working Group. GLIM criteria for the diagnosis of malnutrition - A consensus report from the global clinical nutrition community. Clin Nutr. 2019 Feb;38(1):1-9. doi: 10.1016/j.clnu.2018.08.002. Epub 2018 Sep 3.
PubMed 30181091Rumsfeld JS, Alexander KP, Goff DC Jr, Graham MM, Ho PM, Masoudi FA, Moser DK, Roger VL, Slaughter MS, Smolderen KG, Spertus JA, Sullivan MD, Treat-Jacobson D, Zerwic JJ; American Heart Association Council on Quality of Care and Outcomes Research, Council on Cardiovascular and Stroke Nursing, Council on Epidemiology and Prevention, Council on Peripheral Vascular Disease, and Stroke Council. Cardiovascular health: the importance of measuring patient-reported health status: a scientific statement from the American Heart Association. Circulation. 2013 Jun 4;127(22):2233-49. doi: 10.1161/CIR.0b013e3182949a2e. Epub 2013 May 6. No abstract available.
PubMed 23648778Nieminen MS, Dickstein K, Fonseca C, Serrano JM, Parissis J, Fedele F, Wikstrom G, Agostoni P, Atar S, Baholli L, Brito D, Colet JC, Edes I, Gomez Mesa JE, Gorjup V, Garza EH, Gonzalez Juanatey JR, Karanovic N, Karavidas A, Katsytadze I, Kivikko M, Matskeplishvili S, Merkely B, Morandi F, Novoa A, Oliva F, Ostadal P, Pereira-Barretto A, Pollesello P, Rudiger A, Schwinger RH, Wieser M, Yavelov I, Zymlinski R. The patient perspective: Quality of life in advanced heart failure with frequent hospitalisations. Int J Cardiol. 2015 Jul 15;191:256-64. doi: 10.1016/j.ijcard.2015.04.235. Epub 2015 May 1.
PubMed 25981363Larsson SC, Tektonidis TG, Gigante B, Akesson A, Wolk A. Healthy Lifestyle and Risk of Heart Failure: Results From 2 Prospective Cohort Studies. Circ Heart Fail. 2016 Apr;9(4):e002855. doi: 10.1161/CIRCHEARTFAILURE.115.002855.
PubMed 27072861Kontodimopoulos N, Argiriou M, Theakos N, Niakas D. The impact of disease severity on EQ-5D and SF-6D utility discrepancies in chronic heart failure. Eur J Health Econ. 2011 Aug;12(4):383-91. doi: 10.1007/s10198-010-0252-4. Epub 2010 May 15.
PubMed 20473544Bekfani T, Pellicori P, Morris D, Ebner N, Valentova M, Sandek A, Doehner W, Cleland JG, Lainscak M, Schulze PC, Anker SD, von Haehling S. Iron deficiency in patients with heart failure with preserved ejection fraction and its association with reduced exercise capacity, muscle strength and quality of life. Clin Res Cardiol. 2019 Feb;108(2):203-211. doi: 10.1007/s00392-018-1344-x. Epub 2018 Jul 26.
PubMed 30051186Berg J, Lindgren P, Mejhert M, Edner M, Dahlstrom U, Kahan T. Determinants of Utility Based on the EuroQol Five-Dimensional Questionnaire in Patients with Chronic Heart Failure and Their Change Over Time: Results from the Swedish Heart Failure Registry. Value Health. 2015 Jun;18(4):439-48. doi: 10.1016/j.jval.2015.02.003. Epub 2015 May 16.
PubMed 26091598Balestroni G, Bertolotti G. [EuroQol-5D (EQ-5D): an instrument for measuring quality of life]. Monaldi Arch Chest Dis. 2012 Sep;78(3):155-9. doi: 10.4081/monaldi.2012.121. Italian.
PubMed 23614330Malhotra R, Bakken K, D'Elia E, Lewis GD. Cardiopulmonary Exercise Testing in Heart Failure. JACC Heart Fail. 2016 Aug;4(8):607-16. doi: 10.1016/j.jchf.2016.03.022. Epub 2016 Jun 8.
PubMed 27289406Tager T, Hanholz W, Cebola R, Frohlich H, Franke J, Doesch A, Katus HA, Wians FH Jr, Frankenstein L. Minimal important difference for 6-minute walk test distances among patients with chronic heart failure. Int J Cardiol. 2014 Sep;176(1):94-8. doi: 10.1016/j.ijcard.2014.06.035. Epub 2014 Jul 1.
PubMed 25049008
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Using Nutrition Education as an Intervention Measure on Elevating the Nutritional Status, Quality of Life, and Self-Care Behavior of Patients With Chronic Heart Failure
- ClinicalTrials.gov ID
- NCT03845309
- Acronym / sponsor ID
- 201810039RINA
- Conditions
- Chronic Heart Failure, Nutrition
- Keywords
- Heart failure, Nutritional intervention, Quality of Life, Self-Care Behavior
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 95 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 19 Feb 2019 (actual)
- Primary completion
- 13 Dec 2020 (actual)
- Study completion
- 13 Dec 2020 (actual)
- First posted
- 19 Feb 2019 (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.
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.
Detailed description
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Nutritional intervention for CHF | Experimental | Behavioral: Self-Care Behavior |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients diagnosed with CHF by a cardiologist. Clinical patients with the functional classification of NYHA FcI-NYHA FcⅣ according to the New York Heart Association (NYHA).
- Adults aged 20 years or older who are conscious, have normal cognitive function, can walk without assistance, and do not require breathing aids. Additionally, participants must be able to answer questionnaires in Mandarin Chinese or Taiwanese, either orally or in writing.
- Patients who have agreed to participate in the study by completing a consent form.
Key exclusion criteria (10 listed)
- Patients with an expected survival period of less than 6 months because of a disease not related to CHF
- Long-term bed-bound patients
- Patients with no potential for rehabilitation because of decline in functions of neural or musculoskeletal systems
- Patients with severe disorders of consciousness or cognitive disorders or those with mental illness
- Patients who require breathing aids for an extended period of time
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 |
|---|---|---|
| Self-Care BehaviorLimitations 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. | Behavioural | Nutritional intervention for CHF |
Primary outcome
Mini Nutritional Assessment Short-Form
Time frame: Change from Baseline Mini Nutritional Assessment Short-Form on months 0, 3 at 6 months(Do higher values represent a better outcome).
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.
Instrumental Activities of Daily Living
Time frame: Change from Baseline Instrumental Activities of Daily Living on months 0, 3 at 6 months.
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.
EuroQol-5D
Time frame: Change from Baseline EuroQol-5D on months 0, 3 at 6 months(Do higher values represent a better outcome).
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.
Handgrip strength
Time frame: Change from Baseline Handgrip strength on months 0, 3 at 6 months.
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.
6-Minute walk test
Time frame: Change from Baseline 6-Minute walk test on months 0, 3 at 6 months(Do higher values represent a better outcome).
Changes in this value correlate to quality of life
6 secondary outcomes
Energy intake
Time frame: Change from Baseline Energy intake on months 0, 3 at 6 months.
Carbohydrate intake
Time frame: Change from Baseline Carbohydrate intake on months 0, 3 at 6 months.
Protein intake
Time frame: Change from Baseline Protein intake on months 0, 3 at 6 months.
Fat intake
Time frame: Change from Baseline Fat intake on months 0, 3 at 6 months.
Sodium intake
Time frame: Change from Baseline Sodium intake on months 0, 3 at 6 months.
Water intake
Time frame: Change from Baseline Water intake on months 0, 3 at 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 2 Feb 2021.
- Background: PubMed 26525961Abshire M, Xu J, Baptiste D, Almansa JR, Xu J, Cummings A, Andrews MJ, Dennison Himmelfarb C. Nutritional Interventions in Heart Failure: A Systematic Review of the Literature. J Card Fail. 2015 Dec;21(12):989-99. doi: 10.1016/j.cardfail.2015.10.004. Epub 2015 Oct 23.
- Background: PubMed 20375423Jensen GL, Mirtallo J, Compher C, Dhaliwal R, Forbes A, Grijalba RF, Hardy G, Kondrup J, Labadarios D, Nyulasi I, Castillo Pineda JC, Waitzberg D; International Consensus Guideline Committee. Adult starvation and disease-related malnutrition: a proposal for etiology-based diagnosis in the clinical practice setting from the International Consensus Guideline Committee. JPEN J Parenter Enteral Nutr. 2010 Mar-Apr;34(2):156-9. doi: 10.1177/0148607110361910.
- Background: PubMed 18682588Anthony PS. Nutrition screening tools for hospitalized patients. Nutr Clin Pract. 2008 Aug-Sep;23(4):373-82. doi: 10.1177/0884533608321130.
- Background: PubMed 27642056Cederholm T, Barazzoni R, Austin P, Ballmer P, Biolo G, Bischoff SC, Compher C, Correia I, Higashiguchi T, Holst M, Jensen GL, Malone A, Muscaritoli M, Nyulasi I, Pirlich M, Rothenberg E, Schindler K, Schneider SM, de van der Schueren MA, Sieber C, Valentini L, Yu JC, Van Gossum A, Singer P. ESPEN guidelines on definitions and terminology of clinical nutrition. Clin Nutr. 2017 Feb;36(1):49-64. doi: 10.1016/j.clnu.2016.09.004. Epub 2016 Sep 14.
- Background: PubMed 18783855Soeters PB, Reijven PL, van Bokhorst-de van der Schueren MA, Schols JM, Halfens RJ, Meijers JM, van Gemert WG. A rational approach to nutritional assessment. Clin Nutr. 2008 Oct;27(5):706-16. doi: 10.1016/j.clnu.2008.07.009. Epub 2008 Sep 9.
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- Individual participant dataSharing planned: No. De-identified individual participant data for all primary and secondary outcome meaurses will be made available
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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.
Jien-Jiun Chen, MD principal investigator
National Taiwan University Hospital
Feng-Ching Liao, BS principal investigator
National Taiwan University Hospital
Sheng Nan Chang, PhD principal investigator
National Taiwan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Self-Care Behavior in people with Chronic Heart Failure and Nutrition, run by National Taiwan University Hospital at 1 site in Taiwan.
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 3 inclusion and 10 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 2 Feb 2021. 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 Taiwan. 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?
Mini Nutritional Assessment Short-Form (time frame: Change from Baseline Mini Nutritional Assessment Short-Form on months 0, 3 at 6 months(Do higher values represent a better outcome).). The study lists 5 primary outcomes in all. 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 NCT03845309, which also lists 30 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 2 Feb 2021.