Not provided
Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| CMRPG280251 | Other Grant/Funding Number | CHANG GUNG MEMORIAL HOSPITAL |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Congestive heart failure (CHF) is a major public health problem worldwide. CHF carries a devastating prognosis, which resembles that of some types of malignant cancer. Despite substantial improvements in the management of the disease, the prognosis remains poor especially in advanced stages of the disease. For these patients, self-management plan includes monitoring of symptoms such as fatigue and shortness of breath, daily weighing, and knowing what to do if signs of deterioration appear, and when to report the changes to health. The investigators hypothesize that patients in the heart failure management programs that promote self-management by means of intensive education, edema index-assistance, and telephone follow-up can improve their functional status and quality of life, as well as the biomarkers of CHF, left ventricular systolic function, proteinuria and nutritional status.
Congestive heart failure (CHF) is a major public health problem world-wide. CHF carries a devastating prognosis which resembles that of some types of malignant cancer. Its incidence rises steadily from 0.02 per 1000 population per year in those aged 25 to 34 years to 11.6 in those aged 85 years or older. Despite substantial improvements in the management of the disease, the prognosis remains poor especially in advanced stages of the disease. About half of the patients diagnosed with CHF die within 4 years of diagnosis. With the increasing number of patients with CHF being referred from hospital to primary health care, the demands for expanded services in primary health care have increased. Caring for patients with CHF often involves a number of physical, medical, behavioral, psychological and social factors, and requires appropriate attention to all aspects of care, both pharmacological and non-pharmacological. Educating patients about CHF treatment and the consequences of CHF has been shown to improve self-management behavior. For patients with CHF, the self-management plan includes monitoring of symptoms such as fatigue and shortness of breath, daily weighing, and knowing what to do if signs of deterioration appear, and when to report the changes to health care provider. In patients with CHF, the prognosis worsens considerably once malnutrition develops. Mortality at 18 months in unselected patients with CHF in whom cardiac cachexia had been diagnosed was as high as 50% compared to in non-cachectic patients from the same study population. In addition, amount of proteinuria has been known to be related to atherosclerosis burden and disease severity regarding lots of disease entities. The atherosclerosis score is also probably modifiable by life style intervention and educational program. CHF can also activate a few neurohormone and natriuretic peptides, among which brain natriuretic peptide is the most world-wide used. Summarized, in this study, to estimate the effect of CHF education and self-management program, the parameters adopted include blood brain natriuretic peptide and albumin levels, atherosclerosis scores, proteinuria, renal function, changes in life quality, left ventricular ejection fraction, and cardiac outcomes. In Taiwan, so far, the investigators don't have this kind of CHF education and self-care system. The investigators hypothesize that patients in the heart failure management programs that promote self-management by means of intensive education, edema index-assistance, and telephone follow-up can improve their functional status and quality of life, as well as the biomarkers of CHF, left ventricular systolic function, proteinuria and nutritional status.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| control group | control group receiving regular education from a nurse | ||
| Case management group | This is the study group. Extensive education and case management program will be performed in this group. |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| All-cause Death, Heart Failure-related Re-hospitalizations, and a Composite Outcome of Both Death and Heart Failure-related Re-hospitalizations | Follow-up began after randomization. Follow-up data were prospectively obtained every month from hospital records, personal communication with patients' physicians, telephone interviews, and records of regular visits to staff physicians' outpatient clinics. 'Re-hospitalization'was defined as heart failure-related re-hospitalization.'All causes of death' was also considered to be an event. All-cause death was chosen as an endpoint because of the inter-relationship of heart failure with many other comorbidities in the patient cohort. A committee of three cardiologists adjudicated all hospitalizations without knowledge of the patients' clinical data to determine whether events were related to worsening heart failure. Based on these two different endpoints, time to the first event was analyzed. | 2 year |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Patients hospitalized due to acute cardiogenic pulmonary edema will be consecutively enrolled in the HF center of Chang Gung Memorial Hospital.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| CHAO-HUNG WANG, MD | Chang Gung Memorial Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chang Gung Memorial Hospital | Keelung | 402 | Taiwan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18268174 | Result | Jaarsma T, van der Wal MH, Lesman-Leegte I, Luttik ML, Hogenhuis J, Veeger NJ, Sanderman R, Hoes AW, van Gilst WH, Lok DJ, Dunselman PH, Tijssen JG, Hillege HL, van Veldhuisen DJ; Coordinating Study Evaluating Outcomes of Advising and Counseling in Heart Failure (COACH) Investigators. Effect of moderate or intensive disease management program on outcome in patients with heart failure: Coordinating Study Evaluating Outcomes of Advising and Counseling in Heart Failure (COACH). Arch Intern Med. 2008 Feb 11;168(3):316-24. doi: 10.1001/archinternmed.2007.83. | |
| 20202912 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Of 470 enrolled participants, 121 were excluded (42 were excluded because of met exclusion criteria, 42 refused to participate, and 26 were excluded because of other reasons) , 349 met inclusion criteria and randomized to into the control and the case management groups.
The study enrolled patients consecutively hospitalized for acute or decompensated chronic heart failure in the heart failure center of Chang Gung Memorial Hospital, Keelung, Taiwan from June 1, 2010 to May 30, 2012.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Control Group | control group receiving regular education from a nurse |
| FG001 | Case Management Group | This is the study group. Extensive education and case management program will be performed in this group. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Control Group | control group receiving regular education from a nurse |
| BG001 | Case Management Group | This is the study group. Extensive education and case management program will be performed in this group. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | All-cause Death, Heart Failure-related Re-hospitalizations, and a Composite Outcome of Both Death and Heart Failure-related Re-hospitalizations | Follow-up began after randomization. Follow-up data were prospectively obtained every month from hospital records, personal communication with patients' physicians, telephone interviews, and records of regular visits to staff physicians' outpatient clinics. 'Re-hospitalization'was defined as heart failure-related re-hospitalization.'All causes of death' was also considered to be an event. All-cause death was chosen as an endpoint because of the inter-relationship of heart failure with many other comorbidities in the patient cohort. A committee of three cardiologists adjudicated all hospitalizations without knowledge of the patients' clinical data to determine whether events were related to worsening heart failure. Based on these two different endpoints, time to the first event was analyzed. | Death, HF-related rehospitalization, and composite of death and HF-related rehospitalization | Posted | Count of Participants | Participants | 2 year |
|
2 year
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Control Group | control group receiving regular education from a nurse | 36 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Heart failure-related re-hospitalizations | Cardiac disorders | SNOMED | Systematic Assessment | Patients were re-hospitalized due to unanticipated worsening of heart failure. |
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| CHAO-HUNG WANG, MD | Chang Gung Memorial Hospital | +886-2-24313131 | 2923 | bearty54@gmail.com |
Not provided
| ID | Term |
|---|---|
| D003643 | Death |
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
At baseline and every 6-month visits, 3 ml of venous blood will be collected. At baseline and each 6-month visit, urinary albumin amount will be measured in the core lab in the hospital.
| Result |
| Hoekstra T, Lesman-Leegte I, van der Wal M, Luttik ML, Jaarsma T. Nurse-led interventions in heart failure care: patient and nurse perspectives. Eur J Cardiovasc Nurs. 2010 Dec;9(4):226-32. doi: 10.1016/j.ejcnurse.2010.01.006. Epub 2010 Mar 4. |
| 21769111 | Result | Riegel B, Lee CS, Dickson VV; Medscape. Self care in patients with chronic heart failure. Nat Rev Cardiol. 2011 Jul 19;8(11):644-54. doi: 10.1038/nrcardio.2011.95. |
| 25105284 | Derived | Mao CT, Liu MH, Hsu KH, Fu TC, Wang JS, Huang YY, Yang NI, Wang CH. Effect of multidisciplinary disease management for hospitalized heart failure under a national health insurance programme. J Cardiovasc Med (Hagerstown). 2015 Sep;16(9):616-24. doi: 10.2459/JCM.0000000000000089. |
| 22367574 | Derived | Liu MH, Wang CH, Huang YY, Tung TH, Lee CM, Yang NI, Liu PC, Cherng WJ. Edema index established by a segmental multifrequency bioelectrical impedance analysis provides prognostic value in acute heart failure. J Cardiovasc Med (Hagerstown). 2012 May;13(5):299-306. doi: 10.2459/JCM.0b013e328351677f. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Previous hospitalization due to Heart Failure | Count of Participants | Participants |
|
| New York Heart Association functional class | Class I: No limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation or shortness of breath. Class II: Slight limitation of physical activity. Comfortable at rest. Ordinary physical activity results in fatigue, palpitation, shortness of breath or chest pain. Class III: Marked limitation of physical activity. Comfortable at rest. Less than ordinary activity causes fatigue, palpitation, shortness of breath or chest pain. Class IV: Symptoms of heart failure at rest. Any physical activity causes further discomfort. | Count of Participants | Participants |
|
| Left Ventricular Ejection Fraction | Mean | Standard Deviation | percentage of blood ejected |
|
| Blood Pressure | Mean | Standard Deviation | mmHg |
|
| Co-morbidity | Count of Participants | Participants |
|
| Cause | Count of Participants | Participants |
|
| Body Mass Index | Mean | Standard Deviation | kg/m^2 |
|
| Medication | Count of Participants | Participants |
|
| Laboratory values | Mean | Standard Deviation | g/dl |
|
| Heart rate | Mean | Standard Deviation | beats/min |
|
| Estimated glomerular filtration rate | Mean | Standard Deviation | ml/min/1.73m^2 |
|
| B-type natriuretic peptide | Mean | Standard Deviation | pg/ml |
|
| Serum sodium | Mean | Standard Deviation | mEq/l |
|
| Total bilirubin | Mean | Standard Deviation | mg/dl |
|
| QRS complex | Mean | Standard Deviation | msec |
|
| OG000 | Control Group | control group receiving regular education from a nurse |
| OG001 | Case Management Group | This is the study group. Extensive education and case management program will be performed in this group. |
|
|
|
| 175 |
| 41 |
| 175 |
| 0 |
| 175 |
| EG001 | Case Management Group | This is the study group. Extensive education and case management program will be performed in this group. | 15 | 165 | 18 | 165 | 0 | 165 |
|
Not provided
Not provided