Chronic Heart Failure
Conditions
Keywords
Chronic heart failure, telemedicine, health service platform
Brief summary
The purpose of this study is to determine whether the Hospital-Community-Family-Care Management Platform for Chronic Heart Failure reduces the mortality, readmission rates and costs of the subjects with CHF.
Detailed description
(1) Indication: Chronic Heart Failure. (2) Objectives: Primary objective is to evaluate the efficacy of the Hospital-Community-Family-Care Management Platform online compared with the regular clinic follow up in subjects with CHF (I-IV class by NYHA, of which class IV without strict bed rest).Secondary objectives is to assess the safety of the Management Platform online in subjects with CHF. (3) Study design: Prospective, randomized, controlled study with two follow up management groups: 1) the Hospital-Community-Family-Care Management Follow up Online; 2) the regular monthly clinic follow up. Study population: Totally 1000 male and female subjects with CHF (I-IV functional class according to NYHA classification). (4) Quality assurance plan that addresses data validation and registry procedures, including any plans for site monitoring and auditing. (5) Data checks to compare data entered into the registry against predefined rules for range or consistency with other data fields in the registry. (6) Source data verification to assess the accuracy, completeness, or representativeness of registry data by comparing the data to external data sources. (7) Standard Operating Procedures to address registry operations and analysis activities, such as patient recruitment, data collection, data management, data analysis, reporting for adverse events, and change management. (8) Duration of follow up: The total follow-up time shall be at least 12 months. (9) Safety Assessment: Safety of the study will be evaluated by the following assessments: 1) Subject and object examinations (during the follow up period and extending up to 2 week after the end of the study) consisting of a subject interview (including direct questioning about adverse events), physical examination, assessment of body weight, Electrocardiogram (ECG) and echocardiogram (UCG), Left ventricular ejection fraction (LVEF), assessed by echocardiography, The N-terminal prohormone of brain natriuretic peptide (NT-proBNP), a peptide hormone whose plasma concentration is inversely related to the severity of HF, NYHA functional status, assessed by subject interview, 6-minute walk distance (6MWD), Quality of life (QoL), assessed by the Minnesota Living with Heart Failure questionnaire (MLHFQ), a validated questionnaire assessing QoL in subjects with heart failure. 2) Evaluation of clinically relevant safety laboratory parameters, such as complete blood count, serum creatinine, electrolytes, and liver enzymes. Any Adverse Events (AE) or Serious Adverse Events (SAE) and its potential causal relationship with the study will be recorded and evaluated.
Interventions
Hospital-Community-Family-Care Management Platform Online: the remote monitoring service platform on line based on community and family for subjects with CHF under the guidance of the regional central hospital
OTHERSubjects with CHF via conventional clinic visit according to the latest relevant guidelines
Subjects with CHF via conventional clinic visit according to the latest relevant guidelines
Sponsors
Science and Technology Department of Jiangsu Province
Yangzhou Municipal Health Bureau
Xiang Gu
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Inclusion Criteria:to be considered eligible to participate in this study, a subject must meet the inclusion criteria listed below at the time of screening and randomization: 1. Male and female are aged 18 years old or over. 2. History of CHF for ≥3 months with NYHA functional class I-IV, of which class IV without strict bed rest. 3. Left ventricular ejection fraction (LVEF) ≤45% as assessed by echocardiogram. However, LVEF can be above 45% for patients with cardiac insufficiency caused by atrial fibrillation, valvular heart disease, hypertrophic cardiomyopathy and et al; 4. Treatment of CHF with stable and optimal pharmacological therapy according to Chinese guidelines for treatment of CHF. In general, optimal treatment will include a beta-blocker and an ACE inhibitor and/or an angiotensin receptor blocker, unless not tolerated. Medical therapy is defined as stable, if the subject has not started a new CHF drug class and the dose of drugs taken have not been changed during the 3 months prior to screening and randomization. 5. Ability to understand the requirements of the study and willingness to provide written informed consent (IC), and agreement to abide by the study restrictions and return for the required assessments. 6. Subjects are located in our coverage of the remote monitoring system.
Exclusion criteria
To be eligible for entry into the study, the subject must not meet any of the
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| all cause mortality | one year | Number of subjects with all cause death |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Heart failure morbidity | one year | number of subjects with heart failure - related visits |
Other
| Measure | Time frame | Description |
|---|---|---|
| Average hospitalization time | one year | Average hospitalization time associated with heart failure |
| Costs of medications | one year | Costs of medications associated with heart failure |
| Usability of the HCF intervention for patients | 4 months | it was assessed based on the Perceived Health Web Site Usability Questionnaire (PHWSUQ-12) |
| heart failure worsening | one year | Number of subjects requiring drug or dose changes to intensify concomitant therapy due to worsening of heart failure (HF). |
| Engagement of the intervention | 4 months | It was assessed objectively via daily Web portal log-ins and use of the mobile APP |
| Participants perceptions of intervention components | 4 months | During the interview, qualitative method was used to examine participants perceptions of intervention components |
| Changes of self-management | 4 months | Lifestyle and health behaviors of participants were collected by interview |
| Hospitalization rate | one year | Hospitalization rate associated with heart failure |
Countries
China
Contacts
Primary ContactXiang Gu, Doctor
Outcome results
None listed