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| Name | Class |
|---|---|
| Science and Technology Department of Jiangsu Province | UNKNOWN |
| Yangzhou Municipal Health Bureau | UNKNOWN |
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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.
(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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Subjects with CHF follow-up | Experimental | Subjects with Hospital-Community-Family-Care Management Platform online and those with the clinic follow up.In the program, participants were educated on the use of smart health-tracking devices and mobile application (APP) to collect and upload comprehensive data elements related to the risk of CHF self-care management. They were also instructed to send text messages, view notifications, and receive individualized guidance on the mobile APP. The general practitioners viewed index of each participant on mobile APP and provided primary care periodically, and cardiologists in regional central hospital offered remote guidance and management if necessary. Outcomes assessed included accomplishments of the program, usability and satisfaction, engagement with the intervention, and changes of heart failure-related health behaviors. |
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| Subjects with CHF conventional clinic visit | Active Comparator | Subjects with standardized treatment according to latest guidelines via conventional visit. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hospital-Community-Family-Care Management Platform Online | Other | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| all cause mortality | Number of subjects with all cause death | one year |
| Measure | Description | Time Frame |
|---|---|---|
| Heart failure morbidity | number of subjects with heart failure - related visits | one year |
| Measure | Description | Time Frame |
|---|---|---|
| heart failure worsening | Number of subjects requiring drug or dose changes to intensify concomitant therapy due to worsening of heart failure (HF). | one year |
| Hospitalization rate | Hospitalization rate associated with heart failure |
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:
Exclusion Criteria:To be eligible for entry into the study, the subject must not meet any of the exclusion criteria listed below at screening and randomization:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiang Gu, Doctor | Contact | +86 0514 87373366 | sbyygx189@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Xiang Gu, Docter | Department of cardiovascular medicine | Principal Investigator |
| Jianhua Shen, Docter | Department of cardiovascular medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of cardiovascular medicine,Northern Jiangsu Hospital | Recruiting | Yangzhou | Jiangsu | 225001 | China |
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| Subjects with CHF via conventional clinic visit according to the latest relevant guidelines | Other | Subjects with CHF via conventional clinic visit according to the latest relevant guidelines |
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| one year |
| Average hospitalization time | Average hospitalization time associated with heart failure | one year |
| Costs of medications | Costs of medications associated with heart failure | one year |
| Usability of the HCF intervention for patients | it was assessed based on the Perceived Health Web Site Usability Questionnaire (PHWSUQ-12) | 4 months |
| Changes of self-management | Lifestyle and health behaviors of participants were collected by interview | 4 months |
| Engagement of the intervention | It was assessed objectively via daily Web portal log-ins and use of the mobile APP | 4 months |
| Participants perceptions of intervention components | During the interview, qualitative method was used to examine participants perceptions of intervention components | 4 months |