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Due to the complex nature of HF patients' conditions, long-term treatment and management are required, especially post hospital management, which is of great significance for improving patients' cardiac function and quality of life. With the increasing popularity of smartphones and the continuous development of medical technology, digital health intervention (DHI) has emerged as a new medical model in the treatment of diseases.
This study will establish a comprehensive post hospital management model of HF based on DHI, including cognitive behavioral therapy, digital self-monitoring and remote dielectric sensing (ReDSâ„¢) technology, etc., comprehensively strengthen the post hospital intervention and management of HF. Objective to explore the effect of comprehensive post hospital management based on DHI on cardiac function of patients with HF 6 months after discharge.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Comprehensive post hospital management group | Other | Based on the routine HF management of standard of care (SOC), the intervention group will carry out comprehensive post hospital management based on DHI, including cognitive behavioral therapy, digital self-monitoring and ReDSâ„¢ technology, etc. |
|
| Routine Management Group | No Intervention | The routine management group will accept the routine HF management of SOC throughout the course, and the doctor will carry out treatment and management according to the actual clinical situation, including pre discharge education, precautions for commonly used drugs, guidance for daily life activities, etc. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Comprehensive post hospital management based on digital health intervention(DHI) | Other | Based on the routine HF management of standard of care (SOC), the intervention group will carry out comprehensive post hospital management based on DHI, including cognitive behavioral therapy, digital self-monitoring and ReDSâ„¢ technology, etc. |
| Measure | Description | Time Frame |
|---|---|---|
| 6-minute walk test | Improvement in 6-minute walk test after discharge for 6 months | The 6th month after discharge |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of life index (QLI) rating | The 1st ,3rd and 6th months after discharge | |
| Kansas city cardiomyopathy questionnaire (KCCQ-23) rating | The 1st ,3rd and 6th months after discharge | |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Second Affiliated Hospital of Harbin Medical University | Harbin | Heilongjiang | 150000 | China |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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|
| NYHA classification |
| The 1st ,3rd and 6th months after discharge |
| Left ventricular ejection fraction (LVEF) | Measured by echocardiography | The 6th month after discharge |
| Number of readmissions for heart failure | Number of readmissions for hospitalized patients with heart failure due to worsening heart failure after discharge | Within 6 months after discharge |
| All-cause mortality | Within 6 months after discharge |
| Cardiac death | Any death caused by heart disease (such as myocardial infarction, low output HF, fatal arrhythmia), death without witnesses, death from unknown causes, and all surgery related deaths, including those related to concurrent treatment, are classified as cardiac death | Within 6 months after discharge |
| Composite endpoint of all-cause death or readmission due to heart failure | Within 6 months after discharge |
| Time to first hospitalization for heart failure from baseline | Within 6 months after discharge |