Heart Failure
Conditions
Keywords
Heart Failure, Digital Health Intervention, Remote Dielectric Sensing, ReDS™, Comprehensive Health Care, 6 Min Walk Test, Randomized Controlled Trial
Brief summary
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 (ReDS™) 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.
Interventions
OTHERComprehensive post hospital management based on digital health intervention(DHI)
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 ReDS™ technology, etc.
Sponsors
Harbin Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patients hospitalized for HF, NYHA classification II-IV upon admission 2. The patient's residence is within the urban area of each center, and ReDS™ technology can be performed at home or at the outpatient clinic 3. No difficulty using smartphones, with basic Chinese reading and writing skills 4. Accept the terms and conditions of the study and obtain informed consent from the subjects/their families
Exclusion criteria
1. Age\<21 years old 2. Patients with height\<155 cm or\>190 cm, BMI\<22 kg/m2 or\>36 kg/m2, chest circumference\<80 cm or\>115 cm, and flail chest or rib fractures 3. History of pulmonary embolism 4. chronic renal failure（Scr \> 443umol/L） 5. History of heart transplantation or pacemaker implantation 6. Severe pulmonary hypertension 7. Suffering from end-stage chronic obstructive pulmonary disease, requiring home oxygen therapy 8. Massive pleural effusion 9. The subject is unable to complete the 6-minute walking test 10. Expected lifespan\<6 months 11. Researchers believe that participants are not suitable to participate in this trial (such as pregnancy, severe visual or hearing impairment, etc.) 12. Individuals who are unable to understand and/or comply with this research procedure (such as those who are addicted to alcohol, substance abuse, or have mental illnesses) 13. Currently participating in clinical trials of other devices or drugs 14. Researchers involved in the design and execution of this study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 6-minute walk test | The 6th month after discharge | Improvement in 6-minute walk test after discharge for 6 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
| NYHA classification | The 1st ,3rd and 6th months after discharge | — |
| Left ventricular ejection fraction (LVEF) | The 6th month after discharge | Measured by echocardiography |
| Number of readmissions for heart failure | Within 6 months after discharge | Number of readmissions for hospitalized patients with heart failure due to worsening heart failure after discharge |
| All-cause mortality | Within 6 months after discharge | — |
| Cardiac death | Within 6 months after discharge | 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 |
| 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 | — |
Countries
China
Outcome results
None listed