The Impact of Comprehensive Post Hospital Management Based on DHI on Cardiac Function in Patients With HF

Harbin Medical University

Status: Not yet enrolling

Conditions: Heart Failure

Treatments: Other: Comprehensive post hospital management based on digital health intervention(DHI)

Study type: Interventional

Funder types: Other

Identifiers

NCT06947148

KY2024-024

Details and patient eligibility

About

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.

Enrollment: 300 estimated patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

300 participants in 2 patient groups

Comprehensive post hospital management group

Other group

Description:

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.

Treatment:

Other: Comprehensive post hospital management based on digital health intervention(DHI)

Routine Management Group

No Intervention group

Description:

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.