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

NCT06947148 | Completed

• 1 other identifier: KY2024-024
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Failure

Keywords

Heart Failure; Digital Health Intervention; Remote Dielectric Sensing; ReDS™; Comprehensive Health Care; 6 Min Walk Test; Randomized Controlled Trial

Outcome Measures

Primary Outcomes (1)

• 6-minute walk test

  Improvement in 6-minute walk test after discharge for 6 months

  The 6th month after discharge

Secondary Outcomes (9)

• 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

• Number of readmissions for heart failure

  Within 6 months after discharge

Study Arms (2)

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 ReDS™ technology, etc.

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

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.

Interventions

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 ReDS™ technology, etc.

Comprehensive post hospital management group

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients hospitalized for HF, NYHA classification II-IV upon admission
• 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
• No difficulty using smartphones, with basic Chinese reading and writing skills
• Accept the terms and conditions of the study and obtain informed consent from the subjects/their families

You may not qualify if:

• Age\<21 years old
• 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
• History of pulmonary embolism
• chronic renal failure（Scr \> 443umol/L）
• History of heart transplantation or pacemaker implantation
• Severe pulmonary hypertension
• Suffering from end-stage chronic obstructive pulmonary disease, requiring home oxygen therapy
• Massive pleural effusion
• The subject is unable to complete the 6-minute walking test
• Expected lifespan\<6 months
• Researchers believe that participants are not suitable to participate in this trial (such as pregnancy, severe visual or hearing impairment, etc.)
• 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)
• Currently participating in clinical trials of other devices or drugs
• Researchers involved in the design and execution of this study

Sponsors & Collaborators

• Harbin Medical University: lead

Study Sites (1)

The Second Affiliated Hospital of Harbin Medical University

Harbin, Heilongjiang, 150000, China

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician

Study Record Dates

• First Submitted: April 21, 2025
• First Posted: April 27, 2025
• Study Start: April 1, 2025
• Primary Completion: July 18, 2025
• Study Completion: February 15, 2026
• Last Updated: March 4, 2026

Record last verified: 2026-03

Locations

CN (1)