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

The Impact of Comprehensive Post Hospital Management Based on Digital Health Intervention on Cardiac Function in Patients With Heart Failure: a Prospective, Multicenter, Randomized Controlled Study

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.

Study Overview

• Status: Completed
• Conditions: Heart Failure
• Intervention / Treatment: Other: Comprehensive post hospital management based on digital health intervention(DHI)

• Study Type: Interventional
• Enrollment (Actual): 104
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Heilongjiang
    • Harbin, Heilongjiang, China, 150000
      • The Second Affiliated Hospital of Harbin Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Comprehensive post hospital management group; 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); 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.
No Intervention: Routine Management Group; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
6-minute walk test	Improvement in 6-minute walk test after discharge for 6 months	The 6th month after discharge

Secondary Outcome Measures

Outcome Measure	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
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

Collaborators and Investigators

• Sponsor: Harbin Medical University

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2025
• Primary Completion (Actual): July 18, 2025
• Study Completion (Actual): February 15, 2026

Study Registration Dates

• First Submitted: April 21, 2025
• First Submitted That Met QC Criteria: April 21, 2025
• First Posted (Actual): April 27, 2025

Study Record Updates

• Last Update Posted (Actual): March 4, 2026
• Last Update Submitted That Met QC Criteria: March 2, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Heart Failure; Randomized Controlled Trial; Digital Health Intervention; Comprehensive Health Care; Remote Dielectric Sensing; ReDS™; 6 Min Walk Test
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Heart Failure
• Other Study ID Numbers: KY2024-024

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No