A CSM-Based Volume Management Program for Chronic Heart Failure

Starting soon · Not applicable

Conditions studied: Chronic Heart Failure

In brief

Study Title:A Nurse-Led Intervention Program Based on the Common-Sense Model of Self-Regulation for Volume Management in Patients with Chronic Heart Failure: A Randomized Controlled Trial Brief Summary: The goal of this clinical trial is to learn if a nurse-led, theory-driven intervention based on the Common-Sense Model of Self-Regulation (CSM), supplemented by Bandura's Self-Efficacy Theory, works to improve volume management self-care in patients with chronic heart failure. It will also learn about the intervention's effects on illness perception, self-efficacy, quality of life, emotional status, and clinical outcomes. The main questions it aims to answer are: * Does the CSM-based intervention improve patients' self-care capacity as measured by the Self-Care of Heart Failure Index (SCHFI)? * Does the intervention improve patients' illness perception as assessed by the Brief Illness Perception Questionnaire (BIPQ)? * Does the intervention improve patients' self-efficacy, quality of life, emotional status, cardiac function (LVEF, BNP, heart rate, NYHA class), and dry weight attainment? * Does the intervention reduce heart failure-related readmission rates and emergency department visits within 3 months post-discharge? Researchers will compare the CSM-based intervention group to a standard care control group. The standard care group receives routine in-hospital education, a health handbook, and regular telephone follow-ups. Participants in the intervention group will: * Receive a 5-phase, nurse-led program from hospital admission to 3 months post-discharge * Attend bedside interviews and structured lectures on volume overload mechanisms during hospitalization * Complete questionnaires assessing illness perception, self-care, self-efficacy, quality of life, and emotional status at baseline, 1 month, and 3 months * Receive clinical evaluations including cardiac function tests at baseline and 3 months * Learn practical skills including daily weight monitoring, sodium restriction, fluid management, and diuretic self-adjustment * Receive telephone follow-ups weekly in month 1 and biweekly in month 2, with an outpatient visit at month 3

Key facts

Study ID

NCT07686536

Run by

The Third Xiangya Hospital of Central South University

People needed

88

Starts

2026-07-03

Expected to finish

2026-12-20

Last updated by the study team

2026-07-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosis of chronic heart failure according to the diagnostic criteria of the Chinese Society of Cardiology, with New York Heart Association (NYHA) functional class II-IV.
• Aged 18 years or older.
• Documented diagnosis of heart failure for at least 3 months.
• Experienced documented volume overload symptoms (e.g., dyspnea, lower extremity edema) or related healthcare visits within the past 6 months.
• Adequate communication, reading, and comprehension abilities.
• Willing and able to provide written informed consent to participate in the study.
• Assessed by the investigator as capable of adhering to the study protocol.

You may not qualify if…

• Comorbid other severe end-stage diseases (e.g., malignancy, uremia) or recent major cerebrovascular events.
• History of psychiatric illness or confirmed cognitive impairment.
• Comorbid other conditions that may cause fluid retention.
• Lack of independent decision-making capacity.
• Communication difficulties or inability to cooperate with study procedures.
• Inability to use a smartphone or WeChat application.
• Patients or family members with poor compliance, or those who withdraw or are lost to follow-up.

Full record on ClinicalTrials.gov

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