NCT07686536Not yet recruiting
A CSM-Based Volume Management Program for Chronic Heart Failure
Development and Application of a Common-Sense Model-Based Intervention Protocol for Volume Management in Patients With Chronic Heart Failure: A Randomized Controlled Trial
Source: ClinicalTrials.gov · Last updated 7 Jul 2026
Brief summary (registry, in English)
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
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 88 (estimated)
- First submitted
- 28 Jun 2026
- Start date
- Jul 2026
- Primary completion date
- Jul 2026
- Lead sponsor
- The Third Xiangya Hospital of Central South University
- Diseases
- Heart failure
- NCT number
- NCT07686536
What you commit to
- Study type: Interventional
- Planned participants: 88
- From Jul 2026 to the primary completion date, Jul 2026
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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.
Other
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.