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
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.
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.
Parallel
CSM-Based Intervention Group
BehavioralA 5-phase nurse-led CSM-based intervention with Self-Efficacy Theory. Phase 1: Bedside interviews and lectures on volume overload mechanisms. Phase 2: BIPQ assessment with cognitive correction of misconceptions. Phase 3: GAD-7/PHQ-9 assessment with emotional counseling and regulation techniques. Phase 4: Training on symptom recognition, daily weight monitoring, intake/output recording, sodium restriction, fluid management, diuretic self-management, and problem-solving. Self-efficacy via mastery, vicarious, persuasion, and arousal. Individualized home plan and discharge follow-up. Phase 5: Telephone follow-up weekly in month 1, biweekly in month 2, outpatient visit at month 3 reviewing weight trends, symptom control, and goal attainment.
Standard Care (in control arm)
Other interventionStandard in-hospital care including admission guidance, medication and dietary education, fluid management, weight monitoring, and psychological support. Before discharge: enhanced education, health handbook, and invitation to heart failure WeChat group for online consultation. Telephone follow-ups at month 1 and month 3 assessing symptoms, medication adherence, diet, self-care, psychological status, and adverse events.
Self-Care of Heart Failure Index Score as Measured by the SCHFI
Change from baseline in the Self-Care of Heart Failure Index (SCHFI) score, which includes three subscales: self-care maintenance, self-care management, and self-care confidence. Higher scores indicate better self-care ability.
Illness Perception Change
Change from baseline in illness perception assessed by the Brief Illness Perception Questionnaire (BIPQ). The questionnaire contains 9 items measuring cognitive and emotional representations of illness.
Dry Weight Attainment Rate
Proportion of patients achieving dry weight maintenance, defined as no weight gain exceeding 2kg within 3 days. Dry weight is assessed based on the patient's weight at discharge as the baseline reference.
Self-Efficacy for Self-Care
Change from baseline in self-efficacy for self-care assessed by the Self-Care Self-Efficacy Scale. Higher scores indicate greater confidence in performing self-care behaviors.
Quality of Life as Assessed by the Minnesota Living with Heart Failure Questionnaire
Change from baseline in quality of life assessed by the Minnesota Living with Heart Failure Questionnaire (MLHFQ). The scale contains 21 items with total scores ranging from 0 to 105; lower scores indicate better quality of life.
Anxiety Symptoms
Change from baseline in anxiety symptoms assessed by the Generalized Anxiety Disorder Scale (GAD-7). Higher scores indicate more severe anxiety.
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