Development and Application of a Common-Sense Model-Based Intervention Protocol for Volume Management in Patients With Chronic Heart Failure: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 88
- 主要终点
- Self-Care of Heart Failure Index Score as Measured by the SCHFI
研究概览
简要总结
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
详细描述
This is a prospective, single-center, randomized controlled trial. A total of 88 CHF patients will be enrolled and randomly allocated in a 1:1 ratio to either the intervention group or the control group.
-Intervention Group: Participants receive a 5-phase, nurse-led intervention from admission to 3 months post-discharge.
Phase 1 (Health Threat Stimuli, Days 1-2): Bedside interviews to activate patients' illness experiences by recalling prior acute decompensation episodes, combined with structured lectures on volume overload pathophysiology.
Phase 2 (Cognitive Representation, Days 1-2): BIPQ assessment to identify misconceptions, followed by targeted one-on-one cognitive reframing sessions addressing specific cognitive distortions.
Phase 3 (Emotional Representation, Days 1-2): GAD-7/PHQ-9 assessment with one-on-one emotional counseling and brief emotion regulation techniques (deep breathing, mindfulness).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Self-Care of Heart Failure Index Score as Measured by the SCHFI
时间窗: Baseline, 1 month, and 3 months post-discharge
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
时间窗: Baseline, 1 month, and 3 months post-discharge
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.
次要结局
- Dry Weight Attainment Rate(1 month and 3 months post-discharge)
- Self-Efficacy for Self-Care(Baseline, 1 month, and 3 months post-discharge)
- Quality of Life as Assessed by the Minnesota Living with Heart Failure Questionnaire(Baseline, 1 month, and 3 months post-discharge)
- Anxiety Symptoms(Baseline, 1 month, and 3 months post-discharge)
- Left Ventricular Ejection Fraction(Baseline and 3 months post-discharge)
- Heart Failure Readmission Rate(3 months post-discharge)
- Emergency Department Visits(3 months post-discharge)
- Depression Symptoms(Baseline, 1 month, and 3 months post-discharge)
- B-type Natriuretic Peptide (BNP)(Baseline and 3 months post-discharge)
- NYHA Functional Classification(Baseline and 3 months post-discharge)