A CSM-Based Volume Management Program for Chronic Heart Failure

Официальное название

Development and Application of a Common-Sense Model-Based Intervention Protocol for Volume Management in Patients With Chronic Heart Failure: A Randomized Controlled Trial

Обзор

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

Подробное описание

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).

Phase 4 (Coping Strategy Development, Days 3-4 before discharge): Comprehensive skills training covering: (a) recognition of 6 early signs of volume overload; (b) daily weight monitoring using the "four fixed" method (fixed time, clothing, scale, and recording); (c) 24-hour intake/output recording; (d) sodium restriction (\<3g/d stable, \<2g/d acute) with low-salt cooking skills; (e) fluid management (1500-2000mL/d euvolemic, 1000-1500mL/d overloaded); (f) diuretic self-management with weight-based adjustment guidelines; (g) 4-step problem-solving skills training through scenario simulation. Self-efficacy is enhanced through four pathways: enactive mastery (hands-on practice), vicarious experiences (peer success stories), verbal persuasion (nurse reinforcement), and emotional arousal (stress management). An individualized home volume management plan and structured discharge follow-up schedule are developed collaboratively with each patient.

-Control Group: Participants receive standard in-hospital care including admission guidance, routine medication and dietary education, fluid management, weight monitoring, and psychological support. Before discharge, participants receive enhanced education, a health handbook, and are invited to a heart failure WeChat group for online consultation.

Follow-up Protocol: The intervention group receives telephone follow-ups weekly during month 1, biweekly during month 2, and an outpatient visit at month 3 with systematic review of weight trends, symptom control, and behavioral goal attainment. The control group receives telephone follow-ups at month 1 and month 3 assessing symptoms, medication adherence, and adverse events.

Data Collection Schedule: Assessments are conducted at three time points: baseline (pre-discharge), 1-month post-discharge, and 3-month post-discharge. Clinical indicators (LVEF, BNP, heart rate, NYHA class) are measured at baseline and 3 months only.

Вмешательства

• Поведенческое CSM-Based Intervention Group
  A 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,
• Другое Standard Care (in control arm)
  Standard 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.

Первичные конечные точки

• Self-Care of Heart Failure Index Score as Measured by the SCHFI [Срок оценки: Baseline, 1 month, and 3 months post-discharge]
• Illness Perception Change [Срок оценки: Baseline, 1 month, and 3 months post-discharge]

Вторичные конечные точки (10)

• Dry Weight Attainment Rate [Срок оценки: 1 month and 3 months post-discharge]
• Self-Efficacy for Self-Care [Срок оценки: Baseline, 1 month, and 3 months post-discharge]
• Quality of Life as Assessed by the Minnesota Living with Heart Failure Questionnaire [Срок оценки: Baseline, 1 month, and 3 months post-discharge]
• Anxiety Symptoms [Срок оценки: Baseline, 1 month, and 3 months post-discharge]
• Left Ventricular Ejection Fraction [Срок оценки: Baseline and 3 months post-discharge]
• Heart Failure Readmission Rate [Срок оценки: 3 months post-discharge]
• Emergency Department Visits [Срок оценки: 3 months post-discharge]
• Depression Symptoms [Срок оценки: Baseline, 1 month, and 3 months post-discharge]
• B-type Natriuretic Peptide (BNP) [Срок оценки: Baseline and 3 months post-discharge]
• NYHA Functional Classification [Срок оценки: Baseline and 3 months post-discharge]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Другое

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07686536 · E202665

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗