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
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
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Geschat)
Fase
- Niet toepasbaar
Contacten en locaties
Studiecontact
- Naam: Su Na
- Telefoonnummer: +86 13268395340
- E-mail: 879950198@qq.com
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Beschrijving
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Ander
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Enkel
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
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Experimenteel: 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, 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, symptoms, and goals.
|
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, 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.
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Actieve vergelijker: Standard Care Control Group
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.
|
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.
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Self-Care of Heart Failure Index Score as Measured by the SCHFI
Tijdsspanne: Baseline, 1 month, and 3 months post-discharge
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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.
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Baseline, 1 month, and 3 months post-discharge
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Illness Perception Change
Tijdsspanne: Baseline, 1 month, and 3 months post-discharge
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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.
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Baseline, 1 month, and 3 months post-discharge
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Dry Weight Attainment Rate
Tijdsspanne: 1 month and 3 months post-discharge
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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.
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1 month and 3 months post-discharge
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Self-Efficacy for Self-Care
Tijdsspanne: Baseline, 1 month, and 3 months post-discharge
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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.
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Baseline, 1 month, and 3 months post-discharge
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Quality of Life as Assessed by the Minnesota Living with Heart Failure Questionnaire
Tijdsspanne: Baseline, 1 month, and 3 months post-discharge
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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.
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Baseline, 1 month, and 3 months post-discharge
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Anxiety Symptoms
Tijdsspanne: Baseline, 1 month, and 3 months post-discharge
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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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Baseline, 1 month, and 3 months post-discharge
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Left Ventricular Ejection Fraction
Tijdsspanne: Baseline and 3 months post-discharge
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Change from baseline in left ventricular ejection fraction (LVEF) assessed by echocardiography.
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Baseline and 3 months post-discharge
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Heart Failure Readmission Rate
Tijdsspanne: 3 months post-discharge
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Proportion of patients readmitted to hospital due to heart failure exacerbation within 3 months post-discharge.
Calculated as number of readmissions due to heart failure / total number of patients × 100%.
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3 months post-discharge
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Emergency Department Visits
Tijdsspanne: 3 months post-discharge
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Number of emergency department visits due to heart failure-related causes within 3 months post-discharge.
Calculated as number of emergency visits due to heart failure / total number of patients × 100%.
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3 months post-discharge
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Depression Symptoms
Tijdsspanne: Baseline, 1 month, and 3 months post-discharge
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Change from baseline in depressive symptoms assessed by the Patient Health Questionnaire (PHQ-9).
Higher scores indicate more severe depression.
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Baseline, 1 month, and 3 months post-discharge
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B-type Natriuretic Peptide (BNP)
Tijdsspanne: Baseline and 3 months post-discharge
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Change from baseline in B-type natriuretic peptide (BNP) levels measured by laboratory testing.
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Baseline and 3 months post-discharge
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NYHA Functional Classification
Tijdsspanne: Baseline and 3 months post-discharge
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Change from baseline in New York Heart Association (NYHA) functional class assessed by clinical evaluation.
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Baseline and 3 months post-discharge
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Medewerkers en onderzoekers
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Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- E202665
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