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A CSM-Based Volume Management Program for Chronic Heart Failure

3. Juli 2026 aktualisiert von: The Third Xiangya Hospital of Central South University

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

Studienübersicht

Status

Noch keine Rekrutierung

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Geschätzt)

88

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

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.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Sonstiges
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Single

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: 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.
Verhalten: 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 trends, symptom control, and goal attainment.
Aktiver Komparator: 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.
Sonstiges: 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.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Self-Care of Heart Failure Index Score as Measured by the SCHFI
Zeitfenster: 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.
Baseline, 1 month, and 3 months post-discharge
Illness Perception Change
Zeitfenster: 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.
Baseline, 1 month, and 3 months post-discharge

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Dry Weight Attainment Rate
Zeitfenster: 1 month and 3 months post-discharge
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.
1 month and 3 months post-discharge
Self-Efficacy for Self-Care
Zeitfenster: Baseline, 1 month, and 3 months post-discharge
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.
Baseline, 1 month, and 3 months post-discharge
Quality of Life as Assessed by the Minnesota Living with Heart Failure Questionnaire
Zeitfenster: Baseline, 1 month, and 3 months post-discharge
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.
Baseline, 1 month, and 3 months post-discharge
Anxiety Symptoms
Zeitfenster: Baseline, 1 month, and 3 months post-discharge
Change from baseline in anxiety symptoms assessed by the Generalized Anxiety Disorder Scale (GAD-7). Higher scores indicate more severe anxiety.
Baseline, 1 month, and 3 months post-discharge
Left Ventricular Ejection Fraction
Zeitfenster: Baseline and 3 months post-discharge
Change from baseline in left ventricular ejection fraction (LVEF) assessed by echocardiography.
Baseline and 3 months post-discharge
Heart Failure Readmission Rate
Zeitfenster: 3 months post-discharge
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%.
3 months post-discharge
Emergency Department Visits
Zeitfenster: 3 months post-discharge
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%.
3 months post-discharge
Depression Symptoms
Zeitfenster: Baseline, 1 month, and 3 months post-discharge
Change from baseline in depressive symptoms assessed by the Patient Health Questionnaire (PHQ-9). Higher scores indicate more severe depression.
Baseline, 1 month, and 3 months post-discharge
B-type Natriuretic Peptide (BNP)
Zeitfenster: Baseline and 3 months post-discharge
Change from baseline in B-type natriuretic peptide (BNP) levels measured by laboratory testing.
Baseline and 3 months post-discharge
NYHA Functional Classification
Zeitfenster: Baseline and 3 months post-discharge
Change from baseline in New York Heart Association (NYHA) functional class assessed by clinical evaluation.
Baseline and 3 months post-discharge

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

The Third Xiangya Hospital of Central South University

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

3. Juli 2026

Primärer Abschluss (Geschätzt)

7. Juli 2026

Studienabschluss (Geschätzt)

20. Dezember 2026

Studienanmeldedaten

Zuerst eingereicht

28. Juni 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

3. Juli 2026

Zuerst gepostet (Tatsächlich)

7. Juli 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

7. Juli 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

3. Juli 2026

Zuletzt verifiziert

1. Juni 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • E202665

Plan für individuelle Teilnehmerdaten (IPD)

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NEIN

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

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