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A CSM-Based Volume Management Program for Chronic Heart Failure

3 luglio 2026 aggiornato da: 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

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Stimato)

88

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Altro
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Separare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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.
Comportamentale: 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.
Comparatore attivo: 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.
Altro: 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Self-Care of Heart Failure Index Score as Measured by the SCHFI
Lasso di tempo: 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
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Dry Weight Attainment Rate
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

The Third Xiangya Hospital of Central South University

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

3 luglio 2026

Completamento primario (Stimato)

7 luglio 2026

Completamento dello studio (Stimato)

20 dicembre 2026

Date di iscrizione allo studio

Primo inviato

28 giugno 2026

Primo inviato che soddisfa i criteri di controllo qualità

3 luglio 2026

Primo Inserito (Effettivo)

7 luglio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

7 luglio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

3 luglio 2026

Ultimo verificato

1 giugno 2026

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • E202665

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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