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A CSM-Based Volume Management Program for Chronic Heart Failure

3. juli 2026 opdateret af: 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

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

88

Fase

  • Ikke anvendelig

Kontakter og lokationer

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Studiekontakt

Deltagelseskriterier

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Berettigelseskriterier

Aldre berettiget til at studere

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Ingen

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Andet
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
Adfærdsmæssigt: 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.
Aktiv 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.
Andet: 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Self-Care of Heart Failure Index Score as Measured by the SCHFI
Tidsramme: 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
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Dry Weight Attainment Rate
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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

Samarbejdspartnere og efterforskere

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Sponsor

The Third Xiangya Hospital of Central South University

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

3. juli 2026

Primær færdiggørelse (Anslået)

7. juli 2026

Studieafslutning (Anslået)

20. december 2026

Datoer for studieregistrering

Først indsendt

28. juni 2026

Først indsendt, der opfyldte QC-kriterier

3. juli 2026

Først opslået (Faktiske)

7. juli 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

7. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

3. juli 2026

Sidst verificeret

1. juni 2026

Mere information

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Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • E202665

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