A CSM-Based Volume Management Program for Chronic Heart Failure

NCT07686536 | Not Yet Recruiting

• 1 other identifier: E202665
• Study Type: interventional
• Target: 88
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Chronic Heart Failure

Outcome Measures

Primary Outcomes (2)

• Self-Care of Heart Failure Index Score as Measured by the SCHFI

  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

  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

Secondary Outcomes (10)

• Dry Weight Attainment Rate

  1 month and 3 months post-discharge

• Self-Efficacy for Self-Care

  Baseline, 1 month, and 3 months post-discharge

• Quality of Life as Assessed by the Minnesota Living with Heart Failure Questionnaire

  Baseline, 1 month, and 3 months post-discharge

• Anxiety Symptoms

  Baseline, 1 month, and 3 months post-discharge

• Left Ventricular Ejection Fraction

  Baseline and 3 months post-discharge

Study Arms (2)

CSM-Based Intervention Group

EXPERIMENTAL

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.

Behavioral: CSM-Based Intervention Group

Standard Care Control Group

ACTIVE COMPARATOR

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.

Other: Standard Care (in control arm)

Interventions

CSM-Based Intervention Group BEHAVIORAL

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.

CSM-Based Intervention Group

Standard Care (in control arm) OTHER

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 Care Control Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Third Xiangya Hospital of Central South University: lead

MeSH Terms

Interventions

Standard of Care

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Central Study Contacts

Su Na

CONTACT

+86 13268395340; 879950198@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 28, 2026
• First Posted: July 7, 2026
• Study Start: July 3, 2026
• Primary Completion: July 7, 2026
• Study Completion (Estimated): December 20, 2026
• Last Updated: July 7, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share