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Chronic Heart FailureNCT07686536

A CSM-Based Volume Management Program for Chronic Heart Failure

A study testing CSM-Based Intervention Group in people with Chronic Heart Failure, run by The Third Xiangya Hospital of Central South University.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Chronic Heart Failure
What is being tested?
CSM-Based Intervention Group
Could I receive a placebo?
No, everyone receives an active treatment
How many people
88 participants
Where
No sites listed yet
Study dates
3 Jul 2026to 20 Dec 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

About this study

Official title: 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:

Read more

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
Read the detailed description

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.

Being tested
CSM-Based Intervention Group, Standard Care (in control arm)

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CSM-Based Intervention GroupBehavioural

    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.

  • 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.

Study groups in NCT07686536
Study groupRoleWhat they receive
CSM-Based Intervention GroupExperimentalA 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.
Receives: Behavioral: CSM-Based Intervention Group
Standard Care Control GroupActive comparatorStandard 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.
Receives: Other: Standard Care (in control arm)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline, 1 month, and 3 months post-discharge

  2. 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.

    Measured: Baseline, 1 month, and 3 months post-discharge

Secondary outcomes (10)
  1. Dry Weight Attainment Rate

    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.

    Measured: 1 month and 3 months post-discharge

  2. Self-Efficacy for Self-Care

    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.

    Measured: Baseline, 1 month, and 3 months post-discharge

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

    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.

    Measured: Baseline, 1 month, and 3 months post-discharge

  4. Anxiety Symptoms

    Change from baseline in anxiety symptoms assessed by the Generalized Anxiety Disorder Scale (GAD-7). Higher scores indicate more severe anxiety.

    Measured: Baseline, 1 month, and 3 months post-discharge

  5. Left Ventricular Ejection Fraction

    Change from baseline in left ventricular ejection fraction (LVEF) assessed by echocardiography.

    Measured: Baseline and 3 months post-discharge

  6. Heart Failure Readmission Rate

    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%.

    Measured: 3 months post-discharge

  7. Emergency Department Visits

    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%.

    Measured: 3 months post-discharge

  8. Depression Symptoms

    Change from baseline in depressive symptoms assessed by the Patient Health Questionnaire (PHQ-9). Higher scores indicate more severe depression.

    Measured: Baseline, 1 month, and 3 months post-discharge

  9. B-type Natriuretic Peptide (BNP)

    Change from baseline in B-type natriuretic peptide (BNP) levels measured by laboratory testing.

    Measured: Baseline and 3 months post-discharge

  10. NYHA Functional Classification

    Change from baseline in New York Heart Association (NYHA) functional class assessed by clinical evaluation.

    Measured: Baseline and 3 months post-discharge

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Jul 2026
  2. Study start3 Jul 2026 (estimated)
  3. Primary completion7 Jul 2026 (estimated)
  4. Study completion20 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
88 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07686536
Sponsor's protocol ID
E202665
Status last verified
Jun 2026
First submitted
28 Jun 2026
Last updated
7 Jul 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing CSM-Based Intervention Group in people with Chronic Heart Failure, run by The Third Xiangya Hospital of Central South University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 7 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Su Na (+86 13268395340, 879950198@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Self-Care of Heart Failure Index Score as Measured by the SCHFI (time frame: Baseline, 1 month, and 3 months post-discharge). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2026.

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