[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100646644":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":25,"centralContacts":29,"locations":25,"responsibleParty":35,"collaborators":25,"id":37,"slug":38,"hasResults":39,"nctId":40,"briefTitle":41,"officialTitle":42,"acronym":25,"eligibilityCriteria":43,"healthyVolunteers":39,"sex":44,"minAge":45,"maxAge":25,"enrollmentInfo":46,"targetDuration":25,"studyType":49,"phases":50,"briefSummary":52,"conditions":53,"keywords":25,"overallStatus":55,"whyStopped":25,"lastUpdateSubmitDate":56,"lastUpdatePostDateStruct":57,"startDateStruct":60,"completionDateStruct":61,"leadSponsor":63,"locationsCount":25},{"fullName":5,"class":6},"The Third Xiangya Hospital of Central South University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"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\u002FPHQ-9 assessment with emotional counseling and regulation techniques. Phase 4: Training on symptom recognition, daily weight monitoring, intake\u002Foutput 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.",[13],"Behavioral: CSM-Based Intervention Group",{"label":15,"type":16,"description":17,"interventionNames":18},"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.",[19],"Other: Standard Care (in control arm)",[21,26],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"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\u002FPHQ-9 assessment with emotional counseling and regulation techniques. Phase 4: Training on symptom recognition, daily weight monitoring, intake\u002Foutput 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.",[9],null,{"type":6,"name":27,"description":17,"armGroupLabels":28,"otherNames":25},"Standard Care (in control arm)",[15],[30],{"name":31,"role":32,"phone":33,"phoneExt":25,"email":34},"Su Na","CONTACT","+86 13268395340","879950198@qq.com",{"type":36,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","100646644","a-csm-based-volume-management-program-for-chronic-heart-failure-100646644",false,"NCT07686536","A CSM-Based Volume Management Program for Chronic Heart Failure","Development and Application of a Common-Sense Model-Based Intervention Protocol for Volume Management in Patients With Chronic Heart Failure: A Randomized Controlled Trial","Inclusion Criteria:\n\n* 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.\n* Aged 18 years or older.\n* Documented diagnosis of heart failure for at least 3 months.\n* Experienced documented volume overload symptoms (e.g., dyspnea, lower extremity edema) or related healthcare visits within the past 6 months.\n* Adequate communication, reading, and comprehension abilities.\n* Willing and able to provide written informed consent to participate in the study.\n* Assessed by the investigator as capable of adhering to the study protocol.\n\nExclusion Criteria:\n\n* Comorbid other severe end-stage diseases (e.g., malignancy, uremia) or recent major cerebrovascular events.\n* History of psychiatric illness or confirmed cognitive impairment.\n* Comorbid other conditions that may cause fluid retention.\n* Lack of independent decision-making capacity.\n* Communication difficulties or inability to cooperate with study procedures.\n* Inability to use a smartphone or WeChat application.\n* Patients or family members with poor compliance, or those who withdraw or are lost to follow-up.","ALL","18 Years",{"count":47,"type":48},88,"ESTIMATED","INTERVENTIONAL",[51],"NA","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\n\nBrief Summary:\n\nThe 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:\n\n* Does the CSM-based intervention improve patients' self-care capacity as measured by the Self-Care of Heart Failure Index (SCHFI)?\n* Does the intervention improve patients' illness perception as assessed by the Brief Illness Perception Questionnaire (BIPQ)?\n* Does the intervention improve patients' self-efficacy, quality of life, emotional status, cardiac function (LVEF, BNP, heart rate, NYHA class), and dry weight attainment?\n* 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.\n\nParticipants in the intervention group will:\n\n* Receive a 5-phase, nurse-led program from hospital admission to 3 months post-discharge\n* Attend bedside interviews and structured lectures on volume overload mechanisms during hospitalization\n* Complete questionnaires assessing illness perception, self-care, self-efficacy, quality of life, and emotional status at baseline, 1 month, and 3 months\n* Receive clinical evaluations including cardiac function tests at baseline and 3 months\n* Learn practical skills including daily weight monitoring, sodium restriction, fluid management, and diuretic self-adjustment\n* Receive telephone follow-ups weekly in month 1 and biweekly in month 2, with an outpatient visit at month 3",[54],"Chronic Heart Failure","NOT_YET_RECRUITING","2026-07-03",{"date":58,"type":59},"2026-07-07","ACTUAL",{"date":56,"type":48},{"date":62,"type":48},"2026-12-20",{"name":5,"class":6}]