NCT07686536Toborzás még nem indult
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
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. júl. 7.
Rövid összefoglaló (regiszter, angolul)
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
- Állapot (regiszter)
- Toborzás még nem indult
- Vizsgálattípus
- Beavatkozással járó
- Résztvevők száma
- 88 (tervezett)
- Első benyújtás
- 2026. jún. 28.
- Kezdés
- 2026. júl. 3.
- Elsődleges befejezés
- 2026. júl. 7.
- Fő szponzor
- The Third Xiangya Hospital of Central South University
- Betegségek
- Szívelégtelenség
- NCT-szám
- NCT07686536
Mit vállalsz
- Vizsgálat típusa: Beavatkozással járó
- Tervezett résztvevők: 88
- 2026. júl. 3. és az elsődleges befejezés (2026. júl. 7.) között
- Nincs megadott helyszín, ország nélkül
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
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Más betegség
- 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.
Egyéb
- 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.
Kiket keres a vizsgálat
- 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.
Életkor a regiszterben: 18 év – - · Nem: nők és férfiak · Egészséges önkénteseket nem fogad
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