Hospital-Community-Family-Care Management Platform for Chronic Heart Failure (HCF-CMP-CHF)
24 de julio de 2019 actualizado por: Xiang Gu
Remote Prevention and Treatment Based on Community Under the Guidance of Regional Central Hospital for Patients With Chronic Heart Failure
The purpose of this study is to determine whether the Hospital-Community-Family-Care Management Platform for Chronic Heart Failure reduces the mortality, readmission rates and costs of the subjects with CHF.
Descripción general del estudio
Estado
Desconocido
Condiciones
Descripción detallada
(1) Indication: Chronic Heart Failure.
(2) Objectives: Primary objective is to evaluate the efficacy of the Hospital-Community-Family-Care Management Platform online compared with the regular clinic follow up in subjects with CHF (I-IV class by NYHA, of which class IV without strict bed rest).Secondary objectives is to assess the safety of the Management Platform online in subjects with CHF.
(3) Study design: Prospective, randomized, controlled study with two follow up management groups: 1) the Hospital-Community-Family-Care Management Follow up Online; 2) the regular monthly clinic follow up.
Study population: Totally 1000 male and female subjects with CHF (I-IV functional class according to NYHA classification).
(4) Quality assurance plan that addresses data validation and registry procedures, including any plans for site monitoring and auditing.
(5) Data checks to compare data entered into the registry against predefined rules for range or consistency with other data fields in the registry.
(6) Source data verification to assess the accuracy, completeness, or representativeness of registry data by comparing the data to external data sources.
(7) Standard Operating Procedures to address registry operations and analysis activities, such as patient recruitment, data collection, data management, data analysis, reporting for adverse events, and change management.
(8) Duration of follow up: The total follow-up time shall be at least 12 months.
(9) Safety Assessment: Safety of the study will be evaluated by the following assessments: 1) Subject and object examinations (during the follow up period and extending up to 2 week after the end of the study) consisting of a subject interview (including direct questioning about adverse events), physical examination, assessment of body weight, Electrocardiogram (ECG) and echocardiogram (UCG), Left ventricular ejection fraction (LVEF), assessed by echocardiography, The N-terminal prohormone of brain natriuretic peptide (NT-proBNP), a peptide hormone whose plasma concentration is inversely related to the severity of HF, NYHA functional status, assessed by subject interview, 6-minute walk distance (6MWD), Quality of life (QoL), assessed by the Minnesota Living with Heart Failure questionnaire (MLHFQ), a validated questionnaire assessing QoL in subjects with heart failure.
2) Evaluation of clinically relevant safety laboratory parameters, such as complete blood count, serum creatinine, electrolytes, and liver enzymes.
Any Adverse Events (AE) or Serious Adverse Events (SAE) and its potential causal relationship with the study will be recorded and evaluated.
Tipo de estudio
Intervencionista
Inscripción (Anticipado)
1000
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Jiangsu
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Yangzhou, Jiangsu, Porcelana, 225001
- Reclutamiento
- Department of cardiovascular medicine,Northern Jiangsu Hospital
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Sub-Investigador:
- Lei Sun, Master
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Sub-Investigador:
- Ye Zhu, Master
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Sub-Investigador:
- Shuhang Miao, Bachelor
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Sub-Investigador:
- Yi Zhang, Master
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Sub-Investigador:
- Zhengyu Bao, Doctor
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Contacto:
- Jianhua Shen, Doctor
- Número de teléfono: +86 0514 87373367
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Sub-Investigador:
- Ming Gu, Master
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Sub-Investigador:
- Hui Li, Bachler
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Sub-Investigador:
- Fei Hang, Master
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
18 años y mayores (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:Inclusion Criteria:to be considered eligible to participate in this study, a subject must meet the inclusion criteria listed below at the time of screening and randomization:
- Male and female are aged 18 years old or over.
- History of CHF for ≥3 months with NYHA functional class I-IV, of which class IV without strict bed rest.
- Left ventricular ejection fraction (LVEF) ≤45% as assessed by echocardiogram. However, LVEF can be above 45% for patients with cardiac insufficiency caused by atrial fibrillation, valvular heart disease, hypertrophic cardiomyopathy and et al;
- Treatment of CHF with stable and optimal pharmacological therapy according to Chinese guidelines for treatment of CHF. In general, optimal treatment will include a beta-blocker and an ACE inhibitor and/or an angiotensin receptor blocker, unless not tolerated. Medical therapy is defined as stable, if the subject has not started a new CHF drug class and the dose of drugs taken have not been changed during the 3 months prior to screening and randomization.
- Ability to understand the requirements of the study and willingness to provide written informed consent (IC), and agreement to abide by the study restrictions and return for the required assessments.
- Subjects are located in our coverage of the remote monitoring system.
Exclusion Criteria:To be eligible for entry into the study, the subject must not meet any of the exclusion criteria listed below at screening and randomization:
- Some secondary cardiomyopathy: hyperthyroid heart disease and anemic heart disease, and et al;
- A history of malignancy, and life expectancy is less than 1 year；
- Severe primary hepatic and renal insufficiency (alanine aminotransferase≥100 u/L, serum creatinine >3.0mg/dL, serum albumin <2.5g/L);
- Refusal to participate;
- Unable to visit outpatient clinics periodically;
- Ambulatory population;
- Patients were considered inappropriate to participate by researchers.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Otro
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: Subjects with CHF follow-up
Subjects with Hospital-Community-Family-Care Management Platform online and those with the clinic follow up.In the program, participants were educated on the use of smart health-tracking devices and mobile application (APP) to collect and upload comprehensive data elements related to the risk of CHF self-care management.
They were also instructed to send text messages, view notifications, and receive individualized guidance on the mobile APP.
The general practitioners viewed index of each participant on mobile APP and provided primary care periodically, and cardiologists in regional central hospital offered remote guidance and management if necessary.
Outcomes assessed included accomplishments of the program, usability and satisfaction, engagement with the intervention, and changes of heart failure-related health behaviors.
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Hospital-Community-Family-Care Management Platform Online: the remote monitoring service platform on line based on community and family for subjects with CHF under the guidance of the regional central hospital
Otros nombres:
Subjects with CHF via conventional clinic visit according to the latest relevant guidelines
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Comparador activo: Subjects with CHF conventional clinic visit
Subjects with standardized treatment according to latest guidelines via conventional visit.
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Subjects with CHF via conventional clinic visit according to the latest relevant guidelines
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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all cause mortality
Periodo de tiempo: one year
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Number of subjects with all cause death
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one year
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Heart failure morbidity
Periodo de tiempo: one year
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number of subjects with heart failure - related visits
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one year
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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Compromiso de la intervención
Periodo de tiempo: 4 meses
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Se evaluó objetivamente a través de los inicios de sesión diarios en el portal web y el uso de la aplicación móvil.
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4 meses
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heart failure worsening
Periodo de tiempo: one year
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Number of subjects requiring drug or dose changes to intensify concomitant therapy due to worsening of heart failure (HF).
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one year
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Hospitalization rate
Periodo de tiempo: one year
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Hospitalization rate associated with heart failure
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one year
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Average hospitalization time
Periodo de tiempo: one year
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Average hospitalization time associated with heart failure
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one year
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Costs of medications
Periodo de tiempo: one year
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Costs of medications associated with heart failure
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one year
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Usability of the HCF intervention for patients
Periodo de tiempo: 4 months
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it was assessed based on the Perceived Health Web Site Usability Questionnaire (PHWSUQ-12)
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4 months
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Changes of self-management
Periodo de tiempo: 4 months
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Lifestyle and health behaviors of participants were collected by interview
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4 months
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Participants perceptions of intervention components
Periodo de tiempo: 4 months
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During the interview, qualitative method was used to examine participants perceptions of intervention components
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4 months
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Xiang Gu, Docter, Department of cardiovascular medicine
- Investigador principal: Jianhua Shen, Docter, Department of cardiovascular medicine
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio
1 de diciembre de 2013
Finalización primaria (Anticipado)
1 de agosto de 2020
Finalización del estudio (Anticipado)
1 de diciembre de 2020
Fechas de registro del estudio
Enviado por primera vez
21 de diciembre de 2013
Primero enviado que cumplió con los criterios de control de calidad
5 de enero de 2014
Publicado por primera vez (Estimar)
7 de enero de 2014
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
26 de julio de 2019
Última actualización enviada que cumplió con los criterios de control de calidad
24 de julio de 2019
Última verificación
1 de julio de 2019
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- BL2013022
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .