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Hospital-Community-Family-Care Management Platform for Chronic Heart Failure (HCF-CMP-CHF)

24 de julho de 2019 atualizado 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.

Visão geral do estudo

Status

Desconhecido

Condições

Intervenção / Tratamento

Descrição detalhada

(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 estudo

Intervencional

Inscrição (Antecipado)

1000

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

  • China
    • Jiangsu
      • Yangzhou, Jiangsu, China, 225001
        • Recrutamento
        • Department of cardiovascular medicine,Northern Jiangsu Hospital
        • Subinvestigador:
          • Lei Sun, Master
        • Subinvestigador:
          • Ye Zhu, Master
        • Subinvestigador:
          • Shuhang Miao, Bachelor
        • Subinvestigador:
          • Yi Zhang, Master
        • Subinvestigador:
          • Zhengyu Bao, Doctor
        • Contato:
          • Jianhua Shen, Doctor
          • Número de telefone: +86 0514 87373367
        • Subinvestigador:
          • Ming Gu, Master
        • Subinvestigador:
          • Hui Li, Bachler
        • Subinvestigador:
          • Fei Hang, Master

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

18 anos e mais velhos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Descrição

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:

  1. Male and female are aged 18 years old or over.
  2. History of CHF for ≥3 months with NYHA functional class I-IV, of which class IV without strict bed rest.
  3. 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;
  4. 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.
  5. 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.
  6. 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:

  1. Some secondary cardiomyopathy: hyperthyroid heart disease and anemic heart disease, and et al;
  2. A history of malignancy, and life expectancy is less than 1 year；
  3. Severe primary hepatic and renal insufficiency (alanine aminotransferase≥100 u/L, serum creatinine >3.0mg/dL, serum albumin <2.5g/L);
  4. Refusal to participate;
  5. Unable to visit outpatient clinics periodically;
  6. Ambulatory population;
  7. Patients were considered inappropriate to participate by researchers.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Outro
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
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.
Outro: Hospital-Community-Family-Care Management Platform Online
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
Outros nomes:
  • Subjects with CHF follow-up
Outro: Subjects with CHF via conventional clinic visit according to the latest relevant guidelines
Subjects with CHF via conventional clinic visit according to the latest relevant guidelines
Comparador Ativo: Subjects with CHF conventional clinic visit
Subjects with standardized treatment according to latest guidelines via conventional visit.
Outro: Subjects with CHF via conventional clinic visit according to the latest relevant guidelines
Subjects with CHF via conventional clinic visit according to the latest relevant guidelines

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
all cause mortality
Prazo: one year
Number of subjects with all cause death
one year

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Heart failure morbidity
Prazo: one year
number of subjects with heart failure - related visits
one year

Outras medidas de resultado

Medida de resultado
Descrição da medida
Prazo
Engajamento da intervenção
Prazo: 4 meses
Foi avaliado objetivamente por meio de logins diários no portal da Web e uso do aplicativo móvel
4 meses
heart failure worsening
Prazo: one year
Number of subjects requiring drug or dose changes to intensify concomitant therapy due to worsening of heart failure (HF).
one year
Hospitalization rate
Prazo: one year
Hospitalization rate associated with heart failure
one year
Average hospitalization time
Prazo: one year
Average hospitalization time associated with heart failure
one year
Costs of medications
Prazo: one year
Costs of medications associated with heart failure
one year
Usability of the HCF intervention for patients
Prazo: 4 months
it was assessed based on the Perceived Health Web Site Usability Questionnaire (PHWSUQ-12)
4 months
Changes of self-management
Prazo: 4 months
Lifestyle and health behaviors of participants were collected by interview
4 months
Participants perceptions of intervention components
Prazo: 4 months
During the interview, qualitative method was used to examine participants perceptions of intervention components
4 months

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Xiang Gu

Colaboradores

Science and Technology Department of Jiangsu Province
Yangzhou Municipal Health Bureau

Investigadores

  • Investigador principal: Xiang Gu, Docter, Department of cardiovascular medicine
  • Investigador principal: Jianhua Shen, Docter, Department of cardiovascular medicine

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo

1 de dezembro de 2013

Conclusão Primária (Antecipado)

1 de agosto de 2020

Conclusão do estudo (Antecipado)

1 de dezembro de 2020

Datas de inscrição no estudo

Enviado pela primeira vez

21 de dezembro de 2013

Enviado pela primeira vez que atendeu aos critérios de CQ

5 de janeiro de 2014

Primeira postagem (Estimativa)

7 de janeiro de 2014

Atualizações de registro de estudo

Última Atualização Postada (Real)

26 de julho de 2019

Última atualização enviada que atendeu aos critérios de controle de qualidade

24 de julho de 2019

Última verificação

1 de julho de 2019

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • BL2013022

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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