Affect of Multiple Health Education on Medication Persistence and Clinical Prognosis of Ischemic Stroke Patients
9 de dezembro de 2018 atualizado por: yongjun wang, Yongjun Wang
Affect of Multiple Health Education Interventions on Secondary Prevention Medication Persistence and Clinical Prognosis of Ischemic Stroke Patients: a Prospective Cohort Study
The study aimed to demonstrate the relationship between secondary prevention medication persistence and clinical prognosis of ischemic stroke patients at 3,6,12 months
Visão geral do estudo
Status
Concluído
Condições
Intervenção / Tratamento
Descrição detalhada
The study is a prospective, multicenter, hospital-based study on secondary prevention for patients with ischemic cerebrovascular diseases between May 2014 and June 2015. Physicians from 24 hospitals in Beijing underwent a standard secondary prevention training of ischemic cerebrovascular diseases by professional training, instruction manuals, stratification management software. In order to improve the persistence of taking preventive secondary medicine, IS patients from these 24 hospitals received healthy education through manuals and Digital Video Disc about health education during hospitalization and acquired secondary preventive knowledge of ischemic cerebrovascular diseases through regular health education messages during 6 months after discharge. Patients with IS from other 6 hospitals were used as a control, and no such intervention was given to them.
Telephone follow-up was performed at 3 months, 6 months, and 1 year after the onset of cerebral infarction, during which the use of antiplatelet and statins drugs and recurrence of IS were recorded. Patients who took antiplatelet drugs or statins at three follow-ups were regarded as persistent antiplatelet drugs or statins taking within one year after the onset of the disease. The main prognostic indicator was the recurrence of IS and persistence of antiplatelet and statins medication within 1 year, and the main purpose was to explore the impact of persistent statins and antiplatelet medication use on IS recurrence.
Tipo de estudo
Intervencional
Inscrição (Real)
3111
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
-
-
Beijing
-
Beijing, Beijing, China, 100050
- Beijing Tian Tan Hospital, Capital Medical University
-
-
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 a 80 anos (Adulto, Adulto mais velho)
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Tudo
Descrição
Inclusion Criteria:
- Adult subjects (male or female ≥18 years);
- Acute ischemic stroke occured within 14 days of symptoms onset
- Patients signed informed consent
- Patients have a cell phone and have the ability to receive and view messages
Exclusion Criteria:
- Non-cerebrovascular events or hemorrhagic stroke
- Patients have serious heart, liver, kidney dysfunction or coagulation disorders
- Patients have circumstances that may affect the follow-up such as disturbance of consciousness, severe depression or other mental disorders, aphasia
- Modified Rankin Scale score at discharge ≥3
- Those who are participating in other clinical trials
- Those who can not guarantee with the completion of 1 year follow-up after enrollment
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: Prevenção
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Comparador Ativo: multiple health education interventions
The group will receive health education manuals and Digital Video Disc (DVD) during hospitalization and regular text message during 1 year after discharge.
|
|
|
Comparador de Placebo: conventional health education
The second group will receive conventional health education during hospitalization except health education manuals, text message and Digital Video Disc (DVD)
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Proportion of patients who continued taking antiplatelet drugs at three months after stroke onset, and proportion of patients who continued taking statins drugs at three months after stroke onset.
Prazo: 3 months after stroke onset
|
Medication persistence at 3 months.
Persistence is defined as continuing a therapy or class of therapy from discharge to the 3 months follow-up.
Subjects prescribed an individual medication at discharge but who were not taking that medication at follow up were defined as "nonpersistent".
Persistence for the specified medication classes (antiplatelet, statins) was defined in the same way; however, subjects were considered persistent if there was a switch to another medication within the same class.
|
3 months after stroke onset
|
|
Proportion of patients who continued taking antiplatelet drugs at six months after stroke onset, and proportion of patients who continued taking statins drugs at six months after stroke onset.
Prazo: 6 months after stroke onset
|
Medication persistence at 6 months.
Persistence at 6 months is defined as continuing a therapy or class of therapy at 6 months follow-up.
Subjects prescribed an individual medication at discharge but who were not taking that medication at follow up were defined as "nonpersistent".
Persistence for the specified medication classes (antiplatelet, statins) was defined in the same way; however, subjects were considered persistent if there was a switch to another medication within the same class.
|
6 months after stroke onset
|
|
Proportion of patients who continued taking antiplatelet drugs at 12 months after stroke onset, and proportion of patients who continued taking statins drugs at 12 months after stroke onset.
Prazo: 12 months after stroke onset
|
Medication persistence at 12 months.
Persistence at 12 months is defined as continuing a therapy or class of therapy at 12 months follow-up.
Subjects prescribed an individual medication at discharge but who were not taking that medication at follow up were defined as "nonpersistent".
Persistence for the specified medication classes (antiplatelet, statins) was defined in the same way; however, subjects were considered persistent if there was a switch to another medication within the same class.
|
12 months after stroke onset
|
|
Proportion of patients who continued taking antiplatelet drugs in 1 year after stroke onset, and proportion of patients who continued taking statins drugs in 1 year after stroke onset.
Prazo: 1 year after stroke onset
|
Patients who took statins and antiplatelet medications at 3, 6 and 12 months follow-up were regarded as persistent during one year after stroke onset.
|
1 year after stroke onset
|
|
Recurrence of ischemic stroke in three months after stroke onset
Prazo: 3 months after stroke onset
|
Recurrence of IS was defined as a new focal neurological deficit of vascular origin lasting >24 hours and without hemorrhage on computed tomography or MRI of the brain.
|
3 months after stroke onset
|
|
Recurrence of ischemic stroke in six months after stroke onset
Prazo: 6 months after stroke onset
|
Recurrence of IS was defined as a new focal neurological deficit of vascular origin lasting >24 hours and without hemorrhage on computed tomography or MRI of the brain.
|
6 months after stroke onset
|
|
Recurrence of ischemic stroke in 12 months after stroke onset
Prazo: 12 months after stroke onset
|
Recurrence of IS was defined as a new focal neurological deficit of vascular origin lasting >24 hours and without hemorrhage on computed tomography or MRI of the brain.
|
12 months after stroke onset
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
clinical prognosis
Prazo: 3,6,12 months
|
Death(including Vascular death and non-vascular death); Nonfatal myocardial infarction; Nonfatal hemorrhagic stroke; Severe disabilities(modified Rankin Scale≥4)
|
3,6,12 months
|
Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Investigadores
- Investigador principal: yongjun wang, MD, Beijing Tian Tan Hospital, Capital Medical University, Beijing, China
Publicações e links úteis
A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.
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 (Real)
1 de maio de 2014
Conclusão Primária (Real)
28 de junho de 2015
Conclusão do estudo (Real)
30 de setembro de 2015
Datas de inscrição no estudo
Enviado pela primeira vez
5 de maio de 2014
Enviado pela primeira vez que atendeu aos critérios de CQ
14 de maio de 2014
Primeira postagem (Estimativa)
16 de maio de 2014
Atualizações de registro de estudo
Última Atualização Postada (Real)
11 de dezembro de 2018
Última atualização enviada que atendeu aos critérios de controle de qualidade
9 de dezembro de 2018
Última verificação
1 de dezembro de 2018
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- TTYY-20131201
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
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 .