- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT01823588
Nurse-led Reminder Program for the Prevention of Cardiovascular Diseases
Efficacy of a Nurse-led Reminder Program for the Management of the Risk Factors for Cardiovascular Diseases in Hypertensive Patients: a Randomized Controlled Trial
A number of strategies have been evaluated to improve the prevention and control of the main cardiovascular (CVD) risk factors. Nursing telephonic and tele-counseling individualized lifestyle educational programs were found to improve blood pressure (BP) control and adherence to healthy lifestyle. This study aims at evaluating for the first time the efficacy of a nurse-led reminder program through email (NRP-e) to improve CVD risk factors among hypertensive adults.
Participants will receive usual care and a guideline-based educational program on BP control and healthy lifestyle habits. Subjects in the NRP-e group will also receive weekly email alerts and phone calls from a nurse care manager for 6 months. Emails contain a reminder program on the compliance with a healthy lifestyle based upon current guidelines for CVD prevention. Follow-up visits will be scheduled at 1, 3 and 6 months after enrollment; randomization will be made centrally and blood samples will be evaluated into a single, accredited laboratory.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
-
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Abruzzo
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Chieti, Abruzzo, Itália, 66100
- ASL02Abruzzo
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CH
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Chieti, CH, Itália, 66100
- Department of Medicine and Aging Sciences, University of Chieti
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
- to be eligible, all subjects had to be hypertensive (on active treatment for hypertension, or systolic blood pressure ≥ 140 mmHg; or
- diastolic blood pressure ≥ 90 mmHg).
- speaking and reading Italian,
- having a active phone number and an email address, and
- providing a signed informed consent.
Exclusion Criteria:
- mental illness;
- nursing home institutionalization;
- pregnancy;
- previous cardiovascular major events, non-modifiable cardiovascular risk-factors (i.e. diabetes).
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Prevenção
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
---|---|
Sem intervenção: Usual care
Educational program and usual cardiovascular prevention.
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Experimental: Nurse-led reminder through email
In addition to usual care and educational program, the intervention group will also receive email alerts and phone calls from the nurse-care manager (NCM)
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Both groups will receive an educational program and usual care. The educational program will consist of 1-hour sessions, during which the NCM emphasize the importance of blood pressure control and correct measurement, give advice for a correct blood pressure self-measurement; report non-pharmacological strategies for a healthy lifestyle, and instruction on how to fill the daily self-assessment form. Educational program and usual cardiovascular prevention. The educational program will consist of 1-hour sessions, during which the NCM emphasize the importance of blood pressure control and correct measurement, give advice for a correct blood pressure self-measurement; report non-pharmacological strategies for a healthy lifestyle, and instruction on how to fill the daily self-assessment form. |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Prazo |
---|---|
The main outcome of the study was the mean difference between groups in the average reduction in systolic and diastolic blood pressure between baseline and the end of follow-up
Prazo: 6 months
|
6 months
|
Medidas de resultados secundários
Medida de resultado |
Prazo |
---|---|
Mean difference between groups in the average reduction in LDL cholesterol between baseline and the end of follow-up
Prazo: 6 months
|
6 months
|
Mean difference between groups in the average reduction in physical activity between baseline and the end of follow-up
Prazo: 6 months
|
6 months
|
Mean difference between groups in the average reduction in BMI between baseline and the end of follow-up
Prazo: 6 months
|
6 months
|
Colaboradores e Investigadores
Investigadores
- Investigador principal: Giancarlo GC Cicolini, PhD, ASL 02 Abruzzo - Abruzzo Region - Italy
Publicações e links úteis
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- Nurse led
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