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- Ensaio Clínico NCT00785031
Internet Based Vascular Risk Factor Intervention and Self Management Study (IRIS)
Internet-based Vascular Risk Factor Management for Patients With Clinical Manifest Vascular Disease; a Randomized Controlled Trial
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
The objective of the study is to evaluate the efficacy and cost-effectiveness of an internet based vascular risk factor program on top of usual care compared to usual care alone for treatment of vascular risk factors in patients at high risk for new vascular events.
Study design: randomized non-blinded trial Study population: patients in the Rijnstate Hospital Arnhem and the UMC Utrecht, The Netherlands with a recent diagnosis of cerebral, cardiac or peripheral artery disease that entered the risk factor screening programs in these hospitals revealing 2 or more treatable risk factors.
Intervention: After the screening program patients will be randomized to usual care alone or to the internet program on top of usual care. Usual care for risk factor management will be delivered by the medical specialist and/or the general practitioner. Patients randomized to the internet based intervention program are first seen by the nurse practitioner on a regular clinic visit. The internet dossier is than created and explained to the patient. Subsequent contacts between nurse practitioner and patient about risk factor management is mainly by the internet. The nurse practitioner works according to the national guidelines for cardiovascular risk management ('CardioVascular Risico Management 2006') and is supervised by an internist. The study period is 1 year. All patients in both groups ware asked to return to the clinic for a follow up measurement of risk factors after 1 year.
Outcome measures: Primary outcome is the difference in Framingham heart risk score between baseline and after 1 year. As secondary outcome the percentage of patients achieving treatment goals for each risk factor and the average change in the absolute value of each risk factors after 1 year will be used.
Sample size calculation/data analysis: 380 patients. Changes in risk factors (absolute change and fraction of patients achieving treatment goal of each risk factor) at the start and after 1 year and between the groups are tested with independent sample t-test and Chi-square test.
Economic evaluation: The balance between costs and effects of the internet based vascular risk factor management program will be compared to usual care. Using a previously developed cardiovascular disease model incremental cost-utility analyses will be conducted with remaining life expectancy as the relevant time horizon.
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
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Arnhem, Holanda, 3508 GA
- Rijnstate Hospital
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Utrecht, Holanda, 3584 CX
- Department of Vascular Medicine UMC Utrecht
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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:
- Participation in a cardiovascular risk screening program
- 2 or more modifiable risk factors not on target:
- SBP > 140 mmHg
- LDL-c > 2.5 mmol/l
- Triglycerides > 1.7 mmol/l
- BMI > 25 kg/m2
- Diabetes Mellitus or fasting glucose > 6.1 mmol/l
- Smoking
Exclusion Criteria:
- No internet access at home
- Unable to read and write Dutch
- Dependent in in daily activities (Ranking score >=3)
- Life expectancy < 2 years or an active malignant disease
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
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Comparador Ativo: internet based intervention
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The patient and a nurse practitioner create an internet dossier and the patient is instructed on how to use the internet dossier.
The internet dossier is mainly meant for the patient: to improve knowledge of vascular risk factors, to give an overview of the actual status of the levels of his/her vascular risk factors and to give guidance and personal advice how to treat risk factors with medication and/or lifestyle.
Outros nomes:
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Sem intervenção: usual care
Patients receive their usual care from their specialist or general practitioner.
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Prazo |
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Framingham heart risk score
Prazo: 1 year
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1 year
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Medidas de resultados secundários
Medida de resultado |
Prazo |
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Percentage of patients achieving treatment goals for each risk factor
Prazo: 1 year
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1 year
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Additional costs per additional patient achieving treatment goal
Prazo: 1 year
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1 year
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Cost per life year gained, cost per QALY
Prazo: 1 year
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1 year
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Frank Visseren, MD PhD, UMC Utrecht
- Cadeira de estudo: Yolanda van der Graaf, MD PhD, Julius Center for Health Sciences and Primary Care
- Cadeira de estudo: Ardine de Wit, MD PhD, Julius Center for Health Sciences and Primary Care
- Cadeira de estudo: Karin Kaasjager, MD PhD, Rijnstate Hospital Arnhem
Publicações e links úteis
Publicações Gerais
- Goessens BM, Visseren FL, de Nooijer J, van den Borne HW, Algra A, Wierdsma J, van der Graaf Y; SMART Study Group. A pilot-study to identify the feasibility of an Internet-based coaching programme for changing the vascular risk profile of high-risk patients. Patient Educ Couns. 2008 Oct;73(1):67-72. doi: 10.1016/j.pec.2008.06.004. Epub 2008 Jul 18.
- Goessens BM, Visseren FL, Sol BG, de Man-van Ginkel JM, van der Graaf Y; SMART Study Group. A randomized, controlled trial for risk factor reduction in patients with symptomatic vascular disease: the multidisciplinary Vascular Prevention by Nurses Study (VENUS). Eur J Cardiovasc Prev Rehabil. 2006 Dec;13(6):996-1003. doi: 10.1097/01.hjr.0000216549.92184.40.
- Sol BG, van der Graaf Y, van der Bijl JJ, Goessens BM, Visseren FL. The role of self-efficacy in vascular risk factor management: a randomized controlled trial. Patient Educ Couns. 2008 May;71(2):191-7. doi: 10.1016/j.pec.2007.12.005. Epub 2008 Feb 1.
- Sol BG, van der Graaf Y, van der Bijl JJ, Goessens NB, Visseren FL. Self-efficacy in patients with clinical manifestations of vascular diseases. Patient Educ Couns. 2006 Jun;61(3):443-8. doi: 10.1016/j.pec.2005.05.011. Epub 2005 Jul 11.
- Sol BG, van der Bijl JJ, Banga JD, Visseren FL. Vascular risk management through nurse-led self-management programs. J Vasc Nurs. 2005 Mar;23(1):20-4. doi: 10.1016/j.jvn.2004.12.003.
- Greving JP, Kaasjager HA, Vernooij JW, Hovens MM, Wierdsma J, Grandjean HM, van der Graaf Y, de Wit GA, Visseren FL. Cost-effectiveness of a nurse-led internet-based vascular risk factor management programme: economic evaluation alongside a randomised controlled clinical trial. BMJ Open. 2015 May 20;5(5):e007128. doi: 10.1136/bmjopen-2014-007128.
- Vernooij JW, Kaasjager HA, van der Graaf Y, Wierdsma J, Grandjean HM, Hovens MM, de Wit GA, Visseren FL; SMARTStudy Group. Internet based vascular risk factor management for patients with clinically manifest vascular disease: randomised controlled trial. BMJ. 2012 Jun 12;344:e3750. doi: 10.1136/bmj.e3750.
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
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 80-00702-98-084 ZonMw
- 08-119/O (Outro identificador: METC UMC Utrecht)
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