Internet Based Vascular Risk Factor Intervention and Self Management Study (IRIS)
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|ClinicalTrials.gov Identifier: NCT00785031|
Recruitment Status : Completed
First Posted : November 5, 2008
Last Update Posted : June 14, 2012
|Condition or disease||Intervention/treatment||Phase|
|Cardiovascular Diseases||Other: internet based vascular risk factor intervention||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||330 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Internet-based Vascular Risk Factor Management for Patients With Clinical Manifest Vascular Disease; a Randomized Controlled Trial|
|Study Start Date :||October 2008|
|Actual Primary Completion Date :||March 2011|
|Actual Study Completion Date :||June 2011|
|Active Comparator: internet based intervention||
Other: internet based vascular risk factor intervention
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.
No Intervention: usual care
Patients receive their usual care from their specialist or general practitioner.
- Framingham heart risk score [ Time Frame: 1 year ]
- Percentage of patients achieving treatment goals for each risk factor [ Time Frame: 1 year ]
- Additional costs per additional patient achieving treatment goal [ Time Frame: 1 year ]
- Cost per life year gained, cost per QALY [ Time Frame: 1 year ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00785031
|Arnhem, Netherlands, 3508 GA|
|Department of Vascular Medicine UMC Utrecht|
|Utrecht, Netherlands, 3584 CX|
|Principal Investigator:||Frank Visseren, MD PhD||UMC Utrecht|
|Study Chair:||Yolanda van der Graaf, MD PhD||Julius Center for Health Sciences and Primary Care|
|Study Chair:||Ardine de Wit, MD PhD||Julius Center for Health Sciences and Primary Care|
|Study Chair:||Karin Kaasjager, MD PhD||Rijnstate Hospital Arnhem|