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Internet-based vascular Riskfactor Intervention and Selfmanagement study

Internet-based vascular Riskfactor Intervention and Selfmanagement study - IRIS

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON32176
Enrollment
380
Registered
2008-09-30
Start date
2008-10-20
Completion date
Unknown
Last updated
2024-05-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

atherosclerosis

Interventions

Patients randomised to the internet-program will receive an internet-based risk factor management program on top of usual care for 12 months. Patients will be invited for a visit to the nurse practi

Sponsors

Universitair Medisch Centrum Utrecht
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Patients with an recent clinical manifestation of atherosclerosis in the coronary, cerebral or peripheral arteries undergoing a standardized risk factor screening program revealing 2 or more treatable risk factors. Patients are between 18 and 80 years of age, capable to read and write Dutch, independent in daily activities and have access to internet at home.

Exclusion criteria

Exclusion criteria: No access to internet. Malignant disease, dependancy in daily activities

Design outcomes

Primary

MeasureTime frame
After 1 year all patients (usual care and internet-based care) are asked to return to the clinic for an evaluation visit to obtain the same information on vascular risk factors and risk indicators as was done as at baseline: Total cholesterol, LDL-cholesterol, HDL-cholesterol, triglycerides, glucose, body mass index, waist circumference, blood pressure and smoking. A questionnaire will be used to gather data about health-care use, labour, self-care, exercise, food-choices, self-efficacy, social support, and quality of life. At the beginning of the study and at the end of the intervention period, the 10-year absolute cardiovascular risk will be carculated using the Framingham risk-score. The difference in 10-year risk between end-of-study (after 1 year) and baseline will serve as primairy summary risk outcome. The primairy outcome is the relative difference in absolute risk between the intervention group and copntrol group.

Secondary

MeasureTime frame
The absolute change in each risk factor (the level at 1 year minus the level at baseline) and the percentage of patients reaching the treatment goal for each risk factor will be calculated and serve as secondary outcome. Change in self-management related parameters and actual health behavior between the intervention group and the control group will be related to achieved treatment goals.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)