Internet Based Vascular Risk Factor Intervention and Self Management Study

Cardiovascular Diseases Clinical Trial

— IRIS  

Official title:

Internet-based Vascular Risk Factor Management for Patients With Clinical Manifest Vascular Disease; a Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00785031
• Other study ID #: 80-00702-98-084 ZonMw
• Secondary ID: 08-119/O
• Status: Completed
• Phase: N/A
• First received: November 4, 2008
• Last updated: June 13, 2012
• Start date: October 2008
• Est. completion date: June 2011

Study information

• Verified date: June 2012
• Source: UMC Utrecht
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Medical Ethics Review Committee (METC)
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 330
• Est. completion date: June 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Vascular Diseases

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.

Locations

Country	Name	City	State
Netherlands	Rijnstate Hospital	Arnhem
Netherlands	Department of Vascular Medicine UMC Utrecht	Utrecht

Sponsors (2)

Lead Sponsor	Collaborator
UMC Utrecht	Rijnstate Hospital

Country where clinical trial is conducted

Netherlands, 

References & Publications (5)

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. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. Epub 2005 Jul 11. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Framingham heart risk score		1 year	No
Secondary	Percentage of patients achieving treatment goals for each risk factor		1 year	No
Secondary	Additional costs per additional patient achieving treatment goal		1 year	No
Secondary	Cost per life year gained, cost per QALY		1 year	No

External Links

•   primary site for the internet based vascular risk factor intervention