Internet Based Vascular Risk Factor Intervention and Self Management Study (IRIS)

This study has been completed.
Sponsor:
Collaborator:
Rijnstate Hospital
Information provided by (Responsible Party):
dr.Frank L.J. Visseren, UMC Utrecht
ClinicalTrials.gov Identifier:
NCT00785031
First received: November 4, 2008
Last updated: June 13, 2012
Last verified: June 2012
  Purpose

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.


Condition Intervention
Cardiovascular Diseases
Other: internet based vascular risk factor intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Internet-based Vascular Risk Factor Management for Patients With Clinical Manifest Vascular Disease; a Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by UMC Utrecht:

Primary Outcome Measures:
  • Framingham heart risk score [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Percentage of patients achieving treatment goals for each risk factor [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Additional costs per additional patient achieving treatment goal [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Cost per life year gained, cost per QALY [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Enrollment: 330
Study Start Date: October 2008
Study Completion Date: June 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Other Names:
  • Disease management
  • self management
  • nurse practitioner
  • internet
  • risk factors
  • primary care
  • vascular diseases
No Intervention: usual care
Patients receive their usual care from their specialist or general practitioner.

Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00785031

Locations
Netherlands
Rijnstate Hospital
Arnhem, Netherlands, 3508 GA
Department of Vascular Medicine UMC Utrecht
Utrecht, Netherlands, 3584 CX
Sponsors and Collaborators
UMC Utrecht
Rijnstate Hospital
Investigators
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
  More Information

Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: dr.Frank L.J. Visseren, Prof., UMC Utrecht
ClinicalTrials.gov Identifier: NCT00785031     History of Changes
Other Study ID Numbers: 80-00702-98-084 ZonMw, 08-119/O
Study First Received: November 4, 2008
Last Updated: June 13, 2012
Health Authority: Netherlands: Medical Ethics Review Committee (METC)

Keywords provided by UMC Utrecht:
risk management
Self Management
Self-Efficacy
Disease management
nurse practitioner
internet
risk factors
vascular diseases
economic evaluation

Additional relevant MeSH terms:
Cardiovascular Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on September 18, 2014