Internet Based Vascular Risk Factor Intervention and Self Management Study
Condition: Cardiovascular Diseases
MeSH terms: Cardiovascular Diseases
Study type: Interventional

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.
    

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.
    

Intervention name(s): internet based vascular risk factor intervention
Intervention type(s): Other
Intervention description(s): 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 intervention name(s): Disease management; self management; nurse practitioner; internet; risk factors; primary care; vascular diseases
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: risk management; Self Management; Self-Efficacy; Disease management; nurse practitioner; internet; risk factors; vascular diseases; economic evaluation