Information obtained from ClinicalTrials.gov on May 19, 2013 Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT01449695 34338 NCT01449695 Intervention to Improve Medication Adherence in Cardiovascular Patients Nurse- and Web Based Intervention to Improve Medication Adherence in High Risk Cardiovascular Patients. Radboud University Other Radboud University Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) No The purpose of this study is to investigate whether a nurse-based intervention, consisting of structural informative consulting and motivational counseling, on top of usual care with or without personalized web-based visualization of cardiovascular risk levels, improves the medication adherence in high risk cardiovascular patients. Poor adherence to medication is one of the limitations in the treatment of cardiovascular disease. As a consequence the risk of premature death, hospital admissions and related costs is increasing. Therefore, detection of apparent poor adherence and interventions to improve adherence, are of great importance to enhance cardiovascular risk management over time. This study is a prospective randomized trial, which compares 1) usual care with 2) the effect of a personalized visualization of cardiovascular risk levels (website) to support self management and 3) the additional effect of a communication intervention by a nurse on adherence on top of 2). Adherence is determined and continuously monitored with a dedicated calculation of refill data obtained from patient's pharmacy. Recruiting November 2011 October 2013 N/A Interventional Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention Change in degree of Adherence Change from baseline in degree of Adherence at 12 month No The degree of Adherence to medication for each group at 12 month from baseline, as calculated by prescription refill data Clinical outcome Change from baseline in level of LDL-Cholesterol at 12 months No Change in LDL-Cholesterol level in each group at 12 months from baseline Clinical outcome Change from baseline in Sytolic Blood Pressure at 12 months No Change in Systolic Blood Pressure in each group at 12 months from baseline Clinical outcome Change from baseline in Body Mass Index at 12 months No Change in Body Mass Index (BMI) in each group at 12 months from baseline Clinical outcome Change from baseline in Waist Circumference at 12 months No Change in Waist Circumference in each group at 12 months from baseline 3 600 Cardiovascular Diseases Lifestyle counseling Experimental Group consultation and individual nurse consultation e health Experimental An individual web based entry usual care No Intervention Usual care Behavioral Life style counseling A nurse-based intervention with face-to-face contacts based on motivational interviewing techniques and influence on behavioral determinants. Well-trained nurses in our hospital will apply these behavioral change interventions. An individual contact will take about twenty minutes. Lifestyle counseling Behavioral an individualized web portal This website shows patient's lab results, life style issues, blood pressure and weight in various risk monitors. These lab results and lifestyle changes will be visualized in risk monitors and provide structural feedback to the patient. The results of the screening and the two additional visits can be seen by the patient. Lifestyle counseling e health Behavioral individual and group consultations group consultations with peers and a nurse individual consultation with a nurse Lifestyle counseling Inclusion Criteria: - All subsequent patients, included in the hospital-screening program with manifestations of atherosclerotic disease (acute coronary syndrome, peripheral arterial disease or stroke/TIA) or elevated cardiovascular risk due to hypertension, diabetes or hyperlipidemia. Exclusion Criteria: - Age below 18 years, actual pregnancy, problems with Dutch language or logistic problems, which may hinder intervention on adherence behavior. Severe co-morbidity, including mental handicap, according to their physician. Both 18 Years N/A No Bas JH Bredie, MD Principal Investigator Radboud University Medical Centre Angelien Sieben, M ANP +31 (024) 3668234 a.sieben@chir.umcn.nl Bas Bredie, MD +31 (024)3618819 s.bredie@aig.umcn.nl Radboud University medical centre

Nijmegen 6500 HB Netherlands

Recruiting Netherlands December 2012 December 4, 2012 October 5, 2011 Principal Investigator Radboud University Bas Bredie MD PAD CVA ACS No No Cardiovascular Diseases