Intervention to Improve Medication Adherence in Cardiovascular Patients

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Nurse- and Web Based Intervention to Improve Medication Adherence in High Risk Cardiovascular Patients.

Conditions
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Cardiovascular Diseases

Intervention / Treatment
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* Behavioral: Life style counseling
* Behavioral: an individualized web portal
* Behavioral: individual and group consultations


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lifestyle counseling<br>Group consultation and individual nurse consultation | Behavioral: Life style counseling<br>* 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.<br>Behavioral: an individualized web portal<br>* 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.<br>Behavioral: individual and group consultations<br>* group consultations with peers and a nurse individual consultation with a nurse<br>|
| Experimental: e health<br>An individual web based entry | Behavioral: an individualized web portal<br>* 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.<br>|
| No Intervention: usual care<br>Usual care | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in degree of Adherence | The degree of Adherence to medication for each group at 12 month from baseline, as calculated by prescription refill data | Change from baseline in degree of Adherence at 12 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical outcome | Change in LDL-Cholesterol level in each group at 12 months from baseline | Change from baseline in level of LDL-Cholesterol at 12 months | 
| Clinical outcome | Change in Systolic Blood Pressure in each group at 12 months from baseline | Change from baseline in Sytolic Blood Pressure at 12 months | 
| Clinical outcome | Change in Body Mass Index (BMI) in each group at 12 months from baseline | Change from baseline in Body Mass Index at 12 months | 
| Clinical outcome | Change in Waist Circumference in each group at 12 months from baseline | Change from baseline in Waist Circumference at 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PAD, CVA, ACS