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Clinical Trials/NCT01449695
NCT01449695
Completed
Not Applicable

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

Radboud University Medical Center1 site in 1 country420 target enrollmentNovember 2011

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cardiovascular Diseases
Sponsor
Radboud University Medical Center
Enrollment
420
Locations
1
Primary Endpoint
Change in degree of Adherence
Status
Completed
Last Updated
9 years ago

Overview

Brief Summary

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

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.

Registry
clinicaltrials.gov
Start Date
November 2011
End Date
December 2014
Last Updated
9 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Bas Bredie

MD

Radboud University Medical Center

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Change in degree of Adherence

Time Frame: Change from baseline in degree of Adherence at 12 month

The degree of Adherence to medication for each group at 12 month from baseline, as calculated by prescription refill data

Secondary Outcomes

  • Clinical outcome(Change from baseline in Waist Circumference at 12 months)

Study Sites (1)

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