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OpenTrials
Completed

NCT Number: NCT01449695

Intervention to Improve Medication Adherence in Cardiovascular Patients

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.

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Key information

Conditions

Cardiovascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Radboud University medical centre

Nijmegen, 6500 HB, Netherlands

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Life style counseling

Behavioral

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.

an individualized web portal

Behavioral

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.

individual and group consultations

Behavioral

group consultations with peers and a nurse individual consultation with a nurse

Primary outcomes

  1. 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

  1. Clinical outcome

    Time frame: Change from baseline in level of LDL-Cholesterol at 12 months

    Change in LDL-Cholesterol level in each group at 12 months from baseline

  2. Clinical outcome

    Time frame: Change from baseline in Sytolic Blood Pressure at 12 months

    Change in Systolic Blood Pressure in each group at 12 months from baseline

  3. Clinical outcome

    Time frame: Change from baseline in Body Mass Index at 12 months

    Change in Body Mass Index (BMI) in each group at 12 months from baseline

  4. Clinical outcome

    Time frame: Change from baseline in Waist Circumference at 12 months

    Change in Waist Circumference in each group at 12 months from baseline

Sponsors and collaborators

Lead sponsor

Radboud University Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Oct 10, 2011
Registry last updated
Apr 5, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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