Intervention to Improve Medication Adherence in Cardiovascular Patients

Radboud University Medical Center

Status: Completed

Conditions: Cardiovascular Diseases

Treatments: Behavioral: an individualized web portal; Behavioral: individual and group consultations; Behavioral: Life style counseling

Study type: Interventional

Funder types: Other

Identifiers

NCT01449695

34338

Details and patient eligibility

About

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.

Full 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.

Enrollment: 420 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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420 participants in 3 patient groups

Lifestyle counseling

Experimental group

Description:

Group consultation and individual nurse consultation

Treatment:

Behavioral: an individualized web portal

Behavioral: individual and group consultations

Behavioral: Life style counseling

e health

Experimental group

Description:

An individual web based entry

Treatment:

Behavioral: an individualized web portal

usual care

No Intervention group

Description:

Usual care