Intervention to Improve Medication Adherence in Cardiovascular Patients

Not Applicable

Completed

• Conditions: Cardiovascular Diseases
• Interventions: Behavioral: an individualized web portal; Behavioral: Life style counseling; Behavioral: individual and group consultations

• Registration Number: NCT01449695
• Lead Sponsor: Radboud University Medical Center

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.

Study Timeline

• Study First Submitted: 2011-10-05
• Study First Submitted QC: 2011-10-06
• Study First Posted: 2011-10-10
• Study Start: 2011-11
• Primary Completion: 2014-10
• Study Completion: 2014-12
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-04
• Last Update Posted: 2017-04-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 420

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lifestyle counseling	individual and group consultations	Group consultation and individual nurse consultation
e health	an individualized web portal	An individual web based entry
Lifestyle counseling	an individualized web portal	Group consultation and individual nurse consultation
Lifestyle counseling	Life style counseling	Group consultation and individual nurse consultation

Primary Outcome Measures

Name	Time	Method
Change in degree of Adherence	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 Outcome Measures

Name	Time	Method
Clinical outcome	Change from baseline in Waist Circumference at 12 months	Change in Waist Circumference in each group at 12 months from baseline

Trial Locations

Locations (1)

Radboud University medical centre; 🇳🇱 Nijmegen, Netherlands