Intervention to Improve Medication Adherence in Cardiovascular Patients

Cardiovascular Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01449695
• Other study ID #: 34338
• Status: Completed
• Phase: N/A
• First received: October 5, 2011
• Last updated: April 4, 2017
• Start date: November 2011
• Est. completion date: December 2014

Study information

• Verified date: April 2017
• Source: Radboud University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 420
• Est. completion date: December 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cardiovascular Diseases

Intervention

Behavioral:
• Life style counseling
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
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
group consultations with peers and a nurse individual consultation with a nurse

Locations

Country	Name	City	State
Netherlands	Radboud University medical centre	Nijmegen

Sponsors (1)

Lead Sponsor	Collaborator
Radboud University

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	Clinical outcome	Change in Waist Circumference in each group at 12 months from baseline	Change from baseline in Waist Circumference at 12 months