Clinical trial NCT01449695: Intervention to Improve Medication Adherence in Cardiovascular Patients
Official title: Nurse- and Web Based Intervention to Improve Medication Adherence in High Risk Cardiovascular Patients.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Diseases
Keywords: PAD
CVA
ACS
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
First posted: 2011-10-10
Enrollment: 420
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Change in degree of Adherence
timeFrame: Change from baseline in degree of Adherence at 12 month
Secondary outcomes:
measure: Clinical outcome
timeFrame: Change from baseline in level of LDL-Cholesterol at 12 months
measure: Clinical outcome
timeFrame: Change from baseline in Sytolic Blood Pressure at 12 months
measure: Clinical outcome
timeFrame: Change from baseline in Body Mass Index at 12 months
measure: Clinical outcome
timeFrame: Change from baseline in Waist Circumference at 12 months
Other outcomes:
Locations:
city: Nijmegen
country: Netherlands
facility: Radboud University medical centre
Study officials:
affiliation: Radboud University Medical Center
name: Bas JH Bredie, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sieben A, van Onzenoort HA, van Dulmen S, van Laarhoven C, Bredie SJ. A nurse-based intervention for improving medication adherence in cardiovascular patients: an evaluation of a randomized controlled trial. Patient Prefer Adherence. 2019 May 23;13:837-852. doi: 10.2147/PPA.S197481. eCollection 2019.
citation: Sieben A, van Onzenoort HA, van Laarhoven KJ, Bredie SJ. A Multifaceted Nurse- and Web-Based Intervention for Improving Adherence to Treatment in Patients With Cardiovascular Disease: Rationale and Design of the MIRROR Trial. JMIR Res Protoc. 2016 Sep 13;5(3):e187. doi: 10.2196/resprot.5750.