Intervention to Improve Medication Adherence in Cardiovascular Patients

NCT ID: NCT01449695

Last Updated: 2017-04-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

420 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-11-30

Study Completion Date

2014-12-31

Brief Summary

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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

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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.

Conditions

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Cardiovascular Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Lifestyle counseling

Group consultation and individual nurse consultation

Group Type EXPERIMENTAL

Life style counseling

Intervention Type 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

Intervention Type 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

Intervention Type BEHAVIORAL

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

e health

An individual web based entry

Group Type EXPERIMENTAL

an individualized web portal

Intervention Type 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.

usual care

Usual care

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type BEHAVIORAL

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.

Intervention Type BEHAVIORAL

individual and group consultations

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Radboud University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Bas Bredie

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Bas JH Bredie, MD

Role: PRINCIPAL_INVESTIGATOR

Radboud University Medical Center

Locations

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Radboud University medical centre

Nijmegen, , Netherlands

Site Status

Countries

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Netherlands

References

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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.

Reference Type DERIVED
PMID: 31213778 (View on PubMed)

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.

Reference Type DERIVED
PMID: 27624877 (View on PubMed)

Other Identifiers

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34338

Identifier Type: -

Identifier Source: org_study_id

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