NCT01449695

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
420

participants targeted

Target at P75+ for not_applicable cardiovascular-diseases

Timeline
Completed

Started Nov 2011

Typical duration for not_applicable cardiovascular-diseases

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 5, 2011

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 10, 2011

Completed
22 days until next milestone

Study Start

First participant enrolled

November 1, 2011

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

April 5, 2017

Status Verified

April 1, 2017

Enrollment Period

2.9 years

First QC Date

October 5, 2011

Last Update Submit

April 4, 2017

Conditions

Cardiovascular Diseases

Keywords

PADCVAACS

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Clinical outcome

    Change from baseline in level of LDL-Cholesterol at 12 months

  • Clinical outcome

    Change from baseline in Sytolic Blood Pressure at 12 months

  • Clinical outcome

    Change from baseline in Body Mass Index at 12 months

  • Clinical outcome

    Change from baseline in Waist Circumference at 12 months

Study Arms (3)

Lifestyle counseling

EXPERIMENTAL

Group consultation and individual nurse consultation

Behavioral: Life style counselingBehavioral: an individualized web portalBehavioral: individual and group consultations

e health

EXPERIMENTAL

An individual web based entry

Behavioral: an individualized web portal

usual care

NO INTERVENTION

Usual care

Interventions

Life style counselingBEHAVIORAL

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.

Lifestyle counseling
an individualized web portalBEHAVIORAL

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.

Lifestyle counselinge health
individual and group consultationsBEHAVIORAL

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

Lifestyle counseling

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Radboud University medical centre

Nijmegen, 6500 HB, Netherlands

Location

Related Publications (2)

  • 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.

    PMID: 31213778DERIVED

  • 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.

    PMID: 27624877DERIVED

MeSH Terms

Conditions

Cardiovascular Diseases

Study Officials

  • Bas JH Bredie, MD

    Radboud University Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

October 5, 2011

First Posted

October 10, 2011

Study Start

November 1, 2011

Primary Completion

October 1, 2014

Study Completion

December 1, 2014

Last Updated

April 5, 2017

Record last verified: 2017-04

Locations

NL(1)