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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lifestyle counseling | Experimental | Group consultation and individual nurse consultation |
|
| e health | Experimental | An individual web based entry |
|
| usual care | No Intervention | Usual care |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Life style counseling | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Clinical outcome | Change in Systolic Blood Pressure in each group at 12 months from baseline |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bas JH Bredie, MD | Radboud University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Radboud University medical centre | Nijmegen | 6500 HB | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31213778 | Derived | 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. | |
| 27624877 | Derived |
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| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
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|
| an individualized web portal | 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 | Behavioral | group consultations with peers and a nurse individual consultation with a nurse |
|
| Change from baseline in Sytolic Blood Pressure at 12 months |
| 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 |
| Clinical outcome | Change in Waist Circumference in each group at 12 months from baseline | Change from baseline in Waist Circumference at 12 months |
| 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. |