Cardiovascular Diseases
Conditions
Keywords
PAD, CVA, ACS
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.
Interventions
BEHAVIORALLife 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.
BEHAVIORALan 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.
BEHAVIORALindividual and group consultations
group consultations with peers and a nurse individual consultation with a nurse
Sponsors
Radboud University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in degree of Adherence | Change from baseline in degree of Adherence at 12 month | The degree of Adherence to medication for each group at 12 month from baseline, as calculated by prescription refill data |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical outcome | Change from baseline in level of LDL-Cholesterol at 12 months | Change in LDL-Cholesterol level in each group at 12 months from baseline |
Countries
Netherlands
Outcome results
None listed