Cardiovascular Disease Prevention, Cardiovascular Diseases
Conditions
Keywords
Medication adherence
Brief summary
The goal of this clinical trial is to evaluate a community pharmacist intervention aimed at improving medication adherence in patients starting newly prescribed medication for cardiovascular disease prevention. The main questions it aims to answer are: * Does this community pharmacist intervention improve medication adherence? * Which patients benefit the most from the intervention? * How do patients experience the start-up of newly prescribed medication (which questions do they have and do they experience side effects?)? * How do patients and pharmacists experience the intervention?
Interventions
BEHAVIORALcommunity pharmacist intervention
The community pharmacist intervention comprises 2 parts: (1) first prescription counseling (oral and written information), and (2) a follow-up consultation (by telephone or in person) 7-14 days later, to identify problems with adherence/treatment
Sponsors
University Hospital, Ghent
Vrije Universiteit Brussel
Université de Liège
University Ghent
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients presenting with a first prescription for one of the following drug classes: antihypertensive drugs (= low-ceiling diuretics, beta blocking agents (excl. non-selective beta-blocking agents), ACE inhibitors, angiotensin II receptor blockers, calcium channel blockers), lipid-lowering drugs (= statins), antidiabetic drugs (= metformin, glucagon-like peptide-1 (GLP-1) analogues, sodium-glucose co-transporter 2 (SGLT2) inhibitors), or any combination thereof. * Age 18 years or older * Community-dwelling
Exclusion criteria
* The drug is prescribed for a non-cardiovascular indication (e.g. beta-blocking agent for migraine prophylaxis) * Communication with the patient is not possible (e.g. due to cognitive impairment, insufficient knowledge of Dutch or French language)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| NIH Patient Reported Outcomes Measurement Information System (PROMIS) Medication Adherence Scale (PMAS) | At 6 weeks and at 12 weeks follow-up | Patient-reported measure of medication adherence |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Discontinuation rate | Over 26 weeks post-baseline | % of patients discontinuing the medication |
| Medication knowledge questionnaire | At 6 weeks and at 12 weeks follow-up | Questionnaire evaluating patient's basic knowledge about the medication |
| Medication Possession Ratio (MPR) | Over 26 weeks post-baseline | Measure of medication adherence, using pharmacy refill records |
| Treatment response | At baseline and at 12 weeks follow-up | Systolic and diastolic blood pressure for patients starting an antihypertensive drug; lipid levels (total cholesterol, LDL and HDL) for patients starting a lipid-lowering drug; HbA1c for patients starting an antidiabetic drug |
| Healthcare utilization | Over 12 weeks post-baseline | Number of general practitioner (GP) visits, specialist-physician visits, emergency department (ED) visits and hospital admissions |
| Beliefs about Medicines Questionnaire (BMQ-Specific) | At 6 weeks and at 12 weeks follow-up | Questionnaire evaluating patient's beliefs about the necessity of prescribed medication for controlling their illness (Specific-Necessity) and their concerns about the potential adverse consequences of taking it (Specific-Concerns) |
Countries
Belgium
Contacts
Primary ContactEls Mehuys
Backup ContactKoen Boussery
Outcome results
None listed