Community Pharmacist Intervention to Enhance Adherence in Cardiovascular Drug Initiators

Not Applicable

Recruiting

• Conditions: Cardiovascular Disease Prevention; Cardiovascular Diseases

• Registration Number: NCT06142838
• Lead Sponsor: University Ghent

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?

Detailed Description

Not available

Study Timeline

• Study Start: 2023-10-03
• Status Verified: 2023-11
• Study First Submitted: 2023-11-15
• Study First Submitted QC: 2023-11-15
• Last Update Submitted: 2023-11-15
• Study First Posted: 2023-11-22
• Last Update Posted: 2023-11-22
• Primary Completion: 2024-05-31
• Study Completion: 2024-08-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1600

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Healthcare utilization	Over 12 weeks post-baseline	Number of general practitioner (GP) visits, specialist-physician visits, emergency department (ED) visits and hospital admissions
Medication Possession Ratio (MPR)	Over 26 weeks post-baseline	Measure of medication adherence, using pharmacy refill records
Medication knowledge questionnaire	At 6 weeks and at 12 weeks follow-up	Questionnaire evaluating patient's basic knowledge about the medication
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
Discontinuation rate	Over 26 weeks post-baseline	% of patients discontinuing the medication
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)

Trial Locations

Locations (1)

Pharmaceutical Care Unit (Ghent University); 🇧🇪 Ghent, Belgium