Community Pharmacist Intervention to Enhance Adherence in Cardiovascular Drug Initiators

Not Applicable

Recruiting

• Conditions: Cardiovascular Disease Prevention; Cardiovascular Diseases
• Interventions: Behavioral: community pharmacist intervention

• 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

Arm && Interventions

Group	Intervention	Description
Intervention arm	community pharmacist intervention	Community pharmacist intervention

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
Medication Possession Ratio (MPR)	Over 26 weeks post-baseline	Measure of medication adherence, using pharmacy refill records
Healthcare utilization	Over 12 weeks post-baseline	Number of general practitioner (GP) visits, specialist-physician visits, emergency department (ED) visits and hospital admissions
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