Community Pharmacist Intervention to Enhance Adherence in Cardiovascular Drug Initiators

University Ghent1 site in 1 country1,600 target enrollmentOctober 3, 2023

ConditionsCardiovascular Diseases Cardiovascular Disease Prevention

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Cardiovascular Diseases
Sponsor: University Ghent
Enrollment: 1600
Locations: 1
Primary Endpoint: NIH Patient Reported Outcomes Measurement Information System (PROMIS) Medication Adherence Scale (PMAS)
Status: Recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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?

Registry

clinicaltrials.gov

Start Date

October 3, 2023

End Date

August 31, 2024

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

University Ghent

Responsible Party

Sponsor

Eligibility Criteria

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)

Outcomes

Primary Outcomes

NIH Patient Reported Outcomes Measurement Information System (PROMIS) Medication Adherence Scale (PMAS)

Time Frame: At 6 weeks and at 12 weeks follow-up

Patient-reported measure of medication adherence

Secondary Outcomes

Healthcare utilization(Over 12 weeks post-baseline)
Medication Possession Ratio (MPR)(Over 26 weeks post-baseline)
Medication knowledge questionnaire(At 6 weeks and at 12 weeks follow-up)
Treatment response(At baseline and at 12 weeks follow-up)
Discontinuation rate(Over 26 weeks post-baseline)
Beliefs about Medicines Questionnaire (BMQ-Specific)(At 6 weeks and at 12 weeks follow-up)