Community Pharmacist Intervention to Enhance Adherence in Cardiovascular Drug Initiators (PHARM-ADHERE)

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?

Study Overview

• Status: Recruiting
• Conditions: Cardiovascular Diseases; Cardiovascular Disease Prevention
• Intervention / Treatment: Behavioral: community pharmacist intervention

• Study Type: Interventional
• Enrollment (Estimated): 1600
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Els Mehuys; Phone Number: +32478509830; Email: els.mehuys@ugent.be
• Study Contact Backup: Name: Koen Boussery; Phone Number: +3292648043; Email: koen.boussery@ugent.be

Study Locations

• Belgium
  • Ghent, Belgium
    • Recruiting
    • Pharmaceutical Care Unit (Ghent University)
    • Contact: Els Mehuys; Phone Number: +32478509830; Email: els.mehuys@ugent.be
    • Contact: Koen Boussery; Phone Number: +3292648043; Email: koen.boussery@ugent.be

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control arm; Usual care
Experimental: Intervention arm; Community pharmacist intervention	Behavioral: community 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
NIH Patient Reported Outcomes Measurement Information System (PROMIS) Medication Adherence Scale (PMAS)	Patient-reported measure of medication adherence	At 6 weeks and at 12 weeks follow-up

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University Ghent
• Collaborators: University Hospital, Ghent; Vrije Universiteit Brussel; Université de Liège

Study record dates

Study Major Dates

• Study Start (Actual): October 3, 2023
• Primary Completion (Estimated): May 31, 2024
• Study Completion (Estimated): August 31, 2024

Study Registration Dates

• First Submitted: November 15, 2023
• First Submitted That Met QC Criteria: November 15, 2023
• First Posted (Estimated): November 22, 2023

Study Record Updates

• Last Update Posted (Estimated): November 22, 2023
• Last Update Submitted That Met QC Criteria: November 15, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Medication adherence
• Additional Relevant MeSH Terms: Cardiovascular Diseases
• Other Study ID Numbers: B6702023000469 - ONZ-2023-0360

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No