Community Pharmacist Intervention to Enhance Adherence in Cardiovascular Drug Initiators

Cardiovascular Diseases Clinical Trial

— PHARM-ADHERE  

Official title:

Community Pharmacist Intervention to Enhance Adherence in Cardiovascular Drug Initiators

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06142838
• Other study ID #: B6702023000469 - ONZ-2023-0360
• Status: Recruiting
• Phase: N/A
• Start date: October 3, 2023
• Est. completion date: August 31, 2024

Study information

• Verified date: November 2023
• Source: University Ghent
• Contact: Els Mehuys
• Phone: +32478509830
• Email: els.mehuys[@]ugent.be
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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?

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1600
• Est. completion date: August 31, 2024
• Est. primary completion date: May 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Cardiovascular Disease Prevention
• Cardiovascular Diseases

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

Locations

Country	Name	City	State
Belgium	Pharmaceutical Care Unit (Ghent University)	Ghent

Sponsors (4)

Lead Sponsor	Collaborator
University Ghent	Université de Liège, University Hospital, Ghent, Vrije Universiteit Brussel

Country where clinical trial is conducted

Belgium, 

Outcome

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