Community Pharmacist Intervention to Enhance Adherence in Cardiovascular Drug Initiators

NCT ID: NCT06142838

Last Updated: 2023-11-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

1600 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-03

Study Completion Date

2024-08-31

Brief Summary

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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

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Conditions

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Cardiovascular Diseases Cardiovascular Disease Prevention

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Intervention arm

Community pharmacist intervention

Group Type EXPERIMENTAL

community pharmacist intervention

Intervention Type BEHAVIORAL

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

Control arm

Usual care

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Ghent

OTHER

Sponsor Role collaborator

Vrije Universiteit Brussel

OTHER

Sponsor Role collaborator

Université de Liège

OTHER

Sponsor Role collaborator

University Ghent

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Pharmaceutical Care Unit (Ghent University)

Ghent, , Belgium

Site Status RECRUITING

Countries

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Belgium

Central Contacts

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Els Mehuys

Role: CONTACT

+32478509830

Koen Boussery

Role: CONTACT

+3292648043

Facility Contacts

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Els Mehuys

Role: primary

+32478509830

Koen Boussery

Role: backup

+3292648043

Other Identifiers

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B6702023000469 - ONZ-2023-0360

Identifier Type: -

Identifier Source: org_study_id