NCT06142838

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?

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,600

participants targeted

Target at P75+ for not_applicable cardiovascular-diseases

Timeline
Completed

Started Oct 2023

Shorter than P25 for not_applicable cardiovascular-diseases

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 3, 2023

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 15, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 22, 2023

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2024

Completed
Last Updated

November 22, 2023

Status Verified

November 1, 2023

Enrollment Period

8 months

First QC Date

November 15, 2023

Last Update Submit

November 15, 2023

Conditions

Cardiovascular DiseasesCardiovascular Disease Prevention

Keywords

Medication adherence

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • Medication Possession Ratio (MPR)

    Over 26 weeks post-baseline

  • Discontinuation rate

    Over 26 weeks post-baseline

  • Medication knowledge questionnaire

    At 6 weeks and at 12 weeks follow-up

  • Beliefs about Medicines Questionnaire (BMQ-Specific)

    At 6 weeks and at 12 weeks follow-up

  • Treatment response

    At baseline and at 12 weeks follow-up

  • +1 more secondary outcomes

Study Arms (2)

Intervention arm

EXPERIMENTAL

Community pharmacist intervention

Behavioral: community pharmacist intervention

Control arm

NO INTERVENTION

Usual care

Interventions

community pharmacist interventionBEHAVIORAL

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 arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pharmaceutical Care Unit (Ghent University)

Ghent, Belgium

RECRUITING

MeSH Terms

Conditions

Cardiovascular DiseasesMedication Adherence

Condition Hierarchy (Ancestors)

Patient CompliancePatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Central Study Contacts

Els Mehuys

CONTACT

+32478509830els.mehuys@ugent.be

Koen Boussery

CONTACT

+3292648043koen.boussery@ugent.be

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 15, 2023

First Posted

November 22, 2023

Study Start

October 3, 2023

Primary Completion

May 31, 2024

Study Completion

August 31, 2024

Last Updated

November 22, 2023

Record last verified: 2023-11

Locations

BE(1)