Cardiovascular DiseasesPHARM-ADHERENCT06142838
Community Pharmacist Intervention to Enhance Adherence in Cardiovascular Drug Initiators
A study testing community pharmacist intervention in people with Cardiovascular Diseases and Cardiovascular Disease Prevention, run by University Ghent at 1 site in Belgium.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiovascular Diseases, Cardiovascular Disease Prevention
- What is being tested?
- community pharmacist intervention
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,600 participants
- Where
- 1 siteBelgium
- Study dates
- 3 Oct 2023to 31 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
Pharmaceutical Care Unit (Ghent University)
Ghent
Els Mehuys, +32478509830, els.mehuys@ugent.be
Koen Boussery, +3292648043, koen.boussery@ugent.be
About this study
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?
- Being tested
- community pharmacist intervention
- Keywords
- Medication adherence
- Medical subject headings
- Cardiovascular Diseases, Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
community pharmacist interventionBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| Intervention arm | Experimental | Community pharmacist intervention Receives: Behavioral: community pharmacist intervention |
| Control arm | No intervention | Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
NIH Patient Reported Outcomes Measurement Information System (PROMIS) Medication Adherence Scale (PMAS)
Patient-reported measure of medication adherence
Measured: At 6 weeks and at 12 weeks follow-up
Secondary outcomes (6)
Medication Possession Ratio (MPR)
Measure of medication adherence, using pharmacy refill records
Measured: Over 26 weeks post-baseline
Discontinuation rate
% of patients discontinuing the medication
Measured: Over 26 weeks post-baseline
Medication knowledge questionnaire
Questionnaire evaluating patient's basic knowledge about the medication
Measured: 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)
Measured: 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
Measured: 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
Measured: Over 12 weeks post-baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2023
- Study start3 Oct 2023
- Primary completion31 May 2024 (estimated)
- Study completion31 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- More trials run by University GhentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 1,600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Ghent
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Ghent, Vrije Universiteit Brussel, Université de Liège
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06142838
- Sponsor's protocol ID
- B6702023000469 - ONZ-2023-0360
- Acronym
- PHARM-ADHERE
- Status last verified
- Nov 2023
- First submitted
- 15 Nov 2023
- Last updated
- 22 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Community Pharmacist Intervention to Enhance Adherence in Cardiovascular Drug Initiators
- ClinicalTrials.gov ID
- NCT06142838
- Acronym / sponsor ID
- PHARM-ADHERE / B6702023000469 - ONZ-2023-0360
- Keywords
- Medication adherence
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,600 participants (estimated)
- Lead sponsor
- University GhentUniversity, hospital or other
- Collaborators
- University Hospital, Ghent, Vrije Universiteit Brussel, Université de Liège
- Study start
- 3 Oct 2023 (actual)
- Primary completion
- 31 May 2024 (estimated)
- Study completion
- 31 Aug 2024 (estimated)
- First posted
- 22 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention arm | Experimental | Behavioral: community pharmacist interventionCommunity pharmacist intervention |
| Control arm | No intervention | –Usual care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| community pharmacist interventionThe 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 | Behavioural | Intervention arm |
Primary outcome
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
6 secondary outcomes
Medication Possession Ratio (MPR)
Time frame: Over 26 weeks post-baseline
Discontinuation rate
Time frame: Over 26 weeks post-baseline
Medication knowledge questionnaire
Time frame: At 6 weeks and at 12 weeks follow-up
Beliefs about Medicines Questionnaire (BMQ-Specific)
Time frame: At 6 weeks and at 12 weeks follow-up
Treatment response
Time frame: At baseline and at 12 weeks follow-up
Healthcare utilization
Time frame: Over 12 weeks post-baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing community pharmacist intervention in people with Cardiovascular Diseases and Cardiovascular Disease Prevention, run by University Ghent at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Els Mehuys (+32478509830, els.mehuys@ugent.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
NIH Patient Reported Outcomes Measurement Information System (PROMIS) Medication Adherence Scale (PMAS) (time frame: At 6 weeks and at 12 weeks follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2023.