Cardiovascular Risk FactorNCT04220788
Pharmacist Enhanced Service for Cardiovascular Risk Reduction
A study testing Enhanced pharmacist service in people with Cardiovascular Risk Factor, run by Monash University at 1 site in Malaysia.
Trial summary
Pharmacist services such as medication review, counselling and treatment adherence clinics can improve clinical, health related quality of life and economic outcomes. To prove this hypothesis a step-wedge, cluster randomized controlled trial will be held in primary care centers of the public health system of Malaysia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiovascular Risk Factor
- What is being tested?
- Enhanced pharmacist service
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteMalaysia
- Study dates
- 1 Mar 2020to 31 Dec 2022
- 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 with diabetes
- Patients with chronic kidney disease (eGFR <60ml/min/1.73m2)
- Patients with established atherosclerotic vascular disease (via patient health records or selfreport) including cerebrovascular disease (prior stroke or transient ischemic attack), cardiovascular disease (myocardial infarction, acute coronary syndrome, stable angina, or revascularization), or peripheral arterial disease (symptomatic and/or ankle brachial index <0.9)
- Primary prevention patients with multiple risk factors and Framingham risk score >30%
Who cannot join
- Unwilling to participate/sign consent form
- Unwilling or unable to participate in regular follow-up visits
- Pregnancy
- Undergoing existing medication therapy adherence clinic conducted by the Pharmacy Unit
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pharmacist Enhanced Service in Primary Care for CArdiovascular Risk Reduction (PxES-CAR2+) Project: A Multi-centre Pragmatic, Step-wedge Cluster Randomized Controlled Trial
Pharmacist services such as medication review, counselling and treatment adherence clinics can improve clinical, health related quality of life and economic outcomes. To prove this hypothesis a step-wedge, cluster randomized controlled trial will be held in primary care centers of the public health system of Malaysia. Participants who have a high risk of cardiovascular risk factors currently seeking care in primary care will be recruited. Control group will receive usual care and the intervention arm will be seen by a pharmacist prior to their follow-up, with a comprehensive medication review, counselling and dietary advice consultations every month for three months. Participating pharmacist will be trained in cardiovascular prevention pharmacotherapy, interview skills, educational techniques, and develop personalized plan for every participant. The investigators plan to randomize up to 2100 participants who are currently receiving care in the primary care clinics in the district of Petaling by modifying the current workflow in primary care, whereby the investigators aim to get participants who are at high risk to undergo counselling as well as a medication review with proper pharmaceutical care delivered to them prior to seeking their medical doctor to receive care.
- Conditions
- Cardiovascular Risk Factor
- Being tested
- Enhanced pharmacist service, Usual care
- Keywords
- cardiovascular disease, pharmacist service
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enhanced pharmacist serviceOther
Calculation of cardiovascular risk by an online tool for discussion on the CVD risk. Pharmacist will also provide ducation on cardiovascular risk factors and healthy lifestyle. Any prescription adaptation(s), and/or recommendations where necessary to meet lipid, blood pressure and glycemic control targets and smoking cessation will be initiated
Usual careOther
Participants in the arm will receive their care from their respective nurse, doctor or pharmacists as per usual clinic practice
| Study group | Role | What they receive |
|---|---|---|
| Enhanced pharmacist service | Experimental | The advanced care group will be undergo a Comprehensive Annual Care Plan (CACP) or Standard Medication Management Assessment (SMMA) with the pharmacist Receives: Other: Enhanced pharmacist service |
| Usual care | Active comparator | Patients in the usual care arm will receive their usual care which they will obtain care from their doctor,nurse and pharmacist where appropriate Receives: Other: Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in cardiovascular risk scores
The difference from baseline to 3 months in the estimated cardiovascular risk between advanced care and usual care groups assessed using the Framingham scale
Measured: 3 months
Secondary outcomes (5)
Change in cardiovascular risk scores
The difference from baseline to 6 months in the estimated cardiovascular risk between advanced care and usual care groups assessed using the Framingham scale
Measured: 6 months
Change in cardiovascular risk scores
The difference from baseline to 12 months in the estimated cardiovascular risk between advanced care and usual care groups assessed using the Framingham scale
Measured: 12 months
Change in cardiovascular risk scores
The difference from baseline to 24 months in the estimated cardiovascular risk between advanced care and usual care groups assessed using the Framingham scale
Measured: 24 months
Achievement of recommended cholesterol, blood pressure and glycemic control targets
Number of individual achieving target cholesterol, blood pressure and glycemic control target
Measured: 3 months
Proportion of patients receiving appropriate medication
Number of patients receiving appropriate BP, cholesterol and diabetes medication
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2020
- Study start1 Mar 2020 (estimated)
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Why it stopped: No enrollment due to difficulty in recruitment of study sites
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular Risk FactorStudies of the same condition, open and under way.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Monash University
- Sponsor type
- University, hospital or other
- Collaborators
- Klinik Kesihatan Puchong, Klinik Kesihatan Kelana Jaya, Klinik Kesihatan Shah Alam Seksyen 7, Klinik Kesihatan Shah Alam Seksyen 9, Klinik Kesihatan Taman Medan, Klinik Kesihatan Seri Kembangan
- Responsible party
- Principal investigator, Shaun Lee Wen Huey, Monash University
- Investigators
- Shaun Lee, Principal investigator, Monash University Malaysia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04220788
- Sponsor's protocol ID
- PxES-CAR2+
- Status last verified
- Aug 2020
- First submitted
- 30 Dec 2019
- Last updated
- 2 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacist Enhanced Service in Primary Care for CArdiovascular Risk Reduction (PxES-CAR2+) Project: A Multi-centre Pragmatic, Step-wedge Cluster Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04220788
- Acronym / sponsor ID
- PxES-CAR2+
- Conditions
- Cardiovascular Risk Factor
- Keywords
- cardiovascular disease, pharmacist service
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No enrollment due to difficulty in recruitment of study sites
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Monash UniversityUniversity, hospital or other
- Collaborators
- Klinik Kesihatan Puchong, Klinik Kesihatan Kelana Jaya, Klinik Kesihatan Shah Alam Seksyen 7, Klinik Kesihatan Shah Alam Seksyen 9, Klinik Kesihatan Taman Medan, Klinik Kesihatan Seri Kembangan
- Study start
- 1 Mar 2020 (estimated)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 7 Jan 2020 (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.
Pharmacist services such as medication review, counselling and treatment adherence clinics can improve clinical, health related quality of life and economic outcomes. To prove this hypothesis a step-wedge, cluster randomized controlled trial will be held in primary care centers of the public health system of Malaysia. Participants who have a high risk of cardiovascular risk factors currently seeking care in primary care will be recruited. Control group will receive usual care and the intervention arm will be seen by a pharmacist prior to their follow-up, with a comprehensive medication review, counselling and dietary advice consultations every month for three months. Participating pharmacist will be trained in cardiovascular prevention pharmacotherapy, interview skills, educational techniques, and develop personalized plan for every participant. The investigators plan to randomize up to 2100 participants who are currently receiving care in the primary care clinics in the district of Petaling by modifying the current workflow in primary care, whereby the investigators aim to get participants who are at high risk to undergo counselling as well as a medication review with proper pharmaceutical care delivered to them prior to seeking their medical doctor to receive care.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Enhanced pharmacist service | Experimental | Other: Enhanced pharmacist serviceThe advanced care group will be undergo a Comprehensive Annual Care Plan (CACP) or Standard Medication Management Assessment (SMMA) with the pharmacist |
| Usual care | Active comparator | Other: Usual carePatients in the usual care arm will receive their usual care which they will obtain care from their doctor,nurse and pharmacist where appropriate |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with diabetes
- Patients with chronic kidney disease (eGFR <60ml/min/1.73m2)
- Patients with established atherosclerotic vascular disease (via patient health records or selfreport) including cerebrovascular disease (prior stroke or transient ischemic attack), cardiovascular disease (myocardial infarction, acute coronary syndrome, stable angina, or revascularization), or peripheral arterial disease (symptomatic and/or ankle brachial index <0.9)
- Primary prevention patients with multiple risk factors and Framingham risk score >30%
Key exclusion criteria (4 listed)
- Unwilling to participate/sign consent form
- Unwilling or unable to participate in regular follow-up visits
- Pregnancy
- Undergoing existing medication therapy adherence clinic conducted by the Pharmacy Unit
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 |
|---|---|---|
| Enhanced pharmacist serviceCalculation of cardiovascular risk by an online tool for discussion on the CVD risk. Pharmacist will also provide ducation on cardiovascular risk factors and healthy lifestyle. Any prescription adaptation(s), and/or recommendations where necessary to meet lipid, blood pressure and glycemic control targets and smoking cessation will be initiated | Other | Enhanced pharmacist service |
| Usual careParticipants in the arm will receive their care from their respective nurse, doctor or pharmacists as per usual clinic practice | Other | Usual care |
Primary outcome
Change in cardiovascular risk scores
Time frame: 3 months
The difference from baseline to 3 months in the estimated cardiovascular risk between advanced care and usual care groups assessed using the Framingham scale
5 secondary outcomes
Change in cardiovascular risk scores
Time frame: 6 months
Change in cardiovascular risk scores
Time frame: 12 months
Change in cardiovascular risk scores
Time frame: 24 months
Achievement of recommended cholesterol, blood pressure and glycemic control targets
Time frame: 3 months
Proportion of patients receiving appropriate medication
Time frame: 3 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2020.
- Individual participant dataSharing planned: No
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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.
Shaun Lee principal investigator
Monash University Malaysia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Enhanced pharmacist service in people with Cardiovascular Risk Factor, run by Monash University at 1 site in Malaysia.
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 4 inclusion and 4 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: withdrawn, as of the sponsor's last update on 2 Sep 2020. 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 Malaysia. 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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in cardiovascular risk scores (time frame: 3 months). 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 2 Sep 2020.