Acute Coronary SyndromeNCT05153707
Clinical Pharmacist-led Discharge Education Service in Acute Coronary Syndrome
A study testing Discharge Education Program in people with Acute Coronary Syndrome, run by Marmara University at 1 site in Turkey (Türkiye).
Trial summary
To evaluate the impact of clinical pharmacist-led discharge education service in patients with acute coronary syndrome. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Acute Coronary Syndrome
- What is being tested?
- Discharge Education Program
- 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
- 177 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jan 2021to 15 Jun 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients admitted to the cardiology department due to acute coronary syndrome
- Older than 18 years old
Who cannot join
- Patients who transferred to another ward
- Patients with active malignancy
- Patients with alzheimer and/or dementia diagnosis
- Patient with >%80 visual loss or deaf muteness reported at medical record
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of a Clinical Pharmacist-led Discharge Education Service in Patients With Acute Coronary Syndrome: A Randomized Controlled Study
To evaluate the impact of clinical pharmacist-led discharge education service in patients with acute coronary syndrome.
Read the detailed description
This prospective, randomized controlled study was conducted in patients with acute coronary syndrome in an cardiology service of tertiary training and research hospital. The clinical pharmacist, within the scope of the discharge education services, provided medication reconciliation, medication review, individually prepared patient medicine (pill) card, patient education (based on Health Belief Model by using written material and video, and verbally [by using Teach back method especially for patients with low health literacy]) and counseling (using behavior change techniques based on The Capability, Opportunity, and Motivation Behavior model). The control group received standard care.
- Conditions
- Acute Coronary Syndrome
- Being tested
- Discharge Education Program
- Medical subject headings
- Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Discharge Education ProgramBehavioural
medication reconciliation, medication review, individually prepared patient medicine (pill) card, patient education (based on Health Belief Model by using written material and video, and verbally [by using Teach back method especially for patients with low health literacy]) and counseling (using behavior change techniques based on The Capability, Opportunity, and Motivation Behavior model).
| Study group | Role | What they receive |
|---|---|---|
| Clinical Pharmacist-led discharge education program | Experimental | Clinical pharmacist-led services Receives: Behavioral: Discharge Education Program |
| Control group | No intervention | Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
30 days hospital re-admission for cardiac reasons
Proportion of patients readmitted to hospital for cardiac cause at 1 month
Measured: 30 days
Secondary outcomes (9)
Hospital re-admission for cardiac reasons
Proportion of patients readmitted to hospital for cardiac cause through 1 year.
Measured: 3 months, 6 months, and 12 months
Hospital re-admission for any reasons
Proportion of patients readmitted to hospital for any cause through 1 year.
Measured: 1 month, 3 months, 6 months, and 12 months
Emergency service visits
Proportion of patients visited to emergency service through 1 year.
Measured: 1 month, 3 months, 6 months, and 12 months
Major Adverse Cardiovascular Event
Proportion of patients had major adverse cardiovascular event through 1 year.
Measured: 1 month, 3 months, 6 months, and 12 months
Death for cardiac reason
Proportion of patients died for cardiac cause through 1 year.
Measured: 1 month, 3 months, 6 months, and 12 months
Death for any reason
Proportion of patients dying for any cause through 1 year.
Measured: 1 month, 3 months, 6 months, and 12 months
Medication Adherence
Adherence to Cardioprotective Medications (Clopidogrel, Statins, Beta-blockers, Angiotensin-converting enzyme (ACE) inhibitors/ Angiotensin receptor blocker (ARB) through 1 year assessed by Medication Adherence Report Scale (MARS). MARS assesses adherence through 5-item, summed to give a scale score ranging from 5 to 25, where higher scores indicate higher levels of reported adherence.
Measured: 1 month, 3 months, 6 months, and 12 months
Quality of Life Measurement
Change in quality of life from baseline assessed with EuroQol questionnaire EQ-5D-3L through 1 year. (EQ-5D-3L) is a standardized scale for use as a measure of the quality of life. The EQ-5D-3L descriptive system comprises the following 5 dimensions (5D): mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 3 levels (3L): no problems (1 point), some problems (2 points), extreme problems (3 points).
This gives a total of 245 different health states, adding unconscious and dead.
Measured: 1 month, 3 months, 6 months, and 12 months
Achieved Target Low-density Lipoprotein Value
Rate of patients achieved target low-density lipoprotein value
Measured: 6 months, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2021
- Study start15 Jan 2021
- Primary completion15 Jun 2021
- Study completion15 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Coronary SyndromeStudies of the same condition, open and under way.
- More trials run by Marmara UniversityThe 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 177 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Betul Okuyan, Marmara University
- Investigators
- Betul Okuyan, Principal investigator, Marmara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05153707
- Sponsor's protocol ID
- MARCPD-0001
- Status last verified
- Mar 2023
- First submitted
- 25 Nov 2021
- Last updated
- 16 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Demirci MY, Mutlu B, Sancar M, Okuyan B. Impact of clinical pharmacist-led behavioural theory-based discharge service to promote medication adherence in patients with acute coronary syndrome: a randomised controlled trial. Int J Clin Pharm. 2026 Aug;48(4):1548-1558. doi: 10.1007/s11096-026-02134-y. Epub 2026 Apr 7.
PubMed 41945242
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Clinical Pharmacist-led Discharge Education Service in Patients With Acute Coronary Syndrome: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT05153707
- Acronym / sponsor ID
- MARCPD-0001
- Conditions
- Acute Coronary Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 177 participants (actual)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Study start
- 15 Jan 2021 (actual)
- Primary completion
- 15 Jun 2021 (actual)
- Study completion
- 15 Jun 2022 (actual)
- First posted
- 10 Dec 2021 (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.
To evaluate the impact of clinical pharmacist-led discharge education service in patients with acute coronary syndrome.
Detailed description
This prospective, randomized controlled study was conducted in patients with acute coronary syndrome in an cardiology service of tertiary training and research hospital. The clinical pharmacist, within the scope of the discharge education services, provided medication reconciliation, medication review, individually prepared patient medicine (pill) card, patient education (based on Health Belief Model by using written material and video, and verbally [by using Teach back method especially for patients with low health literacy]) and counseling (using behavior change techniques based on The Capability, Opportunity, and Motivation Behavior model). The control group received standard care.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Clinical Pharmacist-led discharge education program | Experimental | Behavioral: Discharge Education ProgramClinical pharmacist-led services |
| Control group | No intervention | –Usual care |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients admitted to the cardiology department due to acute coronary syndrome
- Older than 18 years old
Key exclusion criteria (4 listed)
- Patients who transferred to another ward
- Patients with active malignancy
- Patients with alzheimer and/or dementia diagnosis
- Patient with >%80 visual loss or deaf muteness reported at medical record
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 |
|---|---|---|
| Discharge Education Programmedication reconciliation, medication review, individually prepared patient medicine (pill) card, patient education (based on Health Belief Model by using written material and video, and verbally [by using Teach back method especially for patients with low health literacy]) and counseling (using behavior change techniques based on The Capability, Opportunity, and Motivation Behavior model). | Behavioural | Clinical Pharmacist-led discharge education program |
Primary outcome
30 days hospital re-admission for cardiac reasons
Time frame: 30 days
Proportion of patients readmitted to hospital for cardiac cause at 1 month
9 secondary outcomes
Hospital re-admission for cardiac reasons
Time frame: 3 months, 6 months, and 12 months
Hospital re-admission for any reasons
Time frame: 1 month, 3 months, 6 months, and 12 months
Emergency service visits
Time frame: 1 month, 3 months, 6 months, and 12 months
Major Adverse Cardiovascular Event
Time frame: 1 month, 3 months, 6 months, and 12 months
Death for cardiac reason
Time frame: 1 month, 3 months, 6 months, and 12 months
Death for any reason
Time frame: 1 month, 3 months, 6 months, and 12 months
Medication Adherence
Time frame: 1 month, 3 months, 6 months, and 12 months
Quality of Life Measurement
Time frame: 1 month, 3 months, 6 months, and 12 months
Achieved Target Low-density Lipoprotein Value
Time frame: 6 months, 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2023.
- Derived from this study: PubMed 41945242Demirci MY, Mutlu B, Sancar M, Okuyan B. Impact of clinical pharmacist-led behavioural theory-based discharge service to promote medication adherence in patients with acute coronary syndrome: a randomised controlled trial. Int J Clin Pharm. 2026 Aug;48(4):1548-1558. doi: 10.1007/s11096-026-02134-y. Epub 2026 Apr 7.
- 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.
Betul Okuyan principal investigator
Marmara University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Discharge Education Program in people with Acute Coronary Syndrome, run by Marmara University at 1 site in Turkey (Türkiye).
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 2 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: finished, as of the sponsor's last update on 16 Mar 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 Turkey (Türkiye). 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
30 days hospital re-admission for cardiac reasons (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05153707, which also lists 1 linked publication.
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 16 Mar 2023.