Acute Coronary SyndromeNCT03218813
A Pharmacist-Led Hospital-Based Intervention to Support Medication Adherence Following Acute Coronary Syndrome
A study testing Intervention cohort ('after' group) in people with Acute Coronary Syndrome, run by King's College London at 1 site in United Kingdom.
Trial summary
Background Medication adherence following acute coronary syndrome (ACS) is often sub-optimal and is associated with poor clinical outcomes. Patients' beliefs about medications have been shown to predict poor adherence and may be targetable for intervention. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Coronary Syndrome
- What is being tested?
- Intervention cohort ('after' group)
- 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
- 56 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 12 Dec 2017to 31 Oct 2018
- 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 aged 18 years and over
- Clinical diagnosis of ACS*
- ACS primary reason for hospitalisation
- Patients to be prescribed medications for secondary prevention (i.e. antiplatelet drugs, statins, ACEi, ARBs, β-blockers)
- Sufficient spoken English to participate in the study
Who cannot join
- Under 18 years of age
- Developed ACS* as a secondary condition (i.e. perioperative MI)
- Not prescribed medications for secondary prevention (i.e. antiplatelet drugs, statins, ACEi, ARBs, β-blockers)
- Non-English speaking
- Medical notes indicate cognitive impairment
- ACS is defined as patients diagnosed with a myocardial infarction or unstable angina (European Society of Cardiology Clinical Practice Guidelines (Roffi et al., 2015; Steg et al., 2012)).
Show all 10Show fewer
- Non-ST-segment elevated myocardial infarction (NSTEMI) - Myocardial ischaemia with elevated cardiac biomarkers (i.e. troponin) in the absence of ST-segment elevation identified via electrocardiogram (ECG).
- ST-segment elevated myocardial infarction (STEMI) - Myocardial ischaemia with elevated cardiac biomarkers (i.e. troponin) and ST-segment elevation identified via electrocardiogram (ECG).
- Unstable angina - Myocardial ischaemia at rest or minimal exertion in the absence of cardiomyocyte necrosis and significantly elevated cardiac biomarkers (i.e. troponin).
- All diagnoses will be made by the patients' clinical team. The research team will play no part in this process.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pharmacist-Led Hospital-Based Intervention to Support Medication Adherence Following Acute Coronary Syndrome: An Intervention Cohort Study
Background Medication adherence following acute coronary syndrome (ACS) is often sub-optimal and is associated with poor clinical outcomes. Patients' beliefs about medications have been shown to predict poor adherence and may be targetable for intervention. Findings novel ways to improve adherence is an important area of research with widespread clinical implications. Pharmacists may currently be underutilised in promoting and monitoring medication-taking behaviour. There have been few effective interventions led by pharmacists to support medication adherence in patients with ACS.
Objectives This study follows on from a feasibility and acceptability study recently conducted (NCT02967588). The primary objective is to pilot a pharmacist-led hospital-based intervention to support medication adherence following an ACS.
Read more
Methods This study will adopt a non-randomised intervention cohort design (i.e. controlled before-and-after (CBA) study). Patients admitted to hospital with an ACS will be recruited for this study. Patients must be prescribed medicines for secondary prevention. The study will be delivered by hospital pharmacists over two sessions and will target both intentional (Session 1) and unintentional (Session 2) adherence barriers. Session 1 will involve eliciting and challenging patients' erroneous beliefs about medications. Session 2 will involve formulating specific action plans to encourage medication-taking habit formation.
Outcome Outcome data will be collected at two time points - 6 week and 12 week follow up. The primary outcome of this proposed study will be treatment beliefs, measured using the Beliefs about Medicines Questionnaire-Specific (BMQ-S) (Horne, Weinman \& Hankin, 1999). Our secondary outcome will be self-reported medication adherence measured using the Medication Adherence Report Scale (MARS-5) (Horne \& Weinman, 2002). Depression, medicines-related self-efficacy and satisfaction with medicines information provision will also be measured.
Study timeline Control cohort ('before' group): eligible patients will receive treatment as usual (TAU) and will complete all outcome measures (i.e. treatment beliefs, medication adherence). Pharmacists will then be trained to deliver the intervention. Intervention cohort ('after' group): eligible patients will receive the pharmacist-led intervention and will complete all outcome measures.
- Conditions
- Acute Coronary Syndrome
- Being tested
- Intervention cohort ('after' group)
- 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.
Intervention cohort ('after' group)Behavioural
The intervention will take place during hospitalisation. Patients will complete the BMQ-S and their responses will form the basis of what will be discussed in Session 1. Pharmacists will elicit patients' thoughts and opinions about their medicines and highlight the need to take them. Any erroneous treatment beliefs will be discussed and any concerns will be addressed.
After Session 1, patients will be given a planning sheet and will be asked to think about their usual daily routine and how taking medicines may fit into it. Session 2 will focus on developing specific action plans for taking medication at home. Patients will be asked to formulate an if-then plan ('If it is time X in place Y and I am doing Z, then I will take my pill dose').
| Study group | Role | What they receive |
|---|---|---|
| Control cohort ('before' group) | No intervention | Control cohort ('before' group): eligible patients will receive treatment as usual (TAU) and will complete all outcome measures. |
| Intervention cohort ('after' group) | Experimental | Eligible patients will receive the pharmacist-led intervention and will complete all outcome measures. Receives: Behavioral: Intervention cohort ('after' group) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment beliefs
Beliefs about Medication Questionnaire-Specific (BMQ-S)
Measured: 12 week follow up
Secondary outcomes (5)
Treatment beliefs
Beliefs about Medication Questionnaire-Specific (BMQ-S)
Measured: 6 week follow up
Medication adherence
Medication Adherence Report Scale-5 (MARS-5)
Measured: 12 week follow up
Medication adherence
Medication Adherence Report Scale-5 (MARS-5)
Measured: 6 week follow up
Depression
Patient Health Questionnaire-2 (PHQ-2)
Measured: 12 week follow up
Medicines-related self-efficacy
Self-Efficacy for Appropriate Medication Use Scale (SEAMS)
Measured: 12 week follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2017
- Study start12 Dec 2017
- Primary completion31 Oct 2018
- Study completion31 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Coronary SyndromeStudies of the same condition, open and under way.
- More trials run by King's College LondonThe 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- This study will adopt a non-randomised prospective intervention cohort design (i.e. controlled before-and-after (CBA) study). Two cohorts of patients will be recruited from a single NHS site over two recruitment periods. Pharmacists will be trained between these recruitment periods to deliver an intervention, thus creating two comparable groups (control/'before' group vs. intervention/'after' group).
- Masking
- None (open label)
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- King's College London
- Sponsor type
- University, hospital or other
- Collaborators
- Guy's and St Thomas' NHS Foundation Trust
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03218813
- Sponsor's protocol ID
- v1 30-06-17
- Status last verified
- Aug 2018
- First submitted
- 12 Jul 2017
- Last updated
- 14 Aug 2019
- 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 14 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pharmacist-Led Hospital-Based Intervention to Support Medication Adherence Following Acute Coronary Syndrome: An Intervention Cohort Study
- ClinicalTrials.gov ID
- NCT03218813
- Acronym / sponsor ID
- v1 30-06-17
- Conditions
- Acute Coronary Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- King's College LondonUniversity, hospital or other
- Collaborators
- Guy's and St Thomas' NHS Foundation Trust
- Study start
- 12 Dec 2017 (actual)
- Primary completion
- 31 Oct 2018 (actual)
- Study completion
- 31 Oct 2018 (actual)
- First posted
- 17 Jul 2017 (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.
Background Medication adherence following acute coronary syndrome (ACS) is often sub-optimal and is associated with poor clinical outcomes. Patients' beliefs about medications have been shown to predict poor adherence and may be targetable for intervention. Findings novel ways to improve adherence is an important area of research with widespread clinical implications. Pharmacists may currently be underutilised in promoting and monitoring medication-taking behaviour. There have been few effective interventions led by pharmacists to support medication adherence in patients with ACS.
Objectives This study follows on from a feasibility and acceptability study recently conducted (NCT02967588). The primary objective is to pilot a pharmacist-led hospital-based intervention to support medication adherence following an ACS.
Methods This study will adopt a non-randomised intervention cohort design (i.e. controlled before-and-after (CBA) study). Patients admitted to hospital with an ACS will be recruited for this study. Patients must be prescribed medicines for secondary prevention. The study will be delivered by hospital pharmacists over two sessions and will target both intentional (Session 1) and unintentional (Session 2) adherence barriers. Session 1 will involve eliciting and challenging patients' erroneous beliefs about medications. Session 2 will involve formulating specific action plans to encourage medication-taking habit formation.
Outcome Outcome data will be collected at two time points - 6 week and 12 week follow up. The primary outcome of this proposed study will be treatment beliefs, measured using the Beliefs about Medicines Questionnaire-Specific (BMQ-S) (Horne, Weinman \& Hankin, 1999). Our secondary outcome will be self-reported medication adherence measured using the Medication Adherence Report Scale (MARS-5) (Horne \& Weinman, 2002). Depression, medicines-related self-efficacy and satisfaction with medicines information provision will also be measured.
Study timeline Control cohort ('before' group): eligible patients will receive treatment as usual (TAU) and will complete all outcome measures (i.e. treatment beliefs, medication adherence). Pharmacists will then be trained to deliver the intervention. Intervention cohort ('after' group): eligible patients will receive the pharmacist-led intervention and will complete all outcome measures.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This study will adopt a non-randomised prospective intervention cohort design (i.e. controlled before-and-after (CBA) study). Two cohorts of patients will be recruited from a single NHS site over two recruitment periods. Pharmacists will be trained between these recruitment periods to deliver an intervention, thus creating two comparable groups (control/'before' group vs. intervention/'after' group).
| Arm | Type | Receives |
|---|---|---|
| Control cohort ('before' group) | No intervention | –Control cohort ('before' group): eligible patients will receive treatment as usual (TAU) and will complete all outcome measures. |
| Intervention cohort ('after' group) | Experimental | Behavioral: Intervention cohort ('after' group)Eligible patients will receive the pharmacist-led intervention and will complete all outcome measures. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients aged 18 years and over
- Clinical diagnosis of ACS*
- ACS primary reason for hospitalisation
- Patients to be prescribed medications for secondary prevention (i.e. antiplatelet drugs, statins, ACEi, ARBs, β-blockers)
- Sufficient spoken English to participate in the study
Key exclusion criteria (10 listed)
- Under 18 years of age
- Developed ACS* as a secondary condition (i.e. perioperative MI)
- Not prescribed medications for secondary prevention (i.e. antiplatelet drugs, statins, ACEi, ARBs, β-blockers)
- Non-English speaking
- Medical notes indicate cognitive impairment
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 |
|---|---|---|
| Intervention cohort ('after' group)The intervention will take place during hospitalisation. Patients will complete the BMQ-S and their responses will form the basis of what will be discussed in Session 1. Pharmacists will elicit patients' thoughts and opinions about their medicines and highlight the need to take them. Any erroneous treatment beliefs will be discussed and any concerns will be addressed. After Session 1, patients will be given a planning sheet and will be asked to think about their usual daily routine and how taking medicines may fit into it. Session 2 will focus on developing specific action plans for taking medication at home. Patients will be asked to formulate an if-then plan ('If it is time X in place Y and I am doing Z, then I will take my pill dose'). | Behavioural | Intervention cohort ('after' group) |
Primary outcome
Treatment beliefs
Time frame: 12 week follow up
Beliefs about Medication Questionnaire-Specific (BMQ-S)
5 secondary outcomes
Treatment beliefs
Time frame: 6 week follow up
Medication adherence
Time frame: 12 week follow up
Medication adherence
Time frame: 6 week follow up
Depression
Time frame: 12 week follow up
Medicines-related self-efficacy
Time frame: 12 week follow up
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 14 Aug 2019.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention cohort ('after' group) in people with Acute Coronary Syndrome, run by King's College London at 1 site in United Kingdom.
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 5 inclusion and 10 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 14 Aug 2019. 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 United Kingdom. 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?
Treatment beliefs (time frame: 12 week 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 14 Aug 2019.