Acute Coronary SyndromeNCT02481024
Impact of Care Transition on Medication Adherence in Cardiac Patients
An observational study of 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. Poor adherence is associated with increased risk of rehospitalisation along with higher rates of morbidity and mortality. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Coronary Syndrome
- How many people
- 8 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jun 2015to Jun 2016
- Phase
- Observational
- 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
Study population: Patients hospitalised after an acute coronary syndrome event.
Who may be able to join
- over 18 years of age
- have a confirmed index diagnosis of ACS
- have sufficient spoken English to partake in an interview
Who cannot join
- under 18 years of age
- lack the level of spoken English required to be interviewed
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Guy's and St Thomas' NHS Foundation Trust
London, SE1 7EH
About this study
Official title: 'Moving From Hospital to Home' - Exploring the Impact of Care Transition on Medication Adherence in Cardiac Patients: a Qualitative Study Protocol
Background:
Medication adherence following acute coronary syndrome (ACS) is often sub-optimal. Poor adherence is associated with increased risk of rehospitalisation along with higher rates of morbidity and mortality. After a cardiac event, transitioning from hospital into primary care can be problematic if it is not organised or coordinated properly. Patients can often find themselves unprepared and lacking the necessary information for self-management of their disease. The impact of care transition on medication adherence has not been studied in ACS.
Read more
Objectives:
This study will explore how an ACS patients' journey from hospital into primary care affects medicines use. Further, to understand how medicine information is communicated and how this influences patient beliefs about medicines.
Methods:
This is an interview study with recently hospitalised ACS patients discussing medication beliefs, communication of medicine information and the challenges when transitioning from specialist to primary care. Patients will be recruited from Guy's and St Thomas' NHS Foundation Trust and telephone interviews will be scheduled 3-4 weeks post-discharge. An inductive thematic analysis will be used to identify, construct and analyse patterns in the data and to develop a framework analysis. Analysis will be an iterative process conducted in parallel with data collection to highlight when data saturation has been reached.
Dissemination:
The primary objective is to develop a pharmacist-led behaviour change intervention to improve rates of medication adherence following an ACS. The in-depth patient data collected in this current study will contribute to the design and development of the intervention. Understanding the research topic from the patients' perspective is a necessity when designing an intervention targeting behaviour change.
- Conditions
- Acute Coronary Syndrome
- Keywords
- Qualitative, Care transition, Medication
- Medical subject headings
- Acute Coronary Syndrome
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient experiences
Analysing patients' experiences of care transition and its impact on adherence and treatment beliefs. This will be done using thematic analysis to identify, construct and assess patterns in the qualitative data to develop a framework analysis.
Measured: 3-4 weeks after discharged from hospital
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2015 (estimated)
- Study startJun 2015
- Primary completionJun 2016
- Study completionJun 2016
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
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- King's College London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02481024
- Sponsor's protocol ID
- V1_18_06_15
- Status last verified
- Aug 2016
- First submitted
- 18 Jun 2015
- Last updated
- 18 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 'Moving From Hospital to Home' - Exploring the Impact of Care Transition on Medication Adherence in Cardiac Patients: a Qualitative Study Protocol
- ClinicalTrials.gov ID
- NCT02481024
- Acronym / sponsor ID
- V1_18_06_15
- Conditions
- Acute Coronary Syndrome
- Keywords
- Qualitative, Care transition, Medication
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- King's College LondonUniversity, hospital or other
- Study start
- Jun 2015
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 25 Jun 2015 (estimated)
- 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. Poor adherence is associated with increased risk of rehospitalisation along with higher rates of morbidity and mortality. After a cardiac event, transitioning from hospital into primary care can be problematic if it is not organised or coordinated properly. Patients can often find themselves unprepared and lacking the necessary information for self-management of their disease. The impact of care transition on medication adherence has not been studied in ACS.
Objectives:
This study will explore how an ACS patients' journey from hospital into primary care affects medicines use. Further, to understand how medicine information is communicated and how this influences patient beliefs about medicines.
Methods:
This is an interview study with recently hospitalised ACS patients discussing medication beliefs, communication of medicine information and the challenges when transitioning from specialist to primary care. Patients will be recruited from Guy's and St Thomas' NHS Foundation Trust and telephone interviews will be scheduled 3-4 weeks post-discharge. An inductive thematic analysis will be used to identify, construct and analyse patterns in the data and to develop a framework analysis. Analysis will be an iterative process conducted in parallel with data collection to highlight when data saturation has been reached.
Dissemination:
The primary objective is to develop a pharmacist-led behaviour change intervention to improve rates of medication adherence following an ACS. The in-depth patient data collected in this current study will contribute to the design and development of the intervention. Understanding the research topic from the patients' perspective is a necessity when designing an intervention targeting behaviour change.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients hospitalised after an acute coronary syndrome event.
Key inclusion criteria (3 listed)
- over 18 years of age
- have a confirmed index diagnosis of ACS
- have sufficient spoken English to partake in an interview
Key exclusion criteria (2 listed)
- under 18 years of age
- lack the level of spoken English required to be interviewed
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Patient experiences
Time frame: 3-4 weeks after discharged from hospital
Analysing patients' experiences of care transition and its impact on adherence and treatment beliefs. This will be done using thematic analysis to identify, construct and assess patterns in the qualitative data to develop a framework analysis.
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 18 Jan 2018.
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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?
An observational study of 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 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: finished, as of the sponsor's last update on 18 Jan 2018. 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?
Patient experiences (time frame: 3-4 weeks after discharged from hospital). 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 18 Jan 2018.