ST Elevation Myocardial InfarctionCABINNCT05848674
CArdiac Brief INtervention: A Feasibility Study to Promote Engagement With Cardiac Rehabilitation
A study testing CArdiac Brief INtervention (CABIN) and Refined version of CABIN in people with ST Elevation Myocardial Infarction, run by Queen's University, Belfast at 2 sites in United Kingdom.
Trial summary
Background: An ST-elevation myocardial infarction (STEMI) is a specific type of heart attack. In a previous study, patients requested more mental and emotional support after a STEMI. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ST Elevation Myocardial Infarction
- What is being tested?
- CArdiac Brief INtervention (CABIN) and Refined version of CABIN
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 1 Feb 2024to 1 Nov 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Aged 18 years and over.
- Confirmed diagnosis of STEMI.
- Physically and mentally capable of participation (judged by Cardiologist or Nurse).
- Willing to provide informed consent.
Who cannot join
- Lacking capacity to give consent (judged by Cardiologist or Nurse).
- Under the age of 18 years.
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
Royal Victoria Hospital, Belfast Health and Social Care Trust
Belfast, Antrim, BT12 6BA
Ulster Hospital, South Eastern Health and Social Care Trust
Dundonald, Down, BT16 1RH
About this study
Official title: CABIN (CArdiac Brief INtervention): A Feasibility Study to Promote Engagement With Cardiac Rehabilitation Through an Early, Personalised, Holistic Intervention
Background:
An ST-elevation myocardial infarction (STEMI) is a specific type of heart attack. In a previous study, patients requested more mental and emotional support after a STEMI. To provide this support, the research team worked with hospital staff and patients to create a brief intervention called CABIN (CArdiac Brief INtervention), which involves a short discussion between a patient and a nurse, along with a leaflet that summarises the information discussed.
Read more
Aim:
To test if the plan for giving CABIN to patients after a STEMI is suitable, and to explore what impact the intervention may have on mental and emotional well-being, along with knowledge about their condition.
Methods:
Forty patients who had a STEMI will be recruited from two hospital centres in Northern Ireland (Royal Victoria Hospital and Ulster Hospital). Participants will be randomly put in a group who receive the full CABIN intervention or a group who receive a shortened version of CABIN. Both groups will receive their respective interventions before leaving the hospital, which will take about twenty minutes. Participants will be asked to complete brief questionnaires before the intervention, after the intervention, 3-4 weeks from diagnosis, and 14 weeks from diagnosis. At the end of the study, patients who took part and staff from the hospitals will be asked to complete an exit interview (patients) or a focus group (staff), which will provide information about their experience of the study / intervention and changes required.
Outcome of Study:
If the study is suitable for patients and appropriate for staff to deliver, the research team will examine the effectiveness of CABIN in a larger study, which may lead to the intervention being used in clinical practice to improve cardiac rehabilitation uptake and outcomes for patients after a STEMI.
- Conditions
- ST Elevation Myocardial Infarction
- Being tested
- CArdiac Brief INtervention (CABIN), Refined version of CABIN
- Medical subject headings
- ST Elevation Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CArdiac Brief INtervention (CABIN)Other
CABIN is designed as a brief intervention with a facilitated discussion between a patient and a nurse, with the provision of a short leaflet that summarises information and acts as an aide memoir. The discussion takes place in a quiet area and is intended to last 15-20 minutes. CABIN involves a nurse listening to the patient and recognising any concerns he / she may have and / or identifying erroneous beliefs. It also provides the patient with personalised education on coronary artery disease and cardiac rehabilitation (i.e., information about stenting, stent placement, medication, and purpose / potential benefits of cardiac rehabilitation), along with facilitating psychological and emotional support discussions with a nurse (i.e., explaining causes of a STEMI, discussing support / treatment options, and exploring methods of improving health).
Refined version of CABINOther
Participants of the control group will receive a refined version of CABIN, which excludes psychological and emotional support discussions with a nurse and details some standard discharge information (information about coronary artery disease and stenting / stent placement).
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | CABIN will be delivered in a single session to each participant (one-to-one) of the intervention group by a Research Assistant who is a cardiac nurse with over 20 years of clinical experience in cardiac rehabilitation. A private space at a Coronary Care Unit (Royal Victoria Hospital or Ulster Hospital) will be used for intervention delivery before patient discharge. Intervention delivery should take approximately 20 minutes. Receives: Other: CArdiac Brief INtervention (CABIN) |
| Control Group | Other | A Research Fellow will deliver (one-to-one) a refined version of CABIN prior to patient discharge from a Coronary Care Unit (Royal Victoria Hospital or Ulster Hospital). A private space will be used, with delivery taking approximately 10 minutes. Receives: Other: Refined version of CABIN |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Percentage of Eligible Patients Who Agreed to Participate in the Study.
The measurement of recruitment rate will allow the efficiency of the recruitment strategy to be assessed, with this information enabling the identification of potential issues and informing the required duration of the recruitment period for a larger study.
Measured: Month 3
The Percentage of Intervention Delivered (Dose)
Dose will represent the percentage of the intervention (completeness) received by participants, which will inform the feasibility of CABIN implementation. This information will be collected via an intervention checklist that is completed by the Research Assistant following each intervention session.
Measured: Week 1
The Percentage of Recruited Participants Providing Data for Each Baseline and Outcome Measure.
The completeness of baseline and outcome measures will be determined as missing data may jeopardise the power of a future study. The Research Fellow will record details about data collection in the study log, which will highlight any problems or required changes to improve data collection for a future study.
Measured: Month 9
Perspectives of Patients on Research Design and Intervention Delivery.
Participants will be invited to a semi-structured interview upon study completion to discuss:
- Acceptability of intervention (i.e., issues for development, required corrections, additional areas for inclusion, aspects enjoyed by participants, and barriers and facilitators to participation).
- Context (i.e., factors influencing study / intervention delivery and functioning, for instance, time and resources).
- Possible mechanisms of impact (i.e., exploring how intervention activities may trigger change for participants).
Measured: Week 14
Perspectives of Clinical Staff on Research Design and Intervention Delivery.
Coronary care unit and cardiac rehabilitation staff will be invited to focus groups to discuss:
- Acceptability of intervention (i.e., issues for development, required corrections, additional areas for inclusion, aspects enjoyed by participants, and barriers and facilitators to participation).
- Context (i.e., factors influencing study / intervention delivery and functioning, for instance, time and resources).
- Possible mechanisms of impact (i.e., exploring how intervention activities may trigger change for participants).
Measured: Week 14
Secondary outcomes (5)
Total Score in Coronary Artery Disease Education Questionnaire, Short Version (CADE-Q SV)
Coronary Artery Disease Education Questionnaire, Short Version (CADE-Q SV) evaluates patients' knowledge of coronary artery disease and core components of cardiac rehabilitation. Total scores will be reported as the number of 20 questions answered correctly. A higher total score represents greater knowledge of coronary artery disease and core components of cardiac rehabilitation.
Measured: Baseline, Week 1 (Post-Intervention), Week 4, and Week 14.
Total Score in Brief Illness Perception Questionnaire
Brief Illness Perception Questionnaire rapidly assesses the cognitive and emotional representations of illness. Total scores will be reported across a range from 0 - 80, with higher scores reflecting worse illness perception and lower scores indicating a more optimistic view of the disease.
Measured: Baseline, Week 1 (Post-Intervention), Week 4, and Week 14.
Total Score in the Hospital Anxiety and Depression Scale.
The Hospital Anxiety and Depression Scale measures states of depression and anxiety. Total scores will be reported across a range from 0 - 42, with higher scores representing greater levels of anxiety and depression.
Measured: Baseline, Week 4, and Week 14.
Total Score in Personal Wellbeing Score
Personal Wellbeing Score measures health status and health confidence. Total scores are reported across a range from 0 - 12, with a higher score indicating greater wellbeing.
Measured: Baseline, Week 4, and Week 14.
Number of Cardiac Rehabilitation Sessions Attended.
Number of cardiac rehabilitation sessions attended (of 8 in total)
Measured: Week 14.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2023
- Study start1 Feb 2024
- Primary completion1 Nov 2024
- Study completion1 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for ST Elevation Myocardial InfarctionStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Group 1: Intervention; Group 2: Control.
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Queen's University, Belfast
- Sponsor type
- University, hospital or other
- Collaborators
- Belfast Health and Social Care Trust, South Eastern Health and Social Care Trust
- Responsible party
- Principal investigator, Gareth Thomson, Queen's University, Belfast
- Investigators
- Donna Fitzsimons, PhD, Principal investigator, Queen's University, BelfastJudy Bradley, PhD, Principal investigator, Queen's University, Belfast
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05848674
- Sponsor's protocol ID
- B23/01
- Acronym
- CABIN
- Status last verified
- Feb 2026
- First submitted
- 17 Apr 2023
- Last updated
- 3 Mar 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Thompson G, Caughers G, Bradley J, Donnelly P, Mooney M, Dixon L, Fitzsimons D. Feasibility and Process Evaluation of CArdiac Brief INtervention (CABIN) in Patients with ST-Elevation Myocardial Infarction: A Mixed-Method, Pilot Randomised Controlled Trial. Eur J Cardiovasc Nurs. 2026 Jun 27:zvag157. doi: 10.1093/eurjcn/zvag157. Online ahead of print.
PubMed 42363733Thompson G, Caughers G, Bradley J, Donnelly P, Mooney M, Fitzsimons D. The feasibility of delivering cardiac brief intervention to patients following ST-elevation myocardial infarction: Protocol for a pilot randomised controlled trial. PLoS One. 2024 Jul 2;19(7):e0306406. doi: 10.1371/journal.pone.0306406. eCollection 2024.
PubMed 38954674
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CABIN (CArdiac Brief INtervention): A Feasibility Study to Promote Engagement With Cardiac Rehabilitation Through an Early, Personalised, Holistic Intervention
- ClinicalTrials.gov ID
- NCT05848674
- Acronym / sponsor ID
- CABIN / B23/01
- Conditions
- ST Elevation Myocardial Infarction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Queen's University, BelfastUniversity, hospital or other
- Collaborators
- Belfast Health and Social Care Trust, South Eastern Health and Social Care Trust
- Study start
- 1 Feb 2024 (actual)
- Primary completion
- 1 Nov 2024 (actual)
- Study completion
- 1 Nov 2024 (actual)
- First posted
- 8 May 2023 (actual)
- Results
- Posted 3 Mar 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background:
An ST-elevation myocardial infarction (STEMI) is a specific type of heart attack. In a previous study, patients requested more mental and emotional support after a STEMI. To provide this support, the research team worked with hospital staff and patients to create a brief intervention called CABIN (CArdiac Brief INtervention), which involves a short discussion between a patient and a nurse, along with a leaflet that summarises the information discussed.
Aim:
To test if the plan for giving CABIN to patients after a STEMI is suitable, and to explore what impact the intervention may have on mental and emotional well-being, along with knowledge about their condition.
Methods:
Forty patients who had a STEMI will be recruited from two hospital centres in Northern Ireland (Royal Victoria Hospital and Ulster Hospital). Participants will be randomly put in a group who receive the full CABIN intervention or a group who receive a shortened version of CABIN. Both groups will receive their respective interventions before leaving the hospital, which will take about twenty minutes. Participants will be asked to complete brief questionnaires before the intervention, after the intervention, 3-4 weeks from diagnosis, and 14 weeks from diagnosis. At the end of the study, patients who took part and staff from the hospitals will be asked to complete an exit interview (patients) or a focus group (staff), which will provide information about their experience of the study / intervention and changes required.
Outcome of Study:
If the study is suitable for patients and appropriate for staff to deliver, the research team will examine the effectiveness of CABIN in a larger study, which may lead to the intervention being used in clinical practice to improve cardiac rehabilitation uptake and outcomes for patients after a STEMI.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Group 1: Intervention; Group 2: Control.
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Other: CArdiac Brief INtervention (CABIN)CABIN will be delivered in a single session to each participant (one-to-one) of the intervention group by a Research Assistant who is a cardiac nurse with over 20 years of clinical experience in cardiac rehabilitation. A private space at a Coronary Care Unit (Royal Victoria Hospital or Ulster Hospital) will be used for intervention delivery before patient discharge. Intervention delivery should take approximately 20 minutes. |
| Control Group | Other | Other: Refined version of CABINA Research Fellow will deliver (one-to-one) a refined version of CABIN prior to patient discharge from a Coronary Care Unit (Royal Victoria Hospital or Ulster Hospital). A private space will be used, with delivery taking approximately 10 minutes. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Aged 18 years and over.
- Confirmed diagnosis of STEMI.
- Physically and mentally capable of participation (judged by Cardiologist or Nurse).
- Willing to provide informed consent.
Key exclusion criteria (2 listed)
- Lacking capacity to give consent (judged by Cardiologist or Nurse).
- Under the age of 18 years.
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 |
|---|---|---|
| CArdiac Brief INtervention (CABIN)CABIN is designed as a brief intervention with a facilitated discussion between a patient and a nurse, with the provision of a short leaflet that summarises information and acts as an aide memoir. The discussion takes place in a quiet area and is intended to last 15-20 minutes. CABIN involves a nurse listening to the patient and recognising any concerns he / she may have and / or identifying erroneous beliefs. It also provides the patient with personalised education on coronary artery disease and cardiac rehabilitation (i.e., information about stenting, stent placement, medication, and purpose / potential benefits of cardiac rehabilitation), along with facilitating psychological and emotional support discussions with a nurse (i.e., explaining causes of a STEMI, discussing support / treatment options, and exploring methods of improving health). | Other | Intervention Group |
| Refined version of CABINParticipants of the control group will receive a refined version of CABIN, which excludes psychological and emotional support discussions with a nurse and details some standard discharge information (information about coronary artery disease and stenting / stent placement). | Other | Control Group |
Primary outcome
The Percentage of Eligible Patients Who Agreed to Participate in the Study.
Time frame: Month 3
The measurement of recruitment rate will allow the efficiency of the recruitment strategy to be assessed, with this information enabling the identification of potential issues and informing the required duration of the recruitment period for a larger study.
The Percentage of Intervention Delivered (Dose)
Time frame: Week 1
Dose will represent the percentage of the intervention (completeness) received by participants, which will inform the feasibility of CABIN implementation. This information will be collected via an intervention checklist that is completed by the Research Assistant following each intervention session.
The Percentage of Recruited Participants Providing Data for Each Baseline and Outcome Measure.
Time frame: Month 9
The completeness of baseline and outcome measures will be determined as missing data may jeopardise the power of a future study. The Research Fellow will record details about data collection in the study log, which will highlight any problems or required changes to improve data collection for a future study.
Perspectives of Patients on Research Design and Intervention Delivery.
Time frame: Week 14
Participants will be invited to a semi-structured interview upon study completion to discuss: 1. Acceptability of intervention (i.e., issues for development, required corrections, additional areas for inclusion, aspects enjoyed by participants, and barriers and facilitators to participation). 2. Context (i.e., factors influencing study / intervention delivery and functioning, for instance, time and resources). 3. Possible mechanisms of impact (i.e., exploring how intervention activities may trigger change for participants).
Perspectives of Clinical Staff on Research Design and Intervention Delivery.
Time frame: Week 14
Coronary care unit and cardiac rehabilitation staff will be invited to focus groups to discuss: 1. Acceptability of intervention (i.e., issues for development, required corrections, additional areas for inclusion, aspects enjoyed by participants, and barriers and facilitators to participation). 2. Context (i.e., factors influencing study / intervention delivery and functioning, for instance, time and resources). 3. Possible mechanisms of impact (i.e., exploring how intervention activities may trigger change for participants).
5 secondary outcomes
Total Score in Coronary Artery Disease Education Questionnaire, Short Version (CADE-Q SV)
Time frame: Baseline, Week 1 (Post-Intervention), Week 4, and Week 14.
Total Score in Brief Illness Perception Questionnaire
Time frame: Baseline, Week 1 (Post-Intervention), Week 4, and Week 14.
Total Score in the Hospital Anxiety and Depression Scale.
Time frame: Baseline, Week 4, and Week 14.
Total Score in Personal Wellbeing Score
Time frame: Baseline, Week 4, and Week 14.
Number of Cardiac Rehabilitation Sessions Attended.
Time frame: Week 14.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 42363733Thompson G, Caughers G, Bradley J, Donnelly P, Mooney M, Dixon L, Fitzsimons D. Feasibility and Process Evaluation of CArdiac Brief INtervention (CABIN) in Patients with ST-Elevation Myocardial Infarction: A Mixed-Method, Pilot Randomised Controlled Trial. Eur J Cardiovasc Nurs. 2026 Jun 27:zvag157. doi: 10.1093/eurjcn/zvag157. Online ahead of print.
- Derived from this study: PubMed 38954674Thompson G, Caughers G, Bradley J, Donnelly P, Mooney M, Fitzsimons D. The feasibility of delivering cardiac brief intervention to patients following ST-elevation myocardial infarction: Protocol for a pilot randomised controlled trial. PLoS One. 2024 Jul 2;19(7):e0306406. doi: 10.1371/journal.pone.0306406. eCollection 2024.
- Individual participant dataSharing planned: No
Related trials for ST Elevation Myocardial Infarction
RecruitingPhase 4
Early Single Antiplatelet Therapy After IVUS-Guided PCI in Acute Coronary Syndrome
Acute Coronary Syndromes, STEMI
RecruitingPhase 2
Prevention of Reperfusion Injury Outcomes Through Effective Cardioprotection Targeting Myocardial Infarction
Myocardial Infarction, Reperfusion Injury
Not yet recruitingObservational study
Incremental Prognostic Utility of CBC-derived Inflammatory Indices After Incomplete Coronary Revascularization: Association With 12-months Cardiovascular Outcomes
STEMI, High Risk NSTEMI
RecruitingObservational study
SuperSaturated Oxygen Comprehensive Observational Registry
STEMI - ST Elevation Myocardial Infarction, AMI
RecruitingPhase 4
Efficacy and Safety of a Half-dose Bolus of r-SAK Prior to Primary PCI in ST-elevation Myocardial Infarction
ST Elevation Myocardial Infarction
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.
Donna Fitzsimons, PhD principal investigator
Queen's University, Belfast
Judy Bradley, PhD principal investigator
Queen's University, Belfast
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CArdiac Brief INtervention (CABIN) and Refined version of CABIN in people with ST Elevation Myocardial Infarction, run by Queen's University, Belfast at 2 sites 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 4 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 3 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Yes. Results are posted in the registry (first posted 3 Mar 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
The Percentage of Eligible Patients Who Agreed to Participate in the Study. (time frame: Month 3). The study lists 5 primary outcomes in all. 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 NCT05848674, which also lists 2 linked publications.
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 3 Mar 2026.