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| Name | Class |
|---|---|
| Belfast Health and Social Care Trust | OTHER |
| South Eastern Health and Social Care Trust | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | 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:
| Week 14 |
| Perspectives of Clinical Staff on Research Design and Intervention Delivery. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Donna Fitzsimons, PhD | Queen's University, Belfast | Principal Investigator |
| Judy Bradley, PhD | Queen's University, Belfast | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Royal Victoria Hospital, Belfast Health and Social Care Trust | Belfast | Antrim | BT12 6BA | United Kingdom | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42363733 | Derived | 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. | |
| 38954674 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Intervention Group | 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. 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). |
| FG001 | Control Group | 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. Refined version of CABIN: 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). |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Intervention Group | 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. 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). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Overall Number of Participants Analysed represents the total number of participants screened for study interest prior to enrollment. | Posted | Count of Participants | Participants | Month 3 |
|
|
7 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Intervention Group | 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. 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). |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Gareth Thompson | Queen's University Belfast | N/A (No work telephone) | gareth.thompson@qub.ac.uk |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 20, 2023 | Jan 6, 2026 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000072657 | ST Elevation Myocardial Infarction |
| ID | Term |
|---|---|
| D009203 | Myocardial Infarction |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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Group 1: Intervention; Group 2: Control.
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|
| Refined version of CABIN | Other | 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). |
|
Coronary care unit and cardiac rehabilitation staff will be invited to focus groups to discuss:
|
| Week 14 |
| 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. | 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. | 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. | Baseline, Week 4, and Week 14. |
| Number of Cardiac Rehabilitation Sessions Attended. | Number of cardiac rehabilitation sessions attended (of 8 in total) | Week 14. |
| Ulster Hospital, South Eastern Health and Social Care Trust |
| Dundonald |
| Down |
| BT16 1RH |
| United Kingdom |
| Thompson 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. |
| BG001 | Control Group | 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. Refined version of CABIN: 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). |
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Participants |
|
|
| Primary | 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. | Posted | Mean | Standard Deviation | Percentage of intervention delivered | Week 1 |
|
|
|
| Primary | 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. | Posted | Count of Participants | Participants | Month 9 |
|
|
|
| Primary | Perspectives of Patients on Research Design and Intervention Delivery. | Participants will be invited to a semi-structured interview upon study completion to discuss:
| Overall number of participants analysed represents the number of participants from the total sample who agreed to complete an interview. | Posted | Count of Participants | Participants | Week 14 |
|
|
|
| Primary | 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:
| This population provided supplementary data to the participants included in the Participant Flow. | Posted | Count of Participants | Participants | Week 14 |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | Units on a Scale | Baseline, Week 1 (Post-Intervention), Week 4, and Week 14. |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | Units on a Scale | Baseline, Week 1 (Post-Intervention), Week 4, and Week 14. |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | Units on a Scale | Baseline, Week 4, and Week 14. |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | Units on a Scale | Baseline, Week 4, and Week 14. |
|
|
|
| Secondary | Number of Cardiac Rehabilitation Sessions Attended. | Number of cardiac rehabilitation sessions attended (of 8 in total) | Overall number of participants analysed represents the number of patients from the total sample for whom data were available. | Posted | Mean | Standard Deviation | Number of CR sessions attended | Week 14. |
|
|
|
| 0 |
| 20 |
| 0 |
| 20 |
| 0 |
| 20 |
| EG001 | Control Group | 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. Refined version of CABIN: 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). | 0 | 20 | 0 | 20 | 0 | 20 |
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| D014652 |
| Vascular Diseases |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
| Identification of possible mechanisms of intervention impact |
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| Week 4 |
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| Week 14 |
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| Week 4 |
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| Week 14 |
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| Week 14 |
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