Trial Outcomes & Findings for CArdiac Brief INtervention: A Feasibility Study to Promote Engagement With Cardiac Rehabilitation (NCT NCT05848674)
NCT ID: NCT05848674
Last Updated: 2026-03-03
Results Overview
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).
COMPLETED
NA
40 participants
Week 14
2026-03-03
Participant Flow
Participant milestones
| Measure |
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).
|
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).
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|---|---|---|
|
Overall Study
STARTED
|
20
|
20
|
|
Overall Study
COMPLETED
|
17
|
18
|
|
Overall Study
NOT COMPLETED
|
3
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
CArdiac Brief INtervention: A Feasibility Study to Promote Engagement With Cardiac Rehabilitation
Baseline characteristics by cohort
| Measure |
Intervention Group
n=20 Participants
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).
|
Control Group
n=20 Participants
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).
|
Total
n=40 Participants
Total of all reporting groups
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|---|---|---|---|
|
Age, Continuous
|
62.4 Years
STANDARD_DEVIATION 11.0 • n=41 Participants
|
64.7 Years
STANDARD_DEVIATION 11.5 • n=35 Participants
|
63.5 Years
STANDARD_DEVIATION 11.1 • n=76 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=41 Participants
|
8 Participants
n=35 Participants
|
12 Participants
n=76 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=41 Participants
|
12 Participants
n=35 Participants
|
28 Participants
n=76 Participants
|
|
Race/Ethnicity, Customized
White
|
20 Participants
n=41 Participants
|
20 Participants
n=35 Participants
|
40 Participants
n=76 Participants
|
PRIMARY outcome
Timeframe: Month 3Population: Overall Number of Participants Analysed represents the total number of participants screened for study interest prior to enrollment.
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.
Outcome measures
| Measure |
Recruitment Rate
n=50 Participants
Total population invited to participate
|
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.
|
|---|---|---|
|
The Percentage of Eligible Patients Who Agreed to Participate in the Study.
|
40 Participants
|
—
|
PRIMARY outcome
Timeframe: Week 1Dose 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.
Outcome measures
| Measure |
Recruitment Rate
n=20 Participants
Total population invited to participate
|
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.
|
|---|---|---|
|
The Percentage of Intervention Delivered (Dose)
|
100 Percentage of intervention delivered
Standard Deviation 0
|
—
|
PRIMARY outcome
Timeframe: Month 9The 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.
Outcome measures
| Measure |
Recruitment Rate
n=20 Participants
Total population invited to participate
|
Control Group
n=20 Participants
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.
|
|---|---|---|
|
The Percentage of Recruited Participants Providing Data for Each Baseline and Outcome Measure.
|
17 Participants
|
18 Participants
|
PRIMARY outcome
Timeframe: Week 14Population: Overall number of participants analysed represents the number of participants from the total sample who agreed to complete an interview.
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).
Outcome measures
| Measure |
Recruitment Rate
n=14 Participants
Total population invited to participate
|
Control Group
n=15 Participants
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.
|
|---|---|---|
|
Perspectives of Patients on Research Design and Intervention Delivery.
Study design and intervention were acceptable
|
10 Participants
|
10 Participants
|
|
Perspectives of Patients on Research Design and Intervention Delivery.
Identification of areas of improvement for study design and intervention
|
2 Participants
|
2 Participants
|
|
Perspectives of Patients on Research Design and Intervention Delivery.
Identification of possible mechanisms of intervention impact
|
2 Participants
|
3 Participants
|
PRIMARY outcome
Timeframe: Week 14Population: This population provided supplementary data to the participants included in the Participant Flow.
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).
Outcome measures
| Measure |
Recruitment Rate
n=8 Participants
Total population invited to participate
|
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.
|
|---|---|---|
|
Perspectives of Clinical Staff on Research Design and Intervention Delivery.
Identified the intervention as acceptable
|
3 Participants
|
—
|
|
Perspectives of Clinical Staff on Research Design and Intervention Delivery.
Identified contextual factors influencing intervention delivery
|
3 Participants
|
—
|
|
Perspectives of Clinical Staff on Research Design and Intervention Delivery.
Identified possible mechanisms of intervention impact
|
2 Participants
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 1 (Post-Intervention), Week 4, and Week 14.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.
Outcome measures
| Measure |
Recruitment Rate
n=20 Participants
Total population invited to participate
|
Control Group
n=20 Participants
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.
|
|---|---|---|
|
Total Score in Coronary Artery Disease Education Questionnaire, Short Version (CADE-Q SV)
Week 4
|
15.7 Units on a Scale
Standard Deviation 2.0
|
13.5 Units on a Scale
Standard Deviation 2.9
|
|
Total Score in Coronary Artery Disease Education Questionnaire, Short Version (CADE-Q SV)
Baseline
|
13.1 Units on a Scale
Standard Deviation 2.3
|
12.0 Units on a Scale
Standard Deviation 2.7
|
|
Total Score in Coronary Artery Disease Education Questionnaire, Short Version (CADE-Q SV)
Week 1 (Post-Intervention)
|
15.0 Units on a Scale
Standard Deviation 2.2
|
12.0 Units on a Scale
Standard Deviation 2.7
|
|
Total Score in Coronary Artery Disease Education Questionnaire, Short Version (CADE-Q SV)
Week 14
|
17.1 Units on a Scale
Standard Deviation 1.2
|
12.7 Units on a Scale
Standard Deviation 3.6
|
SECONDARY outcome
Timeframe: Baseline, Week 1 (Post-Intervention), Week 4, and Week 14.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.
Outcome measures
| Measure |
Recruitment Rate
n=20 Participants
Total population invited to participate
|
Control Group
n=20 Participants
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.
|
|---|---|---|
|
Total Score in Brief Illness Perception Questionnaire
Baseline
|
15.0 Units on a Scale
Standard Deviation 9.5
|
21.7 Units on a Scale
Standard Deviation 10.6
|
|
Total Score in Brief Illness Perception Questionnaire
Week 1 (Post-Intervention)
|
8.6 Units on a Scale
Standard Deviation 8.2
|
21.7 Units on a Scale
Standard Deviation 10.6
|
|
Total Score in Brief Illness Perception Questionnaire
Week 4
|
7.2 Units on a Scale
Standard Deviation 6.3
|
13.2 Units on a Scale
Standard Deviation 8.5
|
SECONDARY outcome
Timeframe: Baseline, Week 4, and Week 14.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.
Outcome measures
| Measure |
Recruitment Rate
n=20 Participants
Total population invited to participate
|
Control Group
n=20 Participants
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.
|
|---|---|---|
|
Total Score in the Hospital Anxiety and Depression Scale.
Baseline
|
21.9 Units on a Scale
Standard Deviation 6.5
|
23.3 Units on a Scale
Standard Deviation 6.1
|
|
Total Score in the Hospital Anxiety and Depression Scale.
Week 14
|
6.7 Units on a Scale
Standard Deviation 4.3
|
20.6 Units on a Scale
Standard Deviation 7.1
|
|
Total Score in the Hospital Anxiety and Depression Scale.
Week 4
|
14.3 Units on a Scale
Standard Deviation 4.4
|
20.0 Units on a Scale
Standard Deviation 8.1
|
SECONDARY outcome
Timeframe: Baseline, Week 4, and Week 14.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.
Outcome measures
| Measure |
Recruitment Rate
n=20 Participants
Total population invited to participate
|
Control Group
n=20 Participants
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.
|
|---|---|---|
|
Total Score in Personal Wellbeing Score
Baseline
|
5.9 Units on a Scale
Standard Deviation 2.2
|
4.7 Units on a Scale
Standard Deviation 1.7
|
|
Total Score in Personal Wellbeing Score
Week 4
|
7.9 Units on a Scale
Standard Deviation 1.9
|
5.7 Units on a Scale
Standard Deviation 2.5
|
|
Total Score in Personal Wellbeing Score
Week 14
|
9.1 Units on a Scale
Standard Deviation 2.0
|
5.7 Units on a Scale
Standard Deviation 2.5
|
SECONDARY outcome
Timeframe: Week 14.Population: Overall number of participants analysed represents the number of patients from the total sample for whom data were available.
Number of cardiac rehabilitation sessions attended (of 8 in total)
Outcome measures
| Measure |
Recruitment Rate
n=13 Participants
Total population invited to participate
|
Control Group
n=14 Participants
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.
|
|---|---|---|
|
Number of Cardiac Rehabilitation Sessions Attended.
|
7.5 Number of CR sessions attended
Standard Deviation 1.2
|
6.9 Number of CR sessions attended
Standard Deviation 1.6
|
Adverse Events
Intervention Group
Control Group
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr Gareth Thompson
Queen's University Belfast
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place