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CArdiac Brief INtervention: A Feasibility Study to Promote Engagement With Cardiac Rehabilitation
NA trial testing CArdiac Brief INtervention (CABIN) in ST Elevation Myocardial Infarction in 40 participants. Completed in 1 November 2024.
| Lead sponsor | Queen's University, Belfast |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | supportive care |
| Enrollment | 40 |
| Start date | 1 February 2024 |
| Primary completion | 1 November 2024 |
| Estimated completion | 1 November 2024 |
| Sites | 2 locations across United Kingdom |
Queen's University, Belfast
18 and older, any sex, with ST Elevation Myocardial Infarction. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
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.
| Group | Value | 95% CI |
|---|---|---|
| Recruitment Rate | 40 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Intervention Group | 100 | ± 0 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Intervention Group | 17 | |
| Control Group | 18 |
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).
| Group | Value | 95% CI |
|---|---|---|
| Intervention Group | 10 | |
| Control Group | 10 | |
| Intervention Group | 2 | |
| Control Group | 2 | |
| Intervention Group | 2 | |
| Control Group | 3 |
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).
| Group | Value | 95% CI |
|---|---|---|
| Clinical Staff | 3 | |
| Clinical Staff | 3 | |
| Clinical Staff | 2 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Intervention Group | 13.1 | ± 2.3 |
| Control Group | 12.0 | ± 2.7 |
| Group | Value | 95% CI |
|---|---|---|
| Intervention Group | 15.0 | ± 2.2 |
| Control Group | 12.0 | ± 2.7 |
| Group | Value | 95% CI |
|---|---|---|
| Intervention Group | 15.7 | ± 2.0 |
| Control Group | 13.5 | ± 2.9 |
| Group | Value | 95% CI |
|---|---|---|
| Intervention Group | 17.1 | ± 1.2 |
| Control Group | 12.7 | ± 3.6 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Intervention Group | 15.0 | ± 9.5 |
| Control Group | 21.7 | ± 10.6 |
| Group | Value | 95% CI |
|---|---|---|
| Intervention Group | 8.6 | ± 8.2 |
| Control Group | 21.7 | ± 10.6 |
| Group | Value | 95% CI |
|---|---|---|
| Intervention Group | 7.2 | ± 6.3 |
| Control Group | 13.2 | ± 8.5 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Intervention Group | 21.9 | ± 6.5 |
| Control Group | 23.3 | ± 6.1 |
| Group | Value | 95% CI |
|---|---|---|
| Intervention Group | 14.3 | ± 4.4 |
| Control Group | 20.0 | ± 8.1 |
| Group | Value | 95% CI |
|---|---|---|
| Intervention Group | 6.7 | ± 4.3 |
| Control Group | 20.6 | ± 7.1 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Intervention Group | 5.9 | ± 2.2 |
| Control Group | 4.7 | ± 1.7 |
| Group | Value | 95% CI |
|---|---|---|
| Intervention Group | 7.9 | ± 1.9 |
| Control Group | 5.7 | ± 2.5 |
| Group | Value | 95% CI |
|---|---|---|
| Intervention Group | 9.1 | ± 2.0 |
| Control Group | 5.7 | ± 2.5 |
Number of cardiac rehabilitation sessions attended (of 8 in total)
| Group | Value | 95% CI |
|---|---|---|
| Intervention Group | 7.5 | ± 1.2 |
| Control Group | 6.9 | ± 1.6 |
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.
1 peer-reviewed publication reference this trial (live from Europe PMC):
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