CArdiac Brief INtervention: A Feasibility Study to Promote Engagement With Cardiac Rehabilitation

Study Overview
=================
Brief 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. 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.

Official Title
-----------------
CABIN (CArdiac Brief INtervention): A Feasibility Study to Promote Engagement With Cardiac Rehabilitation Through an Early, Personalised, Holistic Intervention

Conditions
-----------------
ST Elevation Myocardial Infarction

Intervention / Treatment
-----------------
* Other: CArdiac Brief INtervention (CABIN)
* Other: Refined version of CABIN


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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. Exclusion Criteria: Lacking capacity to give consent (judged by Cardiologist or Nurse). Under the age of 18 years.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Group 1: Intervention; Group 2: Control.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention Group<br>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. | Other: CArdiac Brief INtervention (CABIN)<br>* 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).<br>|
| Other: Control Group<br>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. | Other: Refined version of CABIN<br>* 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).<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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. | Through study completion, an average of 1 year. | 
| The percentage of intervention delivered (Dose) | Dose will assess the completeness of intervention delivery, 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. | Through study completion, an average of 1 year. | 
| 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). | 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). | Week 14 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in Coronary Artery Disease Education Questionnaire, Short Version (CADE-Q SV) score | CADE-Q SV evaluates patients' knowledge of coronary artery disease and core components of cardiac rehabilitation. Score will be reported as the number of 20 questions answered correctly. A higher score represents a better outcome. Change = (follow-up measurement score - baseline score). | Baseline, Week 1, Week 4, and Week 14. | 
| Change from baseline in Brief Illness Perception Questionnaire score | Brief Illness Perception Questionnaire rapidly assesses the cognitive and emotional representations of illness. Scored on a 10-point Likert scale across eight domains. Change = (follow-up measurement score - baseline score). | Baseline, Week 1, Week 4, and Week 14. | 
| Change from baseline in the Hospital Anxiety and Depression Scale score. | The Hospital Anxiety and Depression Scale measures states of depression and anxiety. Each question is scored between zero (no impairment) and three (severe impairment), with a maximum score of 21 for anxiety or depression. Change = (follow-up measurement score - baseline score). | Baseline, Week 1, Week 4, and Week 14. | 
| Change from baseline in Personal Wellbeing Score | Personal Wellbeing Score measures health status and health confidence. Each item is scored as follows: Disagree=0, Neutral=1, Agree=2 and Strongly Agree=3. A high score is better than a low score. Change = (follow-up measurement score - baseline score). | Baseline, Week 1, Week 4, and Week 14. | 
| Number of cardiac rehabilitation sessions attended. |  | Week 14. |