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Completed

NCT Number: NCT05848674

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

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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Key information

Conditions

ST Elevation Myocardial Infarction Cardiovascular Diseases Heart Diseases Infarction Ischemia Myocardial Infarction Myocardial Ischemia Necrosis Pathologic Processes Pathological Conditions, Signs and Symptoms Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Royal Victoria Hospital, Belfast Health and Social Care Trust, Belfast, Antrim, United Kingdom

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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 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).

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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:

    • 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).

  5. 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:

    • 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).

Secondary outcomes

  1. 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.

    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.

  2. Total Score in Brief Illness Perception Questionnaire

    Time frame: 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.

  3. Total Score in the Hospital Anxiety and Depression Scale.

    Time frame: 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.

  4. Total Score in Personal Wellbeing Score

    Time frame: 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.

  5. Number of Cardiac Rehabilitation Sessions Attended.

    Time frame: Week 14.

    Number of cardiac rehabilitation sessions attended (of 8 in total)

Sponsors and collaborators

Lead sponsor

Queen's University, Belfast

Other

Collaborators

  • Belfast Health and Social Care Trust
  • South Eastern Health and Social Care Trust

Registry information

Official study title

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

Acronym: CABIN

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
May 8, 2023
Registry last updated
Mar 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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