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

NCT05848674 | Completed Results

• 1 other identifier: B23/01
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

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.

Conditions

ST Elevation Myocardial Infarction

Outcome Measures

Primary Outcomes (5)

• 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: 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).

  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: 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).

  Week 14

Secondary Outcomes (5)

• Total Score in Coronary Artery Disease Education Questionnaire, Short Version (CADE-Q SV)

  Baseline, Week 1 (Post-Intervention), Week 4, and Week 14.

• Total Score in Brief Illness Perception Questionnaire

  Baseline, Week 1 (Post-Intervention), Week 4, and Week 14.

• Total Score in the Hospital Anxiety and Depression Scale.

  Baseline, Week 4, and Week 14.

• Total Score in Personal Wellbeing Score

  Baseline, Week 4, and Week 14.

• Number of Cardiac Rehabilitation Sessions Attended.

  Week 14.

Study Arms (2)

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.

Other: CArdiac Brief INtervention (CABIN)

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.

Other: Refined version of CABIN

Interventions

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).

Intervention Group

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).

Control Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Lacking capacity to give consent (judged by Cardiologist or Nurse).
• Under the age of 18 years.

Sponsors & Collaborators

• Queen's University, Belfast: lead
• Belfast Health and Social Care Trust: collaborator
• South Eastern Health and Social Care Trust: collaborator

Study Sites (2)

Royal Victoria Hospital, Belfast Health and Social Care Trust

Belfast, Antrim, BT12 6BA, United Kingdom

Location

Ulster Hospital, South Eastern Health and Social Care Trust

Dundonald, Down, BT16 1RH, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 38954674 DERIVED

MeSH Terms

Conditions

ST Elevation Myocardial Infarction

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Dr Gareth Thompson
• Organization: Queen's University Belfast

gareth.thompson@qub.ac.uk

N/A (No work telephone)

Study Officials

• Donna Fitzsimons, PhD

  Queen's University, Belfast

  PRINCIPAL INVESTIGATOR

• Judy Bradley, PhD

  Queen's University, Belfast

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Group 1: Intervention; Group 2: Control.

Study Record Dates

• First Submitted: April 17, 2023
• First Posted: May 8, 2023
• Study Start: February 1, 2024
• Primary Completion: November 1, 2024
• Study Completion: November 1, 2024
• Last Updated: March 3, 2026
• Results First Posted: March 3, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

GB (2)