Clinical trial NCT05848674: CArdiac Brief INtervention: A Feasibility Study to Promote Engagement With Cardiac Rehabilitation
Official title: CABIN (CArdiac Brief INtervention): A Feasibility Study to Promote Engagement With Cardiac Rehabilitation Through an Early, Personalised, Holistic Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: ST Elevation Myocardial Infarction
Lead sponsor: Queen's University, Belfast
Sponsor class: OTHER
Collaborators: name: Belfast Health and Social Care Trust
name: South Eastern Health and Social Care Trust
First posted: 2023-05-08
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Group 1: Intervention; Group 2: Control.
Primary purpose: SUPPORTIVE_CARE

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.


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.

Primary outcomes:
measure: The percentage of eligible patients who agreed to participate in the study.
timeFrame: Through study completion, an average of 1 year.
measure: The percentage of intervention delivered (Dose)
timeFrame: Week 1
measure: The percentage of recruited participants providing data for each baseline and outcome measure.
timeFrame: Through study completion, an average of 1 year.
measure: Perspectives of patients on research design and intervention delivery.
timeFrame: Week 14
measure: Perspectives of clinical staff on research design and intervention delivery.
timeFrame: Week 14
Secondary outcomes:
measure: Change from baseline in Coronary Artery Disease Education Questionnaire, Short Version (CADE-Q SV) score
timeFrame: Baseline, Week 1, Week 4, and Week 14.
measure: Change from baseline in Brief Illness Perception Questionnaire score
timeFrame: Baseline, Week 1, Week 4, and Week 14.
measure: Change from baseline in the Hospital Anxiety and Depression Scale score.
timeFrame: Baseline, Week 1, Week 4, and Week 14.
measure: Change from baseline in Personal Wellbeing Score
timeFrame: Baseline, Week 1, Week 4, and Week 14.
measure: Number of cardiac rehabilitation sessions attended.
timeFrame: Week 14.
Other outcomes:
Locations:
city: Belfast
country: United Kingdom
facility: Royal Victoria Hospital, Belfast Health and Social Care Trust
state: Antrim
city: Dundonald
country: United Kingdom
facility: Ulster Hospital, South Eastern Health and Social Care Trust
state: Down
Study officials:
affiliation: Queen's University, Belfast
name: Donna Fitzsimons, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Queen's University, Belfast
name: Judy Bradley, PhD
role: PRINCIPAL_INVESTIGATOR
References: