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

NCT ID: NCT05848674

Last Updated: 2025-01-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-02-01

Study Completion Date

2024-11-01

Brief Summary

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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.

Detailed Description

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Conditions

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ST Elevation Myocardial Infarction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Group 1: Intervention; Group 2: Control.
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Intervention Group

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.

Group Type EXPERIMENTAL

CArdiac Brief INtervention (CABIN)

Intervention Type 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).

Control Group

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.

Group Type OTHER

Refined version of CABIN

Intervention Type 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).

Interventions

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CArdiac Brief INtervention (CABIN)

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 Type OTHER

Refined version of CABIN

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).

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Belfast Health and Social Care Trust

OTHER

Sponsor Role collaborator

South Eastern Health and Social Care Trust

OTHER

Sponsor Role collaborator

Queen's University, Belfast

OTHER

Sponsor Role lead

Responsible Party

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Gareth Thomson

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Donna Fitzsimons, PhD

Role: PRINCIPAL_INVESTIGATOR

Queen's University, Belfast

Judy Bradley, PhD

Role: PRINCIPAL_INVESTIGATOR

Queen's University, Belfast

Locations

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Royal Victoria Hospital, Belfast Health and Social Care Trust

Belfast, Antrim, United Kingdom

Site Status

Ulster Hospital, South Eastern Health and Social Care Trust

Dundonald, Down, United Kingdom

Site Status

Countries

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United Kingdom

References

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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.

Reference Type DERIVED
PMID: 38954674 (View on PubMed)

Other Identifiers

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B23/01

Identifier Type: -

Identifier Source: org_study_id

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