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

Primary Purpose

ST Elevation Myocardial Infarction

Status
Not yet recruiting
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
CArdiac Brief INtervention (CABIN)
Refined version of CABIN
Sponsored by
Queen's University, Belfast
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for ST Elevation Myocardial Infarction

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Royal Victoria Hospital, Belfast Health and Social Care Trust
  • Ulster Hospital, South Eastern Health and Social Care Trust

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Intervention Group

Control Group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
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.
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.
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).
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).

Secondary Outcome Measures

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).
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).
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).
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).
Number of cardiac rehabilitation sessions attended.

Full Information

First Posted
April 17, 2023
Last Updated
April 28, 2023
Sponsor
Queen's University, Belfast
Collaborators
Belfast Health and Social Care Trust, South Eastern Health and Social Care Trust
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1. Study Identification

Unique Protocol Identification Number
NCT05848674
Brief Title
CArdiac Brief INtervention: A Feasibility Study to Promote Engagement With Cardiac Rehabilitation
Acronym
CABIN
Official Title
CABIN (CArdiac Brief INtervention): A Feasibility Study to Promote Engagement With Cardiac Rehabilitation Through an Early, Personalised, Holistic Intervention
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
July 2023 (Anticipated)
Primary Completion Date
March 2024 (Anticipated)
Study Completion Date
April 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Queen's University, Belfast
Collaborators
Belfast Health and Social Care Trust, South Eastern Health and Social Care Trust

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
ST Elevation Myocardial Infarction

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Group 1: Intervention; Group 2: Control.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control Group
Arm Type
Other
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
CArdiac Brief INtervention (CABIN)
Intervention Description
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
Intervention Name(s)
Refined version of CABIN
Intervention Description
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 Outcome Measure Information:
Title
The percentage of eligible patients who agreed to participate in the study.
Description
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.
Time Frame
Through study completion, an average of 1 year.
Title
The percentage of intervention delivered (Dose)
Description
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.
Time Frame
Week 1
Title
The percentage of recruited participants providing data for each baseline and outcome measure.
Description
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.
Time Frame
Through study completion, an average of 1 year.
Title
Perspectives of patients on research design and intervention delivery.
Description
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).
Time Frame
Week 14
Title
Perspectives of clinical staff on research design and intervention delivery.
Description
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).
Time Frame
Week 14
Secondary Outcome Measure Information:
Title
Change from baseline in Coronary Artery Disease Education Questionnaire, Short Version (CADE-Q SV) score
Description
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).
Time Frame
Baseline, Week 1, Week 4, and Week 14.
Title
Change from baseline in Brief Illness Perception Questionnaire score
Description
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).
Time Frame
Baseline, Week 1, Week 4, and Week 14.
Title
Change from baseline in the Hospital Anxiety and Depression Scale score.
Description
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).
Time Frame
Baseline, Week 1, Week 4, and Week 14.
Title
Change from baseline in Personal Wellbeing Score
Description
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).
Time Frame
Baseline, Week 1, Week 4, and Week 14.
Title
Number of cardiac rehabilitation sessions attended.
Time Frame
Week 14.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Donna Fitzsimons, PhD
Phone
028 9097 2079
Email
d.fitzsimons@qub.ac.uk
First Name & Middle Initial & Last Name or Official Title & Degree
Gareth Thompson, PhD
Phone
028 9097 2696
Email
gareth.thompson@qub.ac.uk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Donna Fitzsimons, PhD
Organizational Affiliation
Queen's University, Belfast
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Judy Bradley, PhD
Organizational Affiliation
Queen's University, Belfast
Official's Role
Principal Investigator
Facility Information:
Facility Name
Royal Victoria Hospital, Belfast Health and Social Care Trust
City
Belfast
State/Province
Antrim
ZIP/Postal Code
BT12 6BA
Country
United Kingdom
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Donna Fitzsimons, PhD
Phone
028 9097 2079
Email
d.fitzsimons@qub.ac.uk
First Name & Middle Initial & Last Name & Degree
Gareth Thompson, PhD
Phone
028 9097 2696
Email
gareth.thompson@qub.ac.uk
Facility Name
Ulster Hospital, South Eastern Health and Social Care Trust
City
Dundonald
State/Province
Down
ZIP/Postal Code
BT16 1RH
Country
United Kingdom
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Donna Fitzsimons, PhD
Phone
028 9097 2079
Email
d.fitzsimons@qub.ac.uk
First Name & Middle Initial & Last Name & Degree
Gareth Thompson, PhD
Phone
028 9097 2696
Email
gareth.thompson@qub.ac.uk

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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