CABIN (CArdiac Brief INtervention): A Feasibility Study to Promote Engagement With Cardiac Rehabilitation Through an Early, Personalised, Holistic Intervention
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- The Percentage of Eligible Patients Who Agreed to Participate in the Study.
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •Lacking capacity to give consent (judged by Cardiologist or Nurse).
- •Under the age of 18 years.
研究组 & 干预措施
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.
干预措施: CArdiac Brief INtervention (CABIN) (Other)
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.
干预措施: Refined version of CABIN (Other)
结局指标
主要结局
The Percentage of Eligible Patients Who Agreed to Participate in the Study.
时间窗: 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.
The Percentage of Intervention Delivered (Dose)
时间窗: 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.
The Percentage of Recruited Participants Providing Data for Each Baseline and Outcome Measure.
时间窗: 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.
Perspectives of Patients on Research Design and Intervention Delivery.
时间窗: Week 14
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).
Perspectives of Clinical Staff on Research Design and Intervention Delivery.
时间窗: Week 14
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).
次要结局
- 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.)
研究者
Gareth Thomson
Principal Investigator
Queen's University, Belfast