The PREBEAT Trial: Digital PREhaBilitation in thE Cardiac Surgical populATion
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Usability of Digital Cardiac Prehabilitation as assessed by the Mhealth Application Usability Questionnaire (MAUQ)
研究概览
简要总结
The goal of this randomised controlled trial is to learn if a digital prehabilitation program is feasible in patients awaiting cardiac surgery. The main questions it aims to answer are:
- Is the digital health program usable?
- Is the digital health program acceptable?
- Do patients adhere to the digital health program?
Researchers will compare a group using the digital prehabilitation program with standard care to see if the program is feasible and explore any differences in health outcomes.
Participants will
- Use a digital health mobile phone application to guide you through exercise, nutrition and preparation for surgery.
- Engage in telehealth consultations.
- Complete questionnaires
- Complete exercise testing
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
盲法说明
Surgeons and Hospital Ward Staff
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •21 days+ prior to cardiac surgery
- •Able to provide consent,
- •Proficient in English to understand questionnaires, training instructions and outcome assessments.
- •Digitally literate to independently navigate a smart device and novel application.
排除标准
- •severe or unstable neurological, cardiorespiratory, or musculoskeletal disease or mental illness that might compromise ability to perform exercise,
- •unstable psychiatric or cognitive disorders,
研究组 & 干预措施
Control
Patients in this arm receive standard preparation for surgery as per hospital procedure. This may include information sessions, pamphlets, and meetings with clinicians.
干预措施: Control (Standard treatment) (Other)
Digital Health Arm
Patients in this arm engage in digital health prehabilitation which involves exercise, nutrition and information and scheduled telehealth to assist with preparation for surgery.
干预措施: Digital Cardiac Prehabilitation (Other)
结局指标
主要结局
Usability of Digital Cardiac Prehabilitation as assessed by the Mhealth Application Usability Questionnaire (MAUQ)
时间窗: 1 day Pre-operatively
mAUQ is an 18-item questionnaire for patients to evaluate the usability of the digital application under the three domains of; Ease of Use, Interface, Satisfaction and Usefulness. Low numbers indicate a higher perception of usability with the digital interface for participants.
Adherence of Digital Cardiac Prehabilitation as measured by usage metrics from Mobile Phone App metrics
时间窗: 1 day Pre-operatively
Metrics Used include * Time and date: when the application is accessed. * Dwell Time: how much time is spent on a particular page. * Number of pages viewed: how many views per page per day. * User input data: data the user submits in the app, including minutes walked, exercises marked as complete, and questionnaires completed.
Acceptability of Digital Cardiac Prehabilitation as measured by Theoretical Framework of Acceptability Questionnaire (TFA)
时间窗: 1 day Pre-operatively
TFA-Q is composed of eight items, in alignment with the eight acceptability constructs (Affective attitude, Burden, Ethicality, Perceived effectiveness, intervention coherence, self-efficacy, opportunity costs, general acceptability). High numbers indicate a more acceptable digital experience.
Incidence of Adverse events
时间窗: Recorded through study completion, an anticipated average of 4 months.
Adverse events, defined as any undesirable event, such as injury, fall, and discomfort related to prehabilitation will be recorded and severity will be reported according to hospital policy. Lower numbers are more favourable, indicating fewer adverse events.
次要结局
- Body metrics as measured by Body Mass Index (BMI)(Baseline, 3 months post-operatively.)
- Health service use as measured by Length of Stay (LOS)(2 weeks post-operatively)
- Health service use as measured by Intensive Care Unit (ICU) Length of Stay (ICU LOS)(2 weeks post-operatively)
- Mortality as measured by days alive out of hospital (DAoH)(30 days post-operatively)
- Health service use as measured by Readmissions(2 weeks, 30 days and 3 months post-operatively)
- Health service use as measured by the Health Utilization Questionnaire (HUQ)(Assessed at Baseline, 1 day pre-operatively, then post-operatively at Time Points: 2 weeks, 30 days, and 3 months.)
- Cost of program delivery as estimated by multiplying the occasions of service by relevant national average hospital award wages for respective staff.(3 months post-operatively)
- Recovery as measured by the Post-Operative Quality of Recovery Scale (PostopQRS).(Baseline, 1 day pre-operatively, Post operatively at Time Points: 1 day, 3 days, day of discharge, and 30 days.)
- Functional outcome as measured by the Functional Difficulties Questionnaire shortened (FDQs)(Baseline, 1 day pre-operatively, Post operatively at day of discharge, 2 weeks, 30 days, and 3 months.)
- Postoperative pulmonary complications (PPCs) as measured the Melbourne Group Score (MGS)(Post operatively at Time Points: 1 day, 3 days, day of discharge and 30 days)
- Functional capacity as measured by 1-Minute Sit-to-Stand (1STS)(Baseline, 1 day pre-operatively, Post operatively at day of discharge, 2 weeks, 30 days and 3 months.)
- Inspiratory muscle strength as measured by Maximal Inspiratory Pressure (MIP)(Baseline, 1 day pre-operatively, and post-operatively at discharge.)
- Adherence to the Mediterranean diet as measured by The MEDAS (Mediterranean Diet Adherence Screener)(Baseline, 1 day pre-operatively, Post operatively at 2 weeks, 30 days, and 3 months.)
- Anxiety as measured by The State-Trait Anxiety Inventory (STAI)(Baseline, 1 day pre-operatively, Post operatively at the day of discharge, 2 weeks, 30 days, and 3 months.)
- Self-Efficacy as measured by The General Self-Efficacy Scale (GSE)(Baseline, 1 day pre-operatively, Post operatively at the day of discharge, 2 weeks, 30 days, and 3 months.)
研究者
Claire Hines
Site Investigator
RMIT University