The PREBEAT Trial: Digital PREhaBilitation in thE Cardiac Surgical populATion
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Usability of Digital Cardiac Prehabilitation as assessed by the Mhealth Application Usability Questionnaire (MAUQ)
Study Overview
Brief Summary
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Masking Description
Surgeons and Hospital Ward Staff
Eligibility Criteria
- Ages
- 18 Years to 100 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
Exclusion Criteria
- •severe or unstable neurological, cardiorespiratory, or musculoskeletal disease or mental illness that might compromise ability to perform exercise,
- •unstable psychiatric or cognitive disorders,
Arms & Interventions
Control
Patients in this arm receive standard preparation for surgery as per hospital procedure. This may include information sessions, pamphlets, and meetings with clinicians.
Intervention: 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.
Intervention: Digital Cardiac Prehabilitation (Other)
Outcomes
Primary Outcomes
Usability of Digital Cardiac Prehabilitation as assessed by the Mhealth Application Usability Questionnaire (MAUQ)
Time Frame: 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
Time Frame: 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)
Time Frame: 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
Time Frame: 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.
Secondary Outcomes
- 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.)
Investigators
Claire Hines
Site Investigator
RMIT University