The PREBEAT Trial: Digital PREhaBilitation in thE Cardiac Surgical populATion

NCT06983808 | Not Yet Recruiting

• 2 other identifiers: RMIT-HREC 28861RMH-HREC 2024.163
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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:

• 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

Conditions

Cardiovascular Diseases

Keywords

Digital Health; Telehealth; CABG; Cardiac Surgery; Heart Surgery; Prehabilitation; Perioperative

Outcome Measures

Primary Outcomes (4)

• Usability of Digital Cardiac Prehabilitation as assessed by the Mhealth Application Usability Questionnaire (MAUQ)

  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.

  2 days Pre-operatively

• Adherence of Digital Cardiac Prehabilitation as measured by usage metrics from Mobile Phone App metrics

  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.

  2 days Pre-operatively

• Acceptability of Digital Cardiac Prehabilitation as measured by Theoretical Framework of Acceptability Questionnaire (TFA)

  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.

  2 days Pre-operatively

• Incidence of Adverse events

  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.

  Recorded through study completion, an average of 7 months.

Secondary Outcomes (17)

• Health service use as measured by Length of Stay (LOS)

  30 days post-operatively

• Health service use as measured by Intensive Care Unit (ICU) Length of Stay (ICU LOS)

  30 days post-operatively

• Health service use as measured by Readmissions

  30 days post-operatively

• Health service use as measured by the Health Utilization Questionnaire (HUQ)

  Post operatively at Time Points: 2 weeks, 30 days, 3 months and 6 months

• Mortality as measured by days alive out of hospital (DAoH)

  6 months post-operatively

Study Arms (2)

Control

ACTIVE COMPARATOR

Patients in this arm receive standard preparation for surgery as per hospital procedure. This may include information sessions, pamphlets, and meetings with clinicians.

Other: Control (Standard treatment)

Digital Health Arm

EXPERIMENTAL

Patients in this arm engage in digital health prehabilitation which involves exercise, nutrition and information and scheduled telehealth to assist with preparation for surgery.

Other: Digital Cardiac Prehabilitation

Interventions

Digital Cardiac Prehabilitation OTHER

Digital Cardiac Prehabilitation - A combined telehealth and app-based preparation for cardiac surgery

Digital Health Arm

Control (Standard treatment) OTHER

Standard preparation for surgery as per Melbourne Health hospital procedures and processes. This may include information sessions, pamphlets, and meetings with clinicians. This does not include a prehabilitation program.

Control

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• severe or unstable neurological, cardiorespiratory, or musculoskeletal disease or mental illness that might compromise ability to perform exercise,
• unstable psychiatric or cognitive disorders,

Sponsors & Collaborators

• Claire Hines: lead
• Melbourne Health: collaborator

Study Sites (1)

Melbourne Health (Royal Melbourne and Melbourne Private Hospital)

Melbourne, Victoria, 3050, Australia

Location

Related Publications (49)

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MeSH Terms

Conditions

Cardiovascular Diseases

Study Officials

• Alistair Royse, MD - Cardiothoracic Surgeon

  Melbourne Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Claire Hines, BSc, BA, M. Physiotherapy

CONTACT

+61404866816; claire.hines@rmit.edu.au

Deputy Dean, Engagement Health and Biomedical Sciences, PhD

CONTACT

+61399258444; doa.el-ansary@rmit.edu.au

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Surgeons and Hospital Ward Staff
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Site Investigator

Study Record Dates

• First Submitted: April 30, 2025
• First Posted: May 21, 2025
• Study Start: July 1, 2025
• Primary Completion: March 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: June 6, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: By at least Jan 2027, for at least 12 months.
• Access Criteria: By Journal Article Publication and/or conference posters, proceedings and/or presentations.

Locations

AU (1)