The goal of this clinical trial is to learn if a virtually monitored, home-based prehabilitation program is feasible and acceptable for adults undergoing major elective surgery. The main questions it aims to answer are:
1. Can researchers successfully recruit and retain participants across multiple sites? 2. Will participants adhere to the prehabilitation program at a high enough rate to justify a larger trial?
Researchers will compare the prehabilitation program to standard preoperative care to see if the intervention is feasible to implement and whether it may help reduce postoperative complications.
Participants will:
* Be randomly assigned to receive either the prehabilitation program or usual care * Complete questionnaires and physical assessments before and after the intervention * (For those in the intervention group) Receive exercise, nutrition, and mindfulness guidance, protein supplements, and use the CloudDX virtual care platform to support their activities
≥ 18 years of age
Undergoing major elective intra-thoracic, intra-abdominal or orthopedic surgery. Major surgery is defined as any operation performed under general and/or spinal anesthesia requiring a skin incision extending beyond the subcutaneous tissue
More than 3 weeks from the date of scheduled operation
Emergency Surgery
Operation in less than 3 weeks from time of initial research contact
Patients who are pregnant
Unable/unwilling to sign written informed consent
Parallel
Virtually Monitored Home-Based Prehabilitation Program
BehavioralA multimodal, home-based prehabilitation program delivered via the CloudDX® virtual platform. Participants in the intervention group will be given a comprehensive prehabilitation pamphlet including: 1. a prescription for aerobic and strength exercises to be completed each week 2. nutritional counselling 3. descriptions of mindfulness deep breathing exercises 4. 36 Premier Protein shakes The participants will complete baseline questionnaires and receive prehabilitation consultation and education after onboarding to the CloudDX virtual platform using a cellular-enabled tablet provided to them, or their own device.
Feasibility of recruiting patients in a timely manner across local and outside sites
We will aim for a patient recruitment rate of 20 patients per month. A recruitment rate of greater than 10 but less than 20 patients per month will be considered feasible with modifications for the definitive study. Feasibility outcomes will be assessed according to the traffic light system. If the results fall within the 'green light' range, the definitive study will proceed as planned. Any results falling into the 'yellow light' range will require review and changes to the protocol before proceeding to the definitive phase. If results fall within the 'red light' range, the study will be considered not feasible without major modifications.
Adherence with virtually monitored home-based prehabilitation program
Adherence will be monitored through the CloudDX activity tracker completed by the study participants. The number of interventions completed will be divided by the number of interventions prescribed to calculate the percent adherence to the overall prehabilitation program. If the mean reported adherence is greater than 80% with an associated lower bound of a 95% CIs of greater than 65%, this will support the feasibility of a definitive study. A mean adherence of greater than 60% (and associated lower bound of a 95% CIs of greater than 50%) but less than 80% will be considered feasible with modifications for the definitive study.
Postoperative complications
30-day CCI will be used. This is a scoring system used to quantify the overall burden of postoperative complications. It consolidates multiple complications into a single score ranging from 0 (no complications) to 100 (death). Each complication is weighted based on severity and impact, providing a cumulative measure that reflects the total morbidity a patient experiences. A severe postoperative complication will be defined as a CCI score of 20 or more. All complications occurring within 30 days of the index operation will be included in the CCI calculation.
Mortality
30-day Postoperative Mortality: Death from any cause occurring within 30-days of the index operation.
Disability
30-day patient-reported disability: This will be assessed using the WHO Disability Assessment Schedule V.2.0 (WHODAS).
Length of stay and readmission
Postoperative Length of Stay (LOS): Postoperative LOS will be calculated as the number of days following the index surgery (i.e., postoperative day 0) that the patient remains in hospital. Every morning that the patient remains in hospital will count as an added day to postoperative LOS. 30-day Readmission: Following discharge from their index postoperative stay, if a patient is readmitted to any hospital for any reason within 30-days of their index operation, this will be counted as an outcome event. Reason for readmission will be recorded.
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Queen's University
Lead sponsor
Canadian Anesthesia Research Foundation
Collaborator
Ottawa Hospital Research Institute
Collaborator
Kingston Health Sciences Centre
Collaborator
Hamilton Health Sciences Centre
Collaborator
St. Joseph's Healthcare Hamilton
Collaborator
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