Elective Surgical Procedures, Postoperative Complications, Prehabilitation, Preoperative Care, Surgical Procedures, Operative
Conditions
Keywords
Home-based Care, Virtual Care, Remote Health Monitoring, Exercise Therapy, Nutritional Support, Psychological Support, Postoperative Outcomes
Brief summary
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
Detailed description
The PRIME pilot trial aims to investigate whether a virtually monitored, home-based multimodal prehabilitation is feasible and can improve postoperative outcomes in adult patient populations undergoing major elective intra-thoracic, intra-abdominal, or orthopedic surgery. The goal of a prehabilitation program is to optimize a patient's health status before surgery to reduce postoperative morbidity and enhance recovery. Despite advances in perioperative care, postoperative morbidity remains high, particularly in frail, obese, or older populations. Multimodal prehabilitation which includes physical exercise, nutritional optimization, and psychological support has demonstrated potential benefits in small trials and feasibility studies, yet definitive evidence remains limited. Intensive in-person prehabilitation, though effective, is not feasible for most centers due to resource limitations. Conversely, home-based programs, while pragmatic, have shown inconsistent adherence and outcomes. This study proposes a virtually monitored, home-based multimodal prehabilitation program designed to balance feasibility, adherence, and effectiveness, using the CloudDX® remote monitoring platform. The program includes exercise prescriptions, nutritional support, mindfulness exercises, and participant accountability through app-based monitoring. The study will be conducted as a multicenter pilot randomized controlled trial at Kingston Health Sciences Centre, The Ottawa Hospital, and Hamilton Health Sciences. A total of 120 adult patients scheduled for major elective intra-thoracic, intra-abdominal, or orthopedic surgery will be randomized 1:1 to receive either standard preoperative care or the multimodal prehabilitation intervention. Participants in the intervention group 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. The structured prehabilitation activities will be completed over a minimum of three weeks before surgery. Primary objectives focus on feasibility, specifically recruitment rates and adherence to the intervention. Adherence will be tracked via the CloudDX® platform. Secondary objectives include assessing the program's impact on postoperative complications (using the Comprehensive Complication Index), mortality, disability (WHODAS 2.0), length of hospital stay, readmission rates, functional capacity (6-Minute Walk Test, CHAMPS, grip strength), quality of life (EQ-5D-5L), and nutritional status (PG-SGA). Data will be collected through patient interaction, app-based monitoring, and medical record review. All study personnel will receive standardized training, and a detailed Manual of Operations will guide procedures at all sites. Data will be entered into a secure, REDCap electronic database using study-specific IDs, with source documents retained for verification. To ensure data quality, the Project Office will review monthly reports on enrollment, follow-up, and data completeness. The database will have built-in validity and range checks, with multi-level data validation and regular quality control reports shared with sites. All study records will be stored securely for at least five years post-study, with controlled access. Additionally, case histories with records of all observations and data related to the investigation will be maintained for each participant. Data will be reported on a hard copy case report form as well as being entered onto online database. Descriptive statistics (means, medians, standard deviations, interquartile ranges, proportions) will be used to characterize the study sample. The outcomes of the pilot study will be descriptive in nature and will focus on feasibility measures, including recruitment, adherence, case report form completion, patient satisfaction, and withdrawal rates. Binary outcomes will be summarized using proportions with corresponding 95% confidence intervals. Differences in continuous outcomes will be described using the difference in means with corresponding 95% confidence intervals. All analyses will follow intent-to-treat (ITT) principles, with the ITT population defined as all randomized participants. Baseline characteristics will be summarized descriptively. The study will be conducted in compliance with the protocol, principles laid down in the Declaration of Helsinki, Good Clinical Practice (GCP), as defined by the International Conference on Harmonisation (ICH), and all applicable laws and regulations of Canada. By addressing the critical gap in accessible prehabilitation services, this trial aims to establish a scalable model that can be integrated across Canadian healthcare settings. The results of this pilot will inform the design and conduct of a larger definitive randomized trial.
Interventions
BEHAVIORALVirtually Monitored Home-Based Prehabilitation Program
A 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.
Sponsors
Queen's University
Canadian Anesthesia Research Foundation
Ottawa Hospital Research Institute
Kingston Health Sciences Centre
Hamilton Health Sciences Centre
St. Joseph's Healthcare Hamilton
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Caregiver, Investigator, Outcomes Assessor)
Masking description
Research staff (with the exception of the individual informing participants of group allocation), healthcare providers, and outcome assessors will be blinded to treatment allocation.
Intervention model description
Participants will be randomly assigned via web-based randomization system in a 1:1 ratio to one of two groups: a virtually monitored, home-based prehabilitation intervention group or a usual care control group. Participants remain in their assigned group for the duration of the study.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* ≥ 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
Exclusion criteria
* 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 * Physical, cognitive or psychological impairment * Unable to understand/communication in English.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of recruiting patients in a timely manner across local and outside sites | From the start to end of patient recruitment (2 years) | 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 | From enrolment to the day of scheduled surgery (3 week timespan) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative complications | 30 days post-surgery | 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 days post-surgery | 30-day Postoperative Mortality: Death from any cause occurring within 30-days of the index operation. |
| Disability | 30 days post-surgery | 30-day patient-reported disability: This will be assessed using the WHO Disability Assessment Schedule V.2.0 (WHODAS). |
| Length of stay and readmission | Length of stay: From day of surgery to date of documented discharge, assessed up to 30-days after surgery. Readmission: From day of surgery until date of first documented hospital readmission, assessed up to 30-days post-surgery | 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. |
| European Quality of Life 5 Dimensions 5 Level Version (EQ5D5L) | Assessed at each major assessment point throughout the study. (1) Baseline - Day 0 (2) 2 days prior to surgery (3) 30 days after surgery | Assessed using the European Quality of Life 5 Dimensions 5 Level Version (EQ5D5L). This questionnaire measures five dimensions-mobility, self-care, usual activities, pain/discomfort, and anxiety/depression-each with 5 severity levels (1=No problem, 5=Extreme problem). It is then scored by creating 5-digit health profiles (e.g., 11111 = No problem for all dimensions). |
| Nutritional Status | Assessed at each major assessment point throughout the study. (1) Baseline - Day 0 (2) 2 days prior to surgery (3) 30 days after surgery | Assessed with the Patient-Generated Subjective Global Assessment (PG-SGA). |
| Percentage of patients approached that are subsequently enrolled | From initial patient approach until enrolment is completed | The proportion of eligible patients approached for study participation who provide informed consent and are successfully enrolled in the study. |
| Case Report Form Completion | From enrolment until final data entry for each participant. | The percentage of case report forms for enrolled patients that are completed in their entirety without missing data, based on pre-specified required data elements. |
| Patient Satisfaction With Prehabilitation Program | After the 3 week prehabilitation program; before surgery | The percentage of participants randomized to the prehabilitation group who report that they would enrol in the program again. |
| Proportion of Participants Who Withdraw Consent to Participate | From enrolment until final study follow-up (30 days postoperative). | The proportion of participants who withdraw consent for any reason after enrolment and prior to study completion. |
| 6-Minute Walk Test Distance | (1) Baseline (2) 2-days prior to surgery (3) 30-days after surgery | Maximal distance achieved during the 6-minute walk test in metres. |
| Self-reported physical activity | (1) baseline (2) 2-days prior to surgery (3) 30-days after surgery | Assessed using the Community Healthy Activities Model Program for Seniors (CHAMPS) survey. |
| Hand Grip Strength | (1) Baseline (2) 2-days before surgery (3) 30-days after surgery | Peak hand grip strength in kilograms measured by a hand dynamometer. |
| Leg strength | (1) Baseline (2) 2-days before surgery (3) 30-days after surgery | Dominant leg strength will be assessed using a HUMAC NORM Dynamometer. The peak torque recorded after three attempts will be presented as leg strength (in newton-meters). |
Countries
Canada
Contacts
CONTACTDeborah DuMerton
CONTACTRachel Phelan
PRINCIPAL_INVESTIGATORJordan Leitch, MSc, MD, FRCPC
Queen's University
Outcome results
None listed