Virtual Care for Frailty After Surgery

(VICTORY Trial)

Overseen By Emily Hladkowicz, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Ottawa Hospital Research Institute

Disqualifiers: Preoperative institutional residence, cognitive impairment, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 2 weeks

1000 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether virtual care using CloudDX technology, a remote monitoring system, can help people with frailty recover from surgery more effectively than standard care. The goal is to increase the number of days patients spend alive and at home after surgery, reducing hospital visits. Participants will either receive standard post-surgery care or use virtual care tools, such as remote monitoring and daily symptom surveys. Ideal candidates are individuals over 60 diagnosed with frailty and planning elective surgery. The trial aims to find better ways to support frail patients and alleviate hospital capacity issues. As an unphased trial, it offers a unique opportunity to contribute to innovative care solutions for frail patients.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that CloudDX technology is safe for virtual care in frail surgical patients?

Research has shown that CloudDX technology is safe. A previous study in Canada using this technology yielded promising results. Patients experienced 24% fewer drug errors and reported 14% less pain. Additionally, hospital readmissions dropped by 5%. These outcomes indicate that patients receive the technology well and that it can enhance their post-surgery care.

Experts have reviewed studies proving the accuracy of CloudDX's monitoring devices. This accuracy is crucial for obtaining regulatory approval, demonstrating that the technology meets strict safety and effectiveness standards. These findings suggest that CloudDX technology is safe, particularly for individuals requiring additional care after surgery. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Virtual Care approach using CloudDX technology because it brings remote monitoring directly to patients recovering from surgery. Unlike traditional standard care, where patients primarily rely on follow-up visits to their doctors, this method allows continuous health monitoring at home through a cellular-enabled tablet. The use of CloudDX technology enables real-time tracking of vital signs and symptoms, giving healthcare providers the ability to tailor care more precisely to a patient's needs right after they leave the hospital. This approach aims to enhance the recovery experience by catching potential issues early and reducing the need for hospital readmissions.

What evidence suggests that CloudDX technology is effective for improving care for surgical patients with frailty?

Research has shown that CloudDX technology, used by participants in the Virtual Care arm of this trial, holds promise for post-surgery care, particularly for frail patients. One study found that 96% of patients were satisfied with the monitoring program, and 99% were willing to manage their health at home. This technology employs remote monitoring to track vital health signs and symptoms, simplifying health management without frequent hospital visits. Another study confirmed its effectiveness in real-world settings, ensuring it meets the necessary standards for patient care. These findings suggest that CloudDX technology can aid frail surgical patients in recovering more comfortably at home. ^{1 4 6 7 8}

Who Is on the Research Team?

Sylvie Aucoin, MD

Principal Investigator

The Ottawa Hospital

Are You a Good Fit for This Trial?

The VICTORY trial is for people over 60 with frailty (Clinical Frailty Score >4) who are scheduled for elective surgery and speak English. It's not specified who can't join, but typically those with conditions that could interfere with virtual care or follow-up might be excluded.

Inclusion Criteria

I have been diagnosed as frail.

I am over 60 years old.

I am fluent in English.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive virtual care from the VRAS nursing and anesthesiologist team following surgical discharge, facilitated by Cloud DX software and monitoring equipment.

2 weeks

Video visits on post-discharge days 1, 3, 5, 7, and every other day until day 14 if needed

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of quality of life, medication issues, and incidence of post-discharge falls.

4 weeks

Long-term follow-up

Participants' resource use and patient-centered outcomes are monitored up to 1 year post-surgery.

1 year

What Are the Treatments Tested in This Trial?

Interventions

• CloudDX technology

Trial Overview This study tests if virtual care using CloudDX technology improves the number of days older adults with frailty spend at home after planned surgery, compared to standard post-surgical care. Participants will receive either the new virtual care method or usual care.

How Is the Trial Designed?

Group I: Virtual Care Experimental Treatment 1 Intervention

Intervention group participants will be enrolled in a PVC program prior to admission, including receipt of a cellular-enabled tablet and Cloud DX remote monitoring equipment. Through Cloud DX remote monitoring technology, intervention group participants will receive the following intervention: remote automated monitoring, frailty-tailored daily symptom survey, Katz Index of Independence in Activities of Daily Living survey, FAM-CAM survey, Virtual RN assessment, medications.

Group II: Standard Care Active Control 1 Intervention

The standard care group will receive their post-hospital discharge management in alignment with standard of care at the hospital where they had surgery.

Who Is Running the Clinical Trial?

Ottawa Hospital Research Institute

Lead Sponsor

Trials

585

Recruited

3,283,000+

Published Research Related to This Trial

A novel prehabilitation program for frail patients before major surgery was found to be feasible and led to significant improvements in functional performance, such as increased gait speed and walking distance, in a study of 43 participants.

The intervention, which included strength training, respiratory muscle training, and nutritional coaching, resulted in clinically meaningful enhancements in physical capabilities, suggesting it could positively influence recovery and surgical outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preoperative Rehabilitation Is Feasible in the Weeks Prior to Surgery and Significantly Improves Functional Performance. Hall, DE., Youk, A., Allsup, K., et al.[2023]

In a study of 295 vascular surgery patients, those classified as frail based on an automated electronic frailty index (eFI) were significantly more likely to be discharged to an acute care facility rather than home, indicating a higher risk of adverse outcomes.

Frail patients also had a higher prevalence of comorbidities and were more likely to be classified as high-risk by the American Society of Anesthesiologists, highlighting the importance of frailty assessment in surgical planning.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Automated Electronic Frailty Index is Associated with Non-home Discharge in Patients Undergoing Open Revascularization for Peripheral Vascular Disease. Stutsrim, AE., Brastauskas, IM., Craven, TE., et al.[2023]

In a study of 308 older surgical patients, those classified as 'vulnerable' or 'frail' had significantly higher rates of readmission or death within 30 days after discharge, with adjusted odds ratios of 4.60 and 4.51, respectively, compared to 'well' patients.

The degree of frailty was shown to be a strong predictor of readmission or death up to 6 months post-surgery, indicating that frailty assessments could be crucial for improving patient outcomes in older adults after surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of frailty on outcomes after discharge in older surgical patients: a prospective cohort study. Li, Y., Pederson, JL., Churchill, TA., et al.[2019]

A walking intervention using an activity tracker and coaching did not improve postoperative stamina or mobility in frail older adults, as measured by the 6-minute walk distance and steps taken after surgery.

In a study of 104 patients aged 60 and older, the intervention group showed no significant differences in recovery outcomes compared to the control group, suggesting that this specific preoperative exercise approach may not be effective for enhancing postoperative recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Supervised preoperative walking on increasing early postoperative stamina and mobility in older adults with frailty traits: A pilot and feasibility study. Rampam, S., Sadiq, H., Patel, J., et al.[2022]

Frailty significantly increases the risk of adverse outcomes in general surgical patients, with a 30-day mortality rate of 8% for frail patients compared to just 1% for non-frail patients, based on a systematic review of 2,281 participants from nine studies.

Frail patients also experience higher rates of surgical complications (24%) and longer hospital stays (average of 9.6 days) compared to non-frail patients (5% complications and 6.4 days stay), highlighting the need for careful management of frail individuals undergoing surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The prevalence of frailty and its association with clinical outcomes in general surgery: a systematic review and meta-analysis. Hewitt, J., Long, S., Carter, B., et al.[2019]

A survey of 168 emergency surgeons revealed that while 98.2% recognized the importance of frailty in surgical patients, only 2.4% actually performed comprehensive geriatric assessments, indicating a significant gap between awareness and practice.

Key barriers to implementing effective frailty management included a lack of knowledge about assessment tools, unclear responsibilities for screening, and insufficiently trained staff, suggesting that improved training and guidelines could enhance frailty care in emergency surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Perceptions and practices surrounding the perioperative management of frail emergency surgery patients: a WSES-endorsed cross-sectional qualitative survey. Viswanath, M., Clinch, D., Ceresoli, M., et al.[2023]

Frailty identified through electronic medical data significantly increases the risk of mortality by 3.57 times and is also linked to higher odds of institutional discharge and increased healthcare costs, based on a meta-analysis of 90 studies.

The review highlighted that most frailty assessment instruments used in electronic data are not multidimensional, indicating a need for future research to explore more comprehensive tools and their practical application in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Systematic Review and Meta-Analysis of Preoperative Frailty Instruments Derived From Electronic Health Data. Alkadri, J., Hage, D., Nickerson, LH., et al.[2023]

In a study of 230 surgical patients aged 60 and older, those who reported signs of frailty, such as fatigue and weight loss, were significantly more likely to be discharged to a post-acute facility rather than home, with an odds ratio of 4.5 for those with a FRAIL screen score of 2 or higher.

The FRAIL screening tool effectively identifies patients at risk for non-home discharge, suggesting it could be a valuable part of preoperative assessments to improve discharge planning and patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Association Between Patient-Reported Frailty and Non-Home Discharge Among Older Adults Undergoing Surgery. Sokas, CM., Cowan, J., Dalton, MK., et al.[2022]

Citations

1. accessnewswire.com accessnewswire.com/newsroom/en/healthcare-and-pharmaceutical/cloud-dx%E2%80%99s-post-surgical-monitoring-wearable-validated-in-peer-reviewe-676656

Cloud DX's Post-Surgical Monitoring Wearable Validated ... The study assessed regulatory compliance and post-surgery use in monitoring patients' vital signs in real-world conditions. The study found ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06503198

The VICTORY Trial: Virtual, Innovative, Postsurgical Care ... Through Cloud DX remote monitoring technology, intervention group participants will receive the following intervention: remote automated monitoring, frailty ...

3. stocktitan.net stocktitan.net/news/CDXFF/cloud-dx-reports-high-satisfaction-amongst-post-surgical-remote-evp35xf1ygag.html

Cloud DX Reports High Satisfaction Amongst Post-Surgical ... 96% patient satisfaction with remote monitoring program. · 99% of patients are willing to continue managing health vitals at home.

4. researchgate.net researchgate.net/figure/The-Cloud-DX-Vitaliti-multibiometric-channel-vital-signs-monitor-Reproduced-with_fig2_324761933

The Cloud DX Vitaliti multibiometric channel vital signs ... The purpose of this study was to evaluate the implementation of a novel Telehealth Home monitoring Enhanced-Frailty And Cardiac Surgery (THE-FACS) intervention ...

5. proactiveinvestors.co.uk proactiveinvestors.co.uk/companies/news/968757/cloud-dx-says-post-surgical-monitoring-wearable-validated-in-peer-reviewed-study-968757.html

Cloud DX says post-surgical monitoring wearable ... The virtual care company said the study assessed regulatory compliance and post-surgery use in monitoring patients' vital signs in real-world ...

6. clouddx.com clouddx.com/templates/indextemplate.html

Cloud DX Connected Health Cloud DX delivers comprehensive Remote Patient Monitoring or RPM solutions deployed across North America. What sets Cloud DX apart from other RPM vendors?

7. finance.yahoo.com finance.yahoo.com/news/canadian-study-using-cloud-dx-123000733.html

Canadian Study Using Cloud DX Technology Proves ... Results show that virtual care patients saw a 24% reduction in drug errors, up to 14% fewer patients reported pain, and there were 5% fewer re- ...

8. clouddx.com clouddx.com/canadarpm/

Leverage RPM for Improved Patient Outcomes in Canada This technology gives health care providers the ability to detect early signs of complications and optimize medical management.