Virtual Care Platform for Home Ventilator Therapy

(TTLive Trial)

Recruiting at 7 trial locations

Overseen By Munazzah Ambreen

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: The Hospital for Sick Children

Disqualifiers: Life expectancy ≤ 2 months, Cognitive impairment, Uncontrolled psychiatric illness, No internet access, Others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

440 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how a virtual care platform called aTouchAway™ can assist individuals new to using a ventilator at home. It aims to determine if this virtual support can reduce emergency healthcare visits, ease caregiver burdens, and lower healthcare costs compared to traditional in-person care. The trial includes two groups: one using the virtual platform and the other receiving standard care. Individuals who have started using a home ventilator within the last two months and can communicate in English may be suitable for this study. As an unphased trial, this study provides a unique opportunity to contribute to innovative healthcare solutions and potentially enhance the quality of life for ventilator users.

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 this virtual care platform is safe for home ventilator therapy?

Studies have shown that the aTouchAway™ platform has been safely used for home mechanical ventilation (HMV). This virtual care tool was part of programs like the Long-Term In-Home Ventilator Engagement (LIVE) program during the COVID-19 pandemic. Research indicates that users find this platform safe and easy to use.

Although specific data on side effects or problems with this platform is lacking, its use in similar situations provides reassurance. Since this trial tests a method of delivering care rather than a new drug or device, there is less concern about physical side effects. Participants in other studies have generally found it helpful and safe. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the aTouchAway™ platform because it offers a new way to manage home ventilator therapy through virtual care. Unlike traditional treatments that rely heavily on face-to-face clinic visits, this platform facilitates a multi-component virtual transition intervention, making it easier for patients to receive care from the comfort of their home. This approach not only aims to improve patient convenience but also seeks to enhance the continuity of care by allowing for more frequent and flexible interactions between patients and healthcare teams. The integration of digital technology in this way could lead to better management of ventilator therapy, potentially improving patient outcomes and quality of life.

What evidence suggests that the aTouchAway™ platform is effective for home ventilator therapy?

Research shows that the aTouchAway™ platform, available to participants in this trial, can be a helpful tool for people using home mechanical ventilation (HMV). Studies have found that this platform, part of the TtLIVE program, enables virtual home visits and provides personalized care plans. These features enhance communication and support for both patients and caregivers. Early results suggest it can reduce the need for healthcare services and lower caregiver stress. This virtual care solution creates a supportive "circle of care," making ventilator therapy management at home easier and more efficient. Overall, it aims to smooth the transition to home care for those who rely on ventilators. ^{1 2 3 4 5}

Who Is on the Research Team?

Louise Rose, PhD

Principal Investigator

King's College London

Andrea Gershon, MD, MSc

Principal Investigator

Sunnybrook Health Sciences Centre

Reshma Amin, MD

Principal Investigator

The Hospital for Sick Children

Are You a Good Fit for This Trial?

This trial is for individuals recently started on home ventilator therapy and their primary caregivers. Participants must understand English or have a caregiver who does, be able to communicate verbally, and provide informed consent. Healthcare providers or those unable to speak during an interview are excluded.

Inclusion Criteria

Reads, writes and understands English if does not have a caregiver than can do so.

Reads, writes and understands English; and

I am the main caregiver for someone who recently started using a ventilator.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Transition Intervention

Participants receive a multi-component Virtual Transition Intervention facilitated through the aTouchAway™ platform, including virtual home visits, customizable care plans, and tele-monitoring.

6 months

Regular virtual visits and tele-monitoring

Follow-up

Participants are monitored for safety and effectiveness after the transition intervention, with assessments of healthcare utilization, caregiver burden, and health-related quality of life.

6 months

Periodic virtual follow-ups

Long-term Follow-up

Participants continue to be monitored for healthcare utilization and quality of life outcomes over a longer period.

12 months

What Are the Treatments Tested in This Trial?

Interventions

• aTouchAway™ platform

Trial Overview The LIVE Study tests the aTouchAway™ virtual care platform's impact on emergency healthcare use, caregiver burden, cost-effectiveness including family caregiver time, and clinical encounter efficiency versus usual care for new home mechanical ventilation users.

How Is the Trial Designed?

Group I: Intervention Experimental Treatment 1 Intervention

Participants will receive multi-component Virtual Transition Intervention facilitated through the aTouchAway™ platform including the usual care provided by specialist HMV programs.

Group II: Control Active Control 1 Intervention

Usual care will be delivered in accordance with the Canadian Thoracic Society (CTS) clinical practice guidelines and includes scheduled face-to-face clinic visits with the ventilator team with the ventilator team within the first month of starting HMV and then every 3, 6, or 12 months depending on medical stability with additional telephone calls/email contact for equipment trouble shooting and management of intercurrent illnesses as needed.

aTouchAway™ platform is already approved in Canada for the following indications:

Approved in Canada as aTouchAway platform for:

• Home Mechanical Ventilation (HMV) support

Who Is Running the Clinical Trial?

The Hospital for Sick Children

Lead Sponsor

Trials

724

Recruited

6,969,000+

Queen's University

Collaborator

Kingston Health Sciences Centre

Collaborator

Trials

312

Recruited

112,000+

West Park Healthcare Centre

Collaborator

Trials

36

Recruited

2,400+

The Ottawa Hospital

Collaborator

Trials

97

Recruited

64,000+

London Health Sciences Centre

Collaborator

Trials

151

Recruited

60,400+

Children's Hospital of Eastern Ontario

Collaborator

Trials

134

Recruited

61,000+

McMaster Children's Hospital

Collaborator

Trials

43

Recruited

19,900+

Queen's University

Collaborator

Trials

382

Recruited

122,000+

Aetonix Systems

Collaborator

Trials

1

Recruited

440+

Published Research Related to This Trial

The implementation of an online adverse drug reaction (ADR) reporting system in France led to a 45% increase in reports from healthcare professionals, demonstrating its effectiveness in improving ADR reporting rates.

Online reports were processed and transmitted to the French Medicine Agency significantly faster, averaging 26 days earlier than conventional methods, which is crucial for generating timely safety signals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Online reporting of adverse drug reactions: a study from a French regional pharmacovigilance center. Abadie, D., Chebane, L., Bert, M., et al.[2014]

Implementing systematic clinical pathways and weaning protocols for patients on long-term mechanical ventilation can lead to improved clinical outcomes and reduced costs, as shown in both a university teaching hospital and a community hospital setting.

Multidisciplinary approaches that involve various healthcare professionals help decrease variability in care, ultimately enhancing the quality of treatment for patients requiring mechanical ventilation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term ventilator management strategies: experiences of two hospitals. Burns, SM., Dempsey, E.[2019]

A systematic analysis of adverse events in home mechanical ventilation (HMV) identified key risk factors such as patient transportation, suction, and tracheostomy decannulation, which can jeopardize patient safety.

The study suggests implementing risk mitigation measures, including checklists and reminder functions for caregivers, to enhance safety and prevent errors associated with HMV.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Causes of adverse events in home mechanical ventilation: a nursing perspective. Lipprandt, M., Liedtke, W., Langanke, M., et al.[2022]

Long-term noninvasive ventilation (LTNIV) is effective in improving symptoms, blood gas levels, survival, and quality of life for patients with chronic hypercapnic respiratory failure, including those with COPD and obesity-hypoventilation syndrome.

Modern LTNIV devices equipped with advanced monitoring software can track patient compliance and ventilation metrics, allowing for remote adjustments to treatment, which can reduce the need for hospital visits and improve patient comfort.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Monitoring Long Term Noninvasive Ventilation: Benefits, Caveats and Perspectives. Janssens, JP., Cantero, C., Pasquina, P., et al.[2022]

A new Web-based peer support program for caregivers of ventilator-assisted individuals (VAIs) has been developed, aiming to improve caregiver health outcomes and reduce caregiver burden, which is significant given the high prevalence of HMV users in North America and Europe.

The program includes training for peer mentors and will be evaluated for feasibility and effectiveness through a pilot randomized controlled trial involving 30 caregivers, with results expected in early 2019.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of a Web-Based Peer Support Program for Family Caregivers of Ventilator-Assisted Individuals Living in the Community: Protocol for a Pilot Randomized Controlled Trial. Wasilewski, MB., Nonoyama, M., Dale, C., et al.[2020]

The TtLIVE virtual care solution, designed for patients transitioning to home mechanical ventilation, is being evaluated in a randomized controlled trial with 440 participants to assess its effectiveness compared to usual care, focusing on emergency department visits and caregiver well-being over 12 months.

This study will also analyze healthcare utilization, caregiver burden, and quality of life, while exploring the acceptability of the TtLIVE intervention through qualitative interviews, providing comprehensive insights into both clinical and experiential outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Transitions to Long-term In Home Ventilator Engagement Study (Transitions to LIVE): study protocol for a pragmatic randomized controlled trial. Amin, R., Gershon, A., Buchanan, F., et al.[2022]

Active, participant-centred monitoring of adverse events following immunization (AEFI) is gaining recognition as a valuable complement to traditional passive surveillance methods, enhancing the understanding of vaccine safety.

A review of 25 studies across various countries highlights the emergence of post-marketing AEFI systems that utilize solicited patient feedback, indicating a shift towards more proactive monitoring approaches, especially with the potential for e-technology in low and middle-income countries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Participant-centred active surveillance of adverse events following immunisation: a narrative review. Cashman, P., Macartney, K., Khandaker, G., et al.[2022]

Approximately 4,300 children in the U.S. rely on home mechanical ventilation, and with proper support, families can provide a safe and enriching environment for these children.

The Pennsylvania Ventilator Assisted Children's Home Program (VACHP) demonstrates that a multidisciplinary professional team is crucial for the effective home management of children on mechanical ventilation, highlighting the importance of coordinated care and community support.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A multidisciplinary approach to the care of the ventilator-dependent child at home: a case study. Boroughs, DS., Dougherty, J.[2009]

A new wireless cellular interface for the Pulmonetic Systems LTV 1200 ventilator allows real-time access to ventilator settings and performance data, which can enhance care for technology-dependent children on chronic ventilator support.

Pediatric pulmonologists overwhelmingly support the remote interface, indicating it could reduce hospital visits and improve comfort for caregivers and children by facilitating better communication and monitoring of patient health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Telemedicine enabled remote critical care ventilator. Seifert, GJ., Hedin, DS., Dahlstrom, RJ., et al.[2020]

The LIVE program, launched during the COVID-19 pandemic for individuals using ventilators, received high acceptability and usability ratings from both patients and healthcare providers, indicating it is a well-received virtual healthcare solution.

With a participation rate of 42% among patients and caregivers and 87.5% among healthcare providers, the program demonstrated feasibility and appropriateness, suggesting it can effectively support ventilator-assisted individuals in a home setting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Opening the digital front door for individuals using long-term in-home ventilation (LIVE) during a pandemic- implementation, feasibility and acceptability. Amin, R., Qazi, AM., Ambreen, M., et al.[2023]

The study successfully developed a mobile application called Cell-PREVEN for real-time monitoring of adverse events related to metronidazole use among female sex workers in Peru, demonstrating its feasibility for public health surveillance.

The system allows for immediate data collection and transmission, enabling quick alerts to health personnel about specific symptoms, which enhances the ability to monitor drug safety effectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Design and implementation of Cell-PREVEN: a real-time surveillance system for adverse events using cell phones in Peru. Curioso, WH., Karras, BT., Campos, PE., et al.[2019]

The Zm-STARSS trial, involving 4560 participants, demonstrated that using SMS and telephone interviews significantly improved the detection of adverse events following immunization (AEFIs) compared to traditional passive surveillance methods, with a detection rate of 2%.

Although the response rate to SMS prompts was low (31%), the study suggests that active surveillance methods like SMS-CATI can enhance AEFI monitoring in low- and middle-income countries, highlighting the potential for digital approaches in vaccine safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and feasibility of SMS m-Health for the detection of adverse events following immunisation (AEFIs) in resource-limited setting-The Zimbabwe stimulated telephone assisted rapid safety surveillance (Zm-STARSS) randomised control trial. Nyambayo, PPM., Gold, MS., Mehta, UC., et al.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8822764/

The Transitions to Long-term In Home Ventilator Engagement ... We co-developed a multi-component virtual care solution (TtLIVE) for the home mechanical ventilation (HMV) population using the aTouchAway™ platform (Aetonix).

2. trialsjournal.biomedcentral.com trialsjournal.biomedcentral.com/articles/10.1186/s13063-022-06035-z

The Transitions to Long-term In Home Ventilator Engagement ... This pragmatic randomized controlled single-blind trial will determine the effectiveness and cost-effectiveness of the TtLIVE virtual care solution compared to ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8101977/

A virtual care innovation for home mechanical ventilation The LIVE program is an intensive clinical management program delivered via an e-health platform (aTouchAway, Aetonix), creating a circle of care ...

4. withpower.com withpower.com/trial/phase-2-2021-4d4d3

Virtual Care Platform for Home Ventilator Therapy (TTLive Trial) The aTouchAway™ platform, as part of the TtLIVE intervention, includes virtual home visits, customizable care plans, and secure communication, which can improve ...

5. journals.sagepub.com journals.sagepub.com/doi/10.1177/20552076241228417

Acceptability of the Long-Term In-Home Ventilator ... The purpose of this qualitative study was to explore the acceptability of the LIVE Program hosted via a digital platform during the COVID-19 pandemic from ...