Virtual Care Platform for Home Ventilator Therapy

(TTLive Trial)

Recruiting in Palo Alto (17 mi)

+7 other locations

Overseen by Reshma Amin, MD

Age: Any Age

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: The Hospital for Sick Children

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

No Placebo Group

Approved in 1 Jurisdiction

Trial Summary

What is the purpose of this trial?

The rising prevalence of ventilator assisted individuals (VAIs) who depend on Home Mechanical Ventilation (HMV) is an escalating public health challenge with important social and economic implications. VAIs are high cost users of the healthcare system, requiring competent healthcare and family caregivers for successful transition to HMV. The TTLive Study will evaluate the effect of a virtual transition intervention delivered through a virtual care platform, compared to usual care on emergent healthcare utilization, caregiver burden, health cost-effectiveness including cost of family caregiver time, and efficiency of clinical encounters for individuals newly transitioning to HMV.

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 data supports the effectiveness of the treatment aTouchAway™ platform for home ventilator therapy?

The aTouchAway™ platform, as part of the TtLIVE intervention, includes virtual home visits, customizable care plans, and secure communication, which can improve patient engagement and management of home mechanical ventilation. Additionally, long-term noninvasive ventilation (LTNIV) has been shown to improve symptoms, survival, and quality of life for patients with chronic respiratory failure, suggesting that virtual care platforms like aTouchAway™ could enhance these benefits by providing remote monitoring and support. ^{1 2 3 4 5}

Is the Virtual Care Platform for Home Ventilator Therapy generally safe for humans?

The research highlights that adverse events (unintended and harmful events) can occur with home mechanical ventilation, often due to human interaction with the devices. Understanding these errors can help prevent harm, suggesting that while the technology can be safe, careful use and monitoring are important. ^{6 7 8 9 10}

How is the aTouchAway™ platform treatment different from other treatments for home ventilator therapy?

The aTouchAway™ platform is unique because it offers a comprehensive virtual care solution for home ventilator therapy, including virtual home visits, customizable care plans, and secure digital communication through messaging, audio, and video calls. This approach allows for continuous tele-monitoring and support, which is particularly beneficial during situations like the COVID-19 pandemic, where in-person visits may be limited. ^{1 3 4 11 12}

Research Team

Andrea Gershon, MD, MSc

Principal Investigator

Sunnybrook Health Sciences Centre

Louise Rose, PhD

Principal Investigator

King's College London

Reshma Amin, MD

Principal Investigator

The Hospital for Sick Children

Eligibility Criteria

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.

Trial Timeline

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

Treatment Details

Interventions

• aTouchAway™ platform (Virtual Care 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.

Participant Groups

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+

Dr. Ronald D. Cohn

The Hospital for Sick Children

Chief Executive Officer since 2019

MD from University of Düsseldorf, Germany

Dr. Lennox Huang

The Hospital for Sick Children

Chief Medical Officer since 2016

MD from McGill University

Kingston Health Sciences Centre

Collaborator

Trials

312

Recruited

112,000+

Dr. Michael Fitzpatrick

Kingston Health Sciences Centre

Chief Medical Officer since 2017

MD, Queen's University

Dr. David Pichora

Kingston Health Sciences Centre

Chief Executive Officer since 2017

MD, Queen's University

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+

Dr. Alex Barron

London Health Sciences Centre

Chief Medical Officer since 2023

MD from Western University

David Musyj

London Health Sciences Centre

Chief Executive Officer

Bachelor of Laws (LLB) from the University of Windsor

Children's Hospital of Eastern Ontario

Collaborator

Trials

134

Recruited

61,000+

Dr. Vera Etches

Children's Hospital of Eastern Ontario

Chief Executive Officer

MD from the University of Western Ontario

Dr. Carrol Pitters

Children's Hospital of Eastern Ontario

Chief Medical Officer since 2010

MD from the University of the West Indies

McMaster Children's Hospital

Collaborator

Trials

43

Recruited

19,900+

Queen's University

Collaborator

Trials

382

Recruited

122,000+

Marie Evangelista

Queen's University

Chief Executive Officer

PhD in Cell and Molecular Biology from Queen's University, Ontario, Canada

Constantine Kreatsoulas

Queen's University

Chief Medical Officer since 2021

PhD in Chemistry from Princeton University

Aetonix Systems

Collaborator

Trials

1

Recruited

440+

Children's Hospital, London Health Sciences Centre

Collaborator

Trials

1

Recruited

440+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

References

1. England 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. [2022]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Monitoring Long Term Noninvasive Ventilation: Benefits, Caveats and Perspectives. [2022]

3. Canada 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. [2020]

4. United States pubmed.ncbi.nlm.nih.gov

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

5. United States pubmed.ncbi.nlm.nih.gov

Long-term ventilator management strategies: experiences of two hospitals. [2019]

6. England pubmed.ncbi.nlm.nih.gov

Causes of adverse events in home mechanical ventilation: a nursing perspective. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Design and implementation of Cell-PREVEN: a real-time surveillance system for adverse events using cell phones in Peru. [2019]

8. Netherlands 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. [2023]

9. France pubmed.ncbi.nlm.nih.gov

Online reporting of adverse drug reactions: a study from a French regional pharmacovigilance center. [2014]

10. England pubmed.ncbi.nlm.nih.gov

Participant-centred active surveillance of adverse events following immunisation: a narrative review. [2022]

11. United States pubmed.ncbi.nlm.nih.gov

Telemedicine enabled remote critical care ventilator. [2020]

12. United States 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. [2023]