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Virtual Care Platform

Virtual Care Platform for Home Ventilator Therapy (TTLive Trial)

N/A

Recruiting

Led By Reshma Amin, MD, MSc

Research Sponsored by The Hospital for Sick Children

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Unable to communicate verbally for the duration of an interview

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

TTLive Trial Summary

This trial will study the effects of a virtual transition intervention for people who are newly transitioning to home mechanical ventilation. The intervention will be delivered through a virtual care platform, and compared to usual care. The study will evaluate things such as healthcare utilization, caregiver burden, and health cost-effectiveness.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

Since this study involves a non-invasive virtual care platform rather than medication or invasive procedures, traditional side effects are not expected. However, participants may experience technical issues or stress related to using new technology.

TTLive Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I cannot speak during an interview.

TTLive Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

ED Visits: ED visit rates at 12 months determined using health administrative databases

To measure patient reported sense of mastery (Pearlin Mastery Scale; scores range up to 28, higher scores = higher mastery)

Secondary outcome measures

Change in Zarit Burden Interview Score from baseline to 12 months.The 22 items are assessed on a 5-point Likert scale, ranging from 0 = 'never' to 4 = 'nearly always'.

Change in Zarit Burden Interview Score from baseline to 6 months.The 22 items are assessed on a 5-point Likert scale, ranging from 0 = 'never' to 4 = 'nearly always'.

Change in study participant health related quality of life using the EQ-5D (adults) and ED-5DY (children) change from baseline and 12 months

+23 more

TTLive Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: InterventionExperimental Treatment1 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: ControlActive Control1 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.

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

The Hospital for Sick ChildrenLead Sponsor

690 Previous Clinical Trials

6,945,038 Total Patients Enrolled

West Park Healthcare CentreOTHER

31 Previous Clinical Trials

1,818 Total Patients Enrolled

The Ottawa HospitalOTHER

93 Previous Clinical Trials

62,478 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many medical centers are currently administering this clinical trial in the city?

"Currently, 8 trial sites are accepting patients from Toronto, Hamilton and London among a few other locations. To lessen travelling needs when participating in the study, selecting the closest site is advised."

Answered by AI

How many individuals are being assessed in this research project?

"Affirmative, the clinicaltrials.gov database reveals that this medical trial is still recruiting patients. It was first posted on March 1st 2021 and has been revised as recently as August 4th 2022. The aim of recruitment is to obtain 440 participants from 8 different sites."

Answered by AI

Are new participants able to join the experiment at this time?

"Affirmative. The clinicaltrials.gov website evidences that this medical research is actively seeking participants, which was first advertised on 1st March 2021 and most recently updated on 4th August 2022. Consequently, the study necessitates 440 patients from 8 distinct locales."

Answered by AI

What are the hoped-for conclusions of this experiment?

"This long-term, 12 month study will predominantly evaluate the impact of patient mastery through the Pearlin Mastery Scale (scores up to 28 points). Secondary objectives include overall survival at one year and economic outcomes from a societal perspective. Additionally, researchers hope to identify respiratory or non-respiratory causes of death after 6 months using health administrative databases."

Answered by AI

Recent research and studies

TrialsJournal

The Transitions to Long-term in Home Ventilator Engagement Study (transitions to LIVE): Study Protocol for a Pragmatic Randomized Controlled Trial

Amin, Reshma, Andrea Gershon, Francine Buchanan, Regina Pizzuti, Adam Qazi, Nishali Patel, Ruxandra Pinto, et al.. 2022. “The Transitions to Long-term in Home Ventilator Engagement Study (transitions to LIVE): Study Protocol for a Pragmatic Randomized Controlled Trial”. Trials. Springer Science and Business Media LLC. doi:10.1186/s13063-022-06035-z.

clinicaltrials.govStudy

Transition to LIVE (Long-term In Home Ventilation Engagement) Study

Reshma Amin 2021. "Transition to LIVE (Long-term In Home Ventilation Engagement) Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04180722.