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Completed

NCT Number: NCT04180722

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

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.

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

McMaster Children's Hospital, Hamilton, Ontario, Canada

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About this study

Ventilator Assisted Individuals (VAIs) on HMVs are an ideal population for a virtual care platform that offers a comprehensive bundle of virtual care solutions, sophisticated enough for the complex care demands of this population. A first complex care demand is the challenging clinical follow ups that impose significant financial and medical costs associated with travel to healthcare appointments, and which can predispose these patients to adverse events during travel periods due to an inability to maintain access to some vital technology such as suctioning.

A second complex care demand is the multiple transitions in care as some VAIs on HMVs move between and within healthcare sectors due to changing health status or care needs, and multi-morbidity. Formalized handovers between providers are lacking. This results in information gaps and additional and sometimes unnecessary time spent by healthcare providers searching for care plan documentation.

A third demand is the lack of timely access to respiratory health professionals experienced in HMV and availability of home follow-up, particularly in the early stages of transition which impedes the transition process.

Virtual Care can be defined as any interaction between patients and/or members of their circle of care, occurring remotely, using any form of communication or information technology, with the aim of facilitating or maximizing the effectiveness and quality of patient care. It includes electronic messaging, tele-consultations and tele-monitoring. The advantages of virtual care include the following: 1) enabling the preconditions for truly empowered patients and patient/family-centered care; 2) overcoming the silos of care, and 3) reducing redundancy within the healthcare system by greater knowledge sharing across healthcare sectors. Virtual care provides an opportunity to make healthcare better by overcoming constraints of distance, cost, and time.

In TTLive Study, a multi-component platform delivered on an electronic tablet developed for complex care management at home is used in partnership with the patient, family and healthcare team to enable the following: 1) virtual home visits; 2) customizable care plans; 3) basic clinical workflows that incorporate reminders, completion of symptom profiles and tele-monitoring, and 4) secure communication via messaging, audio, and video calls. Investigators hypothesize that this virtual transition intervention will reduce emergent healthcare utilization, improve the experience of care, reduce caregiver burden, become more cost-effective than usual care, and enable more efficient use of healthcare provider time.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Participant Eligibility Criteria

Inclusion criteria

i. Individuals newly initiated (in-hospital or as an outpatient) on a ventilator for HMV prescribed by a participating ventilation program in the previous two months.

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

iii. Provides informed consent.

Exclusion criteria

i. Projected life expectancy of ≤ 2 months. ii. Significant cognitive impairment and absence/inability of a family caregiver to use aTouchAway™ or complete questionnaires.

iii. Uncontrolled psychiatric illness. iv. No internet access (SIM cards and data costs will be covered by the project budget).

v. Currently enrolled in a research study to evaluate another eHealth platform or care coordination.

vi. Plans to move outside of Ontario within the next 12 months.

Caregivers Eligibility Criteria

Caregiver Inclusion Criteria:

i. Primary caregiver of an individual newly initiated (in-hospital or outpatient) on a ventilator for HMV prescribed by a participating clinic in the previous two months; ii. Reads, writes and understands English; and iii. Provides informed consent.

Eligibility Criteria for the Qualitative Interviews

Investigators will exclude those participants:

i. Unable to communicate verbally for the duration of an interview

Inclusion criteria

for Healthcare Providers in the Circle of Care for the Intervention Group

Healthcare provider of an individual from a participating centre i. Use of the aTouchAway for at least five participant encounters ii. Provides informed consent.

Treatment and study plan

aTouchAway™ platform

Device

Participants will receive multi-component Virtual Transition Intervention. The four components of the intervention comprise: (1) routine virtual clinic visits scheduled at the same frequency as usual care; (2) virtual care plan and action plan for respiratory infection/deterioration and management of ventilator issues; (3) remote, weekly and monthly monitoring of ventilator and cough assist metrics, VAI symptoms, and oxygen saturations; and (4) as needed clinical consultations triggered by identification of abnormal parameters or requested by the VAI or family caregiver.

Primary outcomes

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

    Time frame: 12 months± 4 weeks

    Using health administrative databases and the Ambulatory Health Care Record-modified

  2. To measure caregiver reported sense of mastery (Pearlin Mastery Scale; scores range up to 28, higher scores = higher mastery), if no caregiver available then patient reported sense of mastery will be utilized

    Time frame: 12 months± 4 weeks

    To measure caregiver reported sense of mastery, an outcome that is often linked to patient empowerment using the Pearlin Self-Mastery Scale, if no caregiver available then patient reported sense of mastery will be utilized

Secondary outcomes

  1. Number of hospital admissions and days in hospital over 6 months using health administrative databases.

    Time frame: 6 months± 4 weeks

    Using health administrative databases and the Ambulatory Health Care Record-modified

  2. Number of hospital admissions and days in hospital over 12 months using health administrative databases.

    Time frame: 12 months ± 4 weeks

    Using health administrative databases and the Ambulatory Health Care Record-modified

  3. Hospital free survival using health administrative data at 6 months.

    Time frame: 6 months ± 4 weeks

    Using health administrative databases and the Ambulatory Health Care Record-modified

  4. Hospital free survival using health administrative data at 12 months.

    Time frame: 12 Months ± 4 weeks

    Using health administrative databases and the Ambulatory Health Care Record-modified

  5. Time to first ED visit and first hospital admission.

    Time frame: 12 months ± 4 weeks

    Using health administrative databases and the Ambulatory Health Care Record-modified

  6. Overall survival at 6 months.

    Time frame: 6 months ± 4 weeks

    Using health administrative databases and the Ambulatory Health Care Record-modified

  7. Overall survival at 12 months.

    Time frame: 12 months ± 4 weeks

    Using health administrative databases and the Ambulatory Health Care Record-modified

  8. Respiratory and non-respiratory causes of death at 6 months.

    Time frame: 6 months ± 4 weeks

    Using health administrative databases and the Ambulatory Health Care Record-modified

  9. Respiratory and non-respiratory causes of death at 12 months.

    Time frame: 12 months ± 4 weeks

    Using health administrative databases and the Ambulatory Health Care Record-modified

  10. Number and type of outpatient specialist visits at 6 months.

    Time frame: 6 months ± 4 weeks

    Using health administrative databases and the Ambulatory Health Care Record-modified

  11. Number and type of outpatient specialist visits at 12 months.

    Time frame: 12 months ± 4 weeks

    Using health administrative databases and the Ambulatory Health Care Record-modified

  12. Number of family physician visits at 6 months.

    Time frame: 6 months ± 4 weeks

    Using health administrative databases and the Ambulatory Health Care Record-modified

  13. Number of family physician visits at 12 months.

    Time frame: 12 months ± 4 weeks

    Using health administrative databases and the Ambulatory Health Care Record-modified

  14. Homecare service use at 6 months.

    Time frame: 6 months ± 4 weeks

    Using health administrative databases and the Ambulatory Health Care Record-modified

  15. Homecare service use at 12 months.

    Time frame: 12 months ± 4 weeks

    Using health administrative databases and the Ambulatory Health Care Record-modified

  16. 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'.

    Time frame: 6 months ± 4 weeks

    Caregiver Outcome

  17. 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'.

    Time frame: 12 months ± 4 weeks

    Caregiver Outcome

  18. Change in study participant health related quality of life using the EQ-5D (adults) and ED-5DY (children) change from baseline and 6 months

    Time frame: 6 months ± 4 weeks

    Health Related Quality of Life Outcome

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

    Time frame: 12 months ± 4 weeks

    Health Related Quality of Life Outcome

  20. Quality of care coordination using Family Experiences with Care Coordination (FECC) for qualitative interview participants only

    Time frame: 6 months ± 4 weeks

    Care Coordination Outcome

  21. Incremental Cost Effectiveness Ratios (ICER) of Virtual Transition intervention compared to usual care in improving patient utility from a societal perspective and using a one-year time horizon

    Time frame: 12 months ± 4 weeks

    Economic Outcome

  22. Mean monthly healthcare costs (public, private and caregiver lost time) over 6 months

    Time frame: 6 months ± 4 weeks

    Economic Outcome: Using health administrative databases and the Ambulatory Health Care Record-modified

  23. Mean monthly healthcare costs (public, private and caregiver lost time) over 12 months

    Time frame: 12 months ± 4 weeks

    Economic Outcome: Using health administrative databases and the Ambulatory Health Care Record-modified

  24. Encounter time spent by clinicians over 12 months measured using the Care Coordination Measurement Tool

    Time frame: 12 months ± 4 weeks

    HealthCare Provider Outcome

  25. Process Measure Outcomes

    Time frame: 12 months ± 4 weeks

    n(%) of 5 clinic visits conducted virtually as opposed to face to face

  26. Process Measure Outcomes

    Time frame: 12 months ± 4 weeks

    n (%) of virtual data downloads available for the virtual clinic visits

  27. Process Measure Outcomes

    Time frame: 12 months ± 4 weeks

    n(%) participants that completed the virtual care plan within 6 weeks after intervention initiation

  28. Process Measure Outcomes

    Time frame: 12 months ± 4 weeks

    n (%) of the 52 weekly check-ins completed

  29. Process Measure Outcomes

    Time frame: 12 months ± 4 weeks

    n(%) of the 12 monthly S3-NIV check-ins completed

  30. Process Measure Outcomes

    Time frame: 12 months ± 4 weeks

    number of ad hoc questions/concerns in which healthcare team contacted via the platform

  31. Process Measure Outcomes

    Time frame: 12 months ± 4 weeks

    number of status yellow monitoring alerts initiated based on the weekly and monthly symptom monitoring and time to alert being addressed by a member of the circle of care

  32. Process Measure Outcome- Qualitative Interviews

    Time frame: 6 months ± 4 weeks

    Qualitative interviews to explore the experience with the aTouchAway intervention by study participants, caregivers and healthcare providers

  33. Process Measure Outcome- Site focus Groups

    Time frame: 24 months ± 4 weeks

    Our LIVE study data has shown reduction in ED visits due to the pandemic and since ED Visits are the primary outcome for TtLIVE, as a process measure, we will conduct a one-time focus group to generate a hierarchy of important study primary and secondary outcomes with participating sites.

    Site focus groups: Every participating site will get an opportunity to participate in a 30-60-minute focus group to discuss and rank outcomes relevant to their practice over zoom

Sponsors and collaborators

Lead sponsor

The Hospital for Sick Children

Other

Collaborators

  • Aetonix Systems
  • Children's Hospital of Eastern Ontario
  • Kingston Health Sciences Centre
  • London Health Sciences Centre
  • McMaster Children's Hospital
  • Sunnybrook Health Sciences Centre
  • The Ottawa Hospital
  • West Park Healthcare Centre

Registry information

Official study title

A Virtual Transition Intervention for Children and Adults Transitioning to Home Ventilation in Ontario: A Pragmatic Randomized Controlled Trial

Acronym: TTLive

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Nov 27, 2019
Registry last updated
Feb 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.