Long-term Ventilation at HomeTTLiveNCT04180722
Transition to LIVE (Long-term In Home Ventilation Engagement) Study
A study testing aTouchAway™ platform in people with Long-term Ventilation at Home, run by The Hospital for Sick Children at 8 sites in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Long-term Ventilation at Home
- What is being tested?
- aTouchAway™ platform
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 444 participants
- Where
- 8 sitesCanada
- Study dates
- 1 Mar 2021to 30 Jan 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
- Reads, writes and understands English if does not have a caregiver than can do so.
- Provides informed consent.
Who cannot join
- Projected life expectancy of ≤ 2 months. ii. Significant cognitive impairment and absence/inability of a family caregiver to use aTouchAway™ or complete questionnaires.
- Uncontrolled psychiatric illness. iv. No internet access (SIM cards and data costs will be covered by the project budget).
- Currently enrolled in a research study to evaluate another eHealth platform or care coordination.
- Plans to move outside of Ontario within the next 12 months.
- Caregivers Eligibility Criteria
- Caregiver Inclusion Criteria:
Show all 12Show fewer
- 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:
- 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.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Canada8 sites
McMaster Children's Hospital
Hamilton, Ontario
Children's Hospital, London Health Sciences
London, Ontario, N6A 5W9
London Health Sciences Center
London, Ontario
Children's Hospital of Eastern Ontario
Ottawa, Ontario
The Ottawa Hospital
Ottawa, Ontario
The Hospital for Sick Children
Toronto, Ontario, M5G 1X8
Sunnybrook Health Sciences Center
Toronto, Ontario
West Park Healthcare Centre
York, Ontario, M6M 2J5
About this study
Official title: A Virtual Transition Intervention for Children and Adults Transitioning to Home Ventilation in Ontario: A Pragmatic Randomized Controlled 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.
Read the detailed description
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.
- Conditions
- Long-term Ventilation at Home
- Being tested
- aTouchAway™ platform
- Keywords
- Home mechanical ventilation, Ventilator assisted individuals, Virtual Intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
aTouchAway™ platformDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Participants will receive multi-component Virtual Transition Intervention facilitated through the aTouchAway™ platform including the usual care provided by specialist HMV programs. Receives: Device: aTouchAway™ platform |
| Control | No 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
ED Visits: ED visit rates at 12 months determined using health administrative databases
Using health administrative databases and the Ambulatory Health Care Record-modified
Measured: 12 months± 4 weeks
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
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
Measured: 12 months± 4 weeks
Secondary outcomes (33)
Number of hospital admissions and days in hospital over 6 months using health administrative databases.
Using health administrative databases and the Ambulatory Health Care Record-modified
Measured: 6 months± 4 weeks
Number of hospital admissions and days in hospital over 12 months using health administrative databases.
Using health administrative databases and the Ambulatory Health Care Record-modified
Measured: 12 months ± 4 weeks
Hospital free survival using health administrative data at 6 months.
Using health administrative databases and the Ambulatory Health Care Record-modified
Measured: 6 months ± 4 weeks
Hospital free survival using health administrative data at 12 months.
Using health administrative databases and the Ambulatory Health Care Record-modified
Measured: 12 Months ± 4 weeks
Time to first ED visit and first hospital admission.
Using health administrative databases and the Ambulatory Health Care Record-modified
Measured: 12 months ± 4 weeks
Overall survival at 6 months.
Using health administrative databases and the Ambulatory Health Care Record-modified
Measured: 6 months ± 4 weeks
Overall survival at 12 months.
Using health administrative databases and the Ambulatory Health Care Record-modified
Measured: 12 months ± 4 weeks
Respiratory and non-respiratory causes of death at 6 months.
Using health administrative databases and the Ambulatory Health Care Record-modified
Measured: 6 months ± 4 weeks
Respiratory and non-respiratory causes of death at 12 months.
Using health administrative databases and the Ambulatory Health Care Record-modified
Measured: 12 months ± 4 weeks
Number and type of outpatient specialist visits at 6 months.
Using health administrative databases and the Ambulatory Health Care Record-modified
Measured: 6 months ± 4 weeks
Number and type of outpatient specialist visits at 12 months.
Using health administrative databases and the Ambulatory Health Care Record-modified
Measured: 12 months ± 4 weeks
Number of family physician visits at 6 months.
Using health administrative databases and the Ambulatory Health Care Record-modified
Measured: 6 months ± 4 weeks
Number of family physician visits at 12 months.
Using health administrative databases and the Ambulatory Health Care Record-modified
Measured: 12 months ± 4 weeks
Homecare service use at 6 months.
Using health administrative databases and the Ambulatory Health Care Record-modified
Measured: 6 months ± 4 weeks
Homecare service use at 12 months.
Using health administrative databases and the Ambulatory Health Care Record-modified
Measured: 12 months ± 4 weeks
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'.
Caregiver Outcome
Measured: 6 months ± 4 weeks
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'.
Caregiver Outcome
Measured: 12 months ± 4 weeks
Change in study participant health related quality of life using the EQ-5D (adults) and ED-5DY (children) change from baseline and 6 months
Health Related Quality of Life Outcome
Measured: 6 months ± 4 weeks
Change in study participant health related quality of life using the EQ-5D (adults) and ED-5DY (children) change from baseline and 12 months
Health Related Quality of Life Outcome
Measured: 12 months ± 4 weeks
Quality of care coordination using Family Experiences with Care Coordination (FECC) for qualitative interview participants only
Care Coordination Outcome
Measured: 6 months ± 4 weeks
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
Economic Outcome
Measured: 12 months ± 4 weeks
Mean monthly healthcare costs (public, private and caregiver lost time) over 6 months
Economic Outcome: Using health administrative databases and the Ambulatory Health Care Record-modified
Measured: 6 months ± 4 weeks
Mean monthly healthcare costs (public, private and caregiver lost time) over 12 months
Economic Outcome: Using health administrative databases and the Ambulatory Health Care Record-modified
Measured: 12 months ± 4 weeks
Encounter time spent by clinicians over 12 months measured using the Care Coordination Measurement Tool
HealthCare Provider Outcome
Measured: 12 months ± 4 weeks
Process Measure Outcomes
n(%) of 5 clinic visits conducted virtually as opposed to face to face
Measured: 12 months ± 4 weeks
Process Measure Outcomes
n (%) of virtual data downloads available for the virtual clinic visits
Measured: 12 months ± 4 weeks
Process Measure Outcomes
n(%) participants that completed the virtual care plan within 6 weeks after intervention initiation
Measured: 12 months ± 4 weeks
Process Measure Outcomes
n (%) of the 52 weekly check-ins completed
Measured: 12 months ± 4 weeks
Process Measure Outcomes
n(%) of the 12 monthly S3-NIV check-ins completed
Measured: 12 months ± 4 weeks
Process Measure Outcomes
number of ad hoc questions/concerns in which healthcare team contacted via the platform
Measured: 12 months ± 4 weeks
Process Measure Outcomes
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
Measured: 12 months ± 4 weeks
Process Measure Outcome- Qualitative Interviews
Qualitative interviews to explore the experience with the aTouchAway intervention by study participants, caregivers and healthcare providers
Measured: 6 months ± 4 weeks
Process Measure Outcome- Site focus Groups
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
Measured: 24 months ± 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2019
- Study start1 Mar 2021
- Primary completion30 Jan 2026
- Study completion30 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Long-term Ventilation at HomeStudies of the same condition, open and under way.
- More trials run by The Hospital for Sick ChildrenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Multicenter, prospective 12 months, 7-centre, pragmatic, parallel group, randomized controlled trial with 1:1 allocation of individuals (children and adults) newly transitioning to Home Mechanical Ventilation (HMV) in Ontario that compares a virtual transition intervention to usual care provided by specialist HMV programs.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 444 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hospital for Sick Children
- Sponsor type
- University, hospital or other
- Collaborators
- West Park Healthcare Centre, The Ottawa Hospital, Sunnybrook Health Sciences Centre, London Health Sciences Centre, Children's Hospital of Eastern Ontario, McMaster Children's Hospital, Kingston Health Sciences Centre, Aetonix Systems
- Responsible party
- Principal investigator, Reshma Amin, The Hospital for Sick Children
- Investigators
- Reshma Amin, MD, MSc, Principal investigator, The Hospital for Sick ChildrenLouise Rose, PhD, Principal investigator, King's College LondonAndrea Gershon, MD, MSc, Principal investigator, Sunnybrook Health Sciences Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04180722
- Sponsor's protocol ID
- 1000000000
- Acronym
- TTLive
- Status last verified
- Jan 2026
- First submitted
- 21 Nov 2019
- Last updated
- 3 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Amin R, Gershon A, Buchanan F, Pizzuti R, Qazi A, Patel N, Pinto R, Moretti ME, Ambreen M; TtLIVE Group; Rose L. The Transitions to Long-term In Home Ventilator Engagement Study (Transitions to LIVE): study protocol for a pragmatic randomized controlled trial. Trials. 2022 Feb 7;23(1):125. doi: 10.1186/s13063-022-06035-z.
PubMed 35130935
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Virtual Transition Intervention for Children and Adults Transitioning to Home Ventilation in Ontario: A Pragmatic Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04180722
- Acronym / sponsor ID
- TTLive / 1000000000
- Conditions
- Long-term Ventilation at Home
- Keywords
- Home mechanical ventilation, Ventilator assisted individuals, Virtual Intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 444 participants (actual)
- Lead sponsor
- The Hospital for Sick ChildrenUniversity, hospital or other
- Collaborators
- West Park Healthcare Centre, The Ottawa Hospital, Sunnybrook Health Sciences Centre, London Health Sciences Centre, Children's Hospital of Eastern Ontario, McMaster Children's Hospital, Kingston Health Sciences Centre, Aetonix Systems
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 30 Jan 2026 (actual)
- Study completion
- 30 Jan 2026 (actual)
- First posted
- 27 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Multicenter, prospective 12 months, 7-centre, pragmatic, parallel group, randomized controlled trial with 1:1 allocation of individuals (children and adults) newly transitioning to Home Mechanical Ventilation (HMV) in Ontario that compares a virtual transition intervention to usual care provided by specialist HMV programs.
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Device: aTouchAway™ platformParticipants will receive multi-component Virtual Transition Intervention facilitated through the aTouchAway™ platform including the usual care provided by specialist HMV programs. |
| Control | No 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
- Reads, writes and understands English if does not have a caregiver than can do so.
- Provides informed consent.
Key exclusion criteria (12 listed)
- Projected life expectancy of ≤ 2 months. ii. Significant cognitive impairment and absence/inability of a family caregiver to use aTouchAway™ or complete questionnaires.
- Uncontrolled psychiatric illness. iv. No internet access (SIM cards and data costs will be covered by the project budget).
- Currently enrolled in a research study to evaluate another eHealth platform or care coordination.
- Plans to move outside of Ontario within the next 12 months.
- Caregivers Eligibility Criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| aTouchAway™ platformParticipants 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. | Device | Intervention |
Primary outcome
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
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
33 secondary outcomes
Number of hospital admissions and days in hospital over 6 months using health administrative databases.
Time frame: 6 months± 4 weeks
Number of hospital admissions and days in hospital over 12 months using health administrative databases.
Time frame: 12 months ± 4 weeks
Hospital free survival using health administrative data at 6 months.
Time frame: 6 months ± 4 weeks
Hospital free survival using health administrative data at 12 months.
Time frame: 12 Months ± 4 weeks
Time to first ED visit and first hospital admission.
Time frame: 12 months ± 4 weeks
Overall survival at 6 months.
Time frame: 6 months ± 4 weeks
Overall survival at 12 months.
Time frame: 12 months ± 4 weeks
Respiratory and non-respiratory causes of death at 6 months.
Time frame: 6 months ± 4 weeks
Respiratory and non-respiratory causes of death at 12 months.
Time frame: 12 months ± 4 weeks
Number and type of outpatient specialist visits at 6 months.
Time frame: 6 months ± 4 weeks
Number and type of outpatient specialist visits at 12 months.
Time frame: 12 months ± 4 weeks
Number of family physician visits at 6 months.
Time frame: 6 months ± 4 weeks
Number of family physician visits at 12 months.
Time frame: 12 months ± 4 weeks
Homecare service use at 6 months.
Time frame: 6 months ± 4 weeks
Homecare service use at 12 months.
Time frame: 12 months ± 4 weeks
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
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
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
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
Quality of care coordination using Family Experiences with Care Coordination (FECC) for qualitative interview participants only
Time frame: 6 months ± 4 weeks
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
Mean monthly healthcare costs (public, private and caregiver lost time) over 6 months
Time frame: 6 months ± 4 weeks
Mean monthly healthcare costs (public, private and caregiver lost time) over 12 months
Time frame: 12 months ± 4 weeks
Encounter time spent by clinicians over 12 months measured using the Care Coordination Measurement Tool
Time frame: 12 months ± 4 weeks
Process Measure Outcomes
Time frame: 12 months ± 4 weeks
Process Measure Outcomes
Time frame: 12 months ± 4 weeks
Process Measure Outcomes
Time frame: 12 months ± 4 weeks
Process Measure Outcomes
Time frame: 12 months ± 4 weeks
Process Measure Outcomes
Time frame: 12 months ± 4 weeks
Process Measure Outcomes
Time frame: 12 months ± 4 weeks
Process Measure Outcomes
Time frame: 12 months ± 4 weeks
Process Measure Outcome- Qualitative Interviews
Time frame: 6 months ± 4 weeks
Process Measure Outcome- Site focus Groups
Time frame: 24 months ± 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2026.
- Derived from this study: PubMed 35130935Amin R, Gershon A, Buchanan F, Pizzuti R, Qazi A, Patel N, Pinto R, Moretti ME, Ambreen M; TtLIVE Group; Rose L. The Transitions to Long-term In Home Ventilator Engagement Study (Transitions to LIVE): study protocol for a pragmatic randomized controlled trial. Trials. 2022 Feb 7;23(1):125. doi: 10.1186/s13063-022-06035-z.
- Individual participant dataSharing planned: Undecided
Related trials for Long-term Ventilation at Home
Not yet recruiting
Long-term Use of Intrapulmonary Percussive Ventilation for Preventing Hospitalizations Due to Respiratory Decompensation in Children With Multiple Disabilities
Respiratory Decompensation, Multiple Disabilities
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Reshma Amin, MD, MSc principal investigator
The Hospital for Sick Children
Louise Rose, PhD principal investigator
King's College London
Andrea Gershon, MD, MSc principal investigator
Sunnybrook Health Sciences Centre
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing aTouchAway™ platform in people with Long-term Ventilation at Home, run by The Hospital for Sick Children at 8 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ED Visits: ED visit rates at 12 months determined using health administrative databases (time frame: 12 months± 4 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04180722, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2026.