Transition to LIVE (Long-term In Home Ventilation Engagement) Study (NCT04180722) | Clinical Trial Compass
CompletedNot Applicable
Transition to LIVE (Long-term In Home Ventilation Engagement) Study
Canada444 participantsStarted 2021-03-01
Plain-language 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. 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.
Who can participate
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 aTouchAwa…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
ED Visits: ED visit rates at 12 months determined using health administrative databases
Timeframe: 12 months± 4 weeks
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