Virtual care intervention for individuals on home ventilation
A Virtual Transition Intervention for Children and Adults Transitioning to Home Ventilation in Ontario: A Pragmatic Randomized Controlled Trial
This study is testing a virtual care program to see if it helps people using home ventilation manage their health better than regular care.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 440 (estimated) |
| Sex | All |
| Sponsor | The Hospital for Sick Children Academic / other |
| Locations | 8 sites (Hamilton, Ontario and 7 other locations) |
| Trial ID | NCT04180722 on ClinicalTrials.gov |
What this trial studies
The TTLive Study aims to evaluate the effectiveness of a virtual care platform in assisting individuals who have recently transitioned to home mechanical ventilation (HMV). This intervention will compare the outcomes of participants receiving virtual care against those receiving usual care, focusing on healthcare utilization, caregiver burden, and cost-effectiveness. The study addresses the complex care demands of ventilator-assisted individuals, including the challenges of clinical follow-ups and transitions between healthcare sectors. By utilizing the aTouchAway™ platform, the study seeks to enhance communication and care coordination for this vulnerable population.
Who should consider this trial
Good fit: Ideal candidates are individuals who have recently started using a ventilator for home mechanical ventilation within the last two months.
Not a fit: Patients with a projected life expectancy of less than two months or significant cognitive impairments may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly improve the quality of care and reduce healthcare costs for patients transitioning to home ventilation.
How similar studies have performed: Other studies have shown promise in using virtual care platforms for similar patient populations, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Hamilton, Ontario and 7 other locations
- McMaster Children's Hospital — Hamilton, Ontario, Canada (Recruiting)
- Children's Hospital, London Health Sciences — London, Ontario, Canada (Not_yet_recruiting)
- London Health Sciences Center — London, Ontario, Canada (Recruiting)
- Children's Hospital of Eastern Ontario — Ottawa, Ontario, Canada (Recruiting)
- The Ottawa Hospital — Ottawa, Ontario, Canada (Recruiting)
- The Hospital for Sick Children — Toronto, Ontario, Canada (Recruiting)
- Sunnybrook Health Sciences Center — Toronto, Ontario, Canada (Recruiting)
- West Park Healthcare Centre — York, Ontario, Canada (Recruiting)
Study contacts
- Principal investigator: Reshma Amin, MD, MSc — The Hospital for Sick Children
- Study coordinator: Munazzah Ambreen
- Email: munazzah.ambreen@sickkids.ca
- Phone: (416) 813-7654
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.