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

NCT04180722 | Completed

• 1 other identifier: 1000000000
• Study Type: interventional
• Target: 444
• Locations: 1 country
• Sites: 8

Brief 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.

Conditions

Long-term Ventilation at Home

Keywords

Home mechanical ventilation; Ventilator assisted individuals; Virtual Intervention

Outcome Measures

Primary Outcomes (2)

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

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

  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

  12 months± 4 weeks

Secondary Outcomes (33)

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

  6 months± 4 weeks

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

  12 months ± 4 weeks

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

  6 months ± 4 weeks

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

  12 Months ± 4 weeks

• Time to first ED visit and first hospital admission.

  12 months ± 4 weeks

Study Arms (2)

Intervention

EXPERIMENTAL

Participants will receive multi-component Virtual Transition Intervention facilitated through the aTouchAway™ platform including the usual care provided by specialist HMV programs.

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.

Interventions

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.

Intervention

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

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

Study Sites (8)

McMaster Children's Hospital

Hamilton, Ontario, Canada

Location

Children's Hospital, London Health Sciences

London, Ontario, N6A 5W9, Canada

Location

London Health Sciences Center

London, Ontario, Canada

Location

Children's Hospital of Eastern Ontario

Ottawa, Ontario, Canada

Location

The Ottawa Hospital

Ottawa, Ontario, Canada

Location

The Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

Location

Sunnybrook Health Sciences Center

Toronto, Ontario, Canada

Location

West Park Healthcare Centre

York, Ontario, M6M 2J5, Canada

Location

Related Publications (1)

• 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.

  PMID: 35130935 DERIVED

Study Officials

• Reshma Amin, MD, MSc

  The Hospital for Sick Children

  PRINCIPAL INVESTIGATOR

• Louise Rose, PhD

  King's College London

  PRINCIPAL INVESTIGATOR

• Andrea Gershon, MD, MSc

  Sunnybrook Health Sciences Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The research coordinator that is consenting the patient and doing the intervention allocation will be different than the research coordinator assessing the outcomes. The outcomes assessor will remain blinded as to whether the participant has received the intervention or not
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Staff Physician

Model Details: 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.

Study Record Dates

• First Submitted: November 21, 2019
• First Posted: November 27, 2019
• Study Start: March 1, 2021
• Primary Completion: January 30, 2026
• Study Completion: January 30, 2026
• Last Updated: February 3, 2026

Record last verified: 2026-01

Locations

CA (8)