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Digital Health Pathway for Tracheostomy Care (DECIDE-T Trial)

N/A
Recruiting
Led By Maria Castro Codesal, MD, PhD
Research Sponsored by University of Alberta
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Children aged 0 to 18 who undergo tracheostomy procedure at participating sites
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights
No Placebo-Only Group

Summary

This trial is creating a standardized plan for children needing a tracheostomy and long-term ventilation. They will use digital tools to support families, caregivers, and healthcare professionals. The aim is to reduce

Who is the study for?
This trial is for children aged 0 to 18 who need a tracheostomy, which is a procedure that involves creating an opening in the neck to place a tube into a person's windpipe. There are no specific exclusion criteria, so all eligible children at participating sites can join.
What is being tested?
The DECIDE-T project tests a digital health pathway designed for kids needing tracheostomy care. It includes hospital-to-home guidelines with digital tools like educational resources, simulations for training, online support centers, and telehealth services after leaving the hospital.
What are the potential side effects?
Since this trial focuses on digital health solutions rather than medications or invasive treatments, traditional side effects aren't expected. However, there may be challenges related to using technology or potential stress associated with adapting to new care routines.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My child, aged 0-18, had a tracheostomy at a participating hospital.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Decannulation
Duration of tracheostomy
Hospital cost
+7 more
Secondary study objectives
Caregivers mental stress

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Active Control
Group I: Post-implementation/InterventionActive Control1 Intervention
Subjects undergoing tracheostomy procedure after the implementation of DECIDE-T
Group II: Pre-implementationActive Control1 Intervention
Subjects undergoing tracheostomy procedure before the implementation of DECIDE-T

Find a Location

Who is running the clinical trial?

University of AlbertaLead Sponsor
937 Previous Clinical Trials
433,644 Total Patients Enrolled
Alberta Innovates Health SolutionsOTHER
53 Previous Clinical Trials
93,963 Total Patients Enrolled
Maria Castro Codesal, MD, PhDPrincipal InvestigatorUniversity of Alberta
~120 spots leftby Dec 2025
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