Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 6:50 PM
Ignite Modification Date:
2025-12-24 @ 6:50 PM
NCT ID:
NCT02928757
Eligibility Criteria:
Inclusion Criteria (Meets at least ONE criterion from EACH of the following four conditions):
* Technology dependent and/or users of high intensity care
* Child is dependent on mechanical ventilators, and/or requires prolonged IV administration of nutritional substances or drugs and/or is to have prolonged dependence on other device-based support. For example: tracheostomy tube care/ artificial airway, suctioning, oxygen support, or tube feeding
* Child has prolonged dependence on medical devices to compensate for vital bodily functions, and requires daily/ near daily nursing care, e.g., cardiorespiratory monitors; renal dialysis due to kidney failure
* Fragility
* The child has severe and/or life-threatening condition
* Lack of availability and/or failure of equipment/technology or treatment places the child at immediate risk resulting in a negative health outcome
* Short-term changes in the child's health status (e.g., an intercurrent illness) put them at immediate serious health risk
* Chronicity
* The child's condition is expected to last at least six more months
* The child's life expectancy is less than six months
* Complexity
* Involvement of at least five healthcare practitioners/ teams and healthcare services are delivered in at least three of the following locations: Home, School/Nursing school, Hospital, Children's Treatment Centre, Community-based clinic (e.g. doctor's office), Other (at clinician's discretion)
Exclusion Criteria:
* High Utilization of hospital level care
* ≥ 3 hospitalizations, ≥ 2 ICU admissions, ≥ 30 days of total hospitalization in previous 3 months, excluding newborn admission
* Patient with tracheostomy and home ventilation
* Medical Status is deemed highly fragile and the need for close follow-up is deemed essential by both referring and triaging team
* Already followed by a complex care team
* \>16.0 years of age
* Inadequate English language skills to comprehend study questionnaires
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
0 Years
Maximum Age:
16 Years
Study:
NCT02928757
Study Brief:
Protocol Section:
NCT02928757