Eligibility Module

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 @ 10:18 PM
Ignite Modification Date: 2025-12-24 @ 10:18 PM
NCT ID: NCT05513235
Eligibility Criteria: Inclusion: * Adult parent/legal guardian (age 18 or older) who is a primary caregiver for a CYSHCN aged 0-16 years * Established care for their child/youth at a participating Duke Pediatrics Primary Care clinic: North Durham, South Durham,Brier Creek or Duke Med-Peds Primary Care sites (established = one or more completed visits in the past 12 months at the clinic) * High level of complex medical needs that could benefit from additional care coordination support (determined by clinical provider at the participating clinic site) * Primary care provider enrolled in the study as a provider participant/clinical provider site champion * Active Duke MyChart (online EHR patient portal) account * Full proxy access activated/enabled for parent to the child/youth's medical record in Epic * Apple iOS device compatible with Caremap app requirements at time of consent Exclusion Criteria: * Non-English speaking * Patients living in long-term, congregate settings - e.g., living in institutionalized settings such as long-term care facility, nursing/long-term rehab facilities * Child is a ward of the state * Lacks requisite technology to access and use mobile app (e.g., device/tablet/smartphone, home internet, active Epic MyChart account) * Lack of decision-making capacity (parent/caregiver or adult patient, clinician-determined)
Healthy Volunteers: False
Sex: ALL
Minimum Age: 18 Years
Study: NCT05513235
Study Brief:
Protocol Section: NCT05513235