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:
2025-12-25 @ 1:17 AM
Ignite Modification Date:
2025-12-25 @ 1:17 AM
NCT ID:
NCT05056493
Eligibility Criteria:
Inclusion criteria for parents/caregivers of children/youth with special health care needs (CYSHCN):
* Adult parent/legal guardian (age 18 or older) of a CYSHCN
* Established care for their child/youth at Duke Pediatrics Primary Care or Duke Children's Cystic Fibrosis clinic (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 pilot site)
* Primary 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
Inclusion criteria for adult patients with multiple chronic conditions (MCC):
* Adult patient (age 18 or older) with MCC
* Established care for the patient at Duke Geriatrics clinic or Duke Pulmonary Transplant clinic (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 provider enrolled in the study as a provider participant/clinical provider site champion
* Active Duke MyChart (online EHR patient portal) account
* Apple iOS device compatible with Caremap app requirements at time of consent
Inclusion criteria for clinical provider site champions (to participate in interviews and quantitative provider-reported surveys):
* Currently practicing at Duke Health
* Primary site of work is participating clinic site
Exclusion criteria:
* Non-English speaking
* Living in long-term, congregate settings - e.g., living in institutionalized settings such as long-term care facility, nursing/long-term rehab facilities
* 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 (clinician-determined; e.g., patients with advanced dementia)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05056493
Study Brief:
Protocol Section:
NCT05056493