NCT06216548 E-PRIME For Children With Medical Complexity
| NCT ID | NCT06216548 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Wake Forest University Health Sciences |
| Condition | Children With Medical Complexity |
| Study Type | INTERVENTIONAL |
| Enrollment | 909 participants |
| Start Date | 2024-06-19 |
| Primary Completion | 2028-04 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 909 participants in total. It began in 2024-06-19 with a primary completion date of 2028-04.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Children with medical complexity (CMC) have very high needs for health and support services. CMC have very rare diseases that involve multiple organ systems. As a result, all CMC have multiple chronic conditions and need care from many specialists and services. While there are important benefits to the child and family in living at home, the continuing need for complex medical care places a profound burden on caregivers. Telehealth has long been considered a potential solution to barriers in access to care for children. The purpose of this research is to test whether telehealth can help pediatric primary care providers (PCPs) as they treat, monitor, and manage children with medical complexity (CMC). Additionally, it is to reduce caregiver and child burden as well as improve care coordination between multiple providers.
Eligibility Criteria
Inclusion Criteria: * Less than 18 years of age on the date of enrollment (date consented) * Presence of a chronic condition, defined as a health condition expected to last ≥ 12 months * Complexity of the condition, defined as needing ongoing care with 4 sub-specialists/ services OR dependent on ≥ 1 technology (e.g. gastrostomy, tracheostomy, oxygen, ventilator, etc.) Exclusion Criteria: * CMC whose permanent address is outside of the state of North Carolina * CMC at a long-term care facility * CMC who are wards of the state, except when the caregiver is a legal guardian and can consent * CMC whose caregivers do not speak English or Spanish
Contact & Investigator
Savithri Nageswaran, MD
PRINCIPAL INVESTIGATOR
Wake Forest University Health Sciences
Frequently Asked Questions
Who can join the NCT06216548 clinical trial?
This trial is open to participants of all sexes, up to 17 Years, studying Children With Medical Complexity. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06216548 currently recruiting?
Yes, NCT06216548 is actively recruiting participants. Contact the research team at snageswa@wakehealth.edu for enrollment information.
Where is the NCT06216548 trial being conducted?
This trial is being conducted at Winston-Salem, United States.
Who is sponsoring the NCT06216548 clinical trial?
NCT06216548 is sponsored by Wake Forest University Health Sciences. The principal investigator is Savithri Nageswaran, MD at Wake Forest University Health Sciences. The trial plans to enroll 909 participants.