RECRUITING

E-PRIME For Children With Medical Complexity

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Enhanced Primary Care Via Telehealth for Children With Medical Complexity

Quick Facts

Study Start:2024-06-19
Study Completion:2028-04
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06216548

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:Not specified to 17 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. * Less than 18 years of age on the date of enrollment (date consented)
  2. * Presence of a chronic condition, defined as a health condition expected to last ≥ 12 months
  3. * 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.)
  1. * CMC whose permanent address is outside of the state of North Carolina
  2. * CMC at a long-term care facility
  3. * CMC who are wards of the state, except when the caregiver is a legal guardian and can consent
  4. * CMC whose caregivers do not speak English or Spanish

Contacts and Locations

Study Contact

Savithri Nageswaran, MD
CONTACT
336-716-6508
snageswa@wakehealth.edu
Madeleine Nieto, MPH
CONTACT
336.978.1913
mnieto@wakehealth.edu

Principal Investigator

Savithri Nageswaran, MD
PRINCIPAL_INVESTIGATOR
Wake Forest University Health Sciences
Sabina Gesell, PhD
PRINCIPAL_INVESTIGATOR
Wake Forest University Health Sciences

Study Locations (Sites)

Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157
United States

Collaborators and Investigators

Sponsor: Wake Forest University Health Sciences

  • Savithri Nageswaran, MD, PRINCIPAL_INVESTIGATOR, Wake Forest University Health Sciences
  • Sabina Gesell, PhD, PRINCIPAL_INVESTIGATOR, Wake Forest University Health Sciences

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-06-19
Study Completion Date2028-04

Study Record Updates

Study Start Date2024-06-19
Study Completion Date2028-04

Terms related to this study

Keywords Provided by Researchers

  • Collaboration
  • Providers
  • Telehealth

Additional Relevant MeSH Terms

  • Children With Medical Complexity