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Behavioural Intervention

Enhanced Primary Care for Children With Medical Complexity (E-PRIME Trial)

N/A
Recruiting
Led By Savithri Nageswaran, MD
Research Sponsored by Wake Forest University Health Sciences
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Less than 18 years of age
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up year 1
Awards & highlights

Summary

This trial is researching whether telehealth can help pediatric primary care providers treat and manage children with complex medical needs. These children have rare diseases that affect multiple organ systems, so they require care from many specialists

Who is the study for?
This trial is for children with complex medical needs involving multiple chronic conditions and organ systems. They require care from various specialists and have high support needs. The study aims to help caregivers by testing if telehealth can ease the burden of coordinating care among different providers.
What is being tested?
The trial is examining whether enhanced primary care that includes telehealth services can improve treatment, monitoring, and management for these children compared to usual care. It seeks to determine if this approach reduces caregiver stress and improves coordination between healthcare providers.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am under 18 years old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~year 1
This trial's timeline: 3 weeks for screening, Varies for treatment, and year 1 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Number of Days Outside the Home (DOH)
Secondary study objectives
Appointment Completion Rate
Change in Caregiver Burden scores
Change in Caregiver Satisfaction with coordination of care scores
+3 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Early Enhanced Primary Care (E-PRIME) GroupExperimental Treatment1 Intervention
Subjects of this arm will receive E-PRIME intervention at the start of enrollment.
Group II: Delayed Enhanced Primary Care (E-PRIME) GroupActive Control1 Intervention
Children will receive usual care before receiving E-PRIME intervention.

Find a Location

Who is running the clinical trial?

Wake Forest University Health SciencesLead Sponsor
1,266 Previous Clinical Trials
1,012,798 Total Patients Enrolled
Patient-Centered Outcomes Research InstituteOTHER
568 Previous Clinical Trials
27,248,500 Total Patients Enrolled
Savithri Nageswaran, MDPrincipal InvestigatorWake Forest University Health Sciences
1 Previous Clinical Trials
96 Total Patients Enrolled
~606 spots leftby Jun 2027
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