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Digital Personal Health Record for Special Healthcare Needs in Children
N/A
Waitlist Available
Led By David Y Ming, MD
Research Sponsored by Duke University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 3 months, 6 months
Awards & highlights
Study Summary
This trial will test the feasibility of a digital personal health record mobile app to help coordinate care for families of children with special healthcare needs.
Who is the study for?
This trial is for adult parents or caregivers of children and youth with special healthcare needs (CYSHCN) aged 0-16 years, who are patients at certain Duke Pediatrics Primary Care clinics. Participants must have an active online patient portal account, full proxy access to the child's medical record, and an Apple iOS device compatible with the app.Check my eligibility
What is being tested?
The study tests a mobile digital personal health record app designed to improve care coordination for families of CYSHCN. It will assess how well this app integrates with electronic health records over a six-month period using feedback from participating families.See study design
What are the potential side effects?
Since this trial involves a digital application rather than medication, traditional side effects are not applicable. However, participants may experience issues related to usability or technical difficulties with the app.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, 3 months, 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 3 months, 6 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in health-related quality of life (HR-QOL)
Change in parent/caregiver-reported degree of care integration, as measured by Pediatric Integrated Care Survey (PIC)
Change in usability, as measured by the System Usability Scale (SUS) (provider)
+6 moreSecondary outcome measures
Adoption (app prescriptions)
Adoption (family engagement)
Adoption (provider engagement)
+5 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: InterventionExperimental Treatment1 Intervention
Parents of eligible children and youth with special healthcare needs will use a digital personal record mobile application to coordinate care for six months.
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Who is running the clinical trial?
Duke UniversityLead Sponsor
2,358 Previous Clinical Trials
3,420,029 Total Patients Enrolled
1 Trials studying Children and Youth With Special Healthcare Needs
20 Patients Enrolled for Children and Youth With Special Healthcare Needs
Boston Children's HospitalOTHER
760 Previous Clinical Trials
5,579,640 Total Patients Enrolled
Agency for Healthcare Research and Quality (AHRQ)FED
399 Previous Clinical Trials
6,822,308 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am an adult caregiver for a child with special health care needs.I am unable to make my own medical decisions.
Research Study Groups:
This trial has the following groups:- Group 1: Intervention
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the aim of this experimental endeavor?
"The primary purpose of the 6-month study is to evaluate the appropriateness of this mobile app. Secondary objectives include assessing parent/caregiver confidence in avoiding hospitalization, measuring their net promoter score (NPS), and evaluating change in global health status with a 1 - 10 numeric rating scale."
Answered by AI
Are there any available slots for participants in this research?
"Per the information provided on clinicaltrials.gov, this particular trial is not presently recruiting patients. It was initially advertised on September 30th 2022 and has been revised since then; however, there are 47 other trials that are still admitting participants at present time."
Answered by AI
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