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Health Communication Intervention for Type 1 Diabetes

N/A
Waitlist Available
Led By Maureen Monaghan, PhD
Research Sponsored by Children's National Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 8 months post-baseline
Awards & highlights

Study Summary

This trial will attempt to improve the transition of adolescents and young adults with type 1 diabetes to adult diabetes care by delivering an intervention focused on communication skills and transition readiness skills.

Who is the study for?
This trial is for young people aged 17-23 with type 1 diabetes who are about to switch from pediatric to adult care in the next 6-8 months. They should have been diagnosed for at least a year, speak and understand English well, and be able to text regularly. Those with life-threatening diseases or major psychiatric disorders that could hinder participation cannot join.Check my eligibility
What is being tested?
The study tests an intervention called 'Plan, Reflect, and Engage with Providers for Diabetes Care' aimed at improving health communication skills as adolescents transition to adult diabetes care. Participants will either receive this new intervention or standard care and their medical data will be tracked over time.See study design
What are the potential side effects?
Since the intervention focuses on communication and planning skills rather than medication or procedures, there are no direct physical side effects expected from participating in this trial.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~8 months post-baseline
This trial's timeline: 3 weeks for screening, Varies for treatment, and 8 months post-baseline for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Adherence to the diabetes care regimen
Diabetes-related hospitalizations
Hemoglobin A1c
+1 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: PREP-DC InterventionExperimental Treatment1 Intervention
50 participants will be randomized to the Plan, Reflect, and Engage with Providers for Diabetes Care (PREP-DC) intervention. Participants will complete 3 intervention sessions with study interventionists and will receive text messages and other study resources during the active intervention period (3 months).
Group II: Standard Care ComparisonActive Control1 Intervention
50 participants will be randomized to standard care and will participate in regular diabetes clinic visits and receive standard materials on the transition to adult diabetes care, as they would have done without participation in this study.

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Who is running the clinical trial?

Children's National Research InstituteLead Sponsor
210 Previous Clinical Trials
207,705 Total Patients Enrolled
American Diabetes AssociationOTHER
137 Previous Clinical Trials
99,450 Total Patients Enrolled
Maureen Monaghan, PhDPrincipal InvestigatorChildren's National Research Institute

Media Library

Plan, Reflect, and Engage with Providers for Diabetes Care Clinical Trial Eligibility Overview. Trial Name: NCT03734107 — N/A
Type 1 Diabetes Research Study Groups: PREP-DC Intervention, Standard Care Comparison
Type 1 Diabetes Clinical Trial 2023: Plan, Reflect, and Engage with Providers for Diabetes Care Highlights & Side Effects. Trial Name: NCT03734107 — N/A
Plan, Reflect, and Engage with Providers for Diabetes Care 2023 Treatment Timeline for Medical Study. Trial Name: NCT03734107 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Improving Health Communication During the Transition From Pediatric to Adult Diabetes Care
Randi Streisand 2018. "Improving Health Communication During the Transition From Pediatric to Adult Diabetes Care". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03734107.
All > Type 1 Diabetes
~8 spots leftby Apr 2025
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