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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

No Placebo-Only Group

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.

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.

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 8 months post-baseline

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Adherence to the diabetes care regimen

Diabetes-related hospitalizations

Hemoglobin A1c

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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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