- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03734107
Improving Health Communication During the Transition From Pediatric to Adult Diabetes Care
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Research Design and Methods Overview of Study Design & Procedure. The aim of this randomized controlled trial (RCT) is to determine the efficacy of a behavioral intervention targeting health communication skills and diabetes self-management skills in preparation for the transfer to adult diabetes care, compared to usual care. The intervention, Plan, Reflect, and Engage with Providers for Diabetes Care (PREP-DC), consists of three intervention sessions with a study interventionist, paired text messages, and access to glucose management software. It is expected that adolescents and young adults allocated to the intervention condition (PREP-DC) will evidence: 1) better glycemic control (lower A1c); 2) shorter gap in time between the last visit in pediatric diabetes care and the first visit in adult diabetes care; 3) better diabetes management (better adherence to the diabetes regimen); 4) fewer reported complications (e.g. hospitalizations and emergency department visits). A total of 100 adolescent and young adult participants (ages 17-23) will be randomly allocated in a 1:1 ratio to either the PREP-DC intervention condition (n=50) or usual care (n=50; standard care comparison condition): all participants receive standard resources for transition to adult diabetes care as part of usual care in both conditions.
Participants include 100 adolescents and young adults (ages 17-23) diagnosed with T1D for at least one year (anticipated 50% female) seen for diabetes care at Children's National Medical Center (CNMC) in Washington, DC. Eligible participants will self-identify as planning to transfer to adult diabetes care within the upcoming 6-8 months. Participants in the PREP-DC intervention will complete three intervention sessions with study team members over a 3 month period (approximately 1 intervention session per month). Two sessions will be with a trained study interventionist focusing on communication with health care providers and preparation for medical visits and adult diabetes care. One session will be with a certified diabetes education focusing on problem-solving using glucose data and glucose data review. PREP-DC intervention participants will also receive text messages (3-4 messages/week) for the 3 month intervention period supporting intervention content. Participants also will be given information about accessing glucose management software specific to their diabetes devices and related study resources (e.g. study website). Participants are evaluated at baseline (pre-randomization to intervention or standard care comparison group) and follow-up (approximately 4 months post-baseline and approximately 8-12 months post-baseline after the transition to adult diabetes care).
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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District of Columbia
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Washington, District of Columbia, United States, 20010
- Children's National Health System
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Diagnosed with type1 diabetes for ≥ 1 year
- Able to adequately understand, speak, and read English to benefit from participation
- Ready and consistent text messaging access to participate
- Within 6-8 months of planned transfer to adult diabetes care
Exclusion Criteria:
- Other life-threatening disease (e.g. cancer) or major psychiatric disorder (e.g. schizophrenia) that significantly limits participation
- Pervasive developmental disorder that significantly limits participation
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: PREP-DC 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).
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Behavioral intervention designed to improve health communication skills and readiness for adult diabetes care
Other Names:
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No Intervention: Standard Care Comparison
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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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Hemoglobin A1c
Time Frame: 8 months post-baseline
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measurement of hemoglobin A1c (A1c; reported as a percentage)
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8 months post-baseline
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Number of days to first adult diabetes care visit
Time Frame: 8 months post-baseline
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Number of days between the last visit in pediatric diabetes care and the first visit in adult diabetes care (reported as number of days)
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8 months post-baseline
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Adherence to the diabetes care regimen
Time Frame: 8 months post-baseline
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Participant report on the Diabetes Management Questionnaire (DMQ), a self-report measure of adherence to the diabetes care regimen.
The DMQ consists of 20 items scored on a 0-4 Likert Scale.
The measure has a total score; the mean score on all items is calculated and multiplied by 25 to arrive at the total score (possible range 0-100).
A higher score indicates greater adherence to diabetes management.
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8 months post-baseline
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Diabetes-related hospitalizations
Time Frame: 8 months post-baseline
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Participant report and medical record review of reported diabetes-related hospitalizations for the duration of the study period.
The total number of hospitalizations is summed.
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8 months post-baseline
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Randi Streisand, PhD, Children's National Research Institute
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 30004426
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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