Improving Health Communication During the Transition From Pediatric to Adult Diabetes Care
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|ClinicalTrials.gov Identifier: NCT03734107|
Recruitment Status : Enrolling by invitation
First Posted : November 7, 2018
Last Update Posted : January 21, 2020
|Condition or disease||Intervention/treatment||Phase|
|Type 1 Diabetes Mellitus||Behavioral: Plan, Reflect, and Engage with Providers for Diabetes Care||Not Applicable|
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 :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Participants are randomized in a 1:1 ratio to the intervention group or standard care comparison group|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Improving Health Communication During the Transition From Pediatric to Adult Diabetes Care|
|Actual Study Start Date :||November 6, 2018|
|Estimated Primary Completion Date :||August 2022|
|Estimated Study Completion Date :||December 2022|
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).
Behavioral: Plan, Reflect, and Engage with Providers for Diabetes Care
Behavioral intervention designed to improve health communication skills and readiness for adult diabetes care
Other Name: PREP-DC
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.
- Hemoglobin A1c [ Time Frame: 8 months post-baseline ]measurement of hemoglobin A1c (A1c; reported as a percentage)
- Number of days to first adult diabetes care visit [ Time Frame: 8 months post-baseline ]Number of days between the last visit in pediatric diabetes care and the first visit in adult diabetes care (reported as number of days)
- Adherence to the diabetes care regimen [ Time Frame: 8 months post-baseline ]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.
- Diabetes-related hospitalizations [ Time Frame: 8 months post-baseline ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03734107
|United States, District of Columbia|
|Children's National Health System|
|Washington, District of Columbia, United States, 20010|
|Principal Investigator:||Maureen Monaghan, PhD||Children's National Research Institute|