Improving Health Communication During the Transition From Pediatric to Adult Diabetes Care

NCT03734107 | Completed Results

• 1 other identifier: 30004426
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief Summary

Adolescents and young adults (AYAs; ages 17-23) with type 1 diabetes are at high risk for negative health outcomes, including poor glycemic control and disengagement from the health care system. The deterioration of glycemic control occurs in parallel with the assumption of independent self-care skills and preparation for adult diabetes care. Effective communication between AYAs and health care providers may be a critical contributor to diabetes self-care skills during the transition to adult diabetes care and related glycemic control. This research will attempt to better prepare adolescents and young adults for adult diabetes care by delivering innovative intervention content focused on both health communication skills and transition readiness skills. The investigators aim to leverage innovative technologies to improve developmentally-appropriate communication skills related to planning for clinic visits, disclosing and discussing diabetes-related concerns, and optimizing glucose data review in preparation for adult diabetes care. Adolescents and young adults with type 1 diabetes (ages 17-23) who are planning to transition to adult diabetes care within the next 6-8 months will be enrolled in the study and randomized to either the intervention group or a standard care control group. Medical, communication and psychosocial data (including A1c, glucose monitoring frequency, communication quality, health care engagement, depressive symptoms) will be collected from adolescent and young adult participants and health care providers at baseline and two follow-up time points, approximately 4 months post-baseline and approximately 8-12 months post-baseline after the transfer to adult diabetes care. This intervention has the potential to improve diabetes self-care skills, including engagement with health care providers, and glycemic control in AYAs with type 1 diabetes during the vulnerable period of transfer to adult diabetes care. The results of this work will inform best practices for the transition to adult diabetes care and can be translated into clinical care.

Conditions

Type 1 Diabetes Mellitus

Keywords

transition to adult medical care; adolescents and young adults; health communication; adherence; type 1 diabetes

Outcome Measures

Primary Outcomes (4)

• Hemoglobin A1c

  percentage of glycated hemoglobin (Hemoglobin A1c)

  8 months post-baseline

• Number of Days to First Adult Diabetes Care Visit

  Number of days between the last visit in pediatric diabetes care and the first visit in adult diabetes care (reported as number of days).

  8 months post-baseline

• Adherence to the Diabetes Care Regimen

  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.

  8 months post-baseline

• Diabetes-related Hospitalizations

  Participant report and medical record review of reported diabetes-related hospitalizations for the duration of the study period. The total number of diabetes-related emergency department visits/hospitalizations is summed.

  8 months post-baseline

Study Arms (2)

PREP-DC Intervention

EXPERIMENTAL

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

Standard Care Comparison

NO 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.

Interventions

Plan, Reflect, and Engage with Providers for Diabetes Care BEHAVIORAL

Behavioral intervention designed to improve health communication skills and readiness for adult diabetes care

Also known as: PREP-DC

PREP-DC Intervention

Eligibility Criteria

• Age: 17 Years - 23 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• American Diabetes Association: collaborator
• Children's National Research Institute: lead

Study Sites (1)

Children's National Health System

Washington D.C., District of Columbia, 20010, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Limitations and Caveats

A total of 52 participants were enrolled in the trial (planned enrollment: 100 participants). This trial was impacted by the COVID-19 pandemic.

Results Point of Contact

• Title: Dr. Randi Streisand
• Organization: Children's National

rstreis@childrensnational.org

202-476-2730

Study Officials

• Randi Streisand, PhD

  Children's National Research Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Participants are randomized in a 1:1 ratio to the intervention group or standard care comparison group

Study Record Dates

• First Submitted: November 1, 2018
• First Posted: November 7, 2018
• Study Start: November 6, 2018
• Primary Completion: December 1, 2023
• Study Completion: January 2, 2026
• Last Updated: May 5, 2026
• Results First Posted: May 5, 2026

Record last verified: 2026-05

Locations

US (1)