Type 1 Diabetes Mellitus Clinical Trial
Official title:
Improving Health Communication During the Transition From Pediatric to Adult Diabetes Care
Verified date | February 2024 |
Source | Children's National Research Institute |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 52 |
Est. completion date | December 15, 2024 |
Est. primary completion date | December 1, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 17 Years to 23 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Children's National Health System | Washington | District of Columbia |
Lead Sponsor | Collaborator |
---|---|
Children's National Research Institute | American Diabetes Association |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Hemoglobin A1c | measurement of hemoglobin A1c (A1c; reported as a percentage) | 8 months post-baseline | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 hospitalizations is summed. | 8 months post-baseline |
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