Clinical trial NCT06626347: Telemedicine for Reach, Education, Access, and Treatment for Diabetes Self-Management Education and Support
Official title: Application of the Telemedicine for Reach, Education, Access, and Treatment Delivery Model to Engage Emerging Adults in Diabetes Self-Management Education and Support
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Type 1 Diabetes (T1D)
Keywords: Type 1 Diabetes
Emerging Adults
Telemedicine
Health Care Delivery
Diabetes Self-Management Education and Support
Visit Attendance
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2024-10-03
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Emerging adults with type 1 diabetes are a vulnerable population. While diabetes self-management and education is known to offer opportunities to develop self-management skills required to achieve and maintain short- and long-term diabetes outcomes, emerging adults are reported to have poor clinic attendance and in turn low participation in diabetes self-management education and support services. This pilot study aims to test a novel approach to diabetes self-management education and support that incorporates technological and applied learning-driven methods delivered through group telemedicine visits to improve emerging adults engagement in diabetes self-management education and support with the ultimate goal of improving diabetes outcomes.

Detailed description: Diabetes self-management education and support is considered a cornerstone of care and essential in helping people navigate self-management decisions and activities. Despite evidence that diabetes self-management education and support is a critical component of diabetes care, participation remains low. Emerging adulthood has been described as the distinct period between 18 and 25 years when adolescents work to achieve autonomy and explore life possibilities in moving toward adulthood. Suboptimal self-management has been identified as a major problem in emerging adults with type 1 diabetes, a particularly vulnerable group with an increased risk for poor diabetes-related outcomes. In its current form diabetes self-management education and support has been cited for not meeting the needs of emerging adults, when emerging adults have expressed interest in diabetes self-management education and support delivered with peer-supported, technological and applied learning-driven methods. To address these challenges, we are applying information gained from the literature and key stakeholder groups to our established Telemedicine for Reach, Education, Access and Treatment (TREAT) delivery model with a specific focus on diabetes self-management education and support. TREAT-ED (for self-management EDucation) will be designed to specifically engage emerging adults by integrating diabetes self-management education and support objectives to support informed decision making, self-care, and preparation for transfer to adult care, to improve outcomes. Diabetes care and education specialists will lead TREAT-ED with a cohort of emerging adults and will 1) help to organize and facilitate group sessions delivered through telehealth and 2) use continuous blood glucose monitoring reports as personalized examples to drive established diabetes self-management education and support content. With user-centered design techniques we developed and built and will now evaluate implementation determinants and test the TREAT-ED model. Feasibility assessment of the impact of the model on emerging adult patient participation in diabetes self-management education and support along with clinical, psychosocial and behavioral outcomes will be examined. We hypothesize that models that rely on current day strategies to engage emerging adults at high risk for diabetes-related problems with effective self-management skills will improve diabetes self-management education and support engagement and outcomes. If proven to be effective, this model is one that could be adapted for emerging adults who have transferred to adult diabetes care and other patient populations throughout the United States.

Eligibility criteria: Inclusion Criteria:

* Diagnosed with type 1 diabetes (ICD10 E10.xx, O24.0x)
* 18 to 25 years of age at time of study enrollment
* Able to communicate via videoconferencing platform
* Intending to maintain status as a patient at participating clinical sites throughout the study duration
* Able to provide informed consent

Exclusion Criteria:

* Do not have a diagnosis of type 1 diabetes (ICD10 E10.xx, O24.0x)
* Less than 18 or older than 25 years old at time of enrollment
* Do not intend to maintain their care at participating clinical sites throughout the duration of the study
* Are unable to communicate via telemedicine
* Has other concerns that may interfere significantly with their ability to participate in the intervention (ongoing health issues, personal events, etc.)

Primary outcomes:
measure: Number of diabetes self-management education and support sessions attended
timeFrame: From baseline to 6 months
Secondary outcomes:
measure: Change from baseline in empowerment at 6 months
timeFrame: Baseline vs. 6 months
measure: Change from baseline in readiness for transition at 6 months
timeFrame: Baseline vs. 6 months
measure: Change from baseline in self-efficacy at 6 months
timeFrame: Baseline vs. 6 months
measure: Change from baseline in diabetes distress at 6 months
timeFrame: Baseline vs. 6 months
measure: Change in percentage of patients with glycemic control from baseline to 6 months.
timeFrame: Baseline vs. 6 months
measure: Percentage of time in target glycemic range (70-180 mg/dL)
timeFrame: From baseline to 6 months
measure: Number of acute care visits
timeFrame: From baseline to 6 months
measure: Number of diabetes clinic visits attended
timeFrame: From baseline to 6 months
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: UPMC Childrens Hospital of Pittsburgh
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Ingrid Libman, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Pittsburgh
name: Linda Siminerio, RN, PhD, CDCES
role: PRINCIPAL_INVESTIGATOR
References: