Diabetes, Diabetes Mellitus, Type 1 Diabetes, Young Adult
Conditions
Brief summary
The objective of this study is to test the early effects and implementation of an enhanced community health worker (CHW) model (T1D-CATCH) that encourages and supports diabetes technology use in young adults from underrepresented minority groups (YA-URMs) with type 1 diabetes (T1D). The investigators will conduct a 9-month randomized controlled trial in which YA-URMs will be randomized to T1D-CATCH or usual care. The investigators will recruit from adult and pediatric endocrinology and primary care practices in a large safety-net health system in the Bronx, New York. Our specific aims are to 1) evaluate T1D-CATCH effects on technology initiation and continued use over 6 months and 2) evaluate T1D-CATCH implementation using Proctor's Taxonomy of Implementation Outcomes: feasibility, adoption, fidelity, and cost.
Detailed description
The study will involve a 9-month randomized control trial of usual care versus T1D-CATCH, an intervention that enhances core community health worker (CHW) service roles to support increased use of T1D technology in young adults (underrepresented minorities) (YA-URM's). Participants will be recruited from primary and specialty care practices at Montefiore Medical Center in the Bronx, New York, which is a large safety-net hospital system in one of the poorest counties in the U.S. Two young adult-aged CHWs from the Montefiore CHW program will be trained extensively per our Supporting Emerging Adults with Diabetes (SEAD) program manuals. For YA-URMs, CHWs will conduct hands-on diabetes technology education, goal-setting, peer support, and social service linkage. CHWs will also help shift insurance approval tasks away from busy providers and better align patient-provider priorities through close communication between the YA-URM and provider. Group sessions will be optional and will follow the YA-centric education curriculum developed in Dr. Agarwal's Supporting Emerging Adults with Diabetes (SEAD) program.
Interventions
BEHAVIORALT1D-CATCH
As defined by the Centers for Disease Control and Prevention (CDC), a CHW is a frontline public health worker who is a trusted member of a community or who has a thorough understanding of the community being served, and leverages this unique position to link health systems, social services, and communities. CHWs engender trust with patients by having direct community and lived experience, offering specific support and empathy that may be difficult for other diabetes care professionals to provide. In addition, CHWs have firsthand understanding of cultural barriers to traditional western healthcare and can promote patient-centered culturally-relevant care. They enhance team-based care by helping providers with extra outreach, social needs management, time-consuming tasks, and aligning patient-provider priorities. CHWs in this project will provide social needs assessment and management, introduction to diabetes technologies, and support for onboarding to technology.
Sponsors
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
The Leona M. and Harry B. Helmsley Charitable Trust
Albert Einstein College of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
DOUBLE (Investigator, Outcomes Assessor)
Masking description
Participants will be randomized after enrollment into the study using REDCap. Study staff will notify CHWs of participant assignment to the intervention arm based on REDCap. Investigators, except the PI, and outcome assessors will remain blinded to arm assignment. The PI will not be able to be blinded because they will be required to do supervision and close oversight of the CHWs.
Intervention model description
9-month randomized controlled trial in which YA-URMs will be randomized to T1D-CATCH or usual care
Eligibility
Sex/Gender
ALL
Age
18 Years to 35 Years
Healthy volunteers
No
Inclusion criteria
* T1D duration ≥6 months * 18-35 years old * Self-identified URM status: non-Hispanic Black or Hispanic * English- or Spanish-speaking * Not currently on a connected diabetes technology system (includes never offered, prescribed but not started within 3 months of receiving the device, discontinued, or previously refused technology)
Exclusion criteria
* Developmental or sensory disability interfering with study participation * Current pregnancy * Participation in another behavioral or diabetes technology intervention study in the past 6 months.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Technology Initiation | 6 months following intervention | Technology use will be tracked using EMR prescriptions, self-reporting, CHW records, and device platforms and will be measured and reported as a binary variable (yes/no). Technology will include any combination of continuous glucose monitor (CGM), pump, or CGM and pump. Technology initiation will be defined as at least 1 week of first use in the 6-month period. Variables will be described using summary statistics with counts/percentages. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Technology Initiation | 3 months following intervention | Technology use will be tracked using EMR prescriptions, self-reporting, CHW records, and device platforms and will be measured and reported as a binary variable (yes/no). Technology will include any combination of continuous glucose monitor (CGM), pump, or CGM and pump. Technology use will be defined as at least 1 week of first use in the 3-month period. Variables will be described using summary statistics with counts/percentages. |
| Continued Technology Use - Percent Use | 9 months following intervention | Continued technology use by study end will be determined from device platform metrics detailing days/percent time used, in addition to self-report. Per standard diabetes technology clinical trial guidelines, CGM use is defined as pump use \>90% time. The percentage of time used (% used) will be summarized by study arm using basic descriptive statistics. A target of at least 90% CGM wear-time is associated with the best outcomes for glycemic control. |
| Continued Technology Use - Days of wear | 9 months following intervention | Continued technology use by study end will be determined from device platform metrics detailing days/percent time used, in addition to self-report. Per standard diabetes technology clinical trial guidelines, CGM use is defined as ≥ 5/7 days wear over the 9 month period. Days of wear will be summarized study arm using basic descriptive statistics. A target of at least 5/7 days of CGM wear-time is associated with the best outcomes for glycemic control. |
Other
| Measure | Time frame | Description |
|---|---|---|
| YA-URM Autonomy/ Competence, Social Support | Baseline | Measured using the Healthcare Self-Determination survey |
| Hemoglobin A1c | Baseline | Obtained by POC (in clinic) or laboratory (DCA Vantage) |
| Feasibility Check | 6 months (post-intervention) | Post-intervention interviews examining intervention content, complexity, comfort, delivery, and credibility |
| Quality of Life (Diabetes Distress | 6 month follow-up | Validated survey: Type 1 Diabetes and Life Scale - Young Adult (T1DAL-YA) Likert Scale: 1-5 (1= no, not at all true, 2=no, not very true, 3=sometimes true, sometimes not true, 4=yes, a little true, 5= yes, very true) |
| Quality of life (Diabetes Distress) | 6 month follow-up | Validated survey: Diabetes Self-Management Questionnaire (DSMQ) |
| Quality of Life (Diabetes Distress) | Baseline | Validated survey: Type 1 Diabetes and Life Scale - Young Adult (T1DAL-YA) Likert Scale: 1-5 (1= no, not at all true, 2=no, not very true, 3=sometimes true, sometimes not true, 4=yes, a little true, 5= yes, very true) |
| Adoption | 9 months (post-intervention) | Measured by recruitment logs |
| Fidelity | Baseline | Measured by the community health worker (CHW) dashboard |
| Cost | 6 months (post-intervention) | Measured by time sheets, receipts, and budget to analyze CHW salary/benefits |
Countries
United States
Outcome results
None listed