Clinical trial NCT06348160: iHERO Study: Insurance, Health and Economic Resources Online for Emerging Adults With Type 1 Diabetes
Official title: iHERO Study: Insurance, Health and Economic Resources Online for Emerging Adults With Type 1 Diabetes
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Type 1 Diabetes
Keywords: Type 1 diabetes
Health insurance
Financial stress
Young adults
Health insurance literacy
Lead sponsor: University Hospitals Cleveland Medical Center
Sponsor class: OTHER
Collaborators: name: The Leona M. and Harry B. Helmsley Charitable Trust
First posted: 2024-04-04
Enrollment: 192
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This research study aims to test a financial and health insurance iHERO Toolkit for young adults with type1 diabetes. The iHERO Toolkit was developed over one year with the type 1 diabetes community, The Diabetes Link organization, and experts. Now, the investigators want to understand the impact of the iHERO Toolkit on diabetes self-management, financial stress, and health insurance literacy outcomes. The investigators are doing this study because it will help to better understand how to support health insurance and financial stress and improve self-management outcomes in young adults with type 1 diabetes. The investigators want to understand how the iHERO Toolkit helps all young adults with diabetes, but especially those on Medicaid and who are racially or ethnically diverse. The investigators will ask participants to participate at four-time points over one year. For the first time, participants will fill out online enrollment and demographic forms and 9 surveys. The 9 surveys have 8-40 short questions each, estimated to take about 45 minutes. Participants will also be asked to complete a home A1c collection with a University Hospitals team member on Zoom.


Eligibility criteria: Inclusion Criteria:

* Age range: 18-30 years
* Diagnosis of type 1 diabetes (T1D)
* T1D duration for one year or longer
* Geographical location: residing in the United States.

Exclusion Criteria:

* Inability to answer questions due to cognitive status.
* Inability to read or understand English.
* Diagnosis of insulin-dependent diabetes that is not T1D such as cystic fibrosis-related diabetes, maturity-onset diabetes of the young, or insulin-dependent type 2 diabetes.

Primary outcomes:
measure: Change in financial stress as measured by the Personal Financial Well-Being Scale© (PFW) Scale (PFW)
timeFrame: Baseline, 1 month, 6 months, 12 months
measure: Change in health insurance literacy as measured by The Health Insurance Literacy Measure (HILM) Measure (HILM)
timeFrame: Baseline, 1 month, 6 months, 12 months
measure: Change in diabetes-specific quality of life as measured by The Type 1 Diabetes and Life Young Adult (T1DAL- Young Adult) for ages 18-25 or The Type 1 Diabetes and Life (T1DAL- Adult) for Ages 26-30.
timeFrame: Baseline, 1 month, 6 months, 12 months
measure: Change in transition navigation readiness as measured by the The Readiness for Emerging Adults with Diabetes Diagnosed in Youth (READDY) Navigation Subscale
timeFrame: Baseline, 1 month, 6 months, 12 months
measure: Change in HbA1c levels as measured by self-collect capillary HbA1c
timeFrame: Baseline, 6 months, 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Children's Hospital Los Angeles
state: California
city: Gainesville
country: United States
facility: University of Florida Diabetes Institute
state: Florida
city: Cleveland
country: United States
facility: University Hospitals
state: Ohio
city: Philadelphia
country: United States
facility: Children's Hospital of Philadelphia
state: Pennsylvania
Study officials:
affiliation: University Hospitals
name: Julia Blanchette, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Blanchette JE, Toly VB, Wood JR. Financial stress in emerging adults with type 1 diabetes in the United States. Pediatr Diabetes. 2021 Aug;22(5):807-815. doi: 10.1111/pedi.13216. Epub 2021 May 18.
citation: Blanchette JE, Allen NA, Litchman ML. The Feasibility and Acceptability of a Community-Developed Health Insurance and Financial Toolkit for Emerging Adults With Type 1 Diabetes. Sci Diabetes Self Manag Care. 2022 Jun;48(3):174-183. doi: 10.1177/26350106221087474. Epub 2022 Mar 15.