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Clinical Trials/NCT06348160
NCT06348160
Active, not recruiting
Not Applicable

iHERO Study: Insurance, Health and Economic Resources Online for Emerging Adults With Type 1 Diabetes

University Hospitals Cleveland Medical Center4 sites in 1 country195 target enrollmentMay 14, 2024

Overview

Phase
Not Applicable
Intervention
iHERO Toolkit Resource
Conditions
Type 1 Diabetes
Sponsor
University Hospitals Cleveland Medical Center
Enrollment
195
Locations
4
Primary Endpoint
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.
Status
Active, not recruiting
Last Updated
3 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
May 14, 2024
End Date
November 22, 2026
Last Updated
3 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Julia Blanchette

Assistant Professor of Medicine, Nurse Scientist

University Hospitals Cleveland Medical Center

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.

Arms & Interventions

iHERO Resource Group

Toolkit consisting of micro-videos and supplemental online resources.

Intervention: iHERO Toolkit Resource

Control

Outcomes

Primary Outcomes

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.

Time Frame: Baseline, 1 month, 6 months, 12 months

T1DAL-Young Adult and T1DAL- Adult are scored on a scale of 0-100 with higher scores indicating better health related quality of life.

Change in HbA1c levels as measured by self-collect capillary HbA1c

Time Frame: Baseline, 6 months, 12 months

Change in financial stress as measured by the Personal Financial Well-Being Scale© (PFW) Scale (PFW)

Time Frame: Baseline, 1 month, 6 months, 12 months

The PFW is an 8-item scale used to measure financial stress with a Likert scale of 1-10 with 1 being no financial stress and 10 being an overwhelming level of financial stress. Lower scores (≤ 4.4) indicate high financial stress, while scores ranging from 4.5-6.4 indicate average stress, and scores ≥ 6.5 indicate low stress.

Change in health insurance literacy as measured by The Health Insurance Literacy Measure (HILM) Measure (HILM)

Time Frame: Baseline, 1 month, 6 months, 12 months

The HILM is a 21-item measure used to rate confidence in selecting and using health insurance with 0 representing little confidence and 4 representing highest confidence. The scores of the items are summed and range from 0 to 84, with higher scores representing greater levels of health insurance literacy.

Change in transition navigation readiness as measured by the The Readiness for Emerging Adults with Diabetes Diagnosed in Youth (READDY) Navigation Subscale

Time Frame: Baseline, 1 month, 6 months, 12 months

READDY navigation sub-scale scores of 1-3 indicate lower levels of confidence and scores of 4-5 indicate higher levels of confidence in healthcare navigation.

Study Sites (4)

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