A diabetes intervention program for American Indian and Alaska Native populations

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This research evaluates the Together Overcoming Diabetes (TOD) intervention, specifically designed to address the unique risk factors and social determinants affecting diabetes in American Indian and Alaska Native populations. The program aims to provide tailored support and resources to improve diabetes management among participants. It includes a randomized approach where some participants receive the TOD intervention while others are placed on a waitlist for standard care. The study focuses on adult individuals who self-identify as American Indian or Alaska Native and reside near the Oyate Health Center.

Why it matters

Who can join: the full rules

Inclusion Criteria - Adult Index Participants:

* 18 years and older
* Self-identifies as American Indian or Alaska Native
* Rapid City-based participants who reside within 1 hour transportation range of the Oyate Health Center
* Verification from a health provider to confirm Type 2 Diabetes diagnosis by laboratory test.
* Caregiver to a 10- to 25-year-old in their home at the time of screening.
* Willing to complete all implementation and follow-up assessments.
* Willing to be randomized for the intervention.

Exclusion Criteria - Adult Index Participants:

* Inability to participate in full intervention or evaluation (e.g., planned move, residential treatment, etc.)
* Willing to serve as 'support person' for the adult participant.
* Has a circumstance that might impact successful participation based on provider judgment considering instances where diabetes control can become more difficult with advanced disease or special conditions including: pregnant, nursing, or planning to become pregnant, end-stage renal disease on dialysis, diabetes due to secondary causes such as Cushing's or Cystic Fibrosis, or any condition that may inhibit participation

Inclusion Criteria - Youth Support Participants:

* Between 10 years and 25 years old
* Self-identifies as American Indian or Alaska Native.
* Willing to serve as 'support person' for the adult participant.
* Willing to complete all implementation and follow-up assessments.
* Willing to be randomized for the intervention.

Exclusion Criteria - Youth Support Participants:

* Cognitively or visually impaired
* Youth in foster care (due to potential mobility of foster youth).

Where it's running

• Center for Indigenous Health - Great Plains Hub
  Rapid City, South Dakota, United States Recruiting

Study contacts

• Principal investigator: Donald Warne, MD, MPH — Johns Hopkins University
• Study coordinator: Courtney Claussen, PhD
• Email: cclauss1@jh.edu
• Phone: 605-200-0043

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.