Medication Use Among American Indians Adults

Type 2 Diabetes Clinical Trial

Official title:

Understanding Medication Use Among Adult American Indians: Aim 3

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT06053359
• Other study ID #: IRB202301346
• Status: Withdrawn
• Start date: April 2024
• Est. completion date: June 2026

Study information

• Verified date: September 2023
• Source: University of Florida
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The goal of this study is to explore facilitators of and barriers to medication adherence within the context of local social determinants of health (SDOH) that are not available in the EHR.

for American Indians with type 2 diabetes. The main aim is:

Identify facilitators of and barriers to medication adherence within the context of SDOH, Electronic Health Record (EHR) derived medication adherence [HbA1c < 7 (at target); HbA1c >7% to ≤9% (above target); and HbA1c > 9% (uncontrolled)].

Description:

The investigators will identify potential participants by drawing a sub sample of 90 patients from the larger sample (based on findings from aims 1 and 2).

Once patients are identified University of Florida (UF) study team members will provide a coded list of eligible patients, from the limited dataset, to the Choctaw Nation of Oklahoma (CNO) Information Management team. The CNO Information Management team will provide the contact information for 135 individuals directly to the CNO community health worker who will then contact patients. UF study team members will not have access to the identifiable data.

The CNO community health worker (not UF study team members) will contact by telephone or in person at a scheduled visit the identified patients within each of the sampling groups (labeled 1-6) to introduce the study and screen for eligibility.

After reviewing the consent, answering any questions, and obtaining written consent for the study, the CNO community health worker will use a structured interview guide containing semi-structured and open-ended questions with probes to collect in-depth information from the patient. As part of the interview session patients will be asked to complete 3 sets of questionnaire items: demographic, SDOH, and medication and utilization.

All interviews will be audio recorded and professionally transcribed and validated for accuracy. Instead of using patient names CNO will link each transcript back to the code number provided by the UF study team. The UF study team will not have access to the link of the code number to the patient identifier. The de-identified transcripts will be sent to UF Study team members for analysis. A UF study team member will use a qualitative data management program to aid in analyzing and managing the data.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 2026
• Est. primary completion date: June 2025
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. enrolled tribal member

2. 18 years and older

3. have been diagnosed with type 2 diabetes

4. live within CNOs 10.5 county service area

5. use CNO Tribal Health Services

6. for whom cardiometabolic levels and medication adherence level will have been generated from the aim 1 analysis of CNO data

7. willing and able to participant in a 60-90-minute interview focused on facilitators of and barriers to medication adherence.

Exclusion Criteria:

(1) has end-stage renal disease

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Medication Adherence
• Type 2 Diabetes

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Florida

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Semi-structured and Open-Ended Interview Questions	We will use a semi-structured interview guide that is structured based on medication adher	1 day
Secondary	Demographic Questionnaire	Each patient will be asked to fill out a questionnaire regarding their demographic information (e.g., age, sex, income, education).	1 day
Secondary	Social Determinants of Health Questionnaire	We will assess facilitators of and barriers to medication adherence within the context of SDOH using adaptation of validated questions from the Toolkit.7 Questions related to housing, transportation, miles to grocery store and tribal clinic, involvement with CNO cultural activities, use of CNO food distribution.	1 day