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Medication Use Among American Indians Adults

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University of Florida

Status

Withdrawn

Conditions

Medication Adherence
Type 2 Diabetes

Study type

Observational

Funder types

Other

Identifiers

NCT06053359
IRB202301346

Details and patient eligibility

About

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)].

Full 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.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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