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Medication Use Among American Indians Adults

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT06053359
Recruitment Status : Withdrawn (The study has not been stopped. The study does not qualify as a clinical trial so it was withdrawn from clinicaltrials.gov.)
First Posted : September 25, 2023
Last Update Posted : October 3, 2023
Sponsor:
Information provided by (Responsible Party):
University of Florida

Study Description
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Brief 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)].


Condition or disease
Type 2 Diabetes Medication Adherence

Detailed 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.

Study Design
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Study Type : Observational
Actual Enrollment : 0 participants
Observational Model: Other
Time Perspective: Retrospective
Official Title: Understanding Medication Use Among Adult American Indians: Aim 3
Estimated Study Start Date : April 2024
Estimated Primary Completion Date : June 2025
Estimated Study Completion Date : June 2026

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. Semi-structured and Open-Ended Interview Questions [ Time Frame: 1 day ]
    We will use a semi-structured interview guide that is structured based on medication adher


Secondary Outcome Measures :
  1. Demographic Questionnaire [ Time Frame: 1 day ]
    Each patient will be asked to fill out a questionnaire regarding their demographic information (e.g., age, sex, income, education).

  2. Social Determinants of Health Questionnaire [ Time Frame: 1 day ]
    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.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
American Indians living on Choctaw Nation's 10.5 county service area who have type 2 diabetes
Criteria

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

Contacts and Locations
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No Contacts or Locations Provided
More Information
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT06053359    
Other Study ID Numbers: IRB202301346
First Posted: September 25, 2023    Key Record Dates
Last Update Posted: October 3, 2023
Last Verified: September 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Florida:
Type 2 diabetes
Medication Adherence
American Indians
 Barriers
Facilitators
Social Determinants of Health
Additional relevant MeSH terms:
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Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases