An observational study in Type 2 Diabetes and Medication Adherence, sponsored by University of Florida. Withdrawn. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-10-03.
Sponsored by University of Florida · Observational
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)].
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.
9,357 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,318 are open to participants now.
Browse Diabetes Mellitus, Type 2 studies →University of Florida is the lead sponsor of 1,254 studies on the registry; 201 are open to participants now.
Of its 170 completed or terminated interventional studies of FDA-regulated products, 136 (80%) have results posted.
Counted across the registry records on this site, refreshed daily.
American Indians living on Choctaw Nation's 10.5 county service area who have type 2 diabetes
Exclusion Criteria:
(1) has end-stage renal disease
Semi-structured and Open-Ended Interview Questions
We will use a semi-structured interview guide that is structured based on medication adher
Time frame: 1 day
Demographic Questionnaire
Each patient will be asked to fill out a questionnaire regarding their demographic information (e.g., age, sex, income, education).
Time frame: 1 day
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.
Time frame: 1 day
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
This study is withdrawn, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.
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University of Florida