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临床试验/NCT06053359
NCT06053359撤回不适用

Understanding Medication Use Among Adult American Indians: Aim 3

University of Florida0 个研究点开始时间: 2024年4月最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
主要终点
Semi-structured and Open-Ended Interview Questions

研究概览

简要总结

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)].

详细描述

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.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • enrolled tribal member
  • 18 years and older
  • have been diagnosed with type 2 diabetes
  • live within CNOs 10.5 county service area
  • use CNO Tribal Health Services
  • for whom cardiometabolic levels and medication adherence level will have been generated from the aim 1 analysis of CNO data
  • willing and able to participant in a 60-90-minute interview focused on facilitators of and barriers to medication adherence.

排除标准

  • (1) has end-stage renal disease

结局指标

主要结局

Semi-structured and Open-Ended Interview Questions

时间窗: 1 day

We will use a semi-structured interview guide that is structured based on medication adher

次要结局

  • Social Determinants of Health Questionnaire(1 day)
  • Demographic Questionnaire(1 day)

研究者

申办方类型
Other
责任方
Sponsor

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Medication Use Among American Indians Adults | 临床试验