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临床试验/NCT03394456
NCT03394456已完成不适用

Technology to Improve the Health of Resource-poor Hispanics With Diabetes

Baylor College of Medicine2 个研究点 分布在 1 个国家目标入组 265 人开始时间: 2018年1月13日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
265
试验地点
2
主要终点
Glycemic control

研究概览

简要总结

This study evaluates the efficacy and implementation of a telehealth-supported, integrated diabetes group visit program led by Community Health Workers (CHWs). Primary study relates to efficacy and a secondary study addresses mentored implementation.

详细描述

The number of Hispanics diagnosed with diabetes is escalating in the US with disproportionately higher prevalence and complication rates than other ethnicities. CHWs are a well-established and culturally sensitive means to bridge gaps in care to individuals with diabetes. However CHWs are often left unsupported, placing patients at risk of substandard care or harm. Telehealth is a term used to describe a range of technologies to support healthcare delivery via communication with the patient or a member of the healthcare delivery team. Though telehealth has been implemented into diabetes programs for many years, there is a paucity of data showing the use of telemedicine for CHW training and support.

The primary study (n=89; Cohorts 1,2) compares clinical outcomes and treatment satisfaction of individuals who receive diabetes care in a 12-month telehealth supported, integrated CHW-led group visit program compared to those in usual care (wait list control). Group visits are 6-months and CHWs contact patients weekly to bimonthly (mobile health (mHealth)) for 12-months. This phase with have two cohort waves, separated by 6-months. The wait list control group for Cohort 2 will explore telehealth, clinician-patient encounters. A secondary study (n=59; Cohorts 3,4) at a new clinic evaluates the ability to implement the program. In the first phase of the secondary study the research team will conduct a RCT of individuals randomized to the diabetes program (intervention) vs usual care (control) to assess clinic feasibility. The clinic team will observe this process and learn the project protocols during Phase 1. In the second phase, the clinic team will lead the group visits while the research team mentors them to conduct the project in-person at the group visits and via telehealth each week (ZOOM video conferencing). Another secondary study (n=138; Cohort 5) aims to expand the reach of the education and CHW intervention for individuals who may not be able to or cannot come to the clinic for group visits. Specifically, individuals will received the education from the program monthly via a secure text message video, CHWs will contact weekly to bimonthly to advocate for their needs, and participants will receive their routine care as usual in the clinic.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

盲法说明

In the last secondary study, there is single blinding (data collectors)

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

  • Hispanic adults with diabetes, low-income (earn less than/equal to 250% federal poverty level)

排除标准

  • not able to understand Spanish, group visit is not appropriate for care i.e., need individualized care, pregnancy, etc

结局指标

主要结局

Glycemic control

时间窗: At baseline and every 6-months until study completion

Hemoglobin A1c (%)

次要结局

  • Survey(at the beginning and end of each cohort (baseline, six-months))
  • Body Mass Index (BMI)(At baseline and every 6-month until study completion)
  • Diabetes-related health(at the beginning and end of each cohort (baseline, six-months))
  • Blood Pressure(At baseline and every 6-month until study completion)
  • Barriers to care(weekly to bimonthly from baseline to 12-months)
  • Adherence to preventive care guidelines(pre/post diabetes group visits)
  • longitudinal outcomes(from the time group visits end and as long as month-24 after)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Elizabeth Vaughan

Principal Investigator

Baylor College of Medicine

研究点 (2)

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