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临床试验/NCT04835493
NCT04835493进行中(未招募)不适用

Evaluating Telementoring to Initiate a Multidimensional Diabetes Program for Latino(a)s in Community Clinics: A Randomized Clinical Trial

The University of Texas Medical Branch, Galveston1 个研究点 分布在 1 个国家目标入组 320 人开始时间: 2022年9月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
320
试验地点
1
主要终点
HbA1c

研究概览

简要总结

Diabetes care is complex and requires a multidimensional approach, but interventional programs are difficult to initiate in low-income and minority populations. In the proposed study, investigators will mentor local clinics via telehealth to initiate our diabetes program involving telehealth-support, integrated CHWs, medication-access, and diabetes Education into their clinics. Mentoring local clinics to initiate this intervention is a promising strategy to enhance sustainable diabetes care and reduce disparities in vulnerable minority populations.

详细描述

Diabetes is a major public health problem in Latino(a)s. There are escalating numbers of Latino(a)s diagnosed with diabetes and at disproportionate rates compared to other ethnicities. Numerous interventions have been initiated to improve minority healthcare including diabetes group visits, which have been valuable in improving education and glycemic control. In our group visit investigations, investigators initiated Community Health Workers (CHWs)-local community members who serve as culturally-sensitive patient liaisons to the healthcare system-as part of the multidisciplinary team. Investigators demonstrated that CHWs are vital team members and particularly helpful in identifying medication-access barriers. However, CHWs are frontline workers and often left unsupported and poorly supervised. Investigators used these data to pioneer the combination of four diabetes interventions. This trial showed that individuals randomized to the intervention significantly improved glycemic control, blood pressure and adherence to American Diabetes Association standards compared to usual care. The study also showed that telehealth (mobile health (mHealth) and ZOOM video conferencing) was instrumental in supporting CHWs in their work and enhancing their communication with patients.

The COVID-19 pandemic has highlighted the expansive use of telehealth and its ability to improve healthcare. It has also underscored the pressing need to improve care for low-income minorities. Though diabetes programs are valuable in improving education and clinical outcomes, they are often difficult to initiate in low-income settings. Pragmatic implementation using telehealth to mentor local clinic teams of providers and CHWs is promising to address these barriers. Investigators have pilot data showing the feasibility of telementoring a local clinic to initiate our program that has resulted in improved HbA1c levels but it needs to be tested within a larger sample. In the proposed study investigators will evaluate this approach in a randomized clinical trial (N=320; intervention=160) of low-income, adult Latino(a)s with type 2 diabetes randomized to the diabetes program intervention versus usual care (UC). Our research group will provide telementoring to local clinic teams to initiate our program into their clinics. To evaluate efficacy, investigators will compare the intervention versus UC clinical changes including HbA1c (primary outcome), blood pressure, cholesterol, and body mass index from baseline to 12-months (AIM 1). To compare longitudinal data of study arms, investigators will follow these clinical measures until 36 months (AIM 2). Investigators will also provide program acceptability and evaluation data for participants and clinic teams from baseline to 12-months (AIM 3). Investigators hypothesize that intervention participants will have superior and more sustainable clinical outcomes compared to UC individuals and that the intervention will have high levels of acceptability and evaluation data. Investigators anticipate that the proposed study will provide justification of telementoring to initiate the intervention and strong evidence to improve the longitudinal care of low-income Latino(a)s with diabetes.

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
Single (Outcomes Assessor)

盲法说明

  1. Randomization will be achieved by blinded study staff using an automatic number generator that allows for stratification and blocking.
  2. Individuals entering and obtaining study data will be blinded to study arm
  3. Data will be collected prior to randomization for blinding purposes. Month-12 clinical data will be obtained in-person for both arms by nurses blinded to the study arm e.g., different nurses than those in the group visits, and chart review will be conducted for ADA measurements and for other clinical data if individuals from either study arm do not show.
  4. Blinded research assistants will gather HbA1c, blood pressure, cholesterol, and BMI data for both arms quarterly until 36-months from baseline.

入排标准

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

入选标准

  • •self-identified Latino(a)
  • •Spanish-speaking
  • •>/=18 years
  • •type 2 diabetes (T2D), e.g., HbA1c >/=6.5%, provider documented T2D, on oral anti-hyperglycemic
  • •uninsured, <150% federal poverty level

排除标准

  • •no show to all group visits
  • •condition that may alter HbA1c levels, e.g., recent blood transfusion
  • •patients at high-risk or not appropriate for care in a group setting e.g., pregnancy, severe cognitive impairment, frequent clinic appointments for labile glucose/medication titration e.g., insulin.

研究组 & 干预措施

Intervention

Experimental

Intervention individuals will receive the 12-month diabetes program

干预措施: Intervention (Other)

Usual Care (UC)

Other

We will define UC as usual clinical care, which consists of diabetes management provider encounters (mean quarterly) plus monthly individual appointments with a pharm-Ds or nutritionists as clinically indicated. In addition, clinics offer multiple other individual and group opportunities.

干预措施: Intervention (Other)

结局指标

主要结局

HbA1c

时间窗: Baseline to 12-months

Compare intervention versus control HbA1c levels

次要结局

  • American Diabetes Association (ADA) adherence measures: Diabetes foot exam(Baseline to 12-months)
  • Sustainable clinical outcomes: HbA1c(baseline to 36-months)
  • ADA adherence measures: B12 screening(Baseline to 12-months)
  • ADA adherence measures: flu vaccination(Baseline to 12-months)
  • Sustainable clinical outcomes: BMI(baseline to 36-months)
  • Community Health Worker (CHW) knowledge(12-months)
  • Program satisfaction(12-months)
  • Body Mass Index (BMI)(Baseline to 12-months)
  • ADA adherence measures: urine microalbumin screening(Baseline to 12-months)
  • ADA adherence measures: statin therapy(Baseline to 12-months)
  • Blood pressure(Baseline to 12-months)
  • Cholesterol(Baseline to 12-months)
  • ADA adherence measures: Diabetes eye exam(Baseline to 12-months)
  • Sustainable clinical outcomes: Blood pressure(baseline to 36-months)
  • Attrition(baseline to 12-months)
  • Telehealth Acceptability(12-months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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