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临床试验/NCT04857411
NCT04857411已完成不适用

Improving Diabetes Programs for Blacks in Wisconsin: Peers as Coaches in Medicine Use

University of Wisconsin, Madison2 个研究点 分布在 1 个国家目标入组 8 人开始时间: 2021年4月19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
8
试验地点
2
主要终点
Mean Systolic Blood Pressure

研究概览

简要总结

The specific goal of this project is to decrease diabetes-related morbidity among African Americans (AAs) in Milwaukee through the integration of Peers LEAD, a culturally-appropriate program to increase medication adherence into Healthy Living with Diabetes (HLWD), an existing diabetes self-management program.

详细描述

This project represents the next phase of prior work at the University of Wisconsin School of Pharmacy to create and implement community-based programs for AAs with diabetes that focus on improving medication use and glycemic control. The overall objective is to integrate Peers LEAD into HLWD using a community-engaged approach and an evaluation to document outcomes. This project will produce a culturally-tailored curriculum that can be used broadly across social service and community organizations, faith-based organizations, and federally-qualified health centers committed to improving AAs diabetes self-management. This project will be achieved through the following objectives:

  • Objective 1: To gather and incorporate key stakeholders input in the current and future adoption of Peers LEAD+HLWD into community organizations, health system and/or practices. Objective 1 is not a clinical trial.
  • Objective 2: To implement and measure the outcomes of Peers LEAD+HLWD to improve medication adherence and hemoglobin A1c. Objective 2 represents the clinical trial aim of this study to be registered in this record.

HLWD is a successful community-based program that offers tools and resources to enhance understanding of what it means to have diabetes, including helping participants to build the confidence to manage diabetes and maintain an active and fulfilling life. HLWD is endorsed by the American Diabetes Association and the Centers for Disease Prevention and Control and proven to reduce emergency department visits by 53%, improve A1c levels, enhance regular treatment and diabetes education, create a community-clinical link in care, provide social benefits for participants, improve self-rated health and communication with physicians, and improve health status, health behavior, and self-efficacy. The investigators chose HLWD as the diabetes self-management education (DSME) program to adapt because it is an effective and widely-disseminated evidence-based DSME program. HLWD has enrolled over 5,000 participants in more than 400 workshops across 52 Wisconsin counties. However, between 2013 and 2016, only 120 AAs (3.1%) participated compared to 1,656 non-Hispanic Whites. In 3 years, only 46% of AAs reported that they took their diabetes pills (HLWD's measure of medication adherence) after the workshop, compared to 55% of non-Hispanic Whites. Despite HLWD's positive outcomes and wide reach, there is limited inclusion of AAs. HLWD does not offer culturally-tailored content for AAs, and lacks one-on-one peer support from an AA who successfully manages diabetes, an important factor influential in improving diabetes outcomes among AAs. There is also insufficient attention to medication adherence. Adding Peers LEAD to HLWD will improve the reach, effectiveness, and impact of diabetes self-management programs among AAs.

Peers LEAD is a culturally-tailored program designed to provide AAs with diabetes and medication beliefs information, behavioral skill-development, and one-on-one peer support to increase medication adherence. Group sessions include discussions of personal discrimination experiences that resulted in provider mistrust, making the most of clinic/pharmacy visits, necessity and concerns about medicines, and enhancing patient-provider communication. Ambassadors are paired with Buddies, and Ambassadors help deliver Peers LEAD content via face-to-face interaction with their Buddies during group sessions and phone follow-ups. Ambassadors address misperceptions of medicines and diabetes, share their experiences managing diabetes and medicines, and discuss building relationships with providers. As well, they are able to provide one-on-one social support.

Peers LEAD+HLWD allows for sufficient attention to medication adherence in a DSME program. For example, HLWD includes only one 20-minute activity on medication use in a 2½ hour session during Week 5. This activity only covers purpose of medicines, medication effects, and remembering to take medicines, but does not address known specific barriers to AAs adherence. In this study, HLWD will be adapted for AAs by adding components of Peers LEAD to overcome key barriers to AAs medication adherence. Core components of Peers LEAD to be incorporated are two group sessions on beliefs about medicines and diabetes, discrimination/mistrust, and provider communication, as well as peer-based phone support from Ambassadors.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
20 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Mean Systolic Blood Pressure

时间窗: 6 months

Blood pressure readings collected via the Omron Healthcare Inc. 7 Series Upper Arm Blood Pressure Monitor.

Mean Hemoglobin A1c

时间窗: 6 months

Participant buddies will have a hemoglobin A1c greater than 8 percent at baseline. will be measured using the A1cNow+ system, the National Glycohemoglobin Standardization Program Certified, CLIA-waived, system that provides results using a finger stick test.

Change in Diastolic Blood Pressure

时间窗: baseline, 3 months, 6 months

Blood pressure readings collected via the Omron Healthcare Inc. 7 Series Upper Arm Blood Pressure Monitor.

次要结局

  • Patient Health Questionnaire (PHQ-4)(baseline, 3 months, 6 months)
  • Brief Illness Perception Questionnaire (Brief IPQ)(baseline, 3 months, 6 months)
  • Beliefs about Medicines Questionnaire (BMQ)(baseline, 3 months, 6 months)
  • Diabetes Empowerment Scale - Short Form (DES-SF)(baseline, 3 months, 6 months)
  • Newest Vital Sign (NVS)(baseline, 3 months, 6 months)
  • Adherence to Refills and Medications Scale for Diabetes (ARMS-D) Score(baseline, 3 months, 6 months)
  • Self-Efficacy for Adherence to Medication Use Scale (SEAMS)(baseline, 3 months, 6 months)
  • Patient's Perceived Involvement in Care Scale (PICS)(baseline, 3 months, 6 months)
  • Diabetes Distress Scale (DDS) 2(baseline, 3 months, 6 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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