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Improving Medication Adherence in the Alabama Black Belt

2020年10月6日 更新者:Weill Medical College of Cornell University
Medication adherence is especially critical in regions like rural Alabama, where residents have among the worst health outcomes in the US. This project was designed in collaboration with our community member partners and builds on a 5-year partnership of community-engaged research on diabetes peer coaching interventions and our experience with peer storytelling. The investigators will test the hypothesis that an intervention designed within the Corbin and Strauss framework can improve adherence and health outcomes compared to usual care.

研究概览

详细说明

Improving medication adherence is one of the greatest challenges in modern medicine. Despite decades of research on the topic, as many as half of patients with chronic diseases are not taking medications as recommended, and costs of nonadherence have been estimated at $290 billion annually. One reason for this persistent finding could be that interventions rarely acknowledge medications within the larger context of the lived experience of illness. Drawing on hundreds of patient interviews, Corbin and Strauss showed that chronic illness is a fundamentally destabilizing influence that forces us to confront the potential limitations of our "new", chronically ill self. Accepting our illness may be a crucial step in embracing medication adherence and other self-management behaviors as ways to restore balance following this disruption. The Corbin and Strauss framework is not often used to develop and test interventions to improve medication adherence, and this is the central objective of this proposal.

Medication adherence is especially critical in regions like rural Alabama, where residents have among the worst health outcomes in the US. Rates of cardiovascular mortality, diabetes and obesity are very high, but resources are scarce and the area's predominately black residents have deep-seated mistrust of the healthcare system (the region includes Tuskegee, site of the infamous syphilis study). This project was designed in collaboration with our community member partners and builds on a 5-year partnership of community-engaged research on diabetes peer coaching interventions and our experience with peer storytelling. The investigators will test the hypothesis that an intervention designed within the Corbin and Strauss framework can improve adherence and health outcomes compared to usual care. Our Aims are:

Aim 1: With our community partners, using qualitative research methods, build on already developed culturally tailored education material to develop the medication adherence intervention. The intervention will consist of educational DVDs with integrated storytelling about how community members accepted their disease and overcame barriers to medication adherence, plus one-on-one telephonic peer coaching. Activities include conducting focus groups with patients; creating the DVDs and the coaching intervention protocol; training peer coaches; and pilot testing.

Aim 2: Conduct a randomized controlled trial with 500 individuals with type 2 diabetes and medication nonadherence. The trial will compare the effect of usual care and the intervention on medication adherence and physiologic risk factors including A1c, blood pressure and low density lipoprotein cholesterol (primary outcomes), and quality of life and self-efficacy (secondary outcomes).

This innovative approach would be a major shift in how patients are helped in under resourced areas living with chronic diseases commit to taking medications, improving health and eventually reducing health disparities.

研究类型

介入性

注册 (实际的)

473

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Alabama
      • Birmingham、Alabama、美国、35210
        • Univeristy of Alabama at Birmingham

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

19年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  • adults
  • type 2 diabetes
  • taking medications for diabetes
  • medication non adherent

Exclusion Criteria:

  • nursing home residence
  • plans to move away in the next year
  • advanced illnesses such as hemodialysis, cancer or dementia

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
实验性的:Peer Coaching
The intervention participants will receive the Living Well with Diabetes Program. The program will consist of educational DVDs with integrated storytelling about how community members accepted their disease and overcame barriers to medication adherence, plus one-on-one telephonic peer coaching.
The intervention participants will receive the Living Well with Diabetes Program. The program will consist of educational DVDs with integrated storytelling about how community members accepted their disease and overcame barriers to medication adherence, plus one-on-one telephonic peer coaching
无干预:Usual Care
At enrollment, the investigators will provide an educational DVD on general health and wellness topics including vaccination, cancer screening, osteoporosis and other topics not related to diabetes care. There will be no peer storytelling on these DVDs.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Change in Self Reported Medication Adherence
大体时间:Baseline, 6 months
Patient-reported adherence to medications as a medication adherence score, from 0-3, where a higher score indicates worse adherence.
Baseline, 6 months
Change in Percentage of HbA1c
大体时间:Baseline, 6 months
Hemoglobin A1c test to identify the average amount of glucose (sugar) present in a patient's blood.
Baseline, 6 months
Change in Blood Pressure
大体时间:Baseline, 6 months
2 BP measures were taken 1 minute apart using a LifeSource UA-789 digital blood pressure monitor.
Baseline, 6 months
Change in Low-Density Lipoprotein (LDL) Cholesterol
大体时间:Baseline, 6 months
Finger stick, spectrophotometer to measure cholesterol level.
Baseline, 6 months

次要结果测量

结果测量
措施说明
大体时间
Change in Quality of Life as Assessed With the Short Form 12- Mental Component
大体时间:Baseline, 6 months
Short Form-12 Mental Component and Physical Component Summary scores range from 0-100; higher scores indicate greater quality of life.
Baseline, 6 months
Change in Quality of Life as Assessed With the Short Form-12- Physical Component
大体时间:Baseline, 6 months
Short Form-12 Mental Component and Physical Component Summary scores range from 0-100; higher scores indicate greater quality of life.
Baseline, 6 months
Change in Medication Use Self-efficacy Score as Measured by SEAMS Scale and the Perceived Diabetes Self-Management Scale, Which is Associated With A1c
大体时间:Baseline, 6 months
Medication use self-efficacy scores for range from 13-39; higher scores indicate higher levels of self-efficacy for medication adherence.
Baseline, 6 months
Change in Diabetes-Specific Quality of Life
大体时间:Baseline, 6 months
Diabetes specific quality of life will be assessed using the validated Diabetes Distress Scale.The DDS is a 17-item instrument that measures diabetes-related emotional distress. Participants rate the degree to which each item is problematic for them on a 6-point Likert scale, from 1 (no problem) to 6 (serious problem). A score of 3 or greater = moderate distress.
Baseline, 6 months
Number of Physician Office Visits 6 Months
大体时间:6 months
6 months
Number of Hospital Stays at 6 Months
大体时间:6 months
6 months
Number of Emergency Visits at 6 Months
大体时间:6 months
6 months
Change in Diabetes Medication Counts
大体时间:Baseline, 6 months
Change in number of diabetes medications.
Baseline, 6 months

其他结果措施

结果测量
措施说明
大体时间
Change in Medication Beliefs- Harm (Beliefs That Medications Are Harmful)
大体时间:Baseline, 6 months
Beliefs about medications questionnaire scores range from 5-25; higher scores indicate stronger beliefs.
Baseline, 6 months
Change in Medication Beliefs- Overuse (Concerns About the Way Doctors Use Medications)
大体时间:Baseline, 6 months
Beliefs about medications questionnaire scores range from 5-25; higher scores indicate stronger beliefs.
Baseline, 6 months
Change in Medication Beliefs-Necessity (Beliefs About the Necessity of Medications)
大体时间:Baseline, 6 months
Beliefs about medications questionnaire scores range from 5-25; higher scores indicate stronger beliefs.
Baseline, 6 months
Change in Medication Beliefs- Concerns (Concerns About the Negative Effects of Medications)
大体时间:Baseline, 6 months
Beliefs about medications questionnaire scores range from 5-25; higher scores indicate stronger beliefs.
Baseline, 6 months

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Monika M Safford, MD、Weill Medical College of Cornell University

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2016年4月1日

初级完成 (实际的)

2019年1月31日

研究完成 (实际的)

2019年1月31日

研究注册日期

首次提交

2014年10月14日

首先提交符合 QC 标准的

2014年10月22日

首次发布 (估计)

2014年10月24日

研究记录更新

最后更新发布 (实际的)

2020年10月29日

上次提交的符合 QC 标准的更新

2020年10月6日

最后验证

2020年10月1日

更多信息

与本研究相关的术语

其他研究编号

  • PCORI-R-AD-1306-03565

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

IPD 计划说明

Data will stay at UAB

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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