Improving Medication Adherence in the Alabama Black Belt
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
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Alabama
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Birmingham、Alabama、美国、35210
- Univeristy of Alabama at Birmingham
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
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
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 |
|---|---|
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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.
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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
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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.
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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 |
|---|---|---|
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Change in Self Reported Medication Adherence
大体时间:Baseline, 6 months
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Patient-reported adherence to medications as a medication adherence score, from 0-3, where a higher score indicates worse adherence.
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Baseline, 6 months
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Change in Percentage of HbA1c
大体时间:Baseline, 6 months
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Hemoglobin A1c test to identify the average amount of glucose (sugar) present in a patient's blood.
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Baseline, 6 months
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Change in Blood Pressure
大体时间:Baseline, 6 months
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2 BP measures were taken 1 minute apart using a LifeSource UA-789 digital blood pressure monitor.
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Baseline, 6 months
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Change in Low-Density Lipoprotein (LDL) Cholesterol
大体时间:Baseline, 6 months
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Finger stick, spectrophotometer to measure cholesterol level.
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Baseline, 6 months
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Change in Quality of Life as Assessed With the Short Form 12- Mental Component
大体时间:Baseline, 6 months
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Short Form-12 Mental Component and Physical Component Summary scores range from 0-100; higher scores indicate greater quality of life.
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Baseline, 6 months
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Change in Quality of Life as Assessed With the Short Form-12- Physical Component
大体时间:Baseline, 6 months
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Short Form-12 Mental Component and Physical Component Summary scores range from 0-100; higher scores indicate greater quality of life.
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Baseline, 6 months
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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
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Medication use self-efficacy scores for range from 13-39; higher scores indicate higher levels of self-efficacy for medication adherence.
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Baseline, 6 months
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Change in Diabetes-Specific Quality of Life
大体时间:Baseline, 6 months
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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.
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Baseline, 6 months
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Number of Physician Office Visits 6 Months
大体时间:6 months
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6 months
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Number of Hospital Stays at 6 Months
大体时间:6 months
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6 months
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Number of Emergency Visits at 6 Months
大体时间:6 months
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6 months
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Change in Diabetes Medication Counts
大体时间:Baseline, 6 months
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Change in number of diabetes medications.
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Baseline, 6 months
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其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Change in Medication Beliefs- Harm (Beliefs That Medications Are Harmful)
大体时间:Baseline, 6 months
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Beliefs about medications questionnaire scores range from 5-25; higher scores indicate stronger beliefs.
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Baseline, 6 months
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Change in Medication Beliefs- Overuse (Concerns About the Way Doctors Use Medications)
大体时间:Baseline, 6 months
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Beliefs about medications questionnaire scores range from 5-25; higher scores indicate stronger beliefs.
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Baseline, 6 months
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Change in Medication Beliefs-Necessity (Beliefs About the Necessity of Medications)
大体时间:Baseline, 6 months
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Beliefs about medications questionnaire scores range from 5-25; higher scores indicate stronger beliefs.
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Baseline, 6 months
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Change in Medication Beliefs- Concerns (Concerns About the Negative Effects of Medications)
大体时间:Baseline, 6 months
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Beliefs about medications questionnaire scores range from 5-25; higher scores indicate stronger beliefs.
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Baseline, 6 months
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合作者和调查者
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
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
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)?
IPD 计划说明
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