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临床试验/NCT02274844
NCT02274844已完成不适用

Improving Medication Adherence in the Alabama Black Belt

Weill Medical College of Cornell University2 个研究点 分布在 1 个国家目标入组 473 人开始时间: 2016年4月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
473
试验地点
2
主要终点
Change in Self Reported Medication Adherence

研究概览

简要总结

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.

详细描述

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

入排标准

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

入选标准

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

排除标准

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

结局指标

主要结局

Change in Self Reported Medication Adherence

时间窗: Baseline, 6 months

Patient-reported adherence to medications as a medication adherence score, from 0-3, where a higher score indicates worse adherence.

Change in Percentage of HbA1c

时间窗: Baseline, 6 months

Hemoglobin A1c test to identify the average amount of glucose (sugar) present in a patient's blood.

Change in Blood Pressure

时间窗: Baseline, 6 months

2 BP measures were taken 1 minute apart using a LifeSource UA-789 digital blood pressure monitor.

Change in Low-Density Lipoprotein (LDL) Cholesterol

时间窗: Baseline, 6 months

Finger stick, spectrophotometer to measure cholesterol level.

次要结局

  • Number of Physician Office Visits 6 Months(6 months)
  • Number of Hospital Stays at 6 Months(6 months)
  • Change in Quality of Life as Assessed With the Short Form 12- Mental Component(Baseline, 6 months)
  • Change in Quality of Life as Assessed With the Short Form-12- Physical Component(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(Baseline, 6 months)
  • Change in Diabetes-Specific Quality of Life(Baseline, 6 months)
  • Number of Emergency Visits at 6 Months(6 months)
  • Change in Diabetes Medication Counts(Baseline, 6 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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