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临床试验/NCT02846220
NCT02846220已完成不适用

Overcoming Immunity to Change: A Feasibility Study of a New Method to Promote Medication Adherence Among Older Adults With Hypertension

Tulane University School of Medicine2 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2016年10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
36
试验地点
2
主要终点
Change in medication adherence (PDC)

研究概览

简要总结

Over 70% of US adults 65 or older are diagnosed with hypertension, the leading cause of cardiovascular disease and premature deaths in the world. Despite availability of effective drugs to control blood pressure, uncontrolled blood pressure and low adherence to antihypertensive drugs persist as major public health and clinical challenges. On average, 50% of adults adhere to chronic disease medications and lower levels of adherence are associated with worse blood pressure control and adverse outcomes. Many barriers to adherence are well known and have been targeted in interventions to improve medication adherence. As of yet, no single intervention has emerged as superior or even particularly effective in improving adherence. The investigators have recently identified unconscious, self-protective 'hidden motives' that contribute to nonadherence to chronic disease medications. There is a critical need to expand on this insight to test the potential for targeting individuals' 'hidden motives' for low adherence using an innovative learning process called Immunity-to-Change.

As a critical step in testing this intervention to target these 'hidden motives', the investigators will undertake a pilot study to assess the feasibility and acceptability of the Overcoming Immunity-to-Change intervention and determine effect sizes of the intervention on adherence, blood pressure (BP) control, and quality of life (QOL). The investigators will test the Immunity-to-Change intervention in a sample of nonadherent older adults with hypertension (n=18). Another sample of nonadherent older adults with hypertension will be monitored for comparison (n=18).

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
55 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Men and women ages 55 and older, with the goal of a sex- and race-balanced sample
  • Diagnosis of essential hypertension
  • Uncontrolled hypertension
  • Current treatment with antihypertensive medication
  • Low antihypertensive pharmacy refill
  • English speaking
  • Telephone access
  • Ability to read print on a computer screen and use the computer keyboard
  • Written consent to participate and HIPAA authorization
  • Written acceptance of study contract
  • Approval of health care provider

排除标准

  • Cognitive impairment
  • Enrollment in another clinical trial

结局指标

主要结局

Change in medication adherence (PDC)

时间窗: Baseline to 6 months

Change in proportion of days covered (PDC) from baseline to 6 months

次要结局

  • Change in medication adherence (MMAS-8)(Baseline to 3 months)
  • Change in proportion with low adherence (PDC)(Baseline to 6 months)
  • Change in proportion with low adherence (MMAS-8)(Baseline to 3 months)
  • Change in proportion with low adherence (KWood-4)(Baseline to 3 months)
  • Change in systolic blood pressure(Baseline to 3 months)
  • Change in diastolic blood pressure(Baseline to 3 months)
  • Change in proportion with controlled blood pressure(Baseline to 3 months)
  • Change in health-related quality of life(Baseline to 3 months)
  • Change in medication adherence (KWood-4)(Baseline to 3 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Marie Krousel-Wood

Professor

Tulane University School of Medicine

研究点 (2)

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