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Promoting Medication Adherence Among Older Adults With Hypertension

2020年10月15日 更新者：Marie Krousel-Wood、Tulane University School of Medicine

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

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).

研究概览

地位

完全的

条件

干预/治疗

研究类型

介入性

注册 (实际的)

36

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

  • 美国
    • Louisiana
      • New Orleans、Louisiana、美国、70112
        • Tulane University

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

55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:

  • 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

Exclusion Criteria:

  • Cognitive impairment
  • Enrollment in another clinical trial

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
无干预：日常护理
实验性的：Health coaching

Two-hour in-person group counseling session led by health coach, involving development of personalized immunity maps that lay out adherence goal, behaviors that distract from goal, hidden motives that compete with achieving goal, and underlying assumptions

Eight 50-minute individual telephone counseling sessions every three weeks with a health coach, focusing on uncovering hidden motives and challenging assumptions with the goal of overturning nonadherence mindsets
行为的：Overcoming Immunity to Change health coaching

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 medication adherence (PDC)
大体时间：Baseline to 6 months
Change in proportion of days covered (PDC) from baseline to 6 months
Baseline to 6 months

次要结果测量

结果测量
措施说明
大体时间
Change in medication adherence (MMAS-8)
大体时间：Baseline to 6 months
Change in MMAS-8 score from baseline to 6 months
Baseline to 6 months
Change in medication adherence (KWood-4)
大体时间：Baseline to 6 months
Change in KWood-4 score from baseline to 6 months
Baseline to 6 months
Change in medication adherence (MMAS-8)
大体时间：Baseline to 3 months
Change in MMAS-8 score from baseline to 3 months
Baseline to 3 months
Change in medication adherence (KWood-4)
大体时间：Baseline to 3 months
Change in KWood-4 score from baseline to 3 months
Baseline to 3 months
Change in proportion with low adherence (PDC)
大体时间：Baseline to 6 months
Change in proportion with low adherence (PDC<0.8) from baseline to 6 months
Baseline to 6 months
Change in proportion with low adherence (MMAS-8)
大体时间：Baseline to 6 months
Change in proportion with low adherence (MMAS-8<6) from baseline to 6 months
Baseline to 6 months
Change in proportion with low adherence (KWood-4)
大体时间：Baseline to 6 months
Change in proportion with low adherence (KWood-4>0) from baseline to 6 months
Baseline to 6 months
Change in proportion with low adherence (MMAS-8)
大体时间：Baseline to 3 months
Change in proportion with low adherence (MMAS-8<6) from baseline to 3 months
Baseline to 3 months
Change in proportion with low adherence (KWood-4)
大体时间：Baseline to 3 months
Change in proportion with low adherence (KWood-4>0) from baseline to 3 months
Baseline to 3 months
Change in systolic blood pressure
大体时间：Baseline to 6 months
Change in systolic blood pressure from baseline to 6 months
Baseline to 6 months
Change in diastolic blood pressure
大体时间：Baseline to 6 months
Change in diastolic blood pressure from baseline to 6 months
Baseline to 6 months
Change in systolic blood pressure
大体时间：Baseline to 3 months
Change in systolic blood pressure from baseline to 3 months (if available from insurance records)
Baseline to 3 months
Change in diastolic blood pressure
大体时间：Baseline to 3 months
Change in diastolic blood pressure from baseline to 3 months (if available from insurance records)
Baseline to 3 months
Change in proportion with controlled blood pressure
大体时间：Baseline to 6 months
Change in proportion with controlled blood pressure (SBP<140 & DBP<90) from baseline to 6 months
Baseline to 6 months
Change in proportion with controlled blood pressure
大体时间：Baseline to 3 months
Change in proportion with controlled blood pressure (SBP<140 & DBP<90) from baseline to 3 months
Baseline to 3 months
Change in health-related quality of life
大体时间：Baseline to 6 months
Change in health-related quality of life score (SF-36) from baseline to 6 months
Baseline to 6 months
Change in health-related quality of life
大体时间：Baseline to 3 months
Change in health-related quality of life score (SF-36) from baseline to 3 months
Baseline to 3 months

其他结果措施

结果测量
措施说明
大体时间
Change in hidden motives score
大体时间：Baseline to 6 months
Change in hidden motives score from baseline to 6 months
Baseline to 6 months
Change in hidden motives score
大体时间：Baseline to 3 months
Change in hidden motives score from baseline to 3 months
Baseline to 3 months
Change in explicit attitudes score
大体时间：Baseline to 6 months
Change in explicit attitudes score (Beliefs about Medicines Questionnaire) from baseline to 6 months
Baseline to 6 months
Change in explicit attitudes score
大体时间：Baseline to 3 months
Change in explicit attitudes score (Beliefs about Medicines Questionnaire) from baseline to 3 months
Baseline to 3 months
Change in implicit attitudes score
大体时间：Baseline to 6 months
Change in implicit attitudes score (d-score from single-category implicit association test) from baseline to 6 months
Baseline to 6 months
Change in explicit ambivalence score
大体时间：Baseline to 6 months
Change in explicit ambivalence score (absolute value of difference between standardized positive and negative explicit attitudes scores) from baseline to 6 months
Baseline to 6 months
Change in explicit ambivalence score
大体时间：Baseline to 3 months
Change in explicit ambivalence score (absolute value of difference between standardized positive and negative explicit attitudes scores) from baseline to 3 months
Baseline to 3 months
Change in implicit ambivalence score
大体时间：Baseline to 6 months
Change in implicit ambivalence score (absolute value of difference between standardized explicit and implicit attitude scores)
Baseline to 6 months
Change in short risk aversion switch point
大体时间：Baseline to 6 months
Change in short switch point on risk aversion scale from baseline to 6 months
Baseline to 6 months
Change in short risk aversion switch point
大体时间：Baseline to 3 months
Change in short switch point on risk aversion scale from baseline to 3 months
Baseline to 3 months
Change in long risk aversion switch point
大体时间：Baseline to 6 months
Change in long switch point on risk aversion scale from baseline to 6 months
Baseline to 6 months
Change in long risk aversion switch point
大体时间：Baseline to 3 months
Change in long switch point on risk aversion scale from baseline to 3 months
Baseline to 3 months
Change in risk valuation
大体时间：Baseline to 6 months
Change in value indicated on risk aversion scale from baseline to 6 months
Baseline to 6 months
Change in risk valuation
大体时间：Baseline to 3 months
Change in value indicated on risk aversion scale from baseline to 3 months
Baseline to 3 months
Change in medication-taking self-efficacy (MUSE)
大体时间：Baseline to 6 months
Change in score on MUSE medication-taking subscale from baseline to 6 months
Baseline to 6 months
Change in medication-taking self-efficacy (MUSE)
大体时间：Baseline to 3 months
Change in score on MUSE medication-taking subscale from baseline to 3 months
Baseline to 3 months
Change in learning-about-medications self-efficacy (MUSE)
大体时间：Baseline to 6 months
Change in score on MUSE learning-about-medications subscale from baseline to 6 months
Baseline to 6 months
Change in learning-about-medications self-efficacy (MUSE)
大体时间：Baseline to 3 months
Change in score on MUSE learning-about-medications subscale from baseline to 3 months
Baseline to 3 months
Change in self-efficacy (MUSE)
大体时间：Baseline to 6 months
Change in score on MUSE scale from baseline to 6 months
Baseline to 6 months
Change in self-efficacy (MUSE)
大体时间：Baseline to 3 months
Change in score on MUSE scale from baseline to 3 months
Baseline to 3 months
Change in self-efficacy (Self-Efficacy for Managing Chronic Disease)
大体时间：Baseline to 6 months
Change in score on SEMCD scale from baseline to 6 months
Baseline to 6 months
Change in self-efficacy (Self-Efficacy for Managing Chronic Disease)
大体时间：Baseline to 3 months
Change in score on SEMCD scale from baseline to 3 months
Baseline to 3 months
Change in chronic stress
大体时间：Baseline to 6 months
Change in chronic stress from baseline to 6 months, as measured by salivary cortisol
Baseline to 6 months
Change in perceived stress
大体时间：Baseline to 6 months
Change in score on 4-item version of Perceived Stress Scale from baseline to 6 months
Baseline to 6 months
Change in perceived stress
大体时间：Baseline to 3 months
Change in score on 4-item version of Perceived Stress Scale from baseline to 3 months
Baseline to 3 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。

赞助

Tulane University School of Medicine

合作者

Ohio State University
Minds at Work

调查人员

  • 首席研究员：Marie A Krousel-Wood, MD MSPH、Tulane University
  • 研究主任：Erin M Peacock, PhD MPH、Tulane University

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

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10月1日

初级完成 (实际的)

2019年12月30日

研究完成 (实际的)

2019年12月30日

研究注册日期

首次提交

2016年5月24日

首先提交符合 QC 标准的

2016年7月22日

首次发布 (估计)

2016年7月27日

研究记录更新

最后更新发布 (实际的)

2020年10月20日

上次提交的符合 QC 标准的更新

2020年10月15日

最后验证

2020年10月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • 735133

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

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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