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临床试验/NCT03924531
NCT03924531已完成不适用

Promoting Adherence to Anti-Hypertensive Medications and Lifestyle Guidelines Through Mindfulness Practice

University of California, Los Angeles2 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2017年8月1日最近更新:
适应症
干预措施

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
Exercise

研究概览

简要总结

Adherence is a major problem for the approximately one-third of Americans over the age of 20 who suffer from Hypertension (HTN). Hypertension can be controlled through medication adherence and lifestyle modifications (diet and exercise). However, nearly 50% of those with HTN report poor adherence to their antihypertensive medications, lifestyle changes, or both as primary reasons for failing to control their blood pressure. Currently, behavioral interventions are limited to providing education or reminding individuals to take better care of themselves by starting and adhering to proper diet and exercise program. Given the lack of adherence reported, education and reminders alone may not be sufficient to promote health behavior change. Interventions that appeal to individual's internal drive may be more effective, given that behavior adoption and maintenance are usually associated with intrinsic motivation and volition. Mindfulness practice is an intervention that shows promise in changing lifestyle behaviors. The purpose of this study is to investigate the use of UCLA's Mindful Awareness Program (UCLAMAP) on promoting self-management behaviors, specifically adherence to medication, diet, and exercise for those individuals with HTN. We will randomize 52 individuals with HTN who have difficulty with adherence to antihypertensive medications and lifestyle changes to the intervention group or the attention-control group. The intervention includes six sessions of the mindfulness training through UCLA's Mindful Awareness Research Center (MARC).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
None

入排标准

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

入选标准

  • over 21 years of age
  • able to understand and speak English
  • self-report of having difficulty with a healthy diet and engaging in regular physical activity.

排除标准

  • On chemotherapy for cancer treatment
  • Current substance abuse disorder (i.e., drugs, alcohol).
  • Current diagnoses of Post-traumatic stress disorders, severe anxiety, or severe depression.
  • On hemodialysis.
  • Pregnant. (Pregnant women may develop Preeclampsia, which is a pregnancy complication characterized by high blood pressure)

研究组 & 干预措施

Mindful Awareness Program

Experimental

The group that received mindfulness training.

干预措施: Mindful Awareness Program (Behavioral)

Health Promotion Program

Active Comparator

The group that received the health information.

干预措施: Health Promotion Program (Behavioral)

结局指标

主要结局

Exercise

时间窗: up to 12 weeks

The instrument used was called the Brief Physical Assessment. The is a 6 item weekly questionnaire that asked the minutes the participants performed a particular exercise behavior.

Blood pressure medication adherence

时间窗: up to 12 weeks

The instrument used was called the Brief Medication Questionnaire (BMQ).The tool includes a 5-item Regimen Screen that asks patients how they took each medication in the past week, a 2-item Belief Screen that asks about drug effects and bothersome features, and a 2-item Recall Screen about potential difficulties remembering. We collected the number of missed medication days.

Diet

时间窗: up to 12 weeks

21 item questionnaire called Rapid Eating and Activity Assessment for Patients (REAP). Various questions related to food choices. The answer choices were rarely, sometimes, and often for each food questions.

次要结局

  • Blood pressure measurements(up to 12 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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