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临床试验/NCT05610059
NCT05610059
已完成
不适用

Improving Hypertension Medication Adherence for Older Adults

University of Arizona2 个研究点 分布在 1 个国家目标入组 200 人2022年11月2日

概览

阶段
不适用
干预措施
Blood Pressure Technology System M
疾病 / 适应症
Aging
发起方
University of Arizona
入组人数
200
试验地点
2
主要终点
adherence
状态
已完成
最后更新
上个月

概览

简要总结

This randomized controlled trial will assess the efficacy and scalability of a blood pressure technology system intervention. The investigators will enroll 224 older adults with hypertension to identify those who are nonadherent for one hypertension medication. The participants will be randomized to one of two groups (112 per group) to use the blood pressure system for 6-months. Both groups receive information about high blood pressure and medications. One group will also receive strategies that can be used to take medications and manage blood pressure. Both groups will complete a mid-assessment at 3-months and a post-assessment at 6-months.

注册库
clinicaltrials.gov
开始日期
2022年11月2日
结束日期
2025年3月14日
最后更新
上个月
研究类型
Interventional
研究设计
Parallel
性别
All

研究者

责任方
Sponsor

入排标准

入选标准

  • age 65 years or older
  • self-manage at least one hypertension medication
  • able to read and speak English
  • willing to participate in the study for six months
  • currently have and use an Apple iPhone
  • have hypertension medication adherence ≤ 90% in the last 2 weeks of the 4-week baseline monitoring period using an AARDEX MEMS® cap

排除标准

  • have inadequate visual acuity (worse than 20/50 corrected near vision on Snellen test)
  • experience severe depression (\> 11 on Geriatric Depression Scale Short Form, GDS-15)
  • are at risk for cognitive impairment (\< 23 on Montreal Cognitive Assessment, MoCA)
  • been instructed by their healthcare provider to withhold their blood pressure medication

研究组 & 干预措施

Blood Pressure Technology System M

These participants will receive information about high blood pressure, medications and strategies that can be used to take medications and manage blood pressure. They will complete a mid-assessment at 3-months and a post-assessment at 6-months.

干预措施: Blood Pressure Technology System M

Blood Pressure Technology System E

These participants receive information about high blood pressure and medications. They will complete a mid-assessment at 3-months and a post-assessment at 6-months.

干预措施: Blood Pressure Technology System E

结局指标

主要结局

adherence

时间窗: Baseline, 3-months, 6-months

Change in adherence (both objective and subjective) after 6 months of M system engagement versus E system use. Objective adherence is measured by Aardex Medication Event Monitoring System (MEMS). Subjective adherence is measured by the five-item Medication Adherence Report Scale (MARS-5). MARS-5 total score ranges between 5 and 25, with higher scores indicating better adherence.

次要结局

  • systolic blood pressure (BP)(Baseline, 3-months, 6-months)
  • perceived autonomy(Baseline, 3-months, 6-months)
  • perceived competence(Baseline, 3-months, 6-months)
  • mobile device proficiency(Baseline, 3-months, 6-months)

研究点 (2)

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