Improving Hypertension Medication Adherence for Older Adults
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- adherence
研究概览
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.
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
- Double (Participant, Outcomes Assessor)
盲法说明
All primary and secondary outcomes completed at 3-months and 6-months are blinded.
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
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 (Other)
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 (Other)
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.
Medication Adherence (MEMS Cap)
时间窗: 3 months, 6 months
The Medication Event Monitoring System (MEMS®Cap) assesses objective medication adherence using the smart pill bottle cap. Digital sensors in the track cap automatically record the date and time of cap opening and upload the information to AARDEX Medication Adherence Software. Percentage of medication taken at the correct time frame.
Medication Adherence Report Scale (MARS-5)
时间窗: 3 months, 6 months
The Medication Adherence Report Scale (MARS-5) is a 5-item self-report scale to assess medication adherence related to the frequency of not taking a prescribed dose of medication or not taking the dose prescribed. Self-report score of 5-25. Item scores are summed for a total scale score, where higher scores reflect greater medication adherence. Scale: 5=never, 4=rarely, 3=sometimes, 2=often, and 1=always.
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)
- Systolic Blood Pressure (SBP)(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)
- Hypertension Knowledge Level Scale(Baseline, 6 months)