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临床试验/NCT03650166
NCT03650166已完成不适用

Adoption and Effectiveness of a mHealth Intervention for Hypertension in Older Adults: a Pilot Clinical Trial

University of Pittsburgh2 个研究点 分布在 1 个国家目标入组 62 人开始时间: 2018年9月21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
62
试验地点
2
主要终点
Change in systolic BP from baseline to trial completion

研究概览

简要总结

High blood pressure is a leading risk factor for cardiovascular and kidney disease, yet is uncontrolled in half of affected individuals, and specifically older adults. The investigators have developed an automated program for patient education and personalized assistance of systematic home BP self-monitoring. Reports are sent to primary care providers at regular intervals. This investigation will collect pilot data on feasibility and effectiveness in older adults with and without a caregiver.

详细描述

Background. Hypertension is a highly prevalent condition and a primary cause of heart disease, kidney failure and cognitive decline. Hypertension is uncontrolled in nearly half of diagnosed adults in the US, with the lowest control rates among older adults (i.e., over 60 y/o). Uncontrolled hypertension is attributable to a mix of factors, most notably suboptimal self-management among patients and clinical inertia due to the reliance on limited BP measurement at office visits, which results in diagnostic uncertainty.

Home BP monitoring (HBPM) is a promising solution to catalyze patient engagement in self-management while offering clinicians reliable and up-to-date data, thereby improving clinical management. Home blood pressure monitoring (HBPM) is now widely recommended as an effective additional tool for improved hypertension management, however broad implementation has not occurred. The convenience of mobile phones has led to high and increasing ownership among all age groups, thus there is great potential to leverage mobile health (mHealth) applications to make HBPM easy, convenient, and even more helpful for both clinicians and patients.

Based upon extensive stakeholder input, the investigators' multidisciplinary team designed a comprehensive mobile phone supported HBPM system called MyBP. MyBP efficiently educates patients via professionally-developed videos and supports bi-weekly BP self-monitoring with recurring feedback using proactive, bidirectional automated texting. Prior pilot testing at three unique clinical sites with middle-aged adults (mean 50 y/o) suggests good usability and positive effects on self-management behaviors. High priority next steps are to: 1) test MyBP specifically with older adults (and caregivers) to fully understand their unique experiences in regards to HBPM via mobile phone, and 2) explore how best to share MyBP data with primary care providers (PCPs). Therefore, the aims of this study are to:

  1. Collect pilot data on longitudinal usage of MyBP and BP reduction over 6-9 months within an older adult population.
  2. Examine factors influencing adoption and sustained use of MyBP and any associated BP reduction.
  3. Identify potentially unique user experiences among older adults with increasing frailty and in those who rely on caregivers.

Methods. Forty-eight older adults (60-85 y/o) with uncontrolled hypertension will be randomized 2:1 to active intervention (MyBP plus a home BP cuff) or usual care (home BP cuff alone) for 6-9 months. Participants will be recruited from UPMC primary care practices. For participants for whom a caregiver has primary responsibility for hypertension-related health behaviors, MyBP will be used by the caregiver. Gait speed will be measured to assess frailty. At baseline and study completion, standardized measurement of home BP will be conducted. Patients and caregivers will complete questionnaires and a semi-structured audio-recorded interview to assess factors associated with MyBP utility and engagement, BP self-management and BP lowering.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
Single (Outcomes Assessor)

盲法说明

Outcome assessor will be blinded to group assignment

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

  • Diagnosis of High blood pressure
  • Office systolic BP reading 150 mm Hg or higher
  • Owns a cell phone with unlimited texting

排除标准

  • Arm circumference > 45 cm

研究组 & 干预措施

Enhanced usual care

Active Comparator

Participants receive a personal, validated home BP monitor with oral and written instruction.

干预措施: Personal BP monitor (Other)

MyBP

Experimental

Participants receive a personal, validated home BP monitor with oral and written instruction. In addition patients receive instruction on, and access to, MyBP. This program provides high BP education through online videos and automated, bidirectional text messaging to assist in continuous home BP self-monitoring.

干预措施: MyBP (Other)

MyBP

Experimental

Participants receive a personal, validated home BP monitor with oral and written instruction. In addition patients receive instruction on, and access to, MyBP. This program provides high BP education through online videos and automated, bidirectional text messaging to assist in continuous home BP self-monitoring.

干预措施: Personal BP monitor (Other)

结局指标

主要结局

Change in systolic BP from baseline to trial completion

时间窗: 5-8 months (Trial duration is not identical across participants but is anticipated to be between 5 and 8 months.)

Seated BP will be measured in duplicate during each of two baseline assessments (4 total readings) and again in duplicate at each of two assessments at trial completion (4 readings). The primary outcome is the change in average systolic BP from baseline to follow-up. This will be calculated as the average systolic BP at follow-up minus the average systolic BP at baseline. The change in BP in two intervention groups will be compared.

次要结局

  • Change in participants' hypertension self-efficacy (confidence in ability to fully understand and manage his or her high BP)(5-8 months)
  • Change in systolic BP from baseline to trial mid-point(Approximately 14 weeks)

研究者

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

Matthew Muldoon

Professor

University of Pittsburgh

研究点 (2)

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High BP and Home Monitoring Experience (HoME) Study | 临床试验