MI-BP: mHealth to Improve Blood Pressure Control
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 162
- 试验地点
- 2
- 主要终点
- Change in mean systolic blood pressure
研究概览
简要总结
This study seeks to evaluate a multicomponent mobile intervention to change multiple hypertension-related health behaviors in minorities and the underserved with uncontrolled hypertension. Half of the participants will receive a mobile intervention designed to improve physical activity, sodium intake, and medication adherence. The other half will receive usual care.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 25 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Detroit-area residents
- •Hypertensive
- •Owning a compatible smartphone
- •Presenting to the Detroit Medical Center Detroit Receiving, Sinai-Grace Hospital, or selected Community Health Screening Events with, but not necessarily for, uncontrolled blood pressure (systolic blood pressure ≥ 135 mm Hg at triage and on repeat measurement using the BpTRU device).
排除标准
- •No self-reported prior history of hypertension
- •No hypertension diagnosis documented in their medical record
- •Non-English speaking
- •Presenting with an acute illness necessitating immediate medical intervention
- •Presenting with an admission to the hospital for critical reasons (as determined by the attending physician)
- •Pregnant (as determined by a dip test at screening), or self-report during trial.
- •Having the following serious comorbidities or confounders due to the fact that they may make blood pressure control difficult or necessitate frequent Emergency Department use or hospitalization:
- •Previous diagnosis of resistant hypertension (or current use of 3 or more maximally dosed antihypertensive agents without achievement of blood pressure control)
- •Steroid dependent asthma or emphysema
- •Cirrhosis or hepatic failure
- •Chronic heart failure (any stage)
- •Previous diagnosis of acute myocardial infarction, angina (stable or unstable), or known coronary artery disease
- •Previous diagnosis of cerebrovascular disease (including transient ischemic attack or stroke)
- •Known valvular heart disease
- •Stage IV or V chronic kidney disease
- •Cancer (terminal or undergoing active chemotherapeutic or radiation therapy)
- •Patients with other serious medical conditions that may affect their ability to self-monitor blood pressure (such a dementia)
- •Having a history of alcohol or drug abuse as determined by the CAGE-AID questionnaire (excluded if 2 or more)
- •Week 2 measurement of systolic blood pressure < 130 mm Hg using the BpTRU device or study-issued BP cuff.
研究组 & 干预措施
Usual care
Usual care participants will be given a prescription for antihypertensive medications, printed educational materials on hypertension, and a home blood pressure monitor for daily use, but will receive no further intervention.
MI-BP
MI-BP participants will receive an antihypertensive medication prescription, and be asked to use technology-mediated devices/services linked to positive changes in target behavior/outcome including the MI-BP app, a secure, mHealth platform that will be installed on participant smartphones.
干预措施: MI-BP (Other)
结局指标
主要结局
Change in mean systolic blood pressure
时间窗: from baseline to 1 year
次要结局
- Change in physical activity as measured by the International Physical Activity Questionnaire (IPAQ-SF)(from baseline to 1 year)
- Change in sodium intake as measured by the Block Sodium Screener(from baseline to 1 year)
- Change in medication adherence as measured by Adherence to Refills and Medications Scale (ARMS)(from baseline to 1 year)
- Change in blood pressure control(from baseline to 1 year)
研究者
Lorraine Buis
Associate Professor of Family Medicine, Medical School and Associate Professor of Information, School of Information
University of Michigan