Remote Monitoring and Virtual Collaborative Care For Hypertension Control to Prevent Cognitive Decline Phase II
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 1,000
- 试验地点
- 4
- 主要终点
- Systolic Blood Pressure (SBP) Control At 24 Months
研究概览
简要总结
This is a randomized, controlled, pragmatic trial designed as a "type I hybrid effectiveness-implementation trial" that tests a hypertension program integrating a virtual Collaborative Care Clinic (vCCC), home blood pressure monitoring, and telehealth for lowering blood pressure (BP) in two health systems.
详细描述
This study tests a hypertension program integrating a virtual Collaborative Care Clinic (vCCC), home blood pressure monitoring, and telehealth for lowering blood pressure (BP) in two health systems (University of Kansas Health System [UKHS] and the University of Utah Health [UUtah]). The vCCC is staffed by clinical pharmacists who remotely monitor home BP and use telehealth to work with patients to lower systolic blood pressure (SBP) to <130 mmHg, as recommended by the current American College of Cardiology/American Heart Association (ACC/AHA) guidelines. Eligible patients with uncontrolled hypertension (HTN) are identified automatically through the electronic health record (EHR) during visits to their Primary Care Provider (PCP) and referred for enrollment into the vCCC.
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
- Double (Investigator, Outcomes Assessor)
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 and older
- •Active patient in participating primary care clinic
- •Access to compatible "smartphone" or device (i.e., Android, Kindle or Apple with internet connectivity or mobile network)
- •Elevated BP as defined by
- •SBP >140 at current visit AND documented history of hypertension OR SBP > 140 at current visit and at another visit in last 18 months OR SBP >160 at current visit
- •Sufficiently fluent in English to participate in study procedures
- •Adequate hearing to complete study procedures
- •Able to give their own signed consent
- •Health insurance coverage by Medicare
排除标准
- •Clinically significant illness that may affect safety or completion per their treating PCP or study physician
- •Needing interpreter for clinic visits (through Electronic Health Record)
- •Currently in hospice care
- •Currently receiving chemotherapy
- •Unable to take accurate BP measurement, either due to inability to follow protocol to check BP or due to medical conditions such as lymphedema or dialysis access on both arms.
- •Currently participating in another intervention trial
- •End stage kidney disease on dialysis
- •Diagnosis of dementia (i.e., dementia, Alzheimer's disease, vascular dementia, dementia with Lewy bodies, frontotemporal dementia)
- •Chronic active disease with expected life expectancy < 2 years as determined by the study team
研究组 & 干预措施
Usual Care with Education
The participant will be provided with educational material and a home BP monitor. Control participants will continue to see their physicians for their usual care for BP management (their BP data will not be reviewed by pharmacists and the patients will not have support from vCCC pharmacists)
Virtual Collaborative Care Clinic
Participants will partake in the virtual collaborative care clinic
干预措施: Virtual Collaborative Care Clinic (Other)
结局指标
主要结局
Systolic Blood Pressure (SBP) Control At 24 Months
时间窗: 24 months.
Our primary outcome is achieving SBP control (\<130 mmHg). Blood pressure measures will be collected in a dashboard system and will be integrated into the common data model table for final analysis. Investigators will utilize the Benjamini-Hochberg approach to control for multiple testing in our primary outcome.
次要结局
- Atherosclerotic Cardiovascular Disease Risk (ASCVD)(24 months)
- Major Adverse Cardiovascular Events (MACE)(24 months)
- Systolic Blood Pressure (SBP) Control At 12 Months(12 Months)
- Health utilization outcome measurement: Carrier Claims(2 years)
- Health utilization outcome measurement: facility claims(2 years)
- Health utilization outcome measurement: coronary care claims(2 years)
- Health utilization outcome measurement: durable medical equipment Medicare payments(2 years)
- Health utilization outcome measurement: imaging and laboratory expenditures(2 years)
- Cognitive Measures(0 months, 12 months, and 24 months)
- Health utilization outcome measurement: general drug claims(2 years)
- Health Care Resource Utilization: Charges Per Patient(2 years)
- Mortality(2 years)
- Health utilization outcome measurement: coronary care expenditures(2 years)
- Health utilization outcome measurement: coronary care unit days(2 years)
- Health utilization outcome measurement: intensive care unit (ICU) days(2 years)
- Health utilization outcome measurement: imaging and laboratory events(2 years)