SupportBP 2.0: Behavioral Science and Enrollment in Remote Monitoring for Hypertension Management
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 425
- 试验地点
- 1
- 主要终点
- Proportion Participating by Recruitment Method
研究概览
简要总结
A 3-arm randomized pilot trial aimed at comparing the effectiveness of different approaches to recruiting patients to participate in a 6-month remote monitoring program for the management of hypertension (HTN).
详细描述
The investigators will utilize the Way to Health (WTH) platform to develop and evaluate a new remote monitoring enrollment model that is integrated with routine clinical care at Penn Family Care (PFC), an academic family medicine practice in West Philadelphia. Among patients with poorly controlled HTN the investigators will:
- Compare the effect of sending eligible patients a blood pressure cuff with the mailed invitation letter and opt-out framing versus the more conventional method of phone calls following mailed letters.
- Evaluate the feasibility and effectiveness of a remote monitoring program with individualized stepped escalation for hypertension management.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Between 18 and 75 years old with HTN (ICD-10 code I10)
- •Has had at least one office visit at Penn Family Care (PFC) within the past 12 months (at time of chart review), with the last visit having a BP reading exceeding HTN guidelines (150/90 if >60 or, 140/90 if ages 21-59 yrs or has CKD or diabetes).
- •Must have a cellular phone with texting capabilities
- •Must be prescribed at least one medication for hypertension
排除标准
- •Has metastatic (Stage IV) cancer
- •Has end stage renal disease
- •Has congestive heart failure
- •Has dementia
- •Is Non-English speaking requiring a translator
研究组 & 干预措施
Opt-In Recruitment
All recruitment messaging will be framed for patients as they must opt-in to participate in the remote monitoring program.
干预措施: Opt-In Recruitment (Behavioral)
Opt-Out
All recruitment messaging will be framed as though participation is the default, and patients must opt-out of participating in the remote monitoring program.
干预措施: Opt-Out Recruitment (Behavioral)
Usual Care
Patients in the usual care arm will not be contacted by study staff, they will not receive a blood pressure cuff, and they will not be asked to participate in any component of the blood pressure monitoring program.
结局指标
主要结局
Proportion Participating by Recruitment Method
时间窗: 6 months, from date of consent to end of remote monitoring program
The proportion of patients participating in each study arm out of the number randomized to that study arm.
次要结局
- Blood Pressure Trajectory by Recruitment Method(6 months, from date of consent to end of remote monitoring program)
- Proportion Engaged by Recruitment Method(6 months, from date of consent to end of remote monitoring period)
- Proportion with Controlled Blood Pressure by Monitoring vs. Usual Care(6 months, from date of consent to end of remote monitoring program)
- Proportion of BP Measurements Submitted by Recruitment Method(6 months, from date of consent to end of remote monitoring program)
研究者
Shivan J Mehta
Principal Investigator
University of Pennsylvania