Remote Monitoring and Enhanced Social Support for Hypertension Management
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- Systolic blood pressure
研究概览
简要总结
A 3-arm randomized pilot trial aimed at comparing the effectiveness of different remote approaches to improving blood pressure (BP) control.
详细描述
The investigators plan to leverage the Way to Health (WTH) platform to develop and evaluate a new HTN service-delivery 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 assess the effects of monitoring blood pressure and medication adherence with feedback to the patient and to the clinical practice, as needed if out of control.
- The investigators will also compare the impact of providing feedback to a social support partner with facilitated cheerleading.
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
- Single (Investigator)
盲法说明
Single (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 two office visits at Penn Family Care (PFC) within the past 12 months (at time of chart review), with at least two of the visits with BP readings exceeding HTN guidelines, including the last visit (150/90 or 140/90 if ages 21-59 yrs with 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) blood or solid tumor cancer
- •Has end stage renal disease
- •Has congestive heart failure
- •Has dementia
- •Has liver cirrhosis
研究组 & 干预措施
Remote Monitoring (RM)
Remote Monitoring subjects will receive a blood pressure cuff and bidirectional text messaging regarding blood pressure and medication adherence.
干预措施: Remote Monitoring (Behavioral)
Usual Care
Usual care subjects will not receive a blood pressure cuff or bidirectional text messaging. They will be asked to take their medication and monitor BP as usual with no additional contact from study staff until the 4 month study follow-up.
Remote Monitoring + Social Support (RM+SS)
Remote Monitoring + Social Support subjects will receive a blood pressure cuff and bidirectional text messaging regarding blood pressure and medication adherence, as well as a social support partner to provide additional feedback to the participant on their monitoring and adherence practices.
干预措施: Remote Monitoring + Social Support (Behavioral)
结局指标
主要结局
Systolic blood pressure
时间窗: 4 months
Systolic blood pressure during the 4-month study visit, adjusted for initial systolic blood pressure
次要结局
- Percent of patients that are normotensive(4 months)
- Medication adherence(4 months)
- Diastolic blood pressure(4 months)