A Cardiometabolic Health Program Linked With Clinical-Community Support and Mobile Health Telemonitoring to Reduce Health Disparities
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 425
- 试验地点
- 6
- 主要终点
- Blood Pressure Control as assessed by percentage of participants with controlled Blood Pressure
研究概览
简要总结
The LINKED- HEARTS Program is a multi-level project that intervenes at the practice level by linking home blood pressure monitoring (HBPM) with a telemonitoring platform (Sphygmo). The program incorporates team-based care by including community health workers (CHWs) and pharmacists to improve the outcomes of multiple chronic conditions (reduced blood pressure (BP), lower blood sugar, and improved kidney function). The LINKED-HEARTS Program will recruit a total of 600 adults with uncontrolled hypertension (BP ≥ 140/90 mm Hg) AND either type 2 diabetes or chronic kidney disease (CKD) across 16 community health centers or primary care practices serving high-risk adults. This cluster-randomized trial consists of two arms: (1) enhanced "usual care arm," wherein patients will be provided with Omron 10 series home BP monitors and will be managed by the patients' primary care clinicians as usual; and (2) the "intervention arm" which will integrate HBPM telemonitoring, a CHW intervention and provider-level interventions into the usual clinical care to improve BP control and provide support for self-management of chronic conditions. The study pharmacist will conduct telehealth, use the Sphygmo app and the Pharmacist Patient Care Process to collaborate with other providers to optimize pharmacologic therapy to improve hypertension outcomes and with payors to ensure consistent access to drug therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years of age as of date of data extraction,
- •Self-identify as non-Hispanic white, non-Hispanic Black/African American and/or Hispanic,
- •Diagnosis of Hypertension (HTN) defined by International Classification of Diseases, Tenth code (ICD-10 code) and elevated systolic blood pressure (SBP) measure (≥140 mm Hg) on their most recent clinic visit.
- •Diagnosis of diabetes or chronic kidney disease (both defined by ICD-10 code), in addition to HTN
- •Receives primary medical care at one of the participating health systems
- •Have a Maryland and D.C. home address
排除标准
- •Age <18 years
- •Diagnosis of end-stage renal disease (ESRD) treated with dialysis
- •Serious medical condition which either limits life expectancy or requires active management (e.g., cancer)
- •Cognitive impairment or other condition preventing participation in the intervention
- •Planning to leave the practice or move out of the geographic area in 24 months
- •No longer consider the practice site their location for primary care
- •Unwillingness to provide informed consent
结局指标
主要结局
Blood Pressure Control as assessed by percentage of participants with controlled Blood Pressure
时间窗: 12 months
Percent of patients with controlled Blood Pressure (\<140/90 mm Hg).
次要结局
- Mean change in Estimated Glomerular Filtration Rate(Baseline and 12 months)
- Change in Health-Related Quality of Life as assessed by the PROMIS 29(12 months and 24 months)
- Percent with Hemoglobin A1c < 7.0(Baseline and 12 months)
- Change in Systolic Blood Pressure(Baseline and 12 months)
- Change in Diastolic blood pressure(Baseline and 12 months)
- Mean change in Hemoglobin A1c(Baseline and 12 months)
- Change in Body Mass Index (BMI)(Baseline and 12 months)