Pilot Study to Evaluate the Feasibility of Using a Sequential Multiple Assignment Randomized Trial to Address Food Insecurity in Patients With Hypertension (Pilot SMART-FI)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 94
- 试验地点
- 2
- 主要终点
- Systolic Blood Pressure Readings
研究概览
简要总结
In the US, 47% of adults have hypertension (HTN), and HTN accounts for more cardiovascular disease (CVD) deaths than any other CVD risk factor. Thus, the lack of an adaptive, stepped-care intervention to address FI in patients with HTN is a critical problem affecting a large, vulnerable population.
详细描述
Despite advances in prevention and treatment, barriers to adherence are common and HTN disparities remain pervasive. Populations that have been socially and economically disadvantaged have a greater prevalence of HTN, worse blood pressure control, and are at higher risk of developing CVD from HTN. Food insecurity (FI), the lack of consistent access to nutritionally adequate foods, is an important social need that affects 30 million people in the US, impacts adherence to treatment, and contributes to HTN disparities. Increasingly, health systems are investing in interventions to address FI as part of routine care, including lower-cost, low intensity (e.g. providing information about community resources) and higher-cost, high intensity (e.g. using community health workers (CHWs), delivery of medical tailored meals (MTM)) interventions
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 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
- •Adult patients (≥18 years of age)
- •diagnosis of Hypertension (HTN) (defined by ICD-10 code) or have been prescribed at least one blood pressure medication (including thiazide diuretic, calcium channel blocker, beta-blocker, angiotensin-converting enzyme inhibitors, or angiotensin receptor blocker)
- •blood pressures at their primary care office was >130/80
- •experience Food Insecurity (FI) based on the 2-item Hunger Vital Sign
- •live in Winston-Salem or Forsyth County
排除标准
- •unable to speak English or Spanish
- •have severe cognitive impairment or major psychiatric illness that prevents consent and participation
- •lack of safe, stable residence and ability to store meals
- •pregnant, breastfeeding, or planning to become pregnant in the next year
- •advance kidney disease (estimated creatine clearance < 30 mL/min)
- •serious medical condition which either limits life expectancy or requires active management
- •those planning on moving out of the geographic area within 12 months
- •lack of a telephone
结局指标
主要结局
Systolic Blood Pressure Readings
时间窗: Month 6
assess blood pressure (using ambulatory blood pressure cuffs)
Feasibility of Retention
时间窗: Month 6
Feasibility will be measured at the proportion of participants who completed 3 and 6 month follow ups
Feasibility of Recruitment Percentage
时间窗: Baseline
Feasibility will be measured based on the proportion of patients screened who consented to be part of the study
Diastolic Blood Pressure Readings
时间窗: Month 6
assess blood pressure (using ambulatory blood pressure cuffs)
次要结局
未报告次要终点