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)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Systolic Blood Pressure Readings
Study Overview
Brief Summary
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.
Detailed Description
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Health Services Research
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Arms & Interventions
resource referral
will receive a tailored list of information about community resources. The list will include information about local emergency food resources (e.g. local food pantries) and government programs to address Food Insecurities (FI) Supplemental Nutrition Assistance Program (SNAP).
Intervention: Resource information Supplemental Nutrition Assistance Program (SNAP) (Behavioral)
community health worker (CHW) intervention
assist participants in addressing FI and supporting them in their blood pressure management
Intervention: community health worker (CHW) (Behavioral)
medically tailored meals (MTM)
Participants will receive 10 medically tailored meals delivery to their home weekly for 3 months
Intervention: medically tailored meals (Behavioral)
Outcomes
Primary Outcomes
Systolic Blood Pressure Readings
Time Frame: Month 6
assess blood pressure (using ambulatory blood pressure cuffs)
Feasibility of Retention
Time Frame: Month 6
Feasibility will be measured at the proportion of participants who completed 3 and 6 month follow ups
Feasibility of Recruitment Percentage
Time Frame: Baseline
Feasibility will be measured based on the proportion of patients screened who consented to be part of the study
Diastolic Blood Pressure Readings
Time Frame: Month 6
assess blood pressure (using ambulatory blood pressure cuffs)
Systolic Blood Pressure Readings
Time Frame: Baseline
assess blood pressure (using ambulatory blood pressure cuffs)
Diastolic Blood Pressure Readings
Time Frame: Baseline
assess blood pressure (using ambulatory blood pressure cuffs)
Systolic Blood Pressure Readings
Time Frame: Month 3
assess blood pressure (using ambulatory blood pressure cuffs)
Diastolic Blood Pressure Readings
Time Frame: Month 3
assess blood pressure (using ambulatory blood pressure cuffs)
Secondary Outcomes
No secondary outcomes reported