Trial to Address Food Insecurity in Patients With Hypertension (SMART-FI)

Study Overview
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Brief Summary
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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
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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

Official Title
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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)

Conditions
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Hypertension

Intervention / Treatment
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* Behavioral: Resource information Supplemental Nutrition Assistance Program (SNAP)
* Behavioral: community health worker (CHW)
* Behavioral: medically tailored meals


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The objective of this study is to conduct a pilot sequential multiple assignment randomized trial (SMART) addressing food insecurity in patients with uncontrolled Hypertension (HTN) to determine the feasibility of recruitment/retention and the potential impact on blood pressure in anticipation of a larger more definitive trial.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: resource referral<br>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). | Behavioral: Resource information Supplemental Nutrition Assistance Program (SNAP)<br>* Participants randomized to the resource referral arm 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 FI (e.g. SNAP).<br>* Other names: SNAP;|
| Active Comparator: community health worker (CHW) intervention<br>assist participants in addressing FI and supporting them in their blood pressure management | Behavioral: community health worker (CHW)<br>* Participants randomized to the CHW intervention will have an initial baseline visit scheduled at a mutually convenient location.<br>* Other names: CHW;|
| Active Comparator: medically tailored meals (MTM)<br>Participants will receive 10 medically tailored meals delivery to their home weekly for 3 months | Behavioral: medically tailored meals<br>* Participants will receive 10 medically tailored meals delivery to their home weekly for 3 months<br>* Other names: MTM;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood Pressure Readings | assess blood pressure (using ambulatory blood pressure cuffs) | Baseline | 
| Blood Pressure Readings | assess blood pressure (using ambulatory blood pressure cuffs) | Month 3 | 
| Blood Pressure Readings | assess blood pressure (using ambulatory blood pressure cuffs) | Month 6 | 
| Feasibility of recruitment Percentage | Feasibility will be measured based on the proportion of patients screened who consented to be part of the study | Month 6 | 
| Feasibility of retention Percentage | Feasibility will be measured at the proportion of participants who completed 3 and 6 month follow ups | Month 6 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Food Insecurities, Systolic Blood Pressure, cardiovascular disease