Clinical trial NCT05800145: Trial to Address Food Insecurity in Patients With Hypertension (SMART-FI)
Official title: 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Keywords: Food Insecurities
Systolic Blood Pressure
cardiovascular disease
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2023-04-05
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: HEALTH_SERVICES_RESEARCH

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

Eligibility criteria: 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

Primary outcomes:
measure: Blood Pressure Readings
timeFrame: Baseline
measure: Blood Pressure Readings
timeFrame: Month 3
measure: Blood Pressure Readings
timeFrame: Month 6
measure: Feasibility of recruitment Percentage
timeFrame: Month 6
measure: Feasibility of retention Percentage
timeFrame: Month 6
Secondary outcomes:
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest University Health Sciences
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Deepak Palakshappa, MD
role: PRINCIPAL_INVESTIGATOR
References: