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

Hypertension Clinical Trial

— 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)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05800145
• Other study ID #: IRB00094934
• Secondary ID: 5K23HL146902-04
• Status: Active, not recruiting
• Phase: N/A
• Start date: May 16, 2023
• Est. completion date: June 2024

Study information

• Verified date: September 2023
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 94
• Est. completion date: June 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hypertension

Intervention

Behavioral:
• Resource information Supplemental Nutrition Assistance Program (SNAP)
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).
• community health worker (CHW)
Participants randomized to the CHW intervention will have an initial baseline visit scheduled at a mutually convenient location.
• medically tailored meals
Participants will receive 10 medically tailored meals delivery to their home weekly for 3 months

Locations

Country	Name	City	State
United States	Wake Forest University Health Sciences	Winston-Salem	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood Pressure Readings	assess blood pressure (using ambulatory blood pressure cuffs)	Baseline
Primary	Blood Pressure Readings	assess blood pressure (using ambulatory blood pressure cuffs)	Month 3
Primary	Blood Pressure Readings	assess blood pressure (using ambulatory blood pressure cuffs)	Month 6
Primary	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
Primary	Feasibility of retention Percentage	Feasibility will be measured at the proportion of participants who completed 3 and 6 month follow ups	Month 6