Back to resultsTrial to Address Food Insecurity in Patients With Hypertension (SMART-FI) (SMART-FI)
Primary Purpose
Hypertension
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Resource information Supplemental Nutrition Assistance Program (SNAP)
community health worker (CHW)
medically tailored meals
Sponsored by
About this trial
This is an interventional health services research trial for Hypertension focused on measuring Food Insecurities, Systolic Blood Pressure, cardiovascular disease
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
Sites / Locations
- Wake Forest University Health SciencesRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Active Comparator
Arm Label
resource referral
community health worker (CHW) intervention
medically tailored meals (MTM)
Arm Description
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).
assist participants in addressing FI and supporting them in their blood pressure management
Participants will receive 10 medically tailored meals delivery to their home weekly for 3 months
Outcomes
Primary Outcome Measures
Blood Pressure Readings
assess blood pressure (using ambulatory blood pressure cuffs)
Blood Pressure Readings
assess blood pressure (using ambulatory blood pressure cuffs)
Blood Pressure Readings
assess blood pressure (using ambulatory blood pressure cuffs)
Feasibility of recruitment Percentage
Feasibility will be measured based on the proportion of patients screened who consented to be part of the study
Feasibility of retention Percentage
Feasibility will be measured at the proportion of participants who completed 3 and 6 month follow ups
Secondary Outcome Measures
Full Information
NCT ID
NCT05800145
First Posted
March 22, 2023
Last Updated
September 20, 2023
Sponsor
Wake Forest University Health Sciences
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
1. Study Identification
Unique Protocol Identification Number
NCT05800145
Brief Title
Trial to Address Food Insecurity in Patients With Hypertension (SMART-FI)
Acronym
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
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 16, 2023 (Actual)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
June 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wake Forest University Health Sciences
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension
Keywords
Food Insecurities, Systolic Blood Pressure, cardiovascular disease
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
resource referral
Arm Type
Experimental
Arm Description
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).
Arm Title
community health worker (CHW) intervention
Arm Type
Active Comparator
Arm Description
assist participants in addressing FI and supporting them in their blood pressure management
Arm Title
medically tailored meals (MTM)
Arm Type
Active Comparator
Arm Description
Participants will receive 10 medically tailored meals delivery to their home weekly for 3 months
Intervention Type
Behavioral
Intervention Name(s)
Resource information Supplemental Nutrition Assistance Program (SNAP)
Other Intervention Name(s)
SNAP
Intervention Description
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).
Intervention Type
Behavioral
Intervention Name(s)
community health worker (CHW)
Other Intervention Name(s)
CHW
Intervention Description
Participants randomized to the CHW intervention will have an initial baseline visit scheduled at a mutually convenient location.
Intervention Type
Behavioral
Intervention Name(s)
medically tailored meals
Other Intervention Name(s)
MTM
Intervention Description
Participants will receive 10 medically tailored meals delivery to their home weekly for 3 months
Primary Outcome Measure Information:
Title
Blood Pressure Readings
Description
assess blood pressure (using ambulatory blood pressure cuffs)
Time Frame
Baseline
Title
Blood Pressure Readings
Description
assess blood pressure (using ambulatory blood pressure cuffs)
Time Frame
Month 3
Title
Blood Pressure Readings
Description
assess blood pressure (using ambulatory blood pressure cuffs)
Time Frame
Month 6
Title
Feasibility of recruitment Percentage
Description
Feasibility will be measured based on the proportion of patients screened who consented to be part of the study
Time Frame
Month 6
Title
Feasibility of retention Percentage
Description
Feasibility will be measured at the proportion of participants who completed 3 and 6 month follow ups
Time Frame
Month 6
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Selina M Quinones
Phone
336.716.7408
Email
squinone@wakehealth.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Deepak Palakshappa, MD
Phone
336.716.1795
Email
dpalaksh@wakehealth.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Deepak Palakshappa, MD
Organizational Affiliation
Wake Forest University Health Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wake Forest University Health Sciences
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Selina M Quinones
Phone
336-716-7408
Email
squinone@wakehealth.edu
First Name & Middle Initial & Last Name & Degree
Deepak Palakshappa, MD
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Individual Participant data that underlie the Results reported in this article, after deidentification (text, tables, figures, and appendices)
IPD Sharing Time Frame
Beginning 9 months and ending 36 months following article publication
IPD Sharing Access Criteria
Investigators whose proposed use of the data has been approved by an independent review committee identified for this purpose
Learn more about this trial
Trial to Address Food Insecurity in Patients With Hypertension (SMART-FI)
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