Trial Outcomes & Findings for Trial to Address Food Insecurity in Patients With Hypertension (SMART-FI) (NCT NCT05800145)
NCT ID: NCT05800145
Last Updated: 2025-08-05
Results Overview
assess blood pressure (using ambulatory blood pressure cuffs)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
60 participants
Primary outcome timeframe
Baseline
Results posted on
2025-08-05
Participant Flow
Participant milestones
| Measure |
Resource Referral Only
This arm included participants who responded to resource information in Stage 1 and participants who were not assessed for response at the end of Stage 1. In Stage 1, participants received 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 Insecurity (FI), such as the Supplemental Nutrition Assistance Program (SNAP).
In Stage 2, responders did not receive any additional intervention than the information provided in Stage 1.
|
Resource Referral + CHW
This arm includes participants who did not respond to resource information in Stage 1. In Stage 1, participants received 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 Insecurity (FI), such as the Supplemental Nutrition Assistance Program (SNAP).
In Stage 2, nonresponders to resource information received assistance from a community health worker (CHW) for 3 months. The CHW helped participants with accessing community resources and worked directly with the patient's care team to assist with any barriers to care.
|
Resource Referral + Medically Tailored Meals (MTM)
This arm included participants who did not respond to resource information in Stage 1. In Stage 1, participants received 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 Insecurity (FI), such as the Supplemental Nutrition Assistance Program (SNAP).
In Stage 2, nonresponders received 10 medically tailored meals delivered to their home weekly for 3 months.
|
Community Health Worker (CHW) Only
This arm included participants who responded to resource information in Stage 1 and participants who were not assessed for response at the end of Stage 1. In Stage 1, participants received assistance from a community health worker (CHW) for 3 months. The CHW helped participants with accessing community resources and worked directly with the patient's care team to assist with any barriers to care.
In Stage 2, responders did not receive any additional intervention than the CHW assistance provided in Stage 1.
|
Community Health Worker (CHW) + CHW Assitance
This arm includes participants who did not respond to CHW assistance in Stage 1. In Stage 1, participants received assistance from a CHW for 3 months. The CHW helped participants with access community resources and worked directly with the patients care team to assist with any barriers to care.
In Stage 2, nonresponders to CHW assistance in Stage 1 received assistance from a CHW for an additional 3 months.
|
Community Health Worker (CHW) Assistance + Medically Tailored Meals (MTM)
This arm includes participants who did not respond to CHW assistance in Stage 1. In Stage 1, participants received assistance from a CHW for 3 months. The CHW helped participants with access community resources and worked directly with the patients care team to assist with any barriers to care.
In Stage 2, nonresponders received 10 medically tailored meals delivered to their home weekly for 3 months.
|
|---|---|---|---|---|---|---|
|
Stage 1 Intervention (Months 1-3)
STARTED
|
13
|
7
|
8
|
18
|
6
|
8
|
|
Stage 1 Intervention (Months 1-3)
COMPLETED
|
5
|
7
|
8
|
12
|
6
|
8
|
|
Stage 1 Intervention (Months 1-3)
NOT COMPLETED
|
8
|
0
|
0
|
6
|
0
|
0
|
|
Stage 2 Intervention (Months 4-6)
STARTED
|
5
|
7
|
8
|
12
|
6
|
8
|
|
Stage 2 Intervention (Months 4-6)
COMPLETED
|
4
|
2
|
8
|
9
|
4
|
7
|
|
Stage 2 Intervention (Months 4-6)
NOT COMPLETED
|
1
|
5
|
0
|
3
|
2
|
1
|
Reasons for withdrawal
| Measure |
Resource Referral Only
This arm included participants who responded to resource information in Stage 1 and participants who were not assessed for response at the end of Stage 1. In Stage 1, participants received 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 Insecurity (FI), such as the Supplemental Nutrition Assistance Program (SNAP).
In Stage 2, responders did not receive any additional intervention than the information provided in Stage 1.
|
Resource Referral + CHW
This arm includes participants who did not respond to resource information in Stage 1. In Stage 1, participants received 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 Insecurity (FI), such as the Supplemental Nutrition Assistance Program (SNAP).
In Stage 2, nonresponders to resource information received assistance from a community health worker (CHW) for 3 months. The CHW helped participants with accessing community resources and worked directly with the patient's care team to assist with any barriers to care.
|
Resource Referral + Medically Tailored Meals (MTM)
This arm included participants who did not respond to resource information in Stage 1. In Stage 1, participants received 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 Insecurity (FI), such as the Supplemental Nutrition Assistance Program (SNAP).
In Stage 2, nonresponders received 10 medically tailored meals delivered to their home weekly for 3 months.
|
Community Health Worker (CHW) Only
This arm included participants who responded to resource information in Stage 1 and participants who were not assessed for response at the end of Stage 1. In Stage 1, participants received assistance from a community health worker (CHW) for 3 months. The CHW helped participants with accessing community resources and worked directly with the patient's care team to assist with any barriers to care.
In Stage 2, responders did not receive any additional intervention than the CHW assistance provided in Stage 1.
|
Community Health Worker (CHW) + CHW Assitance
This arm includes participants who did not respond to CHW assistance in Stage 1. In Stage 1, participants received assistance from a CHW for 3 months. The CHW helped participants with access community resources and worked directly with the patients care team to assist with any barriers to care.
In Stage 2, nonresponders to CHW assistance in Stage 1 received assistance from a CHW for an additional 3 months.
|
Community Health Worker (CHW) Assistance + Medically Tailored Meals (MTM)
This arm includes participants who did not respond to CHW assistance in Stage 1. In Stage 1, participants received assistance from a CHW for 3 months. The CHW helped participants with access community resources and worked directly with the patients care team to assist with any barriers to care.
In Stage 2, nonresponders received 10 medically tailored meals delivered to their home weekly for 3 months.
|
|---|---|---|---|---|---|---|
|
Stage 1 Intervention (Months 1-3)
Lost to Follow-up
|
7
|
0
|
0
|
3
|
0
|
0
|
|
Stage 1 Intervention (Months 1-3)
Withdrawal by Subject
|
1
|
0
|
0
|
3
|
0
|
0
|
|
Stage 2 Intervention (Months 4-6)
Lost to Follow-up
|
1
|
5
|
0
|
3
|
2
|
1
|
Baseline Characteristics
Trial to Address Food Insecurity in Patients With Hypertension (SMART-FI)
Baseline characteristics by cohort
| Measure |
Resource Referral
n=28 Participants
Participants received 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 insecurity, such as the Supplemental Nutrition Assistance Program (SNAP).
|
Community Health Worker (CHW) Intervention
n=32 Participants
Participants received assistance from a CHW. The CHW assisted participant with accessing community resources and worked with the patient's care team to assist with any barriers to care.
|
Total
n=60 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
58.1 years
STANDARD_DEVIATION 10.3 • n=5 Participants
|
58.1 years
STANDARD_DEVIATION 11.1 • n=7 Participants
|
58.1 years
STANDARD_DEVIATION 10.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
28 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
58 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
25 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
52 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Baseline Systolic Blood pressure
|
140.6 mmHg
STANDARD_DEVIATION 10.1 • n=5 Participants
|
151.8 mmHg
STANDARD_DEVIATION 19.5 • n=7 Participants
|
146.6 mmHg
STANDARD_DEVIATION 16.7 • n=5 Participants
|
|
Baseline Diastolic Blood pressure
|
86.6 mmHg
STANDARD_DEVIATION 9.9 • n=5 Participants
|
88.4 mmHg
STANDARD_DEVIATION 10.9 • n=7 Participants
|
87.6 mmHg
STANDARD_DEVIATION 10.4 • n=5 Participants
|
PRIMARY outcome
Timeframe: BaselinePopulation: Participants in Stage 1 and Stage 2 arms
assess blood pressure (using ambulatory blood pressure cuffs)
Outcome measures
| Measure |
Resource Referral Only
n=13 Participants
This arm included participants who responded to resource information in Stage 1 and participants who were not assessed for response at the end of Stage 1. In Stage 1, participants received 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 Insecurity (FI), such as the Supplemental Nutrition Assistance Program (SNAP).
In Stage 2, responders did not receive any additional intervention than the information provided in Stage 1
|
Resource Referral + Community Health Worker (CHW) Intervention
n=7 Participants
This arm includes participants who did not respond to resource information in Stage 1. In Stage 1, participants received 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 Insecurity (FI), such as the Supplemental Nutrition Assistance Program (SNAP).
In Stage 2, nonresponders to resource information received assistance from a community health worker (CHW) for 3 months. The CHW helped participants with accessing community resources and worked directly with the patient's care team to assist with any barriers to care.
|
Resource Referral + Medically Tailored Meals (MTM)
n=8 Participants
This arm included participants who did not respond to resource information in Stage 1. In Stage 1, participants received 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 Insecurity (FI), such as the Supplemental Nutrition Assistance Program (SNAP).
In Stage 2, nonresponders received 10 medically tailored meals delivered to their home weekly for 3 months.
|
Community Health Worker (CHW) Only
n=18 Participants
This arm included participants who responded to resource information in Stage 1 and participants who were not assessed for response at the end of Stage 1. In Stage 1, participants received assistance from a community health worker (CHW) for 3 months. The CHW helped participants with accessing community resources and worked directly with the patient's care team to assist with any barriers to care.
In Stage 2, responders did not receive any additional intervention than the CHW assistance provided in Stage 1.
|
Community Health Worker (CHW) + CHW Assistance
n=6 Participants
This arm includes participants who did not respond to CHW assistance in Stage 1. In Stage 1, participants received assistance from a CHW for 3 months. The CHW helped participants with access community resources and worked directly with the patients care team to assist with any barriers to care.
In Stage 2, nonresponders to CHW assistance in Stage 1 received assistance from a CHW for an additional 3 months.
|
Community Health Worker (CHW) Assistance + Medically Tailored Meals
n=8 Participants
This arm includes participants who did not respond to CHW assistance in Stage 1. In Stage 1, participants received assistance from a CHW for 3 months. The CHW helped participants with access community resources and worked directly with the patients care team to assist with any barriers to care.
In Stage 2, nonresponders received 10 medically tailored meals delivered to their home weekly for 3 months.
|
|---|---|---|---|---|---|---|
|
Systolic Blood Pressure Readings
|
144.3 mmHg
Standard Deviation 8.2
|
138.1 mmHg
Standard Deviation 9.1
|
136.8 mmHg
Standard Deviation 12.6
|
151.7 mmHg
Standard Deviation 18.2
|
150.8 mmHg
Standard Deviation 22.0
|
146.4 mmHg
Standard Deviation 16.1
|
PRIMARY outcome
Timeframe: BaselinePopulation: 61 individuals screened met the inclusion and exclusion criteria. 60 individuals enrolled in the study and 1 declined
Feasibility will be measured based on the proportion of patients screened who consented to be part of the study
Outcome measures
| Measure |
Resource Referral Only
n=61 Participants
This arm included participants who responded to resource information in Stage 1 and participants who were not assessed for response at the end of Stage 1. In Stage 1, participants received 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 Insecurity (FI), such as the Supplemental Nutrition Assistance Program (SNAP).
In Stage 2, responders did not receive any additional intervention than the information provided in Stage 1
|
Resource Referral + Community Health Worker (CHW) Intervention
This arm includes participants who did not respond to resource information in Stage 1. In Stage 1, participants received 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 Insecurity (FI), such as the Supplemental Nutrition Assistance Program (SNAP).
In Stage 2, nonresponders to resource information received assistance from a community health worker (CHW) for 3 months. The CHW helped participants with accessing community resources and worked directly with the patient's care team to assist with any barriers to care.
|
Resource Referral + Medically Tailored Meals (MTM)
This arm included participants who did not respond to resource information in Stage 1. In Stage 1, participants received 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 Insecurity (FI), such as the Supplemental Nutrition Assistance Program (SNAP).
In Stage 2, nonresponders received 10 medically tailored meals delivered to their home weekly for 3 months.
|
Community Health Worker (CHW) Only
This arm included participants who responded to resource information in Stage 1 and participants who were not assessed for response at the end of Stage 1. In Stage 1, participants received assistance from a community health worker (CHW) for 3 months. The CHW helped participants with accessing community resources and worked directly with the patient's care team to assist with any barriers to care.
In Stage 2, responders did not receive any additional intervention than the CHW assistance provided in Stage 1.
|
Community Health Worker (CHW) + CHW Assistance
This arm includes participants who did not respond to CHW assistance in Stage 1. In Stage 1, participants received assistance from a CHW for 3 months. The CHW helped participants with access community resources and worked directly with the patients care team to assist with any barriers to care.
In Stage 2, nonresponders to CHW assistance in Stage 1 received assistance from a CHW for an additional 3 months.
|
Community Health Worker (CHW) Assistance + Medically Tailored Meals
This arm includes participants who did not respond to CHW assistance in Stage 1. In Stage 1, participants received assistance from a CHW for 3 months. The CHW helped participants with access community resources and worked directly with the patients care team to assist with any barriers to care.
In Stage 2, nonresponders received 10 medically tailored meals delivered to their home weekly for 3 months.
|
|---|---|---|---|---|---|---|
|
Feasibility of Recruitment Percentage
|
0.98 Proportion of participants
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Month 6Population: Includes all participants who started Stage 1.
Feasibility will be measured at the proportion of participants who completed 3 and 6 month follow ups
Outcome measures
| Measure |
Resource Referral Only
n=28 Participants
This arm included participants who responded to resource information in Stage 1 and participants who were not assessed for response at the end of Stage 1. In Stage 1, participants received 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 Insecurity (FI), such as the Supplemental Nutrition Assistance Program (SNAP).
In Stage 2, responders did not receive any additional intervention than the information provided in Stage 1
|
Resource Referral + Community Health Worker (CHW) Intervention
n=32 Participants
This arm includes participants who did not respond to resource information in Stage 1. In Stage 1, participants received 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 Insecurity (FI), such as the Supplemental Nutrition Assistance Program (SNAP).
In Stage 2, nonresponders to resource information received assistance from a community health worker (CHW) for 3 months. The CHW helped participants with accessing community resources and worked directly with the patient's care team to assist with any barriers to care.
|
Resource Referral + Medically Tailored Meals (MTM)
This arm included participants who did not respond to resource information in Stage 1. In Stage 1, participants received 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 Insecurity (FI), such as the Supplemental Nutrition Assistance Program (SNAP).
In Stage 2, nonresponders received 10 medically tailored meals delivered to their home weekly for 3 months.
|
Community Health Worker (CHW) Only
This arm included participants who responded to resource information in Stage 1 and participants who were not assessed for response at the end of Stage 1. In Stage 1, participants received assistance from a community health worker (CHW) for 3 months. The CHW helped participants with accessing community resources and worked directly with the patient's care team to assist with any barriers to care.
In Stage 2, responders did not receive any additional intervention than the CHW assistance provided in Stage 1.
|
Community Health Worker (CHW) + CHW Assistance
This arm includes participants who did not respond to CHW assistance in Stage 1. In Stage 1, participants received assistance from a CHW for 3 months. The CHW helped participants with access community resources and worked directly with the patients care team to assist with any barriers to care.
In Stage 2, nonresponders to CHW assistance in Stage 1 received assistance from a CHW for an additional 3 months.
|
Community Health Worker (CHW) Assistance + Medically Tailored Meals
This arm includes participants who did not respond to CHW assistance in Stage 1. In Stage 1, participants received assistance from a CHW for 3 months. The CHW helped participants with access community resources and worked directly with the patients care team to assist with any barriers to care.
In Stage 2, nonresponders received 10 medically tailored meals delivered to their home weekly for 3 months.
|
|---|---|---|---|---|---|---|
|
Feasibility of Retention
|
0.5 Proportion of participants
|
0.625 Proportion of participants
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: BaselinePopulation: Participants in Stage 1 and Stage 2 arms
assess blood pressure (using ambulatory blood pressure cuffs)
Outcome measures
| Measure |
Resource Referral Only
n=13 Participants
This arm included participants who responded to resource information in Stage 1 and participants who were not assessed for response at the end of Stage 1. In Stage 1, participants received 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 Insecurity (FI), such as the Supplemental Nutrition Assistance Program (SNAP).
In Stage 2, responders did not receive any additional intervention than the information provided in Stage 1
|
Resource Referral + Community Health Worker (CHW) Intervention
n=7 Participants
This arm includes participants who did not respond to resource information in Stage 1. In Stage 1, participants received 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 Insecurity (FI), such as the Supplemental Nutrition Assistance Program (SNAP).
In Stage 2, nonresponders to resource information received assistance from a community health worker (CHW) for 3 months. The CHW helped participants with accessing community resources and worked directly with the patient's care team to assist with any barriers to care.
|
Resource Referral + Medically Tailored Meals (MTM)
n=8 Participants
This arm included participants who did not respond to resource information in Stage 1. In Stage 1, participants received 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 Insecurity (FI), such as the Supplemental Nutrition Assistance Program (SNAP).
In Stage 2, nonresponders received 10 medically tailored meals delivered to their home weekly for 3 months.
|
Community Health Worker (CHW) Only
n=18 Participants
This arm included participants who responded to resource information in Stage 1 and participants who were not assessed for response at the end of Stage 1. In Stage 1, participants received assistance from a community health worker (CHW) for 3 months. The CHW helped participants with accessing community resources and worked directly with the patient's care team to assist with any barriers to care.
In Stage 2, responders did not receive any additional intervention than the CHW assistance provided in Stage 1.
|
Community Health Worker (CHW) + CHW Assistance
n=6 Participants
This arm includes participants who did not respond to CHW assistance in Stage 1. In Stage 1, participants received assistance from a CHW for 3 months. The CHW helped participants with access community resources and worked directly with the patients care team to assist with any barriers to care.
In Stage 2, nonresponders to CHW assistance in Stage 1 received assistance from a CHW for an additional 3 months.
|
Community Health Worker (CHW) Assistance + Medically Tailored Meals
n=8 Participants
This arm includes participants who did not respond to CHW assistance in Stage 1. In Stage 1, participants received assistance from a CHW for 3 months. The CHW helped participants with access community resources and worked directly with the patients care team to assist with any barriers to care.
In Stage 2, nonresponders received 10 medically tailored meals delivered to their home weekly for 3 months.
|
|---|---|---|---|---|---|---|
|
Diastolic Blood Pressure Readings
|
87.4 mmHg
Standard Deviation 8.9
|
81.6 mmHg
Standard Deviation 8.1
|
89.8 mmHg
Standard Deviation 12.5
|
89.1 mmHg
Standard Deviation 11.5
|
88.3 mmHg
Standard Deviation 7.6
|
87.1 mmHg
Standard Deviation 12.7
|
PRIMARY outcome
Timeframe: Month 3Population: 8 participants who started Stage 1 intervention did not complete 3 month follow-up (resource referral only arm) and 6 participants in the CHW only arm did not complete 3 month follow up
assess blood pressure (using ambulatory blood pressure cuffs)
Outcome measures
| Measure |
Resource Referral Only
n=5 Participants
This arm included participants who responded to resource information in Stage 1 and participants who were not assessed for response at the end of Stage 1. In Stage 1, participants received 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 Insecurity (FI), such as the Supplemental Nutrition Assistance Program (SNAP).
In Stage 2, responders did not receive any additional intervention than the information provided in Stage 1
|
Resource Referral + Community Health Worker (CHW) Intervention
n=7 Participants
This arm includes participants who did not respond to resource information in Stage 1. In Stage 1, participants received 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 Insecurity (FI), such as the Supplemental Nutrition Assistance Program (SNAP).
In Stage 2, nonresponders to resource information received assistance from a community health worker (CHW) for 3 months. The CHW helped participants with accessing community resources and worked directly with the patient's care team to assist with any barriers to care.
|
Resource Referral + Medically Tailored Meals (MTM)
n=8 Participants
This arm included participants who did not respond to resource information in Stage 1. In Stage 1, participants received 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 Insecurity (FI), such as the Supplemental Nutrition Assistance Program (SNAP).
In Stage 2, nonresponders received 10 medically tailored meals delivered to their home weekly for 3 months.
|
Community Health Worker (CHW) Only
n=12 Participants
This arm included participants who responded to resource information in Stage 1 and participants who were not assessed for response at the end of Stage 1. In Stage 1, participants received assistance from a community health worker (CHW) for 3 months. The CHW helped participants with accessing community resources and worked directly with the patient's care team to assist with any barriers to care.
In Stage 2, responders did not receive any additional intervention than the CHW assistance provided in Stage 1.
|
Community Health Worker (CHW) + CHW Assistance
n=6 Participants
This arm includes participants who did not respond to CHW assistance in Stage 1. In Stage 1, participants received assistance from a CHW for 3 months. The CHW helped participants with access community resources and worked directly with the patients care team to assist with any barriers to care.
In Stage 2, nonresponders to CHW assistance in Stage 1 received assistance from a CHW for an additional 3 months.
|
Community Health Worker (CHW) Assistance + Medically Tailored Meals
n=8 Participants
This arm includes participants who did not respond to CHW assistance in Stage 1. In Stage 1, participants received assistance from a CHW for 3 months. The CHW helped participants with access community resources and worked directly with the patients care team to assist with any barriers to care.
In Stage 2, nonresponders received 10 medically tailored meals delivered to their home weekly for 3 months.
|
|---|---|---|---|---|---|---|
|
Systolic Blood Pressure Readings
|
123.2 mmHg
Standard Deviation 12.1
|
165.8 mmHg
Standard Deviation 35.4
|
147.5 mmHg
Standard Deviation 12.5
|
124.7 mmHg
Standard Deviation 17.1
|
149.7 mmHg
Standard Deviation 20.1
|
171.6 mmHg
Standard Deviation 33.8
|
PRIMARY outcome
Timeframe: Month 3Population: 8 participants in the Resource referral only arm did not complete 3 month follow-up, 6 participants in the CHW only arm did not complete 3 month follow-up,
assess blood pressure (using ambulatory blood pressure cuffs)
Outcome measures
| Measure |
Resource Referral Only
n=5 Participants
This arm included participants who responded to resource information in Stage 1 and participants who were not assessed for response at the end of Stage 1. In Stage 1, participants received 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 Insecurity (FI), such as the Supplemental Nutrition Assistance Program (SNAP).
In Stage 2, responders did not receive any additional intervention than the information provided in Stage 1
|
Resource Referral + Community Health Worker (CHW) Intervention
n=7 Participants
This arm includes participants who did not respond to resource information in Stage 1. In Stage 1, participants received 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 Insecurity (FI), such as the Supplemental Nutrition Assistance Program (SNAP).
In Stage 2, nonresponders to resource information received assistance from a community health worker (CHW) for 3 months. The CHW helped participants with accessing community resources and worked directly with the patient's care team to assist with any barriers to care.
|
Resource Referral + Medically Tailored Meals (MTM)
n=8 Participants
This arm included participants who did not respond to resource information in Stage 1. In Stage 1, participants received 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 Insecurity (FI), such as the Supplemental Nutrition Assistance Program (SNAP).
In Stage 2, nonresponders received 10 medically tailored meals delivered to their home weekly for 3 months.
|
Community Health Worker (CHW) Only
n=12 Participants
This arm included participants who responded to resource information in Stage 1 and participants who were not assessed for response at the end of Stage 1. In Stage 1, participants received assistance from a community health worker (CHW) for 3 months. The CHW helped participants with accessing community resources and worked directly with the patient's care team to assist with any barriers to care.
In Stage 2, responders did not receive any additional intervention than the CHW assistance provided in Stage 1.
|
Community Health Worker (CHW) + CHW Assistance
n=6 Participants
This arm includes participants who did not respond to CHW assistance in Stage 1. In Stage 1, participants received assistance from a CHW for 3 months. The CHW helped participants with access community resources and worked directly with the patients care team to assist with any barriers to care.
In Stage 2, nonresponders to CHW assistance in Stage 1 received assistance from a CHW for an additional 3 months.
|
Community Health Worker (CHW) Assistance + Medically Tailored Meals
n=8 Participants
This arm includes participants who did not respond to CHW assistance in Stage 1. In Stage 1, participants received assistance from a CHW for 3 months. The CHW helped participants with access community resources and worked directly with the patients care team to assist with any barriers to care.
In Stage 2, nonresponders received 10 medically tailored meals delivered to their home weekly for 3 months.
|
|---|---|---|---|---|---|---|
|
Diastolic Blood Pressure Readings
|
78.8 mmHg
Standard Deviation 10.4
|
103.6 mmHg
Standard Deviation 35.1
|
95.5 mmHg
Standard Deviation 6.6
|
79.0 mmHg
Standard Deviation 7.9
|
92.2 mmHg
Standard Deviation 22.3
|
103.8 mmHg
Standard Deviation 23.0
|
PRIMARY outcome
Timeframe: Month 6Population: 1 participant in resource referral only arm did not complete 6 month follow-up, 5 participants in Resource referral + CHW arm did not complete 6 month follow-up, 3 participants in CHW only arm did not complete 6 month follow-up, 2 participants in CHW + CHW arm did not complete 6 month follow-up, and 1 participant in CHW + MTM arm did not complete follow-up
assess blood pressure (using ambulatory blood pressure cuffs)
Outcome measures
| Measure |
Resource Referral Only
n=4 Participants
This arm included participants who responded to resource information in Stage 1 and participants who were not assessed for response at the end of Stage 1. In Stage 1, participants received 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 Insecurity (FI), such as the Supplemental Nutrition Assistance Program (SNAP).
In Stage 2, responders did not receive any additional intervention than the information provided in Stage 1
|
Resource Referral + Community Health Worker (CHW) Intervention
n=2 Participants
This arm includes participants who did not respond to resource information in Stage 1. In Stage 1, participants received 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 Insecurity (FI), such as the Supplemental Nutrition Assistance Program (SNAP).
In Stage 2, nonresponders to resource information received assistance from a community health worker (CHW) for 3 months. The CHW helped participants with accessing community resources and worked directly with the patient's care team to assist with any barriers to care.
|
Resource Referral + Medically Tailored Meals (MTM)
n=8 Participants
This arm included participants who did not respond to resource information in Stage 1. In Stage 1, participants received 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 Insecurity (FI), such as the Supplemental Nutrition Assistance Program (SNAP).
In Stage 2, nonresponders received 10 medically tailored meals delivered to their home weekly for 3 months.
|
Community Health Worker (CHW) Only
n=9 Participants
This arm included participants who responded to resource information in Stage 1 and participants who were not assessed for response at the end of Stage 1. In Stage 1, participants received assistance from a community health worker (CHW) for 3 months. The CHW helped participants with accessing community resources and worked directly with the patient's care team to assist with any barriers to care.
In Stage 2, responders did not receive any additional intervention than the CHW assistance provided in Stage 1.
|
Community Health Worker (CHW) + CHW Assistance
n=4 Participants
This arm includes participants who did not respond to CHW assistance in Stage 1. In Stage 1, participants received assistance from a CHW for 3 months. The CHW helped participants with access community resources and worked directly with the patients care team to assist with any barriers to care.
In Stage 2, nonresponders to CHW assistance in Stage 1 received assistance from a CHW for an additional 3 months.
|
Community Health Worker (CHW) Assistance + Medically Tailored Meals
n=7 Participants
This arm includes participants who did not respond to CHW assistance in Stage 1. In Stage 1, participants received assistance from a CHW for 3 months. The CHW helped participants with access community resources and worked directly with the patients care team to assist with any barriers to care.
In Stage 2, nonresponders received 10 medically tailored meals delivered to their home weekly for 3 months.
|
|---|---|---|---|---|---|---|
|
Systolic Blood Pressure Readings
|
134.3 mmHg
Standard Deviation 23.2
|
158.2 mmHg
Standard Deviation 42.7
|
143.7 mmHg
Standard Deviation 22.9
|
138.3 mmHg
Standard Deviation 21.5
|
146.6 mmHg
Standard Deviation 13.5
|
158.7 mmHg
Standard Deviation 28.1
|
PRIMARY outcome
Timeframe: Month 6Population: 1 participant in resource referral only arm did not complete 6 month follow-up, 5 participants in Resource referral + CHW arm did not complete 6 month follow-up, 3 participants in CHW only arm did not complete 6 month follow-up, 2 participants in CHW + CHW arm did not complete 6 month follow-up, and 1 participant in CHW + MTM arm did not complete follow-up
assess blood pressure (using ambulatory blood pressure cuffs)
Outcome measures
| Measure |
Resource Referral Only
n=4 Participants
This arm included participants who responded to resource information in Stage 1 and participants who were not assessed for response at the end of Stage 1. In Stage 1, participants received 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 Insecurity (FI), such as the Supplemental Nutrition Assistance Program (SNAP).
In Stage 2, responders did not receive any additional intervention than the information provided in Stage 1
|
Resource Referral + Community Health Worker (CHW) Intervention
n=2 Participants
This arm includes participants who did not respond to resource information in Stage 1. In Stage 1, participants received 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 Insecurity (FI), such as the Supplemental Nutrition Assistance Program (SNAP).
In Stage 2, nonresponders to resource information received assistance from a community health worker (CHW) for 3 months. The CHW helped participants with accessing community resources and worked directly with the patient's care team to assist with any barriers to care.
|
Resource Referral + Medically Tailored Meals (MTM)
n=8 Participants
This arm included participants who did not respond to resource information in Stage 1. In Stage 1, participants received 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 Insecurity (FI), such as the Supplemental Nutrition Assistance Program (SNAP).
In Stage 2, nonresponders received 10 medically tailored meals delivered to their home weekly for 3 months.
|
Community Health Worker (CHW) Only
n=9 Participants
This arm included participants who responded to resource information in Stage 1 and participants who were not assessed for response at the end of Stage 1. In Stage 1, participants received assistance from a community health worker (CHW) for 3 months. The CHW helped participants with accessing community resources and worked directly with the patient's care team to assist with any barriers to care.
In Stage 2, responders did not receive any additional intervention than the CHW assistance provided in Stage 1.
|
Community Health Worker (CHW) + CHW Assistance
n=4 Participants
This arm includes participants who did not respond to CHW assistance in Stage 1. In Stage 1, participants received assistance from a CHW for 3 months. The CHW helped participants with access community resources and worked directly with the patients care team to assist with any barriers to care.
In Stage 2, nonresponders to CHW assistance in Stage 1 received assistance from a CHW for an additional 3 months.
|
Community Health Worker (CHW) Assistance + Medically Tailored Meals
n=7 Participants
This arm includes participants who did not respond to CHW assistance in Stage 1. In Stage 1, participants received assistance from a CHW for 3 months. The CHW helped participants with access community resources and worked directly with the patients care team to assist with any barriers to care.
In Stage 2, nonresponders received 10 medically tailored meals delivered to their home weekly for 3 months.
|
|---|---|---|---|---|---|---|
|
Diastolic Blood Pressure Readings
|
84.8 mmHg
Standard Deviation 16.0
|
116.3 mmHg
Standard Deviation 48.6
|
88 mmHg
Standard Deviation 12.4
|
86 mmHg
Standard Deviation 13.4
|
87.8 mmHg
Standard Deviation 12.3
|
98.0 mmHg
Standard Deviation 31.5
|
Adverse Events
Resource Referral Only
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Resource Referral + CHW Intervention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Resource Referral + MTM
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Community Health Worker (CHW) Only
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
CHW + CHW Assistance
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
CHW Assistance + MTM
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Deepak Palakshappa, MD
Wake Forest University Health Sciences
Phone: 3367161795
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place