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| ID | Type | Description | Link |
|---|---|---|---|
| 5K23HL146902-04 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| resource referral | Experimental | 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). |
|
| community health worker (CHW) intervention | Active Comparator | assist participants in addressing FI and supporting them in their blood pressure management |
|
| medically tailored meals (MTM) | Active Comparator | Participants will receive 10 medically tailored meals delivery to their home weekly for 3 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Resource information Supplemental Nutrition Assistance Program (SNAP) | Behavioral | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Systolic Blood Pressure Readings | assess blood pressure (using ambulatory blood pressure cuffs) | Baseline |
| Feasibility of Recruitment Percentage | Feasibility will be measured based on the proportion of patients screened who consented to be part of the study | Baseline |
| Feasibility of Retention | Feasibility will be measured at the proportion of participants who completed 3 and 6 month follow ups | Month 6 |
| Diastolic Blood Pressure Readings | assess blood pressure (using ambulatory blood pressure cuffs) | Baseline |
| Systolic Blood Pressure Readings | assess blood pressure (using ambulatory blood pressure cuffs) | Month 3 |
| Diastolic Blood Pressure Readings | assess blood pressure (using ambulatory blood pressure cuffs) | Month 3 |
| Systolic Blood Pressure Readings | assess blood pressure (using ambulatory blood pressure cuffs) | Month 6 |
| Diastolic Blood Pressure Readings | assess blood pressure (using ambulatory blood pressure cuffs) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Deepak Palakshappa, MD | Wake Forest University Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wake Forest University Health Sciences | Winston-Salem | North Carolina | 27157 | United States |
Individual Participant data that underlie the Results reported in this article, after deidentification (text, tables, figures, and appendices)
Beginning 9 months and ending 36 months following article publication
Investigators whose proposed use of the data has been approved by an independent review committee identified for this purpose
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| FG002 | 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. |
| FG003 | 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. |
| FG004 | 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. |
| FG005 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Stage 1 Intervention (Months 1-3) |
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| ||||||||||||||||||
| Stage 2 Intervention (Months 4-6) |
|
Includes all participants who started Stage 1
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| ID | Title | Description |
|---|---|---|
| BG000 | Resource Referral | 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). |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Systolic Blood Pressure Readings | assess blood pressure (using ambulatory blood pressure cuffs) | Participants in Stage 1 and Stage 2 arms | Posted | Mean | Standard Deviation | mmHg | Baseline |
|
6 Months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Deepak Palakshappa, MD | Wake Forest University Health Sciences | 3367161795 | dpalaksh@wakehealth.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 8, 2023 | Jul 16, 2025 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | May 8, 2023 | Sep 24, 2024 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| D002318 | Cardiovascular Diseases |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| D003150 | Community Health Workers |
| ID | Term |
|---|---|
| D000488 | Allied Health Personnel |
| D006282 | Health Personnel |
| D005159 | Health Care Facilities Workforce and Services |
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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.
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|
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| community health worker (CHW) | Behavioral | Participants randomized to the CHW intervention will have an initial baseline visit scheduled at a mutually convenient location. |
|
|
| medically tailored meals | Behavioral | Participants will receive 10 medically tailored meals delivery to their home weekly for 3 months |
|
|
| Month 6 |
| Withdrawal by Subject |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Community Health Worker (CHW) Intervention |
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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Baseline Systolic Blood pressure | Baseline blood pressure measured with ambulatory blood pressure monitor (mmHg) | Mean | Standard Deviation | mmHg |
|
| Baseline Diastolic Blood pressure | Measured using ambulatory blood pressure monitor at baseline (mmHg) | Mean | Standard Deviation | mmHg |
|
| OG001 |
| 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. |
| OG002 | 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. |
| OG003 | 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. |
| OG004 | 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. |
| OG005 | 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. |
|
|
| Primary | Feasibility of Recruitment Percentage | Feasibility will be measured based on the proportion of patients screened who consented to be part of the study | 61 individuals screened met the inclusion and exclusion criteria. 60 individuals enrolled in the study and 1 declined | Posted | Number | Proportion of participants | Baseline |
|
|
|
| Primary | Feasibility of Retention | Feasibility will be measured at the proportion of participants who completed 3 and 6 month follow ups | Includes all participants who started Stage 1. | Posted | Number | Proportion of participants | Month 6 |
|
|
|
| Primary | Diastolic Blood Pressure Readings | assess blood pressure (using ambulatory blood pressure cuffs) | Participants in Stage 1 and Stage 2 arms | Posted | Mean | Standard Deviation | mmHg | Baseline |
|
|
|
| Primary | Systolic Blood Pressure Readings | assess blood pressure (using ambulatory blood pressure cuffs) | 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 | Posted | Mean | Standard Deviation | mmHg | Month 3 |
|
|
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| Primary | Diastolic Blood Pressure Readings | assess blood pressure (using ambulatory blood pressure cuffs) | 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, | Posted | Mean | Standard Deviation | mmHg | Month 3 |
|
|
|
| Primary | Systolic Blood Pressure Readings | assess blood pressure (using ambulatory blood pressure cuffs) | 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 | Posted | Mean | Standard Deviation | mmHg | Month 6 |
|
|
|
| Primary | Diastolic Blood Pressure Readings | assess blood pressure (using ambulatory blood pressure cuffs) | 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 | Posted | Mean | Standard Deviation | mmHg | Month 6 |
|
|
|
| 0 |
| 13 |
| 0 |
| 13 |
| 0 |
| 13 |
| EG001 | Resource Referral + 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. | 0 | 7 | 0 | 7 | 0 | 7 |
| EG002 | Resource Referral + 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. | 0 | 8 | 0 | 8 | 0 | 8 |
| EG003 | 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 | 0 | 18 | 0 | 18 | 0 | 18 |
| EG004 | 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. | 0 | 6 | 0 | 6 | 0 | 6 |
| EG005 | CHW Assistance + 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. | 0 | 8 | 0 | 8 | 0 | 8 |
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