Hypertension
Conditions
Keywords
Food Insecurities, Systolic Blood Pressure, cardiovascular disease
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
Interventions
BEHAVIORALResource 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).
BEHAVIORALcommunity health worker (CHW)
Participants randomized to the CHW intervention will have an initial baseline visit scheduled at a mutually convenient location.
BEHAVIORALmedically tailored meals
Participants will receive 10 medically tailored meals delivery to their home weekly for 3 months
Sponsors
National Heart, Lung, and Blood Institute (NHLBI)
Wake Forest University Health Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Systolic Blood Pressure Readings | Baseline | assess blood pressure (using ambulatory blood pressure cuffs) |
| Feasibility of Recruitment Percentage | Baseline | Feasibility will be measured based on the proportion of patients screened who consented to be part of the study |
| Feasibility of Retention | Month 6 | Feasibility will be measured at the proportion of participants who completed 3 and 6 month follow ups |
| Diastolic Blood Pressure Readings | Baseline | assess blood pressure (using ambulatory blood pressure cuffs) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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). | 28 |
| 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. | 32 |
| Total | 60 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 |
|---|---|---|---|---|---|---|---|
| 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
| Characteristic | Community Health Worker (CHW) Intervention | Resource Referral | Total |
|---|---|---|---|
| Age, Continuous | 58.1 years STANDARD_DEVIATION 11.1 | 58.1 years STANDARD_DEVIATION 10.3 | 58.1 years STANDARD_DEVIATION 10.6 |
| Baseline Diastolic Blood pressure | 88.4 mmHg STANDARD_DEVIATION 10.9 | 86.6 mmHg STANDARD_DEVIATION 9.9 | 87.6 mmHg STANDARD_DEVIATION 10.4 |
| Baseline Systolic Blood pressure | 151.8 mmHg STANDARD_DEVIATION 19.5 | 140.6 mmHg STANDARD_DEVIATION 10.1 | 146.6 mmHg STANDARD_DEVIATION 16.7 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 0 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 30 Participants | 28 Participants | 58 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 27 Participants | 25 Participants | 52 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) White | 3 Participants | 3 Participants | 6 Participants |
| Sex: Female, Male Female | 23 Participants | 19 Participants | 42 Participants |
| Sex: Female, Male Male | 9 Participants | 9 Participants | 18 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 13 | 0 / 7 | 0 / 8 | 0 / 18 | 0 / 6 | 0 / 8 |
| other Total, other adverse events | 0 / 13 | 0 / 7 | 0 / 8 | 0 / 18 | 0 / 6 | 0 / 8 |
| serious Total, serious adverse events | 0 / 13 | 0 / 7 | 0 / 8 | 0 / 18 | 0 / 6 | 0 / 8 |
Outcome results
Primary
Diastolic Blood Pressure Readings
assess blood pressure (using ambulatory blood pressure cuffs)
Time frame: Month 3
Population: 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,
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Resource Referral Only | Diastolic Blood Pressure Readings | 78.8 mmHg | Standard Deviation 10.4 |
| Resource Referral + Community Health Worker (CHW) Intervention | Diastolic Blood Pressure Readings | 103.6 mmHg | Standard Deviation 35.1 |
| Resource Referral + Medically Tailored Meals (MTM) | Diastolic Blood Pressure Readings | 95.5 mmHg | Standard Deviation 6.6 |
| Community Health Worker (CHW) Only | Diastolic Blood Pressure Readings | 79.0 mmHg | Standard Deviation 7.9 |
| Community Health Worker (CHW) + CHW Assistance | Diastolic Blood Pressure Readings | 92.2 mmHg | Standard Deviation 22.3 |
| Community Health Worker (CHW) Assistance + Medically Tailored Meals | Diastolic Blood Pressure Readings | 103.8 mmHg | Standard Deviation 23 |
Primary
Diastolic Blood Pressure Readings
assess blood pressure (using ambulatory blood pressure cuffs)
Time frame: Baseline
Population: Participants in Stage 1 and Stage 2 arms
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Resource Referral Only | Diastolic Blood Pressure Readings | 87.4 mmHg | Standard Deviation 8.9 |
| Resource Referral + Community Health Worker (CHW) Intervention | Diastolic Blood Pressure Readings | 81.6 mmHg | Standard Deviation 8.1 |
| Resource Referral + Medically Tailored Meals (MTM) | Diastolic Blood Pressure Readings | 89.8 mmHg | Standard Deviation 12.5 |
| Community Health Worker (CHW) Only | Diastolic Blood Pressure Readings | 89.1 mmHg | Standard Deviation 11.5 |
| Community Health Worker (CHW) + CHW Assistance | Diastolic Blood Pressure Readings | 88.3 mmHg | Standard Deviation 7.6 |
| Community Health Worker (CHW) Assistance + Medically Tailored Meals | Diastolic Blood Pressure Readings | 87.1 mmHg | Standard Deviation 12.7 |
Primary
Diastolic Blood Pressure Readings
assess blood pressure (using ambulatory blood pressure cuffs)
Time frame: Month 6
Population: 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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Resource Referral Only | Diastolic Blood Pressure Readings | 84.8 mmHg | Standard Deviation 16 |
| Resource Referral + Community Health Worker (CHW) Intervention | Diastolic Blood Pressure Readings | 116.3 mmHg | Standard Deviation 48.6 |
| Resource Referral + Medically Tailored Meals (MTM) | Diastolic Blood Pressure Readings | 88 mmHg | Standard Deviation 12.4 |
| Community Health Worker (CHW) Only | Diastolic Blood Pressure Readings | 86 mmHg | Standard Deviation 13.4 |
| Community Health Worker (CHW) + CHW Assistance | Diastolic Blood Pressure Readings | 87.8 mmHg | Standard Deviation 12.3 |
| Community Health Worker (CHW) Assistance + Medically Tailored Meals | Diastolic Blood Pressure Readings | 98.0 mmHg | Standard Deviation 31.5 |
Primary
Feasibility of Recruitment Percentage
Feasibility will be measured based on the proportion of patients screened who consented to be part of the study
Time frame: Baseline
Population: 61 individuals screened met the inclusion and exclusion criteria. 60 individuals enrolled in the study and 1 declined
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Resource Referral Only | Feasibility of Recruitment Percentage | 0.98 Proportion of participants |
Primary
Feasibility of Retention
Feasibility will be measured at the proportion of participants who completed 3 and 6 month follow ups
Time frame: Month 6
Population: Includes all participants who started Stage 1.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Resource Referral Only | Feasibility of Retention | 0.5 Proportion of participants |
| Resource Referral + Community Health Worker (CHW) Intervention | Feasibility of Retention | 0.625 Proportion of participants |
Primary
Systolic Blood Pressure Readings
assess blood pressure (using ambulatory blood pressure cuffs)
Time frame: Month 3
Population: 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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Resource Referral Only | Systolic Blood Pressure Readings | 123.2 mmHg | Standard Deviation 12.1 |
| Resource Referral + Community Health Worker (CHW) Intervention | Systolic Blood Pressure Readings | 165.8 mmHg | Standard Deviation 35.4 |
| Resource Referral + Medically Tailored Meals (MTM) | Systolic Blood Pressure Readings | 147.5 mmHg | Standard Deviation 12.5 |
| Community Health Worker (CHW) Only | Systolic Blood Pressure Readings | 124.7 mmHg | Standard Deviation 17.1 |
| Community Health Worker (CHW) + CHW Assistance | Systolic Blood Pressure Readings | 149.7 mmHg | Standard Deviation 20.1 |
| Community Health Worker (CHW) Assistance + Medically Tailored Meals | Systolic Blood Pressure Readings | 171.6 mmHg | Standard Deviation 33.8 |
Primary
Systolic Blood Pressure Readings
assess blood pressure (using ambulatory blood pressure cuffs)
Time frame: Month 6
Population: 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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Resource Referral Only | Systolic Blood Pressure Readings | 134.3 mmHg | Standard Deviation 23.2 |
| Resource Referral + Community Health Worker (CHW) Intervention | Systolic Blood Pressure Readings | 158.2 mmHg | Standard Deviation 42.7 |
| Resource Referral + Medically Tailored Meals (MTM) | Systolic Blood Pressure Readings | 143.7 mmHg | Standard Deviation 22.9 |
| Community Health Worker (CHW) Only | Systolic Blood Pressure Readings | 138.3 mmHg | Standard Deviation 21.5 |
| Community Health Worker (CHW) + CHW Assistance | Systolic Blood Pressure Readings | 146.6 mmHg | Standard Deviation 13.5 |
| Community Health Worker (CHW) Assistance + Medically Tailored Meals | Systolic Blood Pressure Readings | 158.7 mmHg | Standard Deviation 28.1 |
Primary
Systolic Blood Pressure Readings
assess blood pressure (using ambulatory blood pressure cuffs)
Time frame: Baseline
Population: Participants in Stage 1 and Stage 2 arms
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Resource Referral Only | Systolic Blood Pressure Readings | 144.3 mmHg | Standard Deviation 8.2 |
| Resource Referral + Community Health Worker (CHW) Intervention | Systolic Blood Pressure Readings | 138.1 mmHg | Standard Deviation 9.1 |
| Resource Referral + Medically Tailored Meals (MTM) | Systolic Blood Pressure Readings | 136.8 mmHg | Standard Deviation 12.6 |
| Community Health Worker (CHW) Only | Systolic Blood Pressure Readings | 151.7 mmHg | Standard Deviation 18.2 |
| Community Health Worker (CHW) + CHW Assistance | Systolic Blood Pressure Readings | 150.8 mmHg | Standard Deviation 22 |
| Community Health Worker (CHW) Assistance + Medically Tailored Meals | Systolic Blood Pressure Readings | 146.4 mmHg | Standard Deviation 16.1 |