The primary aim of this study is to determine whether community health worker (CHW) navigation improves outcomes of chronic disease and chronic disease risk factors in a low-income, primarily ethnic minority population when combined with an evidence-based population health model as compared to usual care after 10 months.
The I-POP+CHW participants will be paired with a CHW at baseline to assist with navigation for 10-months between health and wellness services in the selected zip codes: 75210, 75215, 75216, 75217, 75223, or 75227. Participants will receive a multi-level intervention utilizing the current I-POP Health model that includes: 1) Access to health services (including oral health), 2) Access to clinical prevention services, 3) Access to education and facilities to increase physical activity and improved nutrition choices, and 4) Scheduled visits with CHWs for education and navigation. Individuals will complete study measures at baseline, 6-months, and 10-months. The control group participants will receive access to the same I-POP Health resources without CHW navigation until the end of 10-months (delayed CHW navigation). The current usual care model is outlined below (section 2.3) Participants will complete study measures at baseline, 6-months, and 10-months timepoints. Upon completion of 10-months measures, these individuals will be assigned a CHW and receive delayed navigation.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE
Enrollment
202
The current I-POP health model includes: 1) BSW HWC primary care medical home (for uninsured or Medicare patients), 2)BSW HWC providing diabetes prevention, nutrition education, weight loss, farm stands, physical activity programming (in collaboration with its onsite City of Dallas Park and Recreation Center), 3) BSW HWC programming at community sites in 75210, 4) Referrals to Parkland Hatcher Station clinic that provides health care to Medicaid patients, 5) Referrals between Parkland Hatcher Station and BSW HWC programming, 6) Community improvement in collaboration with Frazier Revitalization Inc. Individuals will have access to resources within our current, ongoing I-POP Health model, but without CHW navigation between BSW HWC and local service providers. Participants will complete follow-up visits for collection of study measures with study personnel at 6- and 10- months. At the end of the 10-month follow-up period, participants receive an assigned CHW and CHW-navigation.
Individuals randomized to this condition will be paired with a CHW to assist with navigation of I-POP Health resources at BSW HWC and entities in local zip codes. CHW navigation will occur through monthly one-on-one follow-up visits for a period of 10-months. Participants will complete study visits for collection of data measures at baseline, 6- and 10- month timepoints. Study participation ends with completion of 10-months data measures.
Baylor Research Institute
Dallas, Texas, United States
Allostatic load
A composite score of 10 biomarkers to measure chronic stress and health outcomes. The biomarkers are BMI, waist-to-hip ratio, HDL, TC/HDL ratio, triglycerides, HbA1c, SBP, DBP, C-reactive protein, and cortisol. For each marker a value of 1 will be assigned if that exceed the third quartile except for HDL where a value of 1 will be assigned if lower than first quartile; otherwise a score of zero will be assigned. \[scale: Count of risk factors. May be dichotomized as high risk = 6 to 10, low risk=0 to 5\]
Time frame: Baseline
Allostatic load
A composite score of 10 biomarkers to measure chronic stress and health outcomes. The biomarkers are BMI, waist-to-hip ratio, HDL, TC/HDL ratio, triglycerides, HbA1c, SBP, DBP, C-reactive protein, and cortisol. For each marker a value of 1 will be assigned if that exceed the third quartile except for HDL where a value of 1 will be assigned if lower than first quartile; otherwise a score of zero will be assigned. \[scale: Count of risk factors. May be dichotomized as high risk = 6 to 10, low risk=0 to 5\].
Time frame: 6-months
Cortisol
4mL saliva collected fasting in the morning. \[Scale: measured in a continuous scale. Normal range 0.007 - 0.115 ug/dL. Value exceeded the normal range indicates higher level of stress.\]
Time frame: Baseline
Cortisol
4mL saliva collected fasting in the morning. \[Scale: measured in a continuous scale. Normal range 0.007 - 0.115 ug/dL. Value exceeded the normal range indicates higher level of stress.\]
Time frame: 6-months
C-Reactive protein
4mL saliva collected fasting in the morning. \[Scale: measured in a continuous scale. Normal range 25 pg/mL - 1600 pg/mL. Value exceeded the normal range indicates higher level of inflammation.\]
Time frame: Baseline
C-Reactive protein
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4mL saliva collected fasting in the morning. \[Scale: measured in a continuous scale. Normal range 25 pg/mL - 1600 pg/mL. Value exceeded the normal range indicates higher level of inflammation.\]
Time frame: 6-months
Body mass index
Weight in pounds (lbs) divided by height in inches (in) squared and multiplying by a conversion factor of 703
Time frame: Baseline
Body mass index
Weight in pounds (lbs) divided by height in inches (in) squared and multiplying by a conversion factor of 703
Time frame: 6-months
Body mass index
Weight in pounds (lbs) divided by height in inches (in) squared and multiplying by a conversion factor of 703
Time frame: 10-months
Waist - to - Hip ratio
Waist circumference (centimeters) divided by circumference of hips (centimeters)
Time frame: Baseline
Waist - to - Hip ratio
Waist circumference (centimeters) divided by circumference of hips (centimeters)
Time frame: 6-months
Waist - to - Hip ratio
Waist circumference (centimeters) divided by circumference of hips (centimeters)
Time frame: 10-months
HbA1c
Finger stick blood measure (%)
Time frame: Baseline
HbA1c
Finger stick blood measure (%)
Time frame: 6-months
HbA1c
Finger stick blood measure (%)
Time frame: 10-months
Lipids
Finger stick blood measure collected fasting via fingerstick (mg/dL)
Time frame: Baseline
Lipids
Finger stick blood measure collected fasting via fingerstick (mg/dL)
Time frame: 6-months
Lipids
Finger stick blood measure collected fasting via fingerstick (mg/dL)
Time frame: 10-months
Blood pressure
Stadiometer used to measure systolic and diastolic pressures to nearest 1 mm Hg
Time frame: Baseline
Blood pressure
Stadiometer used to measure systolic and diastolic pressures to nearest 1 mm Hg
Time frame: 6-months
Blood pressure
Stadiometer used to measure systolic and diastolic pressures to nearest 1 mm Hg
Time frame: 10-months
Diet
Measured by self report Dietary Screening questionnaire (DSQ). \[scale: dietary nutrients will be calculated on a continuous scale based on NHANES guideline. Score: 0 to any positive value. A score above or below the threshold based on 2000 calories per day would indicate worse outcome.\]
Time frame: Baseline
Diet
Measured by self report Dietary Screening questionnaire (DSQ). \[scale: dietary nutrients will be calculated on a continuous scale based on NHANES guideline. Score: 0 to any positive value. A score above or below the threshold based on 2000 calories per day would indicate worse outcome.\]
Time frame: 6-months
Diet
Measured by self report Dietary Screening questionnaire (DSQ). \[scale: dietary nutrients will be calculated on a continuous scale based on NHANES guideline. Score: 0 to any positive value. A score above or below the threshold based on 2000 calories per day would indicate worse outcome.\]
Time frame: 10-months
Physical activity
Measured by self report questionnaire \[type, frequency, and time completed in minutes\]
Time frame: Baseline
Physical activity
Measured by self report questionnaire \[type, frequency, and time completed in minutes\]
Time frame: 6-months
Physical activity
Measured by self report questionnaire \[type, frequency, and time completed in minutes\]
Time frame: 10-months
Services utilization
Measured by self-report survey. \[scale: count the number visits at healthcare or wellness centers. A higher score would indicate better utilization.\]
Time frame: Baseline
Services utilization
Measured by self-report survey. \[scale: count the number visits at healthcare or wellness centers. A higher score would indicate better utilization.\]
Time frame: 6-months
Services utilization
Measured by self-report survey. \[scale: count the number visits at healthcare or wellness centers. A higher score would indicate better utilization.\]
Time frame: 10-months
Social determinants
Measured by self-report survey
Time frame: Baseline
Social determinants
Measured by self-report survey
Time frame: 6-months
Social determinants
Measured by self-report survey
Time frame: 10-months
Perceived stress
Measured by Perceived Stress Scale (PSS-10) \[scale: high risk=40, moderate risk=20, low risk=0\]
Time frame: Baseline
Perceived stress
Measured by Perceived Stress Scale (PSS-10) \[scale: high risk=40, moderate risk=20, low risk=0\]
Time frame: 6-months
Perceived stress
Measured by Perceived Stress Scale (PSS-10) \[scale: high risk=40, moderate risk=20, low risk=0\]
Time frame: 10-months
Medication use
Measured by self-report survey
Time frame: Baseline
Medication use
Measured by self-report survey
Time frame: 6-months
Medication use
Measured by self-report survey
Time frame: 10-months