The Integrated Population (I-POP) Health Trial

Sponsor
Baylor Research Institute (Other)
Overall Status
Recruiting
CT.gov ID
NCT04761016
Collaborator
(none)
250
1
2
16
15.7

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Usual Care
  • Other: I-POP + CHW navigation
N/A

Detailed Description

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 Design

Study Type:
Interventional
Anticipated Enrollment :
250 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Health Services Research
Official Title:
The Role of Community Health Workers to Reduce Health Disparities Using a Multi-Level Integrated Population Health Intervention
Actual Study Start Date :
Apr 1, 2021
Anticipated Primary Completion Date :
May 31, 2022
Anticipated Study Completion Date :
Jul 31, 2022

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Control

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. 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.

Other: Usual Care
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.

Experimental: I-POP CHW Intervention

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.

Other: I-POP + 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.

Outcome Measures

Primary Outcome Measures

  1. Allostatic load [Baseline]

    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]

  2. Allostatic load [6-months]

    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].

  3. Allostatic load [10-months]

    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].

  4. Cortisol [Baseline]

    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.]

  5. Cortisol [6-months]

    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.]

  6. Cortisol [10-months]

    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.]

  7. C-Reactive protein [Baseline]

    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.]

  8. C-Reactive protein [6-months]

    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.]

  9. C-Reactive protein [10-months]

    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.]

  10. Body mass index [Baseline]

    Weight in pounds (lbs) divided by height in inches (in) squared and multiplying by a conversion factor of 703

  11. Body mass index [6-months]

    Weight in pounds (lbs) divided by height in inches (in) squared and multiplying by a conversion factor of 703

  12. Body mass index [10-months]

    Weight in pounds (lbs) divided by height in inches (in) squared and multiplying by a conversion factor of 703

  13. Waist - to - Hip ratio [Baseline]

    Waist circumference (centimeters) divided by circumference of hips (centimeters)

  14. Waist - to - Hip ratio [6-months]

    Waist circumference (centimeters) divided by circumference of hips (centimeters)

  15. Waist - to - Hip ratio [10-months]

    Waist circumference (centimeters) divided by circumference of hips (centimeters)

  16. HbA1c [Baseline]

    Finger stick blood measure (%)

  17. HbA1c [6-months]

    Finger stick blood measure (%)

  18. HbA1c [10-months]

    Finger stick blood measure (%)

  19. Lipids [Baseline]

    Finger stick blood measure collected fasting via fingerstick (mg/dL)

  20. Lipids [6-months]

    Finger stick blood measure collected fasting via fingerstick (mg/dL)

  21. Lipids [10-months]

    Finger stick blood measure collected fasting via fingerstick (mg/dL)

  22. Blood pressure [Baseline]

    Stadiometer used to measure systolic and diastolic pressures to nearest 1 mm Hg

  23. Blood pressure [6-months]

    Stadiometer used to measure systolic and diastolic pressures to nearest 1 mm Hg

  24. Blood pressure [10-months]

    Stadiometer used to measure systolic and diastolic pressures to nearest 1 mm Hg

Secondary Outcome Measures

  1. Diet [Baseline]

    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.]

  2. Diet [6-months]

    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.]

  3. Diet [10-months]

    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.]

  4. Physical activity [Baseline]

    Measured by self report questionnaire [type, frequency, and time completed in minutes]

  5. Physical activity [6-months]

    Measured by self report questionnaire [type, frequency, and time completed in minutes]

  6. Physical activity [10-months]

    Measured by self report questionnaire [type, frequency, and time completed in minutes]

  7. Services utilization [Baseline]

    Measured by self-report survey. [scale: count the number visits at healthcare or wellness centers. A higher score would indicate better utilization.]

  8. Services utilization [6-months]

    Measured by self-report survey. [scale: count the number visits at healthcare or wellness centers. A higher score would indicate better utilization.]

  9. Services utilization [10-months]

    Measured by self-report survey. [scale: count the number visits at healthcare or wellness centers. A higher score would indicate better utilization.]

  10. Social determinants [Baseline]

    Measured by self-report survey

  11. Social determinants [6-months]

    Measured by self-report survey

  12. Social determinants [10-months]

    Measured by self-report survey

  13. Perceived stress [Baseline]

    Measured by Perceived Stress Scale (PSS-10) [scale: high risk=40, moderate risk=20, low risk=0]

  14. Perceived stress [6-months]

    Measured by Perceived Stress Scale (PSS-10) [scale: high risk=40, moderate risk=20, low risk=0]

  15. Perceived stress [10-months]

    Measured by Perceived Stress Scale (PSS-10) [scale: high risk=40, moderate risk=20, low risk=0]

  16. Medication use [Baseline]

    Measured by self-report survey

  17. Medication use [6-months]

    Measured by self-report survey

  18. Medication use [10-months]

    Measured by self-report survey

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 99 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • Age 18 years or older

  • Ability to alter diet and/or physical activity

  • Willing to participate in a 10-month study

  • Resident of selected zip codes: 75210, 75215, 75216, 75217, 75223, or 75227

  • Not having utilized BSW HWC membership services within the past 12 months

  • Not planning to move outside of the selected zip code area within the next 6 months

Exclusion Criteria:
  • Below the age of 18 years

  • Unable or unwilling to alter diet and/or physical activity

  • Not willing to participate in a 10-month study

  • Not resident of local selected zip codes: 75210, 75215, 75216, 75217, 75223, or 75227

  • Currently using or have used BSW HWC membership services within the past 12 months

  • Planning to move outside of the selected zip code area within the next 6 months

Contacts and Locations

Locations

Site City State Country Postal Code
1 Baylor Research Institute Dallas Texas United States 75210

Sponsors and Collaborators

  • Baylor Research Institute

Investigators

  • Principal Investigator: Heather Kitzman, PhD, Baylor Scott and White Health

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Baylor Research Institute
ClinicalTrials.gov Identifier:
NCT04761016
Other Study ID Numbers:
  • 021-026
First Posted:
Feb 18, 2021
Last Update Posted:
Jul 28, 2021
Last Verified:
Jul 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Baylor Research Institute
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 28, 2021