The Integrated Population (I-POP) Health Trial

Baylor Scott and White Health (BSWH)

Status: Active, not recruiting

Conditions: Chronic Kidney Diseases; Hypertension; Chronic Disease; Diabetes; Obesity

Treatments: Other: I-POP + CHW navigation; Other: Usual Care

Study type: Interventional

Funder types: Other

Identifiers

NCT04761016

021-026

Details and patient eligibility

About

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.

Full 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.

Enrollment: 202 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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202 participants in 2 patient groups

Control

Active Comparator group

Description:

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.

Treatment:

Other: Usual Care

I-POP CHW Intervention

Experimental group

Description:

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.

Treatment:

Other: I-POP + CHW navigation