Recruiting

Observational Study

Sponsor:

Sairam Parthasarathy

Code:

NCT07799961

Conditions

Social Determinants of Health (SDOH)

Hypertension

Diabetes Mellitus

Hypercholesterolaemia

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Community Health Worker intervention

Usual Care

Study Details

Brief summary:

The goal of the Arizona Community Engagement Alliance (AZ-CEAL) will be to combine social care with healthcare programs. The study will be connecting selected patients from clinics with trained community health workers (CHW) who will assist participants in getting the help that is needed for their health such as transportation needs, accessing healthy food, health information, accessing good health care, job opportunities, and housing. The study will collect information from both the patients and the health care systems to test how effectively the care plan works over time.

Conditions

Social Determinants of Health (SDOH)

Hypertension

Diabetes Mellitus

Hypercholesterolaemia

Study ID

NCT07799961

Start date

Dec 5, 2024

Status verified date

Aug, 2026

Completion date

Apr 1, 2028

Anticipated

Primary completion date

Apr 1, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • 18 years of age or older
  • Must meet at least one of the three criteria:

  • Medicaid or dual-insured beneficiary or
  • Racial/ethnic minority or rural resident and
  • Household income in the bottom national quartile of household median income (low SES definition).

Exclusion Criteria:

  • Unable to provide informed consent due to cognitive impairment
  • Other specified reason that, in the opinion of the investigator makes the participant unsuitable for enrollment

Study Design

Enrollment

740 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

experimental: Social Care Linkage within an Healthcare System

Participants will be assigned to CHWs with knowledge of the local community resources based upon participant's residential area. The CHWs will assist the patient participant by systematically assessing and addressing the social drivers of health and Health Related Social Needs (HRSNs). A standardized assessment tool will be implemented to systematically identify baseline drivers of health. The CHWs will set long term goals and create an action plan with the patient.

Through CHW core competencies of coaching, advocacy, and individual capacity building, the CHWs will use an adapted Goal Setting and Action Planning tool to prioritize short and long term goals to ensure patient self-sufficiency, self-determination and ensure patient navigation and mediation are people-centered.

active comparator: Usual Care

Comparator (Description of usual care): Participants receiving care in clinics at the same time of a stepped-wedge design in a different clinic cluster but before the rolling in of the CHW-intervention described in the active comparator. These participants (patients) do not have CHWs addressing social issues and HRSNs within the healthcare system. The social drivers of health are assessed by phone interview as part of annual population health assessments and entered into the Electronic Medical Records system.

Interventions

Community Health Worker intervention

CHWs with knowledge of local community resources will address social needs through through a IVR platform. Both CHWs and participants can access each other through the IVR system. Patients are observed repeatedly so that measurements are nested within members. We will recruit participants into the closed cohort prior to the sequential roll-out of the intervention to ensure individual-level informed consent and patient-reported data. Recruiting individuals before the intervention is rolled into the clinic (cluster) enables both concurrent comparisons of participants receiving care across clinics as well as pre-post comparisons of individual level (patient-reported) data in addition to passive data collection at a system or clinic level. Primary Data collected through patient reported surveys and passive EMR collection will occur at baseline and 6 months. Patients may opt-in to additional data collection at 12, 18, 24, 36 month time points.

Usual Care

Participants (patients) do not have CHWs addressing social issues and HRSNs within the healthcare system. The healthcare personnel act upon the identified social issues independently or with assistance from local clinic resources as usual. The social drivers of health are assessed by phone interview as part of annual population health assessments and entered into the Electronic Medical Records system and that in turn informs the healthcare provider.

Primary outcome measure

  • Change in Healthcare utilization [ Time Frame: Baseline, 6 months, 12 months, 18 months, and 24 months ]

Central Contacts and Locations

Central contacts

Locations

Banner University Medical Center South

Recruiting

Tucson, Arizona, United States, 85713

Contacts

Principal Investigator:

Sairam Parthasarathy, MD

UAHS Center for Sleep, Circadian, & Neuroscience Research Department of Medicine, University of Arizona

Recruiting

Tucson, Arizona, United States, 85724

Contacts

Principal Investigator:

Sairam Parthasarathy, MD

More Information

Sponsor

Sairam Parthasarathy

Last update posted

Sep 2, 2026

Last verified

Aug, 2026

Keywords

  • community health worker
  • Social Determinants of Health
  • Chronic Diseases
  • Chronic Conditions
  • CHW
  • SDOH

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Sairam Parthasarathy on 2026-09-02.