Recruiting

WE CARE

Sponsor:

University of Massachusetts, Worcester

Code:

NCT06903897

Conditions

Hyperlipidemias

Diabetes

Depression

Pediatric Asthma

Hypertension

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Accepted

Interventions

WE CARE SDOH System

Standard Pediatric Care

Study Details

Brief summary:

The goal of this clinical trial is to learn if the implementation of the WE CARE social determinants of health (SDOH) screening and referral intervention with an antiracist lens in primary care settings can lead to a meaningful decrease in chronic disease by monitoring conditions such as hypertension, diabetes, depression, hyperlipidemia, and asthma through clinical measures. The main question it aims to answer is:

Does the WE CARE SDOH screening and referral intervention applying an antiracism lens informed implementation strategies have the potential to reduce racial/ethnic health inequities in chronic diseases for minoritized patients?

Conditions

Hyperlipidemias

Diabetes

Depression

Pediatric Asthma

Hypertension

Study ID

NCT06903897

Start date

Oct 8, 2025

Status verified date

May, 2026

Completion date

Sep 30, 2028

Anticipated

Primary completion date

Sep 30, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Adults and children with diagnosed chronic diseases (hypertension, diabetes mellitus, hyperlipidemia, asthma, or depression) who receive Family Medicine care at one of the study sites.
  • Children (<18 years of age) with a diagnosis of asthma.
  • Adult patients (18 years or older) with a diagnosis of diabetes mellitus, hypertension, hyperlipidemia and/or depression.

Exclusion Criteria:

  • In adults (>18 years of age), those without one or more of the following diagnoses as recorded by ICD-10 codes in their EHR: hypertension, hyperlipidemia, diabetes mellitus, or depression.
  • In children (<18 years of age), those without a diagnosis of asthma.

Study Design

Enrollment

68000 participants

Anticipated

Allocation

Randomized

Intervention Model

Single group

Primary purpose

Screening

Interventions and Outcome Measures

Arms

active comparator: Usual Care - Control

Participants in the usual care group receive standard pediatric care. In this study, participants in the Usual Care arm are a historical cohort of patients who meet eligibility criteria and are identified retrospectively from the Electronic Health Records. As such the investigators have registered this study on Clinical Trial.gov prior to the implementation of the active WE CARE experimental arm.

experimental: WE CARE Implementation Arm

The study team will work with clinic staff and leadership to implement the WE CARE protocol at each clinical site.

Interventions

WE CARE SDOH System

The WE CARE System: A family-centered, highly efficacious approach for addressing adverse SDOH in the clinical setting. Arvin Garg, MD, MPH developed and conceptualized the WE CARE (Well-Child care visit, Evaluation, Community Resources, Advocacy, Referral, Education) intervention in 2005. This approach relies on existing clinical processes and infrastructure and social service resources, thereby making implementation, dissemination, and sustainability feasible. The intervention components include brief training of the clinical team; administration of a short screening tool to parents/patients identifying their desire for help with specific unmet social needs; and provider/clinic staff access to a physical or electronic family resource book containing community- resource listings. Providers generate referrals for families who indicate that they want help with unmet social needs on the WE CARE screener. Existing staff members may assist patients in connecting to referred resources.

Standard Pediatric Care

Standard pediatric care includes any existing screening practices, which can vary at each clinic.

Primary outcome measure

  • Blood pressure (BP) measurements [ Time Frame: Every 3 months for up to 3 years ]

Central Contacts and Locations

Locations

UMass Memorial Medical Center - Hahnemann Campus

Recruiting

Worcester, Massachusetts, United States, 01605

Contacts

Principal Investigator:

Ron Adler, MD

More Information

Sponsor

University of Massachusetts, Worcester

Last update posted

May 22, 2026

Last verified

May, 2026

Keywords

  • Basic Needs
  • Social Determinants of Health
  • Screening tools
  • Antiracism

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Massachusetts, Worcester on 2026-05-22.