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Social needs program aims to lower blood sugar and blood pressure

NCT ID NCT06831162

Disease control Sponsor: Vanderbilt University Medical Center Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only This study
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests a program that helps adults with type 2 diabetes, high blood pressure, or high cholesterol address social needs like food, housing, and transportation. About 4,800 participants will be screened during primary care visits and offered support from providers, care coordinators, and community resources. Researchers will track changes in blood sugar, cholesterol, and blood pressure over 12 months to see if the program improves health outcomes.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Multi-level health-related social needs initiative (screening, provider tools, care coordinator support, community referrals)
What this could lead to
If it works, this could show that addressing social needs in primary care helps control chronic conditions like diabetes and high blood pressure.
What could go wrong
This is a single-arm study with no comparison group, so improvements may be due to other factors. Results may not apply to other clinics or populations.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 4,809 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2025

Expected to finish

Sep 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

ELIGIBILITY CRITERIA FOR EHR DATA EXTRACTION Inclusion Criteria: * 18 years of age or older * Completed the health-related social needs (HRSN) screener as part of a primary care visit * Diagnosed with type 2 diabetes, plus hypertension and/or hyperlipidemia as reflected by ICD-10 billing codes * Receive care at one of six partner Vanderbilt University Medical Center primary care clinics: South One Hundred Oaks, North One Hundred Oaks, Green Hills, Hillsboro Medical Group, Melrose, Bellevue ELIGIBILITY CRITERIA FOR PATIENT SURVEYS (subset of EHR data) Inclusion Criteria: * 18 years of age or older * Completed the HRSN screener as part of a primary care visit * Diagnosed with type 2 diabetes * Receive care at one of six partner Vanderbilt University Medical Center primary care clinics: South One Hundred Oaks, North One Hundred Oaks, Green Hills, Hillsboro Medical Group, Melrose, Bellevue * English-speaking Exclusion Criteria: * Blindness * Hearing impairment * Conditions that would interfere with survey completion (e.g., significant dementia, active psychosis or mania) * Being near the end of life (hospice or home hospice)

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Conditions

The condition(s) this trial relates to.

hyperlipidemia hypertensive disorder type 2 diabetes mellitus

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Health-related social problems Hyperlipidemia Hypertension Type 2 diabetes

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37203, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.