Recruiting

Observational Study

Sponsor:

University of Texas Southwestern Medical Center

Code:

NCT05168605

Conditions

Hypertension

Type 2 Diabetes

Eligibility Criteria

Sex: All

Age: 18 - 60

Healthy Volunteers: Not accepted

Interventions

Home visit

Study Details

Brief summary:

The purpose of study is to evaluate whether home visit programs are an effective method for HTN and T2DM management as compared to standard of care clinic visits.

Conditions

Hypertension

Type 2 Diabetes

Study ID

NCT05168605

Start date

Jul 27, 2022

Status verified date

Feb, 2026

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 60

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Adult patients ages 18-60
  • Spanish or English speaking
  • Diagnosis of HTN or BP >140/90 in last 3 months (based on medical record)
  • Hemoglobin A1C>8 in last 6 months (based on medical record)
  • Not pregnant

Exclusion Criteria:

  • Current oral steroid use
  • History of solid organ transplant
  • Language other than English or Spanish

Study Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

experimental: Home Visit

Participants will receive home visit During the course of the first home visit, patients will receive routine care for diabetes and hypertension management (outcome variables are listed below) and data will be recorded in the EHR for primary outcomes. The resident physician will also assist the patient in completing enrollment in MyChart (if interested), utilizing either the resident's computer or smartphone and an internet hotspot. MyChart is a patient health platform that allows patients to contact their healthcare doctors, log health reminders, see test results, and a list of medications. The resident physician will also review a social determinants of health (SDH) screener (included in the EHR). The research faculty (licensed medical clinician) will collect blood pressure readings during this visit.

no intervention: Standard of care

Participants will receive a standard of care

Interventions

Home visit

Patients receiving home Visits

Primary outcome measure

  • Change in Blood pressure [ Time Frame: Baseline, 6 months ]

Central Contacts and Locations

Central contacts

Silvia Obregon, MSW

214-645-9532silvia.obregon@utsouthwestern.edu

Locations

UT Southwestern Medical Center

Recruiting

Dallas, Texas, United States, 75390

Contacts

Nora Gimpel, MD

Nora.Gimpel@UTSouthwestern.edu

More Information

Sponsor

University of Texas Southwestern Medical Center

Last update posted

Feb 10, 2026

Last verified

Feb, 2026

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 Texas Southwestern Medical Center on 2026-02-10.