Assessing the Efficacy of Targeted Home Visits in the Management of Chronic Conditions

NCT05168605 | Recruiting

• 1 other identifier: STU- 2019-1264
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Change in Blood pressure

  Change in blood pressure will be measured at baseline, 6 months using an automated blood pressure machine. Blood pressure is measured as systolic blood pressure/diastolic blood pressure in millimeters of mercury

  Baseline, 6 months

Study Arms (2)

Home Visit

EXPERIMENTAL

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.

Other: Home visit

Standard of care

NO INTERVENTION

Participants will receive a standard of care

Interventions

Home visit OTHER

Patients receiving home Visits

Home Visit

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead

Study Sites (1)

UT Southwestern Medical Center

Dallas, Texas, 75390, United States

RECRUITING

MeSH Terms

Conditions

Hypertension; Diabetes Mellitus, Type 2

Interventions

House Calls

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Professional Practice; Organization and Administration; Health Services Administration

Study Officials

• Nora Gimpel, M.D.

  University of Texas Southwestern Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Silvia Obregon, MSW

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Family and Community Medicine

Model Details: This study includes prospective intervention arm and historical control arm (data will be collected via retrospective chart review).

Study Record Dates

• First Submitted: December 9, 2021
• First Posted: December 23, 2021
• Study Start: July 27, 2022
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: February 10, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)