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

NCT ID: NCT05168605

Last Updated: 2026-02-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-07-27

Study Completion Date

2026-12-31

Brief Summary

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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.

Detailed Description

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The purpose of this study is to compare the health outcomes utilizing home medical visits to manage hypertension and type 2 diabetes as compared to standard of care clinic visits.

This project has 3 overall objectives:

1. To test the efficacy of home medical visits by Family Medicine physicians specifically designed for patients with hypertension (HTN) and Type 2 Diabetes Mellitus (T2DM)
2. To compare primary outcome of the patients randomly selected for home visits to similar patients receiving usual care in the clinical setting
3. To understand the efficacy and impact of the home visit from the patient perspective

Study participant will receive usual care from a resident doctor in home. There will be (2) home visits conducted over the course of this study that will include a comprehensive assessment of hypertension, type 2 diabetes, and social factors that may be impacting their health. Study participants will also be asked to complete several questionnaires related to their knowledge of chronic diseases, personal health management, and experience of the study home visits.

Conditions

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Hypertension Type 2 Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This study includes prospective intervention arm and historical control arm (data will be collected via retrospective chart review).
Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Home visit

Intervention Type OTHER

Patients receiving home Visits

Standard of care

Participants will receive a standard of care

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Home visit

Patients receiving home Visits

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Texas Southwestern Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Nora Gimpel

Professor of Family and Community Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Nora Gimpel, M.D.

Role: PRINCIPAL_INVESTIGATOR

University of Texas Southwestern Medical Center

Locations

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UT Southwestern Medical Center

Dallas, Texas, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Silvia Obregon, MSW

Role: CONTACT

214-645-9532

Facility Contacts

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Nora Gimpel, MD

Role: primary

Other Identifiers

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STU- 2019-1264

Identifier Type: -

Identifier Source: org_study_id

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