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

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.

Study Overview

• Status: Recruiting
• Conditions: Hypertension; Type 2 Diabetes
• Intervention / Treatment: Other: Home visit

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Silvia Obregon, MSW; Phone Number: 214-645-9532; Email: silvia.obregon@utsouthwestern.edu

Study Locations

• United States
  • Texas
    • Dallas, Texas, United States, 75390
      • Recruiting
      • UT Southwestern Medical Center
      • Contact: Nora Gimpel, MD; Email: Nora.Gimpel@UTSouthwestern.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Other: Home visit; Patients receiving home Visits
No Intervention: Standard of care; Participants will receive a standard of care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University of Texas Southwestern Medical Center
• Investigators: Principal Investigator: Nora Gimpel, M.D., UT Southwestern Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): July 27, 2022
• Primary Completion (Estimated): July 5, 2024
• Study Completion (Estimated): July 5, 2024

Study Registration Dates

• First Submitted: December 9, 2021
• First Submitted That Met QC Criteria: December 9, 2021
• First Posted (Actual): December 23, 2021

Study Record Updates

• Last Update Posted (Estimated): February 14, 2024
• Last Update Submitted That Met QC Criteria: February 12, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Chronic Disease
• Other Study ID Numbers: STU- 2019-1264

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No