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Clinical Trials/NCT05168605
NCT05168605
Recruiting
Not Applicable

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

University of Texas Southwestern Medical Center1 site in 1 country100 target enrollmentJuly 27, 2022

Overview

Phase
Not Applicable
Intervention
Home visit
Conditions
Hypertension
Sponsor
University of Texas Southwestern Medical Center
Enrollment
100
Locations
1
Primary Endpoint
Change in Blood pressure
Status
Recruiting
Last Updated
2 months ago

Overview

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.

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.

Registry
clinicaltrials.gov
Start Date
July 27, 2022
End Date
December 31, 2026
Last Updated
2 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Nora Gimpel

Professor of Family and Community Medicine

University of Texas Southwestern Medical Center

Eligibility Criteria

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

Arms & Interventions

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.

Intervention: Home visit

Standard of care

Participants will receive a standard of care

Outcomes

Primary Outcomes

Change in Blood pressure

Time Frame: Baseline, 6 months

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

Study Sites (1)

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