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NCT05168605 Clinical Trial

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

Hypertension Clinical Trial

Official title:
Assessing the Efficacy of Targeted Home Visits in the Management of Chronic Conditions

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05168605
Other study ID # STU- 2019-1264
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date July 27, 2022
Est. completion date July 5, 2024

Study information
Verified date February 2024
Source University of Texas Southwestern Medical Center
Contact Silvia Obregon, MSW
Phone 214-645-9532
Email silvia.obregon@utsouthwestern.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 100
Est. completion date July 5, 2024
Est. primary completion date July 5, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 60 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Other:
• Home visit
Patients receiving home Visits

Locations
Country Name City State
United States UT Southwestern Medical Center Dallas Texas

Sponsors (1)
Lead Sponsor Collaborator
University of Texas Southwestern Medical Center

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
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