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

• Sponsor: University of Texas Southwestern Medical Center (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05168605
• Collaborator: (none)
• Enrollment: 100
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 23.3
• Patients Per Site Per Month: 4.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hypertension; Type 2 Diabetes	Other: Home visit	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 100 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: This study includes prospective intervention arm and historical control arm (data will be collected via retrospective chart review).This study includes prospective intervention arm and historical control arm (data will be collected via retrospective chart review).
• Masking: None (Open Label)
• Primary Purpose: Health Services Research
• Official Title: Assessing the Efficacy of Targeted Home Visits in the Management of Chronic Conditions
• Actual Study Start Date: Jul 27, 2022
• Anticipated Primary Completion Date: Jul 5, 2024
• Anticipated Study Completion Date: Jul 5, 2024

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Change in Blood pressure [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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 60 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	UT Southwestern Medical Center	Dallas	Texas	United States	75390

Sponsors and Collaborators

• University of Texas Southwestern Medical Center

Investigators

• Principal Investigator: Nora Gimpel, M.D., UT Southwestern Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Nora Gimpel, Professor of Family and Community Medicine, University of Texas Southwestern Medical Center
• ClinicalTrials.gov Identifier: NCT05168605
• Other Study ID Numbers: STU- 2019-1264
• First Posted: Dec 23, 2021
• Last Update Posted: Aug 24, 2022
• Last Verified: Aug 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Hypertension

Study Results

No Results Posted as of Aug 24, 2022