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

The University of Texas System (UT)

Status: Enrolling

Conditions: Hypertension; Type 2 Diabetes

Treatments: Other: Home visit

Study type: Interventional

Funder types: Other

Identifiers

NCT05168605

STU- 2019-1264

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Home Visit

Experimental group

Description:

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.

Treatment:

Other: Home visit

Standard of care

No Intervention group

Description:

Participants will receive a standard of care