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

Primary Purpose

Hypertension, Type 2 Diabetes

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Home visit
Sponsored by
University of Texas Southwestern Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Hypertension

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept 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

Sites / Locations

  • UT Southwestern Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Home Visit

Standard of care

Arm 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.

Participants will receive a standard of care

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
December 9, 2021
Last Updated
February 25, 2023
Sponsor
University of Texas Southwestern Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT05168605
Brief Title
Assessing the Efficacy of Targeted Home Visits in the Management of Chronic Conditions
Official Title
Assessing the Efficacy of Targeted Home Visits in the Management of Chronic Conditions
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 27, 2022 (Actual)
Primary Completion Date
July 5, 2024 (Anticipated)
Study Completion Date
July 5, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Texas Southwestern Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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: 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) To compare primary outcome of the patients randomly selected for home visits to similar patients receiving usual care in the clinical setting 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension, Type 2 Diabetes

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
This study includes prospective intervention arm and historical control arm (data will be collected via retrospective chart review).
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Home Visit
Arm Type
Experimental
Arm 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.
Arm Title
Standard of care
Arm Type
No Intervention
Arm Description
Participants will receive a standard of care
Intervention Type
Other
Intervention Name(s)
Home visit
Intervention Description
Patients receiving home Visits
Primary Outcome Measure Information:
Title
Change in Blood pressure
Description
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
Time Frame
Baseline, 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Silvia Obregon, MSW
Phone
214-645-9532
Email
silvia.obregon@utsouthwestern.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nora Gimpel, M.D.
Organizational Affiliation
UT Southwestern Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
UT Southwestern Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nora Gimpel, MD
Email
Nora.Gimpel@UTSouthwestern.edu

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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