HypertensionNCT05168605
Assessing the Efficacy of Targeted Home Visits in the Management of Chronic Conditions
A study testing Home visit in people with Hypertension and Type 2 Diabetes, run by University of Texas Southwestern Medical Center at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Hypertension, Type 2 Diabetes
- What is being tested?
- Home visit
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Jul 2022to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- Current oral steroid use
- History of solid organ transplant
- Language other than English or Spanish
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
UT Southwestern Medical Center
Dallas, Texas, 75390
Nora Gimpel, MD, Nora.Gimpel@UTSouthwestern.edu
About this study
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.
Read the 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.
- Conditions
- Hypertension, Type 2 Diabetes
- Being tested
- Home visit
- Medical subject headings
- Hypertension, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home visitOther
Patients receiving home Visits
| Study group | Role | What they receive |
|---|---|---|
| Home Visit | Experimental | 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. Receives: Other: Home visit |
| Standard of care | No intervention | Participants will receive a standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2021
- Study start27 Jul 2022
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by University of Texas Southwestern Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study includes prospective intervention arm and historical control arm (data will be collected via retrospective chart review).
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nora Gimpel, University of Texas Southwestern Medical Center
- Investigators
- Nora Gimpel, M.D., Principal investigator, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05168605
- Sponsor's protocol ID
- STU- 2019-1264
- Status last verified
- Feb 2026
- First submitted
- 9 Dec 2021
- Last updated
- 10 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Efficacy of Targeted Home Visits in the Management of Chronic Conditions
- ClinicalTrials.gov ID
- NCT05168605
- Acronym / sponsor ID
- STU- 2019-1264
- Conditions
- Hypertension, Type 2 Diabetes
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Study start
- 27 Jul 2022 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 23 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This study includes prospective intervention arm and historical control arm (data will be collected via retrospective chart review).
| Arm | Type | Receives |
|---|---|---|
| Home Visit | Experimental | Other: Home visitParticipants 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. |
| Standard of care | No intervention | –Participants will receive a standard of care |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- Current oral steroid use
- History of solid organ transplant
- Language other than English or Spanish
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Home visitPatients receiving home Visits | Other | Home Visit |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Nora Gimpel, M.D. principal investigator
University of Texas Southwestern Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Home visit in people with Hypertension and Type 2 Diabetes, run by University of Texas Southwestern Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Silvia Obregon, MSW (214-645-9532, silvia.obregon@utsouthwestern.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Blood pressure (time frame: Baseline, 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2026.