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Targeted Home Visits for High Blood Pressure
N/A
Recruiting
Led By Nora Gimpel, M.D.
Research Sponsored by University of Texas Southwestern Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Diagnosis of HTN or BP >140/90 in last 3 months (based on medical record)
Adult patients ages 18-60
Must not have
Language other than English or Spanish
Current oral steroid use
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 6 months
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing whether home visits are more effective than clinic visits for managing hypertension and type 2 diabetes.
Who is the study for?
This trial is for adults aged 18-60 who speak English or Spanish and have high blood pressure (BP >140/90 in the last 3 months) or poorly controlled Type 2 Diabetes (Hemoglobin A1C>8 in the last 6 months). Pregnant individuals, those on oral steroids, or with a history of organ transplant cannot participate.
What is being tested?
The study is testing if home visits can better manage chronic conditions like high blood pressure and Type 2 Diabetes compared to usual care received at clinics. Participants will receive targeted home visits as part of their treatment plan.
What are the potential side effects?
Since this trial involves non-medical interventions such as home visits, there are no direct side effects from medications. However, participants may experience changes in stress levels or inconvenience due to scheduling.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with high blood pressure or had readings above 140/90 in the last 3 months.
Select...
I am between 18 and 60 years old.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I speak a language other than English or Spanish.
Select...
I am currently taking oral steroids.
Select...
I have had a solid organ transplant.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 6 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in Blood pressure
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Home VisitExperimental Treatment1 Intervention
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.
Group II: Standard of careActive Control1 Intervention
Participants will receive a standard of care
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Who is running the clinical trial?
University of Texas Southwestern Medical CenterLead Sponsor
1,083 Previous Clinical Trials
1,058,089 Total Patients Enrolled
Nora Gimpel, M.D.Principal InvestigatorUT Southwestern Medical Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I speak a language other than English or Spanish.I have had a solid organ transplant.I have been diagnosed with high blood pressure or had readings above 140/90 in the last 3 months.Your average blood sugar level has been very high in the last 6 months.I am between 18 and 60 years old.I am currently taking oral steroids.I speak English or Spanish.
Research Study Groups:
This trial has the following groups:- Group 1: Home Visit
- Group 2: Standard of care
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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