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临床试验/NCT05168605
NCT05168605招募中不适用

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

University of Texas Southwestern Medical Center1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2022年7月27日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
100
试验地点
1
主要终点
Change in Blood pressure

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • Current oral steroid use
  • History of solid organ transplant
  • Language other than English or Spanish

研究组 & 干预措施

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.

干预措施: Home visit (Other)

Standard of care

No Intervention

Participants will receive a standard of care

结局指标

主要结局

Change in Blood pressure

时间窗: 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

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Nora Gimpel

Professor of Family and Community Medicine

University of Texas Southwestern Medical Center

研究点 (1)

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