Using Lay Health Advisors to Improve Hypertension Management
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03515005|
Recruitment Status : Enrolling by invitation
First Posted : May 3, 2018
Last Update Posted : March 30, 2020
|Condition or disease||Intervention/treatment||Phase|
|Hypertension||Behavioral: Lay Health Advisor||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||312 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Using Lay Health Advisors to Help African Americans Address the Social Context of Hypertension Management|
|Actual Study Start Date :||December 3, 2018|
|Estimated Primary Completion Date :||December 2023|
|Estimated Study Completion Date :||December 2023|
Experimental: Lay Health Advisors
Intervention patients will meet monthly in small groups with a trained Lay Health Advisor.
Behavioral: Lay Health Advisor
Patients will meet regularly Lay Health Advisors who will address the social context of their hypertension.
No Intervention: Usual Care
Control patients will receive usual care from their doctors.
- Change in systolic and diastolic blood pressure [ Time Frame: 1 year ]Difference between final and initial systolic and diastolic blood pressure readings
- Change in quality of life. [ Time Frame: 1 year ]Differences in quality of life between final and initial measurements using the 12 item short form survey (SF-12). The SF-12 provides physical and mental health composite scores ranging from 0 (lowest level of health) to 100 (highest level of health)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03515005
|United States, Ohio|
|The MetroHealth System|
|Cleveland, Ohio, United States, 44109|
|Principal Investigator:||John D Thornton, MD, MPH||The MetroHealth System|