Back to resultsA Study of Cardiovascular Disparities in the Greater Mankato Somali Community to Prevent Hypertension
Primary Purpose
Hypertension
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Health Education
Home Blood Pressure Monitor
Sponsored by
About this trial
This is an interventional health services research trial for Hypertension
Eligibility Criteria
Inclusion Criteria: Greater Mankato Somali community members. Non-pregnant. At the Mosque or Halal stores between 5/2/2022-5/31/2023. Exclusion Criteria: Pregnant. Are not at the Mosque or Halal stores between 5/2/2022-5/31/2023.
Sites / Locations
- Erin WestfallRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Treatment Group
Control Group
Arm Description
Participants will be given access to health education, home blood pressure monitor, and referral to a primary care provider.
Participants receive referrals only to a primary care provider (PCP) for blood pressure monitoring.
Outcomes
Primary Outcome Measures
Changes in blood pressure
Measured in millimeters of mercury (mmHg)
Change in Primary Care Provider status
Number of subjects to follow up with a primary care provider
Secondary Outcome Measures
Full Information
NCT ID
NCT05873153
First Posted
May 15, 2023
Last Updated
May 15, 2023
Sponsor
Mayo Clinic
Collaborators
National Institute on Minority Health and Health Disparities (NIMHD)
1. Study Identification
Unique Protocol Identification Number
NCT05873153
Brief Title
A Study of Cardiovascular Disparities in the Greater Mankato Somali Community to Prevent Hypertension
Official Title
Reducing Cardiovascular Disparities in the Greater Mankato Somali Community by Utilizing Community-based Interventions to Build Capacity Within the Community to Identify, Manage and Prevent Hypertension
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 21, 2023 (Actual)
Primary Completion Date
June 30, 2024 (Anticipated)
Study Completion Date
June 30, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
Collaborators
National Institute on Minority Health and Health Disparities (NIMHD)
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 this research is to develop ways to reduce hypertension-management-related disparities in the Greater Mankato Area Somali population.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Treatment Group
Arm Type
Experimental
Arm Description
Participants will be given access to health education, home blood pressure monitor, and referral to a primary care provider.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
Participants receive referrals only to a primary care provider (PCP) for blood pressure monitoring.
Intervention Type
Behavioral
Intervention Name(s)
Health Education
Intervention Description
Education materials on high blood pressure, lowering sodium, starting an exercise program, and weight management.
Intervention Type
Other
Intervention Name(s)
Home Blood Pressure Monitor
Intervention Description
Blood pressure cuff for home use
Primary Outcome Measure Information:
Title
Changes in blood pressure
Description
Measured in millimeters of mercury (mmHg)
Time Frame
Baseline, 3 weeks, 3 months
Title
Change in Primary Care Provider status
Description
Number of subjects to follow up with a primary care provider
Time Frame
Baseline, 3 weeks, 3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Greater Mankato Somali community members.
Non-pregnant.
At the Mosque or Halal stores between 5/2/2022-5/31/2023.
Exclusion Criteria:
Pregnant.
Are not at the Mosque or Halal stores between 5/2/2022-5/31/2023.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Erin Westfall, DO
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Erin Westfall
City
Mankato
State/Province
Minnesota
ZIP/Postal Code
56082
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Erin Westfall, DO
Phone
507-594-6500
Email
westfall.erin@mayo.edu
12. IPD Sharing Statement
Plan to Share IPD
No
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials
Learn more about this trial
A Study of Cardiovascular Disparities in the Greater Mankato Somali Community to Prevent Hypertension
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