NCT05873153

Brief Summary

The purpose of this research is to develop ways to reduce hypertension-management-related disparities in the Greater Mankato Area Somali population.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P25-P50 for not_applicable hypertension

Timeline
2mo left

Started Feb 2023

Typical duration for not_applicable hypertension

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress96%
Feb 2023Jun 2026

Study Start

First participant enrolled

February 21, 2023

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 15, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 24, 2023

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 21, 2025

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2026

Expected
Last Updated

July 24, 2025

Status Verified

July 1, 2025

Enrollment Period

2.4 years

First QC Date

May 15, 2023

Last Update Submit

July 23, 2025

Conditions

Hypertension

Outcome Measures

Primary Outcomes (2)

  • Changes in systolic and diastolic blood pressure

    Measured in millimeters of mercury (mmHg) of Systolic and Diastolic Blood pressure

    Baseline, 3 weeks, 3 months

  • Change in Primary Care Provider status

    Number of subjects to follow up with a primary care provider

    Baseline, 3 weeks, 3 months

Study Arms (2)

Treatment Group

EXPERIMENTAL

Participants will be given access to health education, home blood pressure monitor, and referral to a primary care provider.

Behavioral: Health EducationOther: Home Blood Pressure Monitor

Control Group

NO INTERVENTION

Participants receive referrals only to a primary care provider (PCP) for blood pressure monitoring.

Interventions

Health EducationBEHAVIORAL

Education materials on high blood pressure, lowering sodium, starting an exercise program, and weight management.

Treatment Group
Home Blood Pressure MonitorOTHER

Blood pressure cuff for home use

Treatment Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Greater Mankato Somali community members.
  • Non-pregnant.
  • At the Mosque or Halal stores between 5/2/2022-5/31/2023.

You may not qualify if:

  • Pregnant.
  • Are not at the Mosque or Halal stores between 5/2/2022-5/31/2023.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Erin Westfall

Mankato, Minnesota, 56082, United States

Location

Related Links

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Officials

  • Erin Westfall, DO

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 15, 2023

First Posted

May 24, 2023

Study Start

February 21, 2023

Primary Completion

July 21, 2025

Study Completion (Estimated)

June 30, 2026

Last Updated

July 24, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations

US(1)