HypertensionNCT05873153
A Study of Cardiovascular Disparities in the Greater Mankato Somali Community to Prevent Hypertension
A study testing Health Education and Home Blood Pressure Monitor in people with Hypertension, run by Mayo Clinic at 1 site in United States.
Trial summary
The purpose of this research is to develop ways to reduce hypertension-management-related disparities in the Greater Mankato Area Somali population. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension
- What is being tested?
- Health Education and Home Blood Pressure Monitor
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Feb 2023to 8 Oct 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Greater Mankato Somali community members.
- Non-pregnant.
- At the Mosque or Halal stores between 5/2/2022-5/31/2023.
Who cannot join
- Pregnant.
- Are not at the Mosque or Halal stores between 5/2/2022-5/31/2023.
Trial locations and contacts
1 site in 1 country.
About this study
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
The purpose of this research is to develop ways to reduce hypertension-management-related disparities in the Greater Mankato Area Somali population.
Read the detailed description
- We will randomly assign participants to either the treatment or control group. Participants in the treatment group will be given access to the education or BP monitor. Participants in the control group will receive referrals only to a PCP. We will use pre- and post-intervention to examine baseline data (during randomization) and assess changes in BP status and PCP follow up. A 3 weeks and 3 months assessment will determine BP control and PCP status. By comparing between pre- and post-intervention data, we can identify whether the educational content is effective in improving participants' knowledge, attitude, and health seeking behavior for high BP. By comparing between the treatment and control groups, we can examine to what extent the education and BP monitoring influences the effectiveness of the educational intervention.
- We will assess reach by tracking and recording the number of community members screened at each screening station, the Mosque and Halal Store. Each person will only be screened at baseline, 6 weeks and 3 months and we will record their systolic and diastolic blood pressures, age, sex, PCP status, and most recent visit with a healthcare provider. Additionally, the CHW will follow up with those that were referred for education and/or PCP visit to identify how many followed through with the recommendations (daily BP check, 30 minutes physical activity, dietary changes). Interviews will be conducted with community members who were referred to PCP and health educators due to high BP to assess the impact of the CHW/educators on their health seeking behaviors including motivation to make changes such as checking blood pressures, making dietary changes, increasing physical activity and seeking primary care, as well as how their experience with peer education was. CHW will also be interviewed to understand their overall perception of screening, suggestions for improvement. Following a community members referral to the champions for acute care needs (if they don't have a PCP or are unable to get in in a timely manner), participants' feedback about their visit with the provider will be collected to assess their overall experience with the provider.
Approach for Aim 2: Test the effectiveness of training Halal staff and Somali leaders to educate community members regarding culturally appropriate dietary recommendations and other lifestyle interventions for hypertension. For this aim Halal store owners and community leaders will keep a weekly record of the number of community members they reached out to. Additionally, community members who receive peer education will be interviewed to determine if the education from the Halal store owners was helpful, and what their experience was like Halal store owners and community leaders will also be interviewed to assess their overall perception of the peer education.
Approach for Aim 3: Build research capacity within the GMHEP members to engage in community-based research projects. Focus group will be conducted with GMHEP members following educational session to determine their experience with research education and comfort with conducting focus groups to peers.
- Conditions
- Hypertension
- Being tested
- Health Education, Home Blood Pressure Monitor
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Health EducationBehavioural
Education materials on high blood pressure, lowering sodium, starting an exercise program, and weight management.
Home Blood Pressure MonitorOther
Blood pressure cuff for home use
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group | Experimental | Participants will be given access to health education, home blood pressure monitor, and referral to a primary care provider. Receives: Behavioral: Health Education; Other: Home Blood Pressure Monitor |
| Control Group | No intervention | Participants receive referrals only to a primary care provider (PCP) for blood pressure monitoring. |
What is being measured
The primary outcome is the main question the study is designed to answer.
PCP Follow up
Number of subjects to follow up with a primary care provider
Measured: 3 months
Secondary outcomes (2)
Number of Participants Completing Blood Pressure Follow-up at 3 Months
The number of participants completing blood pressure follow up at 3 months. Qualitative interviews identified work schedules, relocation, denial of hypertension, fear of consent, and difficulty contacting participants as potential contributors to incomplete follow-up.
Measured: 3 Months
Number of Participants With Controlled Blood Pressure (<140/90 mmHg) at 3 Months
The number of participants with controlled Blood Pressure (<140/90 mmHg) at 3 Months. Qualitative interviews suggested that community health worker support, hypertension education, and self-management behaviors may have contributed to blood pressure improvement, while medication beliefs and structural barriers were identified as ongoing challenges to blood pressure control.
Measured: 3 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2023
- Study start21 Feb 2023
- Primary completion21 Jul 2025
- Study completion8 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Responsible party
- Principal investigator, Erin C. Westfall, Mayo Clinic
- Investigators
- Erin Westfall, DO, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05873153
- Sponsor's protocol ID
- 22-003544
- Other IDs
- P50MD017342
- Status last verified
- Oct 2026
- First submitted
- 15 May 2023
- Last updated
- 27 Oct 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05873153
- Acronym / sponsor ID
- 22-003544
- Conditions
- Hypertension
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Study start
- 21 Feb 2023 (actual)
- Primary completion
- 21 Jul 2025 (actual)
- Study completion
- 8 Oct 2025 (actual)
- First posted
- 24 May 2023 (actual)
- Results
- Posted 24 Jul 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this research is to develop ways to reduce hypertension-management-related disparities in the Greater Mankato Area Somali population.
Detailed description
- We will randomly assign participants to either the treatment or control group. Participants in the treatment group will be given access to the education or BP monitor. Participants in the control group will receive referrals only to a PCP. We will use pre- and post-intervention to examine baseline data (during randomization) and assess changes in BP status and PCP follow up. A 3 weeks and 3 months assessment will determine BP control and PCP status. By comparing between pre- and post-intervention data, we can identify whether the educational content is effective in improving participants' knowledge, attitude, and health seeking behavior for high BP. By comparing between the treatment and control groups, we can examine to what extent the education and BP monitoring influences the effectiveness of the educational intervention.
- We will assess reach by tracking and recording the number of community members screened at each screening station, the Mosque and Halal Store. Each person will only be screened at baseline, 6 weeks and 3 months and we will record their systolic and diastolic blood pressures, age, sex, PCP status, and most recent visit with a healthcare provider. Additionally, the CHW will follow up with those that were referred for education and/or PCP visit to identify how many followed through with the recommendations (daily BP check, 30 minutes physical activity, dietary changes). Interviews will be conducted with community members who were referred to PCP and health educators due to high BP to assess the impact of the CHW/educators on their health seeking behaviors including motivation to make changes such as checking blood pressures, making dietary changes, increasing physical activity and seeking primary care, as well as how their experience with peer education was. CHW will also be interviewed to understand their overall perception of screening, suggestions for improvement. Following a community members referral to the champions for acute care needs (if they don't have a PCP or are unable to get in in a timely manner), participants' feedback about their visit with the provider will be collected to assess their overall experience with the provider.
Approach for Aim 2: Test the effectiveness of training Halal staff and Somali leaders to educate community members regarding culturally appropriate dietary recommendations and other lifestyle interventions for hypertension. For this aim Halal store owners and community leaders will keep a weekly record of the number of community members they reached out to. Additionally, community members who receive peer education will be interviewed to determine if the education from the Halal store owners was helpful, and what their experience was like Halal store owners and community leaders will also be interviewed to assess their overall perception of the peer education.
Approach for Aim 3: Build research capacity within the GMHEP members to engage in community-based research projects. Focus group will be conducted with GMHEP members following educational session to determine their experience with research education and comfort with conducting focus groups to peers.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment Group | Experimental | Behavioral: Health Education, Other: Home Blood Pressure MonitorParticipants will be given access to health education, home blood pressure monitor, and referral to a primary care provider. |
| Control Group | No intervention | –Participants receive referrals only to a primary care provider (PCP) for blood pressure monitoring. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Greater Mankato Somali community members.
- Non-pregnant.
- At the Mosque or Halal stores between 5/2/2022-5/31/2023.
Key exclusion criteria (2 listed)
- Pregnant.
- Are not at the Mosque or Halal stores between 5/2/2022-5/31/2023.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Health EducationEducation materials on high blood pressure, lowering sodium, starting an exercise program, and weight management. | Behavioural | Treatment Group |
| Home Blood Pressure MonitorBlood pressure cuff for home use | Other | Treatment Group |
Primary outcome
PCP Follow up
Time frame: 3 months
Number of subjects to follow up with a primary care provider
2 secondary outcomes
Number of Participants Completing Blood Pressure Follow-up at 3 Months
Time frame: 3 Months
Number of Participants With Controlled Blood Pressure (<140/90 mmHg) at 3 Months
Time frame: 3 Months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- clinical trials.govLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Erin Westfall, DO principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Health Education and Home Blood Pressure Monitor in people with Hypertension, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Jul 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PCP Follow up (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2026.