Asymptomatic HypertensionaHTN-ManageNCT07539597
Innovative Approaches to Hypertension Management in High-Risk Emergency Department Populations
A study testing Community Health Worker engagement in people with Asymptomatic Hypertension, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
Trial summary
This single-center, single-arm quasi-experimental study will assess the feasibility and acceptability of a community health worker (CHW)-led intervention to address social determinants of health (SDOH) among emergency department patients with hypertension. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Asymptomatic Hypertension
- What is being tested?
- Community Health Worker engagement
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Feb 2026to 31 Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- 18 years and older who reside in the 5 boroughs of NYC,
- whom speak English or Spanish,
- have a known diagnosis of hypertension, and
- have uncontrolled hypertension, defined as two measures of systolic blood pressure (SBP) ≥140 mmHg or diastolic blood pressure (DBP) ≥ 90 mmHg obtained during their ED visit.
Who cannot join
- Patients who are unable to consent,
- pregnant patients,
- patients with a history of end stage renal disease, a history of heart failure or a BMI of greater than 50.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
Marcee Wilder, MD MPH
About this study
Official title: Innovative Approaches to Hypertension Management in High-Risk Emergency Department Populations: A Feasibility Study
This single-center, single-arm quasi-experimental study will assess the feasibility and acceptability of a community health worker (CHW)-led intervention to address social determinants of health (SDOH) among emergency department patients with hypertension. At enrollment, participants (N=15) will complete standardized SDOH surveys in REDCap, and CHWs will facilitate referrals to local community-based organizations that address identified social needs. With participant consent, the study will also include medical record review through EPIC and Healthix to evaluate healthcare utilization-including emergency department visits, hospitalizations, and outpatient encounters-during the one-year period before and after the index ED visit.
- Conditions
- Asymptomatic Hypertension
- Being tested
- Community Health Worker engagement
- Keywords
- Hypertension, Social Determinates of Health, Community Health Worker
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Community Health Worker engagementBehavioural
Engagement with Community Health Worker who will facilitate referrals to local community-based organizations
| Study group | Role | What they receive |
|---|---|---|
| Participants with Hypertension | Experimental | Participants with hypertension in high-risk Emergency Department populations Receives: Behavioral: Community Health Worker engagement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants on study at 3 months
Number of participants on study at 3 months to assess retention
Measured: 3 months
Number of intervention engagement
Number of interventions engagement based on number of types of CHW encounters
Measured: 6 months
Secondary outcomes (2)
Acceptability of Intervention Measure (AIM)
AIM is a 4-item measure, each item scored on a 5-point Likert scale. Full scaled scored from 4 to 20, with higher score indicating greater acceptability, appropriateness and feasibility.
Measured: baseline, 3 months, 6 months
Intervention Appropriateness Measure (IAM)
IAM is a 4-item measure, each item scored on a 5-point Likert scale. Full scale scored from 4 to 20, with higher score indicating a greater level of appropriateness.
Measured: baseline, 3 months, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2026
- Study start12 Feb 2026
- Primary completion31 Jul 2026 (estimated)
- Study completion31 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Asymptomatic HypertensionStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Responsible party
- Principal investigator, Marcee Wilder, Icahn School of Medicine at Mount Sinai
- Investigators
- Marcee Wilder, MD MPH, Principal investigator, ISMMS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07539597
- Sponsor's protocol ID
- STUDY-25-00363
- Other IDs
- 1P50MD019475
- Acronym
- aHTN-Manage
- Status last verified
- Apr 2026
- First submitted
- 13 Apr 2026
- Last updated
- 20 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD data is for research purposes only and will not be shared with any entity outside of those approved by PPHS.
Publications
Ahuja R, Ayala C, Tong X, Wall HK, Fang J. Public Awareness of Health-Related Risks From Uncontrolled Hypertension. Prev Chronic Dis. 2018 Apr 5;15:E40. doi: 10.5888/pcd15.170362.
PubMed 29625630Akinyelure OP, Jaeger BC, Oparil S, Carson AP, Safford MM, Howard G, Muntner P, Hardy ST. Social Determinants of Health and Uncontrolled Blood Pressure in a National Cohort of Black and White US Adults: the REGARDS Study. Hypertension. 2023 Jul;80(7):1403-1413. doi: 10.1161/HYPERTENSIONAHA.122.20219. Epub 2023 Apr 21.
PubMed 37082942Ware KS, Chidume T, Chou C. Social determinants of health and preventable emergency department patient encounters among adults with hypertension. Public Health Nurs. 2023 Jan;40(1):171-174. doi: 10.1111/phn.13152. Epub 2022 Nov 15.
PubMed 36380448Foster B, Dawood K, Pearson C, Manteuffel J, Levy P. Community Health Workers in the Emergency Department-Can they Help with Chronic Hypertension Care. Curr Hypertens Rep. 2019 May 21;21(7):49. doi: 10.1007/s11906-019-0955-6.
PubMed 31115736
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Innovative Approaches to Hypertension Management in High-Risk Emergency Department Populations: A Feasibility Study
- ClinicalTrials.gov ID
- NCT07539597
- Acronym / sponsor ID
- aHTN-Manage / STUDY-25-00363
- Conditions
- Asymptomatic Hypertension
- Keywords
- Hypertension, Social Determinates of Health, Community Health Worker
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Study start
- 12 Feb 2026 (actual)
- Primary completion
- 31 Jul 2026 (estimated)
- Study completion
- 31 Jul 2026 (estimated)
- First posted
- 20 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This single-center, single-arm quasi-experimental study will assess the feasibility and acceptability of a community health worker (CHW)-led intervention to address social determinants of health (SDOH) among emergency department patients with hypertension. At enrollment, participants (N=15) will complete standardized SDOH surveys in REDCap, and CHWs will facilitate referrals to local community-based organizations that address identified social needs. With participant consent, the study will also include medical record review through EPIC and Healthix to evaluate healthcare utilization-including emergency department visits, hospitalizations, and outpatient encounters-during the one-year period before and after the index ED visit.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants with Hypertension | Experimental | Behavioral: Community Health Worker engagementParticipants with hypertension in high-risk Emergency Department populations |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18 years and older who reside in the 5 boroughs of NYC,
- whom speak English or Spanish,
- have a known diagnosis of hypertension, and
- have uncontrolled hypertension, defined as two measures of systolic blood pressure (SBP) ≥140 mmHg or diastolic blood pressure (DBP) ≥ 90 mmHg obtained during their ED visit.
Key exclusion criteria (3 listed)
- Patients who are unable to consent,
- pregnant patients,
- patients with a history of end stage renal disease, a history of heart failure or a BMI of greater than 50.
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 |
|---|---|---|
| Community Health Worker engagementEngagement with Community Health Worker who will facilitate referrals to local community-based organizations | Behavioural | Participants with Hypertension |
Primary outcome
Number of participants on study at 3 months
Time frame: 3 months
Number of participants on study at 3 months to assess retention
Number of intervention engagement
Time frame: 6 months
Number of interventions engagement based on number of types of CHW encounters
2 secondary outcomes
Acceptability of Intervention Measure (AIM)
Time frame: baseline, 3 months, 6 months
Intervention Appropriateness Measure (IAM)
Time frame: baseline, 3 months, 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2026.
- Background: PubMed 29625630Ahuja R, Ayala C, Tong X, Wall HK, Fang J. Public Awareness of Health-Related Risks From Uncontrolled Hypertension. Prev Chronic Dis. 2018 Apr 5;15:E40. doi: 10.5888/pcd15.170362.
- Background: PubMed 37082942Akinyelure OP, Jaeger BC, Oparil S, Carson AP, Safford MM, Howard G, Muntner P, Hardy ST. Social Determinants of Health and Uncontrolled Blood Pressure in a National Cohort of Black and White US Adults: the REGARDS Study. Hypertension. 2023 Jul;80(7):1403-1413. doi: 10.1161/HYPERTENSIONAHA.122.20219. Epub 2023 Apr 21.
- Background: PubMed 36380448Ware KS, Chidume T, Chou C. Social determinants of health and preventable emergency department patient encounters among adults with hypertension. Public Health Nurs. 2023 Jan;40(1):171-174. doi: 10.1111/phn.13152. Epub 2022 Nov 15.
- Background: PubMed 31115736Foster B, Dawood K, Pearson C, Manteuffel J, Levy P. Community Health Workers in the Emergency Department-Can they Help with Chronic Hypertension Care. Curr Hypertens Rep. 2019 May 21;21(7):49. doi: 10.1007/s11906-019-0955-6.
- Individual participant dataSharing planned: No. IPD data is for research purposes only and will not be shared with any entity outside of those approved by PPHS.
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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.
Marcee Wilder, MD MPH principal investigator
ISMMS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Community Health Worker engagement in people with Asymptomatic Hypertension, run by Icahn School of Medicine at Mount Sinai 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 4 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 20 Apr 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Cindy Clesca (212-824-8057, cindy.clesca@mountsinai.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants on study at 3 months (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07539597, which also lists 4 linked publications.
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 20 Apr 2026.