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Nashville - Hypertension Management Model

Implementing the Los Angeles Barber - Pharmacist Model Hypertension Management in Nashville

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04232124
Enrollment
30
Registered
2020-01-18
Start date
2020-02-15
Completion date
2021-07-15
Last updated
2024-01-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension

Brief summary

Black men face a shorter life expectancy than white men due to poorer health outcomes associated with many chronic diseases, most notably hypertension and its cardiovascular complications. A lack of access to healthcare resources and poor engagement with healthcare providers drive these inequities. A seminal trial conducted in the Metro Los Angeles area demonstrated the effectiveness of using collaborative care partnerships between black-owned barbershops and pharmacists to reduce blood pressure in black men. The purpose of this study is to test the feasibility and success of implementing a single-arm, smaller-scale version of the Los Angeles study in the Nashville area to provide additional empiric support for collaborative care partnerships to treat hypertension in other geographic locations.

Detailed description

Uncontrolled hypertension (HTN) is a significant risk factor for mortality among non-Hispanic black men, and black men have the highest incidence of death from HTN of any race, ethnic, or gender group in the United States. Sustained, trusting interactions with healthcare professionals and a lack of access to healthcare resources are both significant drivers of these disparities. A cluster, randomized controlled trial in the Metro Los Angeles area demonstrated that health promotion by black barbers resulted in greater reductions in blood pressure (BP) when combined with medication management by specialty-trained pharmacists, as compared to health promotion by barbers alone. The purposes of this single arm, pre-test/post-test study are to a) establish an effective network of barbershop research hubs in Nashville, b) test the feasibility of engaging with a specialty-trained pharmacist in collaboration with a barbershop to treat blood pressure in black men, and c) create a local registry of potential subjects as a platform for enrolling black men in future studies. There is no central hypothesis in this pilot implementation study, but the study will evaluate the ability of the barbershop-based research methodology to recruit and retain black men in a study; the fidelity to the intervention by barbers, the pharmacist, and the hypertensive male participants; and the effectiveness of the intervention on systolic blood pressure reduction and patient satisfaction. All participants will also be offered the opportunity to participate in a separate research registry for recruitment into future studies. Research staff will offer free BP screening to all adult black men entering each shop for approximately 4 weeks, or until recruitment targets have been met. Patrons with a systolic BP \> 140 mm Hg on two separate occasions will be eligible to participate. The patrons' existing physician or the lead physician or a study physician will sign a collaborative practice agreement for a specialty-trained pharmacist to provide care and prescribe BP medications within the study protocol. All participants in this study will execute a visit with the study physician for an evaluation to establish care, supported by the funding for this proposal. Barbers will participate in training related to skills on BP measurement and counseling performed by either collaborating researchers from the University of California, Los Angeles-Cedars Sinai or from local study personnel. Barbers will frequently check and transmit the BP readings of their enrolled patrons and motivate them to work with the clinical pharmacist, who will meet them in their barbershops to optimize BP medication. The pharmacist will promote patient activation, intensify drug therapy under a collaborative practice agreement as permitted by Tennessee state law, send progress notes to the participant's physicians, and ensure appropriate safety monitoring after each medication change.

Interventions

BEHAVIORALHypertension Management Model

1. Blood Pressure readings by barbers 2. Clinical Pharmacist evaluation and counseling 3. Blood pressure measurement 4. Point of care basic metabolic panel measurement

Sponsors

University of California, Los Angeles
CollaboratorOTHER
Cedars-Sinai Medical Center
CollaboratorOTHER
Vanderbilt University Medical Center
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

Execute a smaller version of the LA Barbershop BP Study through the new Nashville network as the test case for: A) recruiting regular patrons with uncontrolled HTN, B) conducting a research protocol and evaluating a HTN intervention; and C) creating a local registry of potential subjects as platform for enrolling black men in future research studies.

Eligibility

Sex/Gender
MALE
Age
35 Years to 79 Years
Healthy volunteers
No

Inclusion criteria

* Adults 35-79 years old * Self - identify as Non-Hispanic black male * Patron of one of the participating barbershops (4 haircuts in the last 6 months) * Systolic BP\> 140mm Hg on two screening days at least one day apart

Exclusion criteria

* Severe cognitive impairment * Non-fluent in English * Women * Age \< 35 years or \> 79 years * Systolic BP \< 140 mm Hg at either screening * Currently receiving chemotherapy for cancer * Organ transplant patient * Currently receiving dialysis * Other conditions the physician investigator deem unsafe to participate * Plans to move/relocate in next 12 months and/or travel out of area for \> 1 month

Design outcomes

Primary

MeasureTime frameDescription
Change in Systolic and Diastolic Blood PressureBaseline to 6 monthsBlood pressure changes were quantified as the baseline minus the 6 month value.

Countries

United States

Participant flow

Recruitment details

Non-Hispanic Black male clients, age 35-79 with systolic blood pressure \> 140 mmHG on two screening visits. Enrolled participants were monitored closely throughout the 6-month study timeline and descriptive statistics preformed.

Participants by arm

ArmCount
Male Participants Who Received the Hypertension Management Model.
Adult Black males 39 to 79 years who were clients of one of our participating Barber Shops were screened for hypertension. Those with systolic BPs greater than 140 mmHg were asked to participate.
30
Total30

Withdrawals & dropouts

PeriodReasonFG000
Overall StudyLost to Follow-up3

Baseline characteristics

CharacteristicMale Participants Who Received the Hypertension Management Model.
Age, Categorical
<=18 years
0 Participants
Age, Categorical
>=65 years
4 Participants
Age, Categorical
Between 18 and 65 years
26 Participants
Age, Continuous50.1 years
STANDARD_DEVIATION 10.4
Diastolic Blood Pressure95.1 mmHg
STANDARD_DEVIATION 13.9
Ethnicity (NIH/OMB)
Hispanic or Latino
0 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
30 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
Region of Enrollment
United States
30 participants
Sex: Female, Male
Female
0 Participants
Sex: Female, Male
Male
30 Participants
Systolic Blood Pressure157.7 mmHg
STANDARD_DEVIATION 17.1

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
0 / 30
other
Total, other adverse events
6 / 30
serious
Total, serious adverse events
3 / 30

Outcome results

Primary

Change in Systolic and Diastolic Blood Pressure

Blood pressure changes were quantified as the baseline minus the 6 month value.

Time frame: Baseline to 6 months

Population: Change in BP from baseline to 6 months

ArmMeasureGroupValue (MEAN)Dispersion
Male Participants Who Received the Hypertension Management ModelChange in Systolic and Diastolic Blood PressureSystolic21.1 mmHgStandard Deviation 21.6
Male Participants Who Received the Hypertension Management ModelChange in Systolic and Diastolic Blood PressureDiastolic19.5 mmHgStandard Deviation 14.1

Source: ClinicalTrials.gov · Data processed: Feb 14, 2026