Trial Outcomes & Findings for Nashville - Hypertension Management Model (NCT NCT04232124)
NCT ID: NCT04232124
Last Updated: 2024-01-22
Results Overview
Blood pressure changes were quantified as the baseline minus the 6 month value.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
30 participants
Primary outcome timeframe
Baseline to 6 months
Results posted on
2024-01-22
Participant Flow
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.
Participant milestones
| Measure |
PharmD Community-based Delivery of Hypertension Management Including Medication Adjustment as Needed
Aim 1. 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.
Hypertension 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
|
|---|---|
|
Overall Study
STARTED
|
30
|
|
Overall Study
COMPLETED
|
27
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
| Measure |
PharmD Community-based Delivery of Hypertension Management Including Medication Adjustment as Needed
Aim 1. 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.
Hypertension 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
|
|---|---|
|
Overall Study
Lost to Follow-up
|
3
|
Baseline Characteristics
Nashville - Hypertension Management Model
Baseline characteristics by cohort
| Measure |
Male Participants Who Received the Hypertension Management Model.
n=30 Participants
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.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
26 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
4 Participants
n=99 Participants
|
|
Age, Continuous
|
50.1 years
STANDARD_DEVIATION 10.4 • n=99 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
30 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
30 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
30 participants
n=99 Participants
|
|
Systolic Blood Pressure
|
157.7 mmHg
STANDARD_DEVIATION 17.1 • n=99 Participants
|
|
Diastolic Blood Pressure
|
95.1 mmHg
STANDARD_DEVIATION 13.9 • n=99 Participants
|
PRIMARY outcome
Timeframe: Baseline to 6 monthsPopulation: Change in BP from baseline to 6 months
Blood pressure changes were quantified as the baseline minus the 6 month value.
Outcome measures
| Measure |
Male Participants Who Received the Hypertension Management Model
n=27 Participants
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.
|
|---|---|
|
Change in Systolic and Diastolic Blood Pressure
Systolic
|
21.1 mmHg
Standard Deviation 21.6
|
|
Change in Systolic and Diastolic Blood Pressure
Diastolic
|
19.5 mmHg
Standard Deviation 14.1
|
Adverse Events
Male Participants Who Received the Hypertension Management Model
Serious events: 3 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Male Participants Who Received the Hypertension Management Model
n=30 participants at risk
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.
|
|---|---|
|
Nervous system disorders
Seizure
|
3.3%
1/30 • Number of events 1 • Baseline to 6 months
Adverse events were assessed for participants once they signed their consent form. When a serious event was reported study personnel completed an adverse event form, submitted to the physician monitor for review and then submitted it to the DSMB if required.
|
|
Blood and lymphatic system disorders
Transient Ischemic Attack
|
3.3%
1/30 • Number of events 1 • Baseline to 6 months
Adverse events were assessed for participants once they signed their consent form. When a serious event was reported study personnel completed an adverse event form, submitted to the physician monitor for review and then submitted it to the DSMB if required.
|
|
Endocrine disorders
hyperglycemia
|
3.3%
1/30 • Number of events 1 • Baseline to 6 months
Adverse events were assessed for participants once they signed their consent form. When a serious event was reported study personnel completed an adverse event form, submitted to the physician monitor for review and then submitted it to the DSMB if required.
|
Other adverse events
| Measure |
Male Participants Who Received the Hypertension Management Model
n=30 participants at risk
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.
|
|---|---|
|
Immune system disorders
Covid Pneumonia
|
10.0%
3/30 • Number of events 3 • Baseline to 6 months
Adverse events were assessed for participants once they signed their consent form. When a serious event was reported study personnel completed an adverse event form, submitted to the physician monitor for review and then submitted it to the DSMB if required.
|
|
Product Issues
dizziness
|
10.0%
3/30 • Number of events 3 • Baseline to 6 months
Adverse events were assessed for participants once they signed their consent form. When a serious event was reported study personnel completed an adverse event form, submitted to the physician monitor for review and then submitted it to the DSMB if required.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place