Community-engaged Hypertension Prevention Program in Black Men

Hypertension Clinical Trial

Official title:

Community-engaged Implementation Study of Hypertension Prevention and Navigation in Black Men

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05447962
• Other study ID #: 21-01586
• Status: Recruiting
• Phase: N/A
• Start date: October 1, 2022
• Est. completion date: September 2025

Study information

• Verified date: August 2023
• Source: NYU Langone Health
• Contact: Joseph Ravenell, MD
• Phone: 646-501-9932
• Email: Joseph.Ravenell[@]nyulangone.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The CLIP program will train Community Health Workers (CHWs) to screen and identify Black men with elevated blood pressure (BP) or stage 1 hypertension (HTN), initiate lifestyle counseling; and link them to primary care and social services.

Description:

The study will consist of:

1. An implementation phase that will use a cluster randomized cluster trial of 20 barbershops among Black men with elevated BP or Stage 1 HTN, to compare the effect of the Barbershop-based Facilitation (BF) strategy (n=10 barbershops; n=210 participants) vs. self-directed control (i.e. receipt of information for implementation of CLIP without the BF strategy; n=10 barbershops; n=210 participants), on BP reduction, HTN prevention, linkage to care, and adoption of CLIP at 12 months

2. A post-implementation phase that will use Reach Effectiveness Adoption Implementation and Maintenance (RE-AIM) to evaluate the effect of the BF strategy versus self-directed control on sustainability of CLIP 6 months after completion of the trial; and cost-effectiveness over a 10-year time horizon.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 420
• Est. completion date: September 2025
• Est. primary completion date: January 2025
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

1. 18 years of age as of date of data extraction

2. Repeat customer within the last 3 months

3. Self-identify as Black

4. Self-identify as male

5. Have elevated blood pressure (PB) (120-129/<80 millimeters of mercury (mm Hg)) or untreated stage 1 hypertension (HTN) (130-139/80-89 mm Hg) (defined by American Heart Association's 2017 HTN clinical guidelines)

Exclusion Criteria:

1. Age <18 years

2. Prescribed antihypertensive medication

3. Diagnosis of end-stage renal disease (ESRD)

4. Condition which interferes with outcome measurement (e.g., dialysis)

5. Serious medical condition which either limits life expectancy or requires active management (e.g., cancer)

6. Cognitive impairment or other condition preventing participation in the intervention

7. Upper arm circumference >50 cm (maximum limit of the extra-large BP cuff)

8. Active alcohol or substance use disorder (i.e., not sober/abstinent for = 30 days)

9. Pregnant or planning pregnancy in the next 24 months

10. Currently nursing a child

11. Current participation in another research study focused on reducing BP

12. Unwillingness to provide informed consent

Related Conditions & MeSH terms

• Hypertension

Intervention

Behavioral:
• Community-to-Clinic Linkage Implementation Program in Barbershops (CLIP)
Multilevel intervention designed to mitigate adverse social determinants of health (SDoH) via linkage to care, health system navigation, and referral to social services.
• Barbershop-Based Facilitation (BF)
Trained and qualified facilitators assist community health workers (CHWs) to: 1) increase their confidence in delivering CLIP; 2) understand participants' concerns and beliefs about hypertension (HTN); and 3) develop skills in lifestyle counseling to help the men initiate lifestyle modification.

Locations

Country	Name	City	State
United States	NYU Langone Health	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
NYU Langone Health	American Heart Association

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Systolic Blood Pressure (SBP) Levels	All participants will have office blood pressure (BP) measured on their non-dominant arm with an Omron HEM-907XL BP device.; 3 BP readings separated by one minute will be obtained at each visit. The 3 BP readings will be averaged to obtain mean BP.; SBP Levels are classified as follows: Normal: Below 120 millimeters of mercury (mm Hg); Elevated: 120-129 mm Hg; Stage 1 hypertension: 130-139 mm Hg; Stage 2 hypertension: 140 mm Hg or more; Hypertensive crisis: 180 mm Hg or more	Baseline, Month 12
Secondary	Change in Diastolic Blood Pressure (DBP) Levels	All participants will have office blood pressure (BP) measured on their non-dominant arm with an Omron HEM-907XL BP device.; At each visit, 3 BP readings separated by one minute will be obtained. The 3 BP readings will be averaged to obtain study BP.; DBP Levels are classified as follows: Normal: Lower than 80 millimeters of mercury (mm Hg); Stage 1 hypertension: 80-89 mm Hg; Stage 2 hypertension: 90 mm Hg or more; Hypertensive crisis: 120 mm Hg or more.	Baseline, Month 12
Secondary	Number of Participants Presenting to Referral Clinics within 3 Months of Community Health Worker (CHW) Referral	Measurement of linkage to care. Data will be gathered via telephone interview or during barbershop visit.	Baseline
Secondary	Number of Participants Presenting to Referral Clinics within 3 Months of Community Health Worker (CHW) Referral	Measurement of linkage to care. Data will be gathered via telephone interview or during barbershop visit.	Month 6
Secondary	Number of Participants Presenting to Referral Clinics within 3 Months of Community Health Worker (CHW) Referral	Measurement of linkage to care. Data will be gathered via telephone interview or during barbershop visit.	Month 12
Secondary	Number of Participants Presenting to Referral Clinics within 3 Months of Community Health Worker (CHW) Referral	Measurement of linkage to care. Data will be gathered via telephone interview or during barbershop visit.	Month 18
Secondary	Number of Barbershops Completing all Components of CLIP	Measurement of the rate of adoption of Community-to-Clinic Linkage Implementation Program in Barbershops (CLIP).	Month 12
Secondary	Number of Barbershops Continuing to Use CLIP at 6 Months Post-Completion of Intervention	Measurement of the sustainability of Community-to-Clinic Linkage Implementation Program in Barbershops (CLIP).	Month 18
Secondary	Number of Participants Presenting with Incident Stage 2 HTN	Incident Stage 2 hypertension (HTN) is defined as: Systolic Blood Pressure (SBP) of at least 140 millimeters of mercury (mm Hg)/Diastolic Blood Pressure (DBP) of at least 90 mm Hg; or; Antihypertensive medication initiation.	Baseline
Secondary	Number of Participants Presenting with Incident Stage 2 HTN	Incident Stage 2 hypertension (HTN) is defined as: Systolic Blood Pressure (SBP) of at least 140 millimeters of mercury (mm Hg)/Diastolic Blood Pressure (DBP) of at least 90 mm Hg; or; Antihypertensive medication initiation.	Month 6
Secondary	Number of Participants Presenting with Incident Stage 2 HTN	Incident Stage 2 hypertension (HTN) is defined as: Systolic Blood Pressure (SBP) of at least 140 millimeters of mercury (mm Hg)/Diastolic Blood Pressure (DBP) of at least 90 mm Hg; or; Antihypertensive medication initiation.	Month 12
Secondary	Number of Participants Presenting with Incident Stage 2 HTN	Incident Stage 2 hypertension (HTN) is defined as: Systolic Blood Pressure (SBP) of at least 140 millimeters of mercury (mm Hg)/Diastolic Blood Pressure (DBP) of at least 90 mm Hg; or; Antihypertensive medication initiation.	Month 18
Secondary	12-Item Short Form Survey (SF-12) Questionnaire Score	The SF-12 is a self-reported outcome measure assessing the impact of health on an individual's everyday life. It is often used as a quality-of-life measure. SF-12 consists of 12 questions that are scored in various ways. The total score range is 12-48; the higher the score, the better the physical and mental health functioning.	Baseline
Secondary	12-Item Short Form Survey (SF-12) Questionnaire Score	The SF-12 is a self-reported outcome measure assessing the impact of health on an individual's everyday life. It is often used as a quality-of-life measure. SF-12 consists of 12 questions that are scored in various ways. The total score range is 12-48; the higher the score, the better the physical and mental health functioning.	Month 6
Secondary	12-Item Short Form Survey (SF-12) Questionnaire Score	The SF-12 is a self-reported outcome measure assessing the impact of health on an individual's everyday life. It is often used as a quality-of-life measure. SF-12 consists of 12 questions that are scored in various ways. The total score range is 12-48; the higher the score, the better the physical and mental health functioning.	Month 12
Secondary	12-Item Short Form Survey (SF-12) Questionnaire Score	The SF-12 is a self-reported outcome measure assessing the impact of health on an individual's everyday life. It is often used as a quality-of-life measure. SF-12 consists of 12 questions that are scored in various ways. The total score range is 12-48; the higher the score, the better the physical and mental health functioning.	Month 18
Secondary	Cost per Millimeters of Mercury (mm Hg) Reduction in Blood Pressure (BP)	Dollar amount associated with a 1-mm Hg reduction in BP. Lower costs are considered more desirable outcomes.	Up to Month 18
Secondary	Cost per Incident Stage 2 Hypertension (HTN) Case Prevented	Dollar amount associated with the prevention of an Incident Stage 2 HTN case. Lower costs are considered more desirable outcomes.; Incident Stage 2 HTN is defined as: Systolic Blood Pressure (SBP) of at least 140 millimeters of mercury (mm Hg)/Diastolic Blood Pressure (DBP) of at least 90 mm Hg; or; Antihypertensive medication initiation.	Up to Month 18