Back to resultsCommunity-engaged Hypertension Prevention Program in Black Men
Primary Purpose
Hypertension
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Community-to-Clinic Linkage Implementation Program in Barbershops (CLIP)
Barbershop-Based Facilitation (BF)
Sponsored by
About this trial
This is an interventional prevention trial for Hypertension focused on measuring Barbershop-based facilitation, Blood pressure
Eligibility Criteria
Inclusion Criteria:
- 18 years of age as of date of data extraction
- Repeat customer within the last 3 months
- Self-identify as Black
- Self-identify as male
- 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:
- Age <18 years
- Prescribed antihypertensive medication
- Diagnosis of end-stage renal disease (ESRD)
- Condition which interferes with outcome measurement (e.g., dialysis)
- Serious medical condition which either limits life expectancy or requires active management (e.g., cancer)
- Cognitive impairment or other condition preventing participation in the intervention
- Upper arm circumference >50 cm (maximum limit of the extra-large BP cuff)
- Active alcohol or substance use disorder (i.e., not sober/abstinent for ≥ 30 days)
- Pregnant or planning pregnancy in the next 24 months
- Currently nursing a child
- Current participation in another research study focused on reducing BP
- Unwillingness to provide informed consent
Sites / Locations
- NYU Langone HealthRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Barbershop-Based Facilitation (BF)
Self-Directed
Arm Description
Participants will receive the Community-to-Clinic Linkage Implementation Program in Barbershops (CLIP) program manual and receive exposure to Barbershop-Based Facilitation (BF), which is designed to stimulate specific, actionable steps that community health workers (CHWs) can undertake to implement CLIP at the barbershop.
Participants will receive the Community-to-Clinic Linkage Implementation Program in Barbershops (CLIP) program manual.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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.
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.
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.
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.
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.
Number of Barbershops Completing all Components of CLIP
Measurement of the rate of adoption of Community-to-Clinic Linkage Implementation Program in Barbershops (CLIP).
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).
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Full Information
NCT ID
NCT05447962
First Posted
June 29, 2022
Last Updated
August 30, 2023
Sponsor
NYU Langone Health
Collaborators
American Heart Association
1. Study Identification
Unique Protocol Identification Number
NCT05447962
Brief Title
Community-engaged Hypertension Prevention Program in Black Men
Official Title
Community-engaged Implementation Study of Hypertension Prevention and Navigation in Black Men
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 1, 2022 (Actual)
Primary Completion Date
January 2025 (Anticipated)
Study Completion Date
September 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health
Collaborators
American Heart Association
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
Detailed Description
The study will consist of:
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension
Keywords
Barbershop-based facilitation, Blood pressure
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
420 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Barbershop-Based Facilitation (BF)
Arm Type
Experimental
Arm Description
Participants will receive the Community-to-Clinic Linkage Implementation Program in Barbershops (CLIP) program manual and receive exposure to Barbershop-Based Facilitation (BF), which is designed to stimulate specific, actionable steps that community health workers (CHWs) can undertake to implement CLIP at the barbershop.
Arm Title
Self-Directed
Arm Type
Active Comparator
Arm Description
Participants will receive the Community-to-Clinic Linkage Implementation Program in Barbershops (CLIP) program manual.
Intervention Type
Behavioral
Intervention Name(s)
Community-to-Clinic Linkage Implementation Program in Barbershops (CLIP)
Intervention Description
Multilevel intervention designed to mitigate adverse social determinants of health (SDoH) via linkage to care, health system navigation, and referral to social services.
Intervention Type
Behavioral
Intervention Name(s)
Barbershop-Based Facilitation (BF)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Systolic Blood Pressure (SBP) Levels
Description
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
Time Frame
Baseline, Month 12
Secondary Outcome Measure Information:
Title
Change in Diastolic Blood Pressure (DBP) Levels
Description
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.
Time Frame
Baseline, Month 12
Title
Number of Participants Presenting to Referral Clinics within 3 Months of Community Health Worker (CHW) Referral
Description
Measurement of linkage to care. Data will be gathered via telephone interview or during barbershop visit.
Time Frame
Baseline
Title
Number of Participants Presenting to Referral Clinics within 3 Months of Community Health Worker (CHW) Referral
Description
Measurement of linkage to care. Data will be gathered via telephone interview or during barbershop visit.
Time Frame
Month 6
Title
Number of Participants Presenting to Referral Clinics within 3 Months of Community Health Worker (CHW) Referral
Description
Measurement of linkage to care. Data will be gathered via telephone interview or during barbershop visit.
Time Frame
Month 12
Title
Number of Participants Presenting to Referral Clinics within 3 Months of Community Health Worker (CHW) Referral
Description
Measurement of linkage to care. Data will be gathered via telephone interview or during barbershop visit.
Time Frame
Month 18
Title
Number of Barbershops Completing all Components of CLIP
Description
Measurement of the rate of adoption of Community-to-Clinic Linkage Implementation Program in Barbershops (CLIP).
Time Frame
Month 12
Title
Number of Barbershops Continuing to Use CLIP at 6 Months Post-Completion of Intervention
Description
Measurement of the sustainability of Community-to-Clinic Linkage Implementation Program in Barbershops (CLIP).
Time Frame
Month 18
Title
Number of Participants Presenting with Incident Stage 2 HTN
Description
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.
Time Frame
Baseline
Title
Number of Participants Presenting with Incident Stage 2 HTN
Description
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.
Time Frame
Month 6
Title
Number of Participants Presenting with Incident Stage 2 HTN
Description
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.
Time Frame
Month 12
Title
Number of Participants Presenting with Incident Stage 2 HTN
Description
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.
Time Frame
Month 18
Title
12-Item Short Form Survey (SF-12) Questionnaire Score
Description
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.
Time Frame
Baseline
Title
12-Item Short Form Survey (SF-12) Questionnaire Score
Description
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.
Time Frame
Month 6
Title
12-Item Short Form Survey (SF-12) Questionnaire Score
Description
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.
Time Frame
Month 12
Title
12-Item Short Form Survey (SF-12) Questionnaire Score
Description
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.
Time Frame
Month 18
Title
Cost per Millimeters of Mercury (mm Hg) Reduction in Blood Pressure (BP)
Description
Dollar amount associated with a 1-mm Hg reduction in BP. Lower costs are considered more desirable outcomes.
Time Frame
Up to Month 18
Title
Cost per Incident Stage 2 Hypertension (HTN) Case Prevented
Description
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.
Time Frame
Up to Month 18
10. Eligibility
Sex
Male
Gender Based
Yes
Gender Eligibility Description
Based on self-identification.
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
18 years of age as of date of data extraction
Repeat customer within the last 3 months
Self-identify as Black
Self-identify as male
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:
Age <18 years
Prescribed antihypertensive medication
Diagnosis of end-stage renal disease (ESRD)
Condition which interferes with outcome measurement (e.g., dialysis)
Serious medical condition which either limits life expectancy or requires active management (e.g., cancer)
Cognitive impairment or other condition preventing participation in the intervention
Upper arm circumference >50 cm (maximum limit of the extra-large BP cuff)
Active alcohol or substance use disorder (i.e., not sober/abstinent for ≥ 30 days)
Pregnant or planning pregnancy in the next 24 months
Currently nursing a child
Current participation in another research study focused on reducing BP
Unwillingness to provide informed consent
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Joseph Ravenell, MD
Phone
646-501-9932
Email
Joseph.Ravenell@nyulangone.org
First Name & Middle Initial & Last Name or Official Title & Degree
Tanisha Green
Phone
646-501-3868
Email
Tanisha.Green@nyulangone.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joseph Ravenell, MD
Organizational Affiliation
NYU Langone Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
NYU Langone Health
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joseph Ravenell, MD
Phone
646-501-9932
Email
Joseph.Ravenell@nyulangone.org
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
The de-identified participant data from the final research dataset used in the published manuscript will be shared upon reasonable request beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the investigator who proposes to use the data executes a data use agreement with NYU Langone Health. Requests may be directed to:
Joseph Ravenell, MD Telephone: 646-501-9932 Email: Joseph.Ravenell@nyulangone.org
The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
IPD Sharing Time Frame
Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
IPD Sharing Access Criteria
The investigator who proposed to use the data will have access upon reasonable request. Requests should be directed to Joseph.Ravenell@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.
Learn more about this trial
Community-engaged Hypertension Prevention Program in Black Men
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