Community-engaged Implementation Study of Hypertension Prevention and Navigation in Black Men
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 430
- 试验地点
- 1
- 主要终点
- Change in Systolic Blood Pressure (SBP) Levels
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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
研究组 & 干预措施
Barbershop-Based Facilitation (BF)
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.
干预措施: Community-to-Clinic Linkage Implementation Program in Barbershops (CLIP) (Behavioral)
Barbershop-Based Facilitation (BF)
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.
干预措施: Barbershop-Based Facilitation (BF) (Behavioral)
Self-Directed
Participants will receive the Community-to-Clinic Linkage Implementation Program in Barbershops (CLIP) program manual.
干预措施: Community-to-Clinic Linkage Implementation Program in Barbershops (CLIP) (Behavioral)
结局指标
主要结局
Change in Systolic Blood Pressure (SBP) Levels
时间窗: Baseline, Month 12
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
次要结局
- Number of Barbershops Continuing to Use CLIP at 6 Months Post-Completion of Intervention(Month 18)
- Number of Participants Presenting to Referral Clinics within 3 Months of Community Health Worker (CHW) Referral(Month 18)
- Number of Participants Presenting with Incident Stage 2 HTN(Month 18)
- Change in Diastolic Blood Pressure (DBP) Levels(Baseline, Month 12)
- 12-Item Short Form Survey (SF-12) Questionnaire Score(Month 18)
- Number of Barbershops Completing all Components of CLIP(Month 12)
- Cost per Millimeters of Mercury (mm Hg) Reduction in Blood Pressure (BP)(Up to Month 18)
- Cost per Incident Stage 2 Hypertension (HTN) Case Prevented(Up to Month 18)
- Number of Participants Presenting to Referral Clinics within 3 Months of Community Health Worker (CHW) Referral(Baseline)
- Number of Participants Presenting to Referral Clinics within 3 Months of Community Health Worker (CHW) Referral(Month 6)
- Number of Participants Presenting to Referral Clinics within 3 Months of Community Health Worker (CHW) Referral(Month 12)
- Number of Participants Presenting with Incident Stage 2 HTN(Baseline)
- Number of Participants Presenting with Incident Stage 2 HTN(Month 6)
- Number of Participants Presenting with Incident Stage 2 HTN(Month 12)
- 12-Item Short Form Survey (SF-12) Questionnaire Score(Baseline)
- 12-Item Short Form Survey (SF-12) Questionnaire Score(Month 6)
- 12-Item Short Form Survey (SF-12) Questionnaire Score(Month 12)