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临床试验/NCT03100812
NCT03100812已完成不适用

Asian American Partnerships in Research and Empowerment (AsPIRE)

NYU Langone Health1 个研究点 分布在 1 个国家目标入组 1,000 人开始时间: 2010年9月23日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
1,000
试验地点
1
主要终点
Medication Adherance measured using the Hill-Bone Compliance to High Blood Pressure Therapy Scale

研究概览

简要总结

The proposed intervention is part of a multi-year year grant awarded to the NYU Center for the Study of Asian American Health by to the National Institutes of Health/National Center for Minority Health and Health Disparities (NIH/NCMHD). The funding mechanism is specifically the NCMHD Community-Based Participatory Research (CBPR) Initiative in Reducing and Eliminating Health Disparities: Intervention Research Phase (R24).

The objective of this study is to implement and assess the efficacy of a Community Health worker (CHW) intervention to improve hypertension management and access to care among Filipino Americans living in New York and New Jersey. It is believed that when compared to individuals receiving the less intensive CHW intervention, Filipino Americans receiving the more intensive CHW intervention will:

H1: Exhibit greater compliance with appointment keeping. H2: Exhibit greater compliance with medication taking H3: Show greater reductions in mean systolic and mean diastolic blood pressure. H4: Be more likely to exhibit controlled blood pressure

详细描述

Filipino Americans exhibit high rates of hypertension and are therefore at high risk for cardiovascular disease and stroke. However, few interventions have been developed and implemented for this population to address these concerns. A CHW intervention, developed with community input to ensure its cultural and linguistic appropriateness, has the potential to prevent cardiovascular disease and stroke by helping Filipino Americans control their blood pressure. This study has the overall goal of improving health access and cardiovascular health status, particularly hypertension, in the Filipino American community living in New York City and New Jersey through the use of Community Health Workers (CHW).

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 25 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • The population of interest is Filipino American men and women residing in New York City. An individual is eligible for the CHW intervention if he/she is
  • of Filipino descent,
  • an English or Tagalog-speaker
  • a resident of New York City.
  • identified as hypertensive based on
  • The average of the 2nd and 3rd readings from both arms (right arm) with at least 1 high systolic BP (>140mmHg) or 1 high diastolic BP reading (>90mmHg) for nondiabetics, or 1 high systolic BP (>130mmHg) or 1 high diastolic BP reading (>80mmHg) for diabetics at point of screening for this study.
  • Or if participant reports to be taking antihypertensive medication. Therefore this study will include individuals with untreated hypertension (not taking antihypertensive medication), uncontrolled hypertension (i.e. elevated blood pressure despite taking antihypertensive medication), and controlled hypertension (i.e. taking antihypertensive medication but BP is under control). Individuals presenting with untreated high blood pressure will be referred to a physician to confirm diagnosis of hypertension.
  • An individual is ineligible for enrollment in the CHW intervention if he/she
  • is on renal dialysis since their treatment is beyond the scope of this CHW intervention
  • has an acute or terminal illness or serious mental illness that deems an individual ineligible for study participation
  • is participating in another hypertension or CVD study
  • has had a history of a heart attack, stroke, or congestive heart failure, since their treatment is beyond the scope of this CHW intervention
  • has a blood pressure average below 140/90 for non-diabetics and not taking antihypertensive medication, and an average of 130/80 for diabetics not taking antihypertensive medication.
  • is below 25 or over 75 years of age
  • lives outside of NYC

排除标准

  • An individual is ineligible for enrollment in the CHW intervention if he/she
  • is on renal dialysis since their treatment is beyond the scope of this CHW intervention
  • has an acute or terminal illness or serious mental illness that deems an individual ineligible for study participation
  • is participating in another hypertension or CVD study
  • has had a history of a heart attack, stroke, or congestive heart failure, since their treatment is beyond the scope of this CHW intervention
  • has a blood pressure average below 140/90 for non-diabetics and not taking antihypertensive medication, and an average of 130/80 for diabetics not taking antihypertensive medication.
  • is below 25 or over 75 years of age
  • lives outside of NYC
  • An individual is ineligible for enrollment in the CHW intervention if he/she
  • is on renal dialysis since their treatment is beyond the scope of this CHW intervention
  • has an acute or terminal illness or serious mental illness that deems an individual ineligible for study participation
  • is participating in another hypertension or CVD study
  • has had a history of a heart attack, stroke, or congestive heart failure, since their treatment is beyond the scope of this CHW intervention
  • has a blood pressure average below 140/90 for non-diabetics and not taking antihypertensive medication, and an average of 130/80 for diabetics not taking antihypertensive medication.
  • is below 25 or over 75 years of age
  • lives outside of NYC
  • An individual is ineligible for enrollment in the CHW intervention if he/she
  • is on renal dialysis since their treatment is beyond the scope of this CHW intervention
  • has an acute or terminal illness or serious mental illness that deems an individual ineligible for study participation
  • is participating in another hypertension or CVD study
  • has had a history of a heart attack, stroke, or congestive heart failure, since their treatment is beyond the scope of this CHW intervention
  • has a blood pressure average below 140/90 for non-diabetics and not taking antihypertensive medication, and an average of 130/80 for diabetics not taking antihypertensive medication.
  • is below 25 or over 75 years of age
  • lives outside of NYC

结局指标

主要结局

Medication Adherance measured using the Hill-Bone Compliance to High Blood Pressure Therapy Scale

时间窗: 12 Months

This scale is comprised of 14 items in three subscales; one subscale pertains to adherence to medication taking. Three blood pressure readings will be taken; the second and third will be averaged.

Measures of Intensity and Fidelity of Community Health Worker Intervention

时间窗: 12 Months

Attendance at group sessions and individual home visits will be recorded to determine intervention dosage.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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