search
Back to results

Asian American Partnerships in Research and Empowerment (AsPIRE) (AsPIRE)

Primary Purpose

Hypertensive Heart Disease, Hypertension

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
More intensive CHW Intervention
Less Intensive CHW Intervention
Sponsored by
NYU Langone Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hypertensive Heart Disease focused on measuring Hypertensive, Hypertension, Filipino

Eligibility Criteria

18 Years - 25 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

    1. of Filipino descent,
    2. an English or Tagalog-speaker
    3. a resident of New York City.
    4. 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

  1. is on renal dialysis since their treatment is beyond the scope of this CHW intervention
  2. has an acute or terminal illness or serious mental illness that deems an individual ineligible for study participation
  3. is participating in another hypertension or CVD study
  4. has had a history of a heart attack, stroke, or congestive heart failure, since their treatment is beyond the scope of this CHW intervention
  5. 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.
  6. is below 25 or over 75 years of age
  7. lives outside of NYC

Exclusion Criteria:

  • An individual is ineligible for enrollment in the CHW intervention if he/she

    1. is on renal dialysis since their treatment is beyond the scope of this CHW intervention
    2. has an acute or terminal illness or serious mental illness that deems an individual ineligible for study participation
    3. is participating in another hypertension or CVD study
    4. has had a history of a heart attack, stroke, or congestive heart failure, since their treatment is beyond the scope of this CHW intervention
    5. 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.
    6. is below 25 or over 75 years of age
    7. lives outside of NYC

  • An individual is ineligible for enrollment in the CHW intervention if he/she

    1. is on renal dialysis since their treatment is beyond the scope of this CHW intervention
    2. has an acute or terminal illness or serious mental illness that deems an individual ineligible for study participation
    3. is participating in another hypertension or CVD study
    4. has had a history of a heart attack, stroke, or congestive heart failure, since their treatment is beyond the scope of this CHW intervention
    5. 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.
    6. is below 25 or over 75 years of age
    7. lives outside of NYC

  • An individual is ineligible for enrollment in the CHW intervention if he/she

    1. is on renal dialysis since their treatment is beyond the scope of this CHW intervention
    2. has an acute or terminal illness or serious mental illness that deems an individual ineligible for study participation
    3. is participating in another hypertension or CVD study
    4. has had a history of a heart attack, stroke, or congestive heart failure, since their treatment is beyond the scope of this CHW intervention
    5. 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.
    6. is below 25 or over 75 years of age
    7. lives outside of NYC

Sites / Locations

  • New York University School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Group A

Group B

Arm Description

Outcomes

Primary Outcome Measures

Medication Adherance measured using the Hill-Bone Compliance to High Blood Pressure Therapy Scale
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
Attendance at group sessions and individual home visits will be recorded to determine intervention dosage.

Secondary Outcome Measures

Full Information

First Posted
March 29, 2017
Last Updated
March 29, 2017
Sponsor
NYU Langone Health
search

1. Study Identification

Unique Protocol Identification Number
NCT03100812
Brief Title
Asian American Partnerships in Research and Empowerment (AsPIRE)
Acronym
AsPIRE
Official Title
Asian American Partnerships in Research and Empowerment (AsPIRE)
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
September 23, 2010 (Actual)
Primary Completion Date
May 3, 2016 (Actual)
Study Completion Date
May 3, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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
Detailed Description
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertensive Heart Disease, Hypertension
Keywords
Hypertensive, Hypertension, Filipino

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1000 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group A
Arm Type
Experimental
Arm Title
Group B
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
More intensive CHW Intervention
Intervention Description
Group A participants will attend 4 monthly 90 minute group health education sessions that provide the tools and strategies to promote heart health to Filipino American individuals, families, and communities on high blood pressure and CVD. The CHWs will lead these sessions utilizing NHLBI's Healthy Heart Healthy Family, A CHW's Manual for the Filipino Community. Each of the group health education sessions will discuss different content related to CVD, hypertension, and other CVD risk factors. The first session focuses on assessing heart disease risk and recognition of heart attack signs. The second session focuses on physical activity and weight management and blood pressure control. The third session addresses control of cholesterol, and diabetes. The final 4th session teaches participants about nutrition and living smoke free.
Intervention Type
Behavioral
Intervention Name(s)
Less Intensive CHW Intervention
Intervention Description
Individuals randomized to the less intensive CHW intervention will have the baseline, 4 month, and 8 month interviews and blood pressure measurements will be collected in those succeeding time points. Participants will also receive a 30 minute one on one session from the CHW and a referral to a physician if needed.
Primary Outcome Measure Information:
Title
Medication Adherance measured using the Hill-Bone Compliance to High Blood Pressure Therapy Scale
Description
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.
Time Frame
12 Months
Title
Measures of Intensity and Fidelity of Community Health Worker Intervention
Description
Attendance at group sessions and individual home visits will be recorded to determine intervention dosage.
Time Frame
12 Months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chau Trinh, MD
Organizational Affiliation
NYU Langone Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
New York University School of Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
36273386
Citation
Wyatt LC, Katigbak C, Riley L, Zanowiak JM, Ursua R, Kwon SC, Trinh-Shevrin C, Islam NS. Promoting Physical Activity Among Immigrant Asian Americans: Results from Four Community Health Worker Studies. J Immigr Minor Health. 2023 Apr;25(2):291-305. doi: 10.1007/s10903-022-01411-y. Epub 2022 Oct 23.
Results Reference
derived

Learn more about this trial

Asian American Partnerships in Research and Empowerment (AsPIRE)

We'll reach out to this number within 24 hrs