Asian American Partnerships in Research and Empowerment (AsPIRE)

Hypertension Clinical Trial

— AsPIRE  

Official title:

Asian American Partnerships in Research and Empowerment (AsPIRE)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03100812
• Other study ID #: 07-1131
• Status: Completed
• Phase: N/A
• First received: March 29, 2017
• Last updated: March 29, 2017
• Start date: September 23, 2010
• Est. completion date: May 3, 2016

Study information

• Verified date: March 2017
• Source: New York University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1000
• Est. completion date: May 3, 2016
• Est. primary completion date: May 3, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 25 Years

Eligibility

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

Related Conditions & MeSH terms

• Heart Diseases
• Hypertension
• Hypertensive Heart Disease

Intervention

Behavioral:
• More intensive CHW Intervention
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.
• Less Intensive CHW Intervention
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.

Locations

Country	Name	City	State
United States	New York University School of Medicine	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
New York University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	12 Months
Primary	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.	12 Months