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

29. marts 2017 opdateret af: NYU Langone Health

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

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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).

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

1000

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • New York
      • New York, New York, Forenede Stater, 10016
        • New York University School of Medicine

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 25 år (Voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Forebyggelse
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Gruppe A
Adfærdsmæssigt: 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.
Eksperimentel: Gruppe B
Adfærdsmæssigt: 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Medication Adherance measured using the Hill-Bone Compliance to High Blood Pressure Therapy Scale
Tidsramme: 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.
12 Months
Measures of Intensity and Fidelity of Community Health Worker Intervention
Tidsramme: 12 Months
Attendance at group sessions and individual home visits will be recorded to determine intervention dosage.
12 Months

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

NYU Langone Health

Efterforskere

  • Ledende efterforsker: Chau Trinh, MD, NYU Langone Health

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

23. september 2010

Primær færdiggørelse (Faktiske)

3. maj 2016

Studieafslutning (Faktiske)

3. maj 2016

Datoer for studieregistrering

Først indsendt

29. marts 2017

Først indsendt, der opfyldte QC-kriterier

29. marts 2017

Først opslået (Faktiske)

4. april 2017

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

4. april 2017

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

29. marts 2017

Sidst verificeret

1. marts 2017

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 07-1131

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

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Kliniske forsøg med Forhøjet blodtryk

Kliniske forsøg med More intensive CHW Intervention

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Sponsorer og samarbejdspartnere

Medicinske tilstande

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Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner