Denne siden ble automatisk oversatt og nøyaktigheten av oversettelsen er ikke garantert. Vennligst referer til engelsk versjon for en kildetekst.

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

29. mars 2017 oppdatert av: 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

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert 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).

Studietype

Intervensjonell

Registrering (Faktiske)

1000

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Forente stater
    • New York
      • New York, New York, Forente stater, 10016
        • New York University School of Medicine

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år til 25 år (Voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Forebygging
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Gruppe A
Atferdsmessig: 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.
Eksperimentell: Gruppe B
Atferdsmessig: 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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

NYU Langone Health

Etterforskere

  • Hovedetterforsker: Chau Trinh, MD, NYU Langone Health

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

23. september 2010

Primær fullføring (Faktiske)

3. mai 2016

Studiet fullført (Faktiske)

3. mai 2016

Datoer for studieregistrering

Først innsendt

29. mars 2017

Først innsendt som oppfylte QC-kriteriene

29. mars 2017

Først lagt ut (Faktiske)

4. april 2017

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

4. april 2017

Siste oppdatering sendt inn som oppfylte QC-kriteriene

29. mars 2017

Sist bekreftet

1. mars 2017

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 07-1131

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Kliniske studier på Hypertensjon

Kliniske studier på More intensive CHW Intervention

Søk i lignende forsøk

Sponsorer og samarbeidspartnere

Medisinsk tilstand

Legemiddelintervensjoner

CROs by country

CROs in Philippines

Forhold

Sjeldne sykdommer

Legemiddelintervensjoner

Kosttilskudd

Sponsor / samarbeidspartnere

Steder

Abonnere