- ICH GCP
- Yhdysvaltain kliinisten tutkimusten rekisteri
- Kliininen tutkimus NCT03100812
Asian American Partnerships in Research and Empowerment (AsPIRE) (AsPIRE)
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
Tutkimuksen yleiskatsaus
Tila
Yksityiskohtainen kuvaus
Opintotyyppi
Ilmoittautuminen (Todellinen)
Vaihe
- Ei sovellettavissa
Yhteystiedot ja paikat
Opiskelupaikat
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New York
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New York, New York, Yhdysvallat, 10016
- New York University School of Medicine
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Osallistumiskriteerit
Kelpoisuusvaatimukset
Opintokelpoiset iät
Hyväksyy terveitä vapaaehtoisia
Sukupuolet, jotka voivat opiskella
Kuvaus
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
Opintosuunnitelma
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Ennaltaehkäisy
- Jako: Satunnaistettu
- Inventiomalli: Rinnakkaistehtävä
- Naamiointi: Ei mitään (avoin tarra)
Aseet ja interventiot
Osallistujaryhmä / Arm |
Interventio / Hoito |
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Kokeellinen: Ryhmä A
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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.
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Kokeellinen: Ryhmä B
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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.
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Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
---|---|---|
Medication Adherance measured using the Hill-Bone Compliance to High Blood Pressure Therapy Scale
Aikaikkuna: 12 Months
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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.
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12 Months
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Measures of Intensity and Fidelity of Community Health Worker Intervention
Aikaikkuna: 12 Months
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Attendance at group sessions and individual home visits will be recorded to determine intervention dosage.
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12 Months
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Yhteistyökumppanit ja tutkijat
Sponsori
Tutkijat
- Päätutkija: Chau Trinh, MD, NYU Langone Health
Julkaisuja ja hyödyllisiä linkkejä
Opintojen ennätyspäivät
Opi tärkeimmät päivämäärät
Opiskelun aloitus (Todellinen)
Ensisijainen valmistuminen (Todellinen)
Opintojen valmistuminen (Todellinen)
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Ensimmäinen Lähetetty (Todellinen)
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Viimeksi vahvistettu
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Avainsanat
Muita asiaankuuluvia MeSH-ehtoja
Muut tutkimustunnusnumerot
- 07-1131
Lääke- ja laitetiedot, tutkimusasiakirjat
Tutkii yhdysvaltalaista FDA sääntelemää lääkevalmistetta
Tutkii yhdysvaltalaista FDA sääntelemää laitetuotetta
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University of California, IrvineNational Institute on Aging (NIA)Rekrytointi