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

29 mars 2017 mis à jour par: 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

Aperçu de l'étude

Statut

Complété

Les conditions

Intervention / Traitement

Description détaillée

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).

Type d'étude

Interventionnel

Inscription (Réel)

1000

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

  • États-Unis
    • New York
      • New York, New York, États-Unis, 10016
        • New York University School of Medicine

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans à 25 ans (Adulte)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

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

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: La prévention
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: Groupe A
Comportemental: 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.
Expérimental: Groupe B
Comportemental: 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.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Medication Adherance measured using the Hill-Bone Compliance to High Blood Pressure Therapy Scale
Délai: 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
Délai: 12 Months
Attendance at group sessions and individual home visits will be recorded to determine intervention dosage.
12 Months

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

NYU Langone Health

Les enquêteurs

  • Chercheur principal: Chau Trinh, MD, NYU Langone Health

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

23 septembre 2010

Achèvement primaire (Réel)

3 mai 2016

Achèvement de l'étude (Réel)

3 mai 2016

Dates d'inscription aux études

Première soumission

29 mars 2017

Première soumission répondant aux critères de contrôle qualité

29 mars 2017

Première publication (Réel)

4 avril 2017

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

4 avril 2017

Dernière mise à jour soumise répondant aux critères de contrôle qualité

29 mars 2017

Dernière vérification

1 mars 2017

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • 07-1131

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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Essais cliniques sur More intensive CHW Intervention

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