Asian American Partnerships in Research and Empowerment (AsPIRE) (AsPIRE)
29 de março de 2017 atualizado por: 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
Visão geral do estudo
Status
Concluído
Condições
Intervenção / Tratamento
Descrição detalhada
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).
Tipo de estudo
Intervencional
Inscrição (Real)
1000
Estágio
- Não aplicável
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
-
-
New York
-
New York, New York, Estados Unidos, 10016
- New York University School of Medicine
-
-
Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
18 anos a 25 anos (Adulto)
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Tudo
Descrição
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
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Prevenção
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: Grupo A
|
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.
|
|
Experimental: Grupo B
|
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.
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Medication Adherance measured using the Hill-Bone Compliance to High Blood Pressure Therapy Scale
Prazo: 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
Prazo: 12 Months
|
Attendance at group sessions and individual home visits will be recorded to determine intervention dosage.
|
12 Months
|
Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Investigadores
- Investigador principal: Chau Trinh, MD, NYU Langone Health
Publicações e links úteis
A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Real)
23 de setembro de 2010
Conclusão Primária (Real)
3 de maio de 2016
Conclusão do estudo (Real)
3 de maio de 2016
Datas de inscrição no estudo
Enviado pela primeira vez
29 de março de 2017
Enviado pela primeira vez que atendeu aos critérios de CQ
29 de março de 2017
Primeira postagem (Real)
4 de abril de 2017
Atualizações de registro de estudo
Última Atualização Postada (Real)
4 de abril de 2017
Última atualização enviada que atendeu aos critérios de controle de qualidade
29 de março de 2017
Última verificação
1 de março de 2017
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 07-1131
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .