- ICH GCP
- Реестр клинических исследований США
- Клиническое испытание 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
Обзор исследования
Статус
Вмешательство/лечение
Подробное описание
Тип исследования
Регистрация (Действительный)
Фаза
- Непригодный
Контакты и местонахождение
Места учебы
-
-
New York
-
New York, New York, Соединенные Штаты, 10016
- New York University School of Medicine
-
-
Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Описание
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
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Профилактика
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Нет (открытая этикетка)
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
|
Экспериментальный: Группа А
|
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.
|
|
Экспериментальный: Группа Б
|
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.
|
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Medication Adherance measured using the Hill-Bone Compliance to High Blood Pressure Therapy Scale
Временное ограничение: 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
Временное ограничение: 12 Months
|
Attendance at group sessions and individual home visits will be recorded to determine intervention dosage.
|
12 Months
|
Соавторы и исследователи
Спонсор
Следователи
- Главный следователь: Chau Trinh, MD, NYU Langone Health
Публикации и полезные ссылки
Даты записи исследования
Изучение основных дат
Начало исследования (Действительный)
Первичное завершение (Действительный)
Завершение исследования (Действительный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- 07-1131
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .
Клинические исследования More intensive CHW Intervention
-
Stockholm UniversityYale University; University of Chile; EDI Global; Elizabeth Glaser Pediatric AIDS Foundation... и другие соавторыЗавершенныйВоспитание детей | Раннее развитие ребенкаТанзания