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Breathe With Ease: A Unique Approach to Managing Stress (BEAMS)

22 августа 2019 г. обновлено: Stephen J. Teach, MD, MPH

Improving Asthma Outcomes Through Stress Management

Uncontrolled asthma in at-risk youth responds well to guideline-based therapy when patients remain adherent to their management plans. Adherence to inhaled corticosteroids (ICS), when indicated for persistent or uncontrolled asthma, is a critical component of most asthma management plans, and other self-management practices such as trigger avoidance are similarly related to improved asthma outcomes. Adherence to self-management practices is mediated by multiple factors, including psychosocial stress of parents and their children.

A targeted, culturally appropriate intervention to manage psychosocial stress among the parents of young, African American, and socioeconomically disadvantaged urban children with asthma who are receiving guideline-based care may improve asthma self-management, and therefore asthma outcomes.

Our overall aim is to implement and evaluate a highly collaborative, multi-dimensional, culturally appropriate and community-based asthma intervention to augment existing guideline-based best practice. The intervention will target the parents of at-risk, urban, African American youth, and will employ individualized psychosocial stress management and peer support.

Обзор исследования

Статус

Завершенный

Условия

Вмешательство/лечение

Подробное описание

Uncontrolled asthma in at-risk youth responds well to guideline-based therapy when patients remain adherent to their management plans. Adherence to inhaled corticosteroids (ICS), when indicated for persistent or uncontrolled asthma, is a critical component of most asthma management plans, and other self-management practices such as trigger avoidance are similarly related to improved asthma outcomes. Adherence to self-management practices is mediated by multiple factors, including psychosocial stress of parents and their children.

A targeted, culturally appropriate intervention to manage psychosocial stress among the parents of young, African American, and socioeconomically disadvantaged urban children with asthma who are receiving guideline-based care may improve asthma self-management, and therefore asthma outcomes.

Our overall aim is to implement and evaluate a highly collaborative, multi-dimensional, culturally appropriate and community-based asthma intervention to augment existing guideline-based best practice. The intervention will target the parents of at-risk, urban, African American youth, and will employ individualized psychosocial stress management and peer support.

We will conduct a single blind, prospective randomized controlled trial comparing the IMPACT DC Asthma Clinic's existing intervention of guideline-based clinical care, education, and short-term care coordination (usual care) to usual care plus parental stress management in a cohort of up to 200 parent-child dyads of AA youth aged 4-12 years.

Тип исследования

Интервенционный

Регистрация (Действительный)

217

Фаза

  • Непригодный

Контакты и местонахождение

В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.

Места учебы

  • Соединенные Штаты
    • District of Columbia
      • Washington, District of Columbia, Соединенные Штаты, 20010
        • Children's National Medical Center

Критерии участия

Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.

Критерии приемлемости

Возраст, подходящий для обучения

От 4 года до 12 лет (Ребенок)

Принимает здоровых добровольцев

Нет

Полы, имеющие право на обучение

Все

Описание

We plan to enroll parent-child dyads that meet the following criteria:

Inclusion criteria (Parent):

  • self-identify as African-American
  • both the legal guardian and primary asthma caregiver of an eligible child.

Exclusion criteria (Parent):

  • unable or unwilling to sign informed consent document
  • exclusionary psychiatric condition, including but not limited to psychosis, based on the screening form at recruitment
  • enrolled in another asthma research study.

Inclusion criteria (Child):

  • parent-identified as African-American
  • age 4-12 years inclusive at recruitment
  • physician diagnosis of persistent asthma
  • publicly financed insurance

Exclusion criteria (Child):

- chronic medical condition (other than asthma) including but not limited to diabetes, sickle cell disease, heart disease, lung disease or neurological disorder.

In addition, the PI may choose to not include a participant if he does not believe it is in the family's best interest to participate.

Учебный план

В этом разделе представлена ​​подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.

Как устроено исследование?

Детали дизайна

  • Основная цель: Уход
  • Распределение: Рандомизированный
  • Интервенционная модель: Параллельное назначение
  • Маскировка: Одинокий

Оружие и интервенции

Группа участников / Армия
Вмешательство/лечение
Активный компаратор: Usual Care
IMPACT DC Asthma Clinic intervention of guideline-based clinical care, education, and short-term care coordination
Другой: Usual Care
IMPACT DC Asthma Clinic intervention of guideline-based clinical care, education, and short-term care coordination
Экспериментальный: Intervention
Parental stress management in addition to IMPACT DC intervention of guideline-based clinical care, education, and short-term care coordination.
Поведенческий: Parental stress management
The intervention for this study is a multi-dimensional stress management program designed to be responsive to parent and other stakeholder preferences. The intervention will have two separate yet coordinated components: one-on-one stress management sessions and peer group sessions led by "community wellness coaches."

Что измеряет исследование?

Первичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Symptom-free Days in the Last 14 Days
Временное ограничение: Repeated Measures at 6 months (3 month data collected to allow for repeated measures)
Symptom-free days are defined as a 24-hour period with no coughing, wheezing, chest tightness, or shortness of breath and no need for rescue medications
Repeated Measures at 6 months (3 month data collected to allow for repeated measures)

Вторичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Asthma Morbidity - Nighttime Asthma Symptoms
Временное ограничение: Repeated Measures at 6 and 12 months (3m data collected for repeated measures)
Nights of asthma symptoms in prior 14d
Repeated Measures at 6 and 12 months (3m data collected for repeated measures)
Asthma Severity and Control
Временное ограничение: Repeated Measures at 3, 6, and 12 months
Repeated Measures at 3, 6, and 12 months
Asthma Medication Adherence
Временное ограничение: Repeated Measures at 6 and 12 months (3m data collected for repeated measures)
Reported use of inhaled corticosteroids and LTRA in past two days
Repeated Measures at 6 and 12 months (3m data collected for repeated measures)
Health Care Utilization - Emergency Department Visits for Asthma
Временное ограничение: 12 months after enrollment
Health care utilization - emergency department visits for asthma over six month and twelve month follow up periods. Reported as those documented in the electronic medical record of Children's National Health System plus parent report of visits elsewhere
12 months after enrollment
Asthma Exacerbations - Courses of Systemic Steroids
Временное ограничение: Assessed at 6m and 12m following enrollment
Courses of systemic steroids over 12m follow up period
Assessed at 6m and 12m following enrollment
Parental Stress
Временное ограничение: Repeated Measures at 6 and 12 months (3m data collected for repeated measures)
Score on Perceived Stress Scale (PSS). The Perceived Stress Scale consists of 10 questions and is a measure of the degree to which situations in one's life are appraised as stressful. Scores range from 0 - 40, with higher scores indicating a higher level of perceived stress.
Repeated Measures at 6 and 12 months (3m data collected for repeated measures)
Parental Depression
Временное ограничение: Repeated Measures at 6 and 12 months (3m data collected for repeated measures)
Score on Center for Epidemiologic Studies Depression Scale (CES-D - 10). The CESD-10 scale screens for depressive symptoms. Scores range from 0-30, with higher scores indicating a higher degree of depressive symptoms.
Repeated Measures at 6 and 12 months (3m data collected for repeated measures)
Child Anxiety
Временное ограничение: Repeated Measures at 6 and 12 months (3m data collected for repeated measures)
PROMIS Parent Proxy Anxiety. For PROMIS instruments, T-scores rescale the raw score into a standardized score with a mean of 50 and a standard deviation of 10. A higher T-score represents higher anxiety and/or depression.
Repeated Measures at 6 and 12 months (3m data collected for repeated measures)
Child Depression
Временное ограничение: Repeated Measures at 6 and 12 months (3m data collected for repeated measures)
PROMIS Parent Proxy Depressive Symptoms is a parent-report assessment of child depression. For PROMIS instruments, T-scores rescale the raw score into a standardized score with a mean of 50 and a standard deviation of 10. A higher T-score represents higher anxiety and/or depression.
Repeated Measures at 6 and 12 months (3m data collected for repeated measures)
Caregiver Quality of Life
Временное ограничение: Repeated Measures at 6 and 12 months (3m data collected for repeated measures)
Caregiver quality of life score, assessed by modified Pediatric Asthma Caregiver Quality of Life Questionnaire (PACQLQ). The measure had five response options, with scores ranging from 13-65 and higher scores meaning better quality of life. No subscales were analyzed.
Repeated Measures at 6 and 12 months (3m data collected for repeated measures)
Number of Participants With AEs and SAEs
Временное ограничение: 12m follow up period
Safety data: Number of Participants with AEs and SAEs
12m follow up period
Economic Outcomes
Временное ограничение: 12m follow-up period
Analysis of costs of care in both groups
12m follow-up period
Caregiver Smoking Behavior
Временное ограничение: Repeated Measures at 6 and 12 months
parent report of cigarettes smoked per day
Repeated Measures at 6 and 12 months
Coping Strategies
Временное ограничение: Repeated measures at 12m FU (6m data used for repeated measures)
Brief COPE
Repeated measures at 12m FU (6m data used for repeated measures)
Mindfulness
Временное ограничение: Repeated Measures at 6 and 12 months
Interpersonal Mindfulness in Parenting
Repeated Measures at 6 and 12 months
Parental Resilience
Временное ограничение: Repeated Measures at 6 and 12 months
Parental resilience assessed by score on Revised Life Orientation Test (LOT-R) measure. The LOT-R assesses optimism/resilience, and is comprised of 10 questions. Scores range from 0-40, with a higher score indicating a higher level of optimism.
Repeated Measures at 6 and 12 months
Exacerbations - Hospital Admissions
Временное ограничение: Assessed at 6m and 12m after enrollment
Number of participants with hospital admissions due to exacerbations
Assessed at 6m and 12m after enrollment
Symptom-free Days in the Last 14 Days
Временное ограничение: Repeated Measures at 12 months (with data also assessed at 3m and 6m)
Symptom-free days are defined as a 24-hour period with no coughing, wheezing, chest tightness, or shortness of breath and no need for rescue medications
Repeated Measures at 12 months (with data also assessed at 3m and 6m)
Asthma Morbidity - Daytime Asthma Symptoms, Days of Activity Limitations, and Days of Quick Relief Medicine Use
Временное ограничение: Repeated measures at 6 and 12 months (3m data collected for repeated measures)
Days of asthma symptoms, activity limitation, and quick relief medicine use in prior 14d
Repeated measures at 6 and 12 months (3m data collected for repeated measures)

Другие показатели результатов

Мера результата
Мера Описание
Временное ограничение
Sociodemographics
Временное ограничение: Baseline
Age, gender, race, ethnicity, insurance type, parental education, household income, family medical history
Baseline
Number of Participants With Positive Smoke Exposure
Временное ограничение: Repeated Measures at 6 and 12 months (3m data collected for repeated measures)
Participants with environmental smoke exposure. Responses were regrouped as negative (none) or positive (daily, often, or rarely) based on two questions: "How often did anyone smoke inside the home where child usually lives?" or "How often did anyone smoke in the room where child usually sleeps?" A positive response on either or both questions was considered positive exposure.
Repeated Measures at 6 and 12 months (3m data collected for repeated measures)
Parental Health Literacy
Временное ограничение: Baseline
Single Item Literacy Screener (SILS)
Baseline
Use of Existing Ancillary Services
Временное ограничение: Assessed at 6m and 12m following enrollment
Assessed at 6m and 12m following enrollment
Parental Resilience
Временное ограничение: Baseline
Parental resilience assessed by score on Revised Life Orientation Test (LOT-R) measure. The LOT-R assesses optimism/resilience, and is comprised of 10 questions. Scores range from 0-40, with a higher score indicating a higher level of optimism.
Baseline
Intervention Component Uptake
Временное ограничение: 6 month intervention period
Completion of intervention sessions
6 month intervention period
Intervention Satisfaction
Временное ограничение: 6 month intervention period
Brief survey of satisfaction with intervention components.
6 month intervention period
Intervention Fidelity
Временное ограничение: 6 month intervention period
Checklist of staff's fidelity to individual components of intervention protocol
6 month intervention period

Соавторы и исследователи

Здесь вы найдете людей и организации, участвующие в этом исследовании.

Спонсор

Stephen J. Teach, MD, MPH

Соавторы

Patient-Centered Outcomes Research Institute

Следователи

  • Главный следователь: Stephen Teach, MD, MPH, Children's National Health System

Публикации и полезные ссылки

Лицо, ответственное за внесение сведений об исследовании, добровольно предоставляет эти публикации. Это может быть что угодно, связанное с исследованием.

Общие публикации

Даты записи исследования

Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.

Изучение основных дат

Начало исследования (Действительный)

1 мая 2015 г.

Первичное завершение (Действительный)

1 ноября 2016 г.

Завершение исследования (Действительный)

1 мая 2017 г.

Даты регистрации исследования

Первый отправленный

10 февраля 2015 г.

Впервые представлено, что соответствует критериям контроля качества

26 февраля 2015 г.

Первый опубликованный (Оценивать)

27 февраля 2015 г.

Обновления учебных записей

Последнее опубликованное обновление (Действительный)

23 сентября 2019 г.

Последнее отправленное обновление, отвечающее критериям контроля качества

22 августа 2019 г.

Последняя проверка

1 августа 2019 г.

Дополнительная информация

Термины, связанные с этим исследованием

Ключевые слова

Дополнительные соответствующие термины MeSH

Другие идентификационные номера исследования

  • 5819

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. .

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