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CAMP Air: эффективность и экономичность для городских подростков

17 сентября 2026 г. обновлено: Jean-Marie Bruzzese, Columbia University

Эффективность CAMP Air, интернет-вмешательства против астмы, среди городских подростков с неконтролируемой астмой

This study will test the efficacy and cost-effectiveness of Controlling Asthma Program for Adolescents (CAMP Air), an e-health intervention, among urban predominately Black and Hispanic adolescents with uncontrolled asthma. It will also examine barriers and facilitators to adoption and implementation of CAMP Air in high-schools.

Обзор исследования

Статус

Завершенный

Условия

Вмешательство/лечение

Подробное описание

Asthma prevalence and morbidity are high among adolescents, especially among Black and Hispanic youth. Yet, few interventions have been tested in adolescents. Despite the important role that technology plays in the lives of adolescents, only one intervention for adolescents with asthma is web-based. Additionally, research informing the scale-up of asthma interventions as well as their cost-effectiveness are scant. This study aims to address these treatment and methodological gaps by (1) systematically evaluating the efficacy of Controlling Asthma Program for Adolescents (CAMP Air), an e-health intervention, in urban adolescents with uncontrolled asthma; (2) assessing CAMP Air's cost-effectiveness; and (3) identifying multi-level factors associated with successful implementation of CAMP Air to inform its future scale-up. Due to COVID, at the start of the study, the spirometry data will not be collected from the participants (Secondary Outcomes 7 - 9).

The investigators plan to interview adolescents as the primary respondent for all outcomes.

Caregivers and school personnel are invited to be interviewed.

Тип исследования

Интервенционный

Регистрация (Действительный)

374

Фаза

  • Непригодный

Контакты и местонахождение

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

Места учебы

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 13 лет до 17 лет (Ребенок)

Принимает здоровых добровольцев

Нет

Полы, имеющие право на обучение

Все

Описание

Inclusion Criteria: Adolescents must report

  • A prior diagnosis of asthma;
  • Asthma medication use in the last 12 months; and
  • Symptoms consistent with uncontrolled asthma, defined as: in the last month (a) daytime symptoms 3+ days a week, (b) night awakenings 3+ nights per month, or (c) activity limitations 3+ days per week; OR in the last 12 months (d) 2+ unscheduled visits to a clinic or medical provider because having asthma symptoms, (e) 2+ ED visits; (f) 1+ hospitalization for asthma, or (g) taken oral or systemic steroids in the past year.

Exclusion Criteria:

  • Pregnant teenagers due to the stress of adolescent pregnancy and hormonal changes of pregnancy that could change asthma control;
  • Students enrolled in 12th grade because those randomized to the control group will not be in the school the following school year to receive CAMP Air;
  • Teenagers with a co-morbid disease or condition that might affect lung function, such as cystic fibrosis or sickle cell anemia; and
  • Teenagers with highly specialized learning needs (e.g., Down's syndrome, mental retardation, severe ADHD) which may preclude completion of the intervention or assessments.

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
Экспериментальный: CAMP Air

This is an e-health intervention consisting of 7 online modules. This behavioral intervention combines instruction, hands-on learning, interactive practice opportunities and tailored sessions. Teens learn about asthma, including treatment and triggers, the importance of seeing a medical provider and how they can overcome their specific barriers to seeing a medical provider, how they can talk to their parents about their asthma, and how they can care for their asthma, including managing stress and triggers. They also receive personalized feedback throughout the intervention and guidance on navigating the health care system.

Controlling Asthma Program for Adolescents (CAMP Air) is an e-health intervention grounded in social cognitive theory and motivational interviewing to guide teens through asthma self-care and how to navigate the health care system. It makes use of various interactive and personalized approaches.

Другие имена:
  • КЭМП Эйр
Активный компаратор: Attention Control Asthma Education Intervention

The control intervention consists of 7 online sessions delivered via PowerPoint slides with voice-over. Teens receive information on asthma and other related health conditions, such as stress and sleep, and will be given a list of relevant websites to learn more about these topics. They will learn how to monitor their health using checklists and will be referred to a medical provider for asthma and other conditions; if they do have a medical provider, they will be provided with a referral. The asthma education component for this group lacks the interactive and personalized elements of CAMP Air, differentiating it from the experimental arm.

Using Asthma Plus, an asthma education program, teens learn about asthma and other conditions relevant to asthma and adolescents.

Другие имена:
  • Астма Плюс

Что измеряет исследование?

Первичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Mean score on the Asthma Control Questionnaire (ACQ-5)
Временное ограничение: Up to 1 year

This measure, which is completed by the adolescents, assesses the adolescent's level of asthma control over the past week using 5-item version. The overall score is the mean of all questions; range = 0 - 6; lower scores indicate better control.

Up to 1 year
Total number of asthma-related urgent care visits
Временное ограничение: Up to 1 year

This measure assesses the adolescent's number of asthma-related visits to a medical provider for urgent or immediate treatment, emergency room visits, and hospitalizations over 3 months. Completed by adolescents. Higher counts indicate more urgent health care utilization.

Up to 1 year

Вторичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Mean score on the Asthma Symptom Prevention Index
Временное ограничение: Up to 1 year

This measure assesses the number of steps adolescents take to prevent the onset of symptoms. Completed by the adolescents. Score range = 0 - 9; higher scores indicate better asthma self-care.

Up to 1 year
Mean score on the Asthma Management Index
Временное ограничение: Up to 1 year

This measure assesses the number of steps adolescents take to care for symptoms once they start. Completed by the adolescents. Score range = 0 - 7; higher scores indicate better asthma self-care.

Up to 1 year
Mean score on the Asthma Management Self-efficacy Index
Временное ограничение: Up to 1 year

This measure assesses the confidence adolescents have in caring for their asthma. Completed by adolescents. Score range = 0 - 7; higher scores indicate better asthma management self-efficacy.

Up to 1 year
Proportion of adolescents taking controller medication
Временное ограничение: Up to 1 year

Adolescents report the names of asthma medication they take, which will used to determine if controller medications are currently used.

Up to 1 year
Lung function - Overall functioning (Absolute ratio)
Временное ограничение: Up to 1 year

The investigator will use spirometry to assess how well adolescents' lungs work. Spirometry is a test that measures how much air people can hold in their lungs as well as how much air they can exhale, or blow out, and how fast they can blow it out. The investigator will calculate the FEV1/FVC ratio, which is a proportion of how much air a person can exhale from the lung in the first second relative to the total amount of air that comes out during a full exhale. Forced expiratory volume (FEV) is the amount of air exhaled from the lung in one second and forced vital capacity (FVC) is the total amount of air that comes out during a full exhale. A ratio of 0.75 indicates the lungs are working well.

Up to 1 year
Lung Function - Obstruction to airflow (Maximum mid-expiratory flow rate)
Временное ограничение: Up to 1 year

The investigators will use spirometry to assess how well air is flowing out of the smaller airways of the lungs via FEF25%-75%, or the maximum mid-expiratory flow rate. Forced expiratory flow (FEF) is the speed at which air comes out of the lungs during the middle portion of a person's full exhale. FEF25-75% is the average speed at which air flows out of the lungs from the moment a person has exhaled 25% of their full breathe to the moment they have exhaled 75% of their full breathe; it is expressed as a percentage. FEF25-75% values of more than 60% suggest normal airflow.

Up to 1 year
Lung function - Severity of impairment (FEV1% predicted)
Временное ограничение: Up to 1 year

The investigators will use spirometry to assess how difficult it is for the adolescent's lungs to work when there is any indication that the lungs are not working properly. This will be measured as FEV1% predicted (FEV1% pred), and will be calculated by dividing the FEV1% of the adolescent by the average FEV1% in the population of adolescents with similar characteristics, such as age and sex. FEV1% is the FEV1/FVC absolute ratio expressed as a percentage. FEV1 is the amount of air exhaled from the lung in one second and FVC is the total amount of air that comes out during a full exhale. FEV1% pred values of 69 or less indicate moderate to severe difficulties in lung functioning; values of 70 or greater indicate mild difficulties in lung functioning.

Up to 1 year
Mean score on the Paediatric Asthma Quality of Life Questionnaire
Временное ограничение: Up to 1 year

Adolescents complete the Paediatric Asthma Quality of Life Questionnaire, which measures how they have felt in the past week because of their asthma. Comprised of 3 sub scales, which are combined for an overall mean score ranging from 1 - 7; higher scores indicate better pediatric asthma quality of life.

Up to 1 year
Total number of oral steroid bursts
Временное ограничение: Up to 1 year

Using the list of medications obtained from adolescents, the investigator will determine if there is use of oral steroids. If so, adolescents will also be asked how many times those medications were used over a period of 5 to 7 days in 3 months. Oral steroids are medications used to reduce acute inflammation and swelling in the lungs when other asthma medications are not working. A burst refers to a single period of 5 to 7 days in which a person takes oral steroids.

Up to 1 year
Total number of days with asthma symptoms
Временное ограничение: Up to 1 year

Adolescents report the number of days they had asthma symptoms over the last 2 weeks.

Up to 1 year
Total number of nights woken due to asthma
Временное ограничение: Up to 1 year

Adolescents report on how many nights asthma symptoms disrupted sleep or caused wakening over 2 weeks.

Up to 1 year
Total number of days with activity limitations due to asthma
Временное ограничение: Up to 1 year

Adolescents report on the number of days usual activities could not be carried out over 2 weeks due to asthma.

Up to 1 year
Total number of school absences due to asthma
Временное ограничение: Up to 1 year

Adolescents report on the number of days school was missed due to asthma over 2 weeks.

Up to 1 year
Frequency of school absences due to asthma
Временное ограничение: Up to 1 year

Adolescents reporting any school absences due to asthma in the last 2 weeks will also be asked how typical this attendance was over 3 months.

Up to 1 year
Total number of school absences
Временное ограничение: Up to 1 year

The investigators will compute adolescents' total number of school absences, regardless of the reason, from attendance records obtained from each school.

Up to 1 year

Соавторы и исследователи

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

Спонсор

Соавторы

Следователи

  • Главный следователь: Jean-Marie Bruzzese, PhD, Columbia University

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)

8 ноября 2021 г.

Первичное завершение (Действительный)

12 мая 2026 г.

Завершение исследования (Действительный)

12 мая 2026 г.

Даты регистрации исследования

Первый отправленный

12 октября 2021 г.

Впервые представлено, что соответствует критериям контроля качества

12 октября 2021 г.

Первый опубликованный (Действительный)

25 октября 2021 г.

Обновления учебных записей

Последнее опубликованное обновление (Действительный)

21 сентября 2026 г.

Последнее отправленное обновление, отвечающее критериям контроля качества

17 сентября 2026 г.

Последняя проверка

1 сентября 2026 г.

Дополнительная информация

Термины, связанные с этим исследованием

Другие идентификационные номера исследования

  • AAAT2274
  • 1R61HL151958-01A1 (Грант/контракт NIH США)

Планирование данных отдельных участников (IPD)

Планируете делиться данными об отдельных участниках (IPD)?

ДА

Описание плана IPD

The 3-C Institute will house the web-based intervention on their server, and conduct all data management activities for the study. Data stored electronically and shared between sites will be de-identified by HIPAA standards using the "safe-harbor" method (i.e., all 18 identifiers will be stripped) whenever possible, otherwise it will be sent encrypted. Data will be stored on a password-protected webserver.

Сроки обмена IPD

Up to 7 years from the end of the study

Критерии совместного доступа к IPD

De-identified

Совместное использование IPD Поддерживающий тип информации

  • STUDY_PROTOCOL
  • САП
  • АНАЛИТИЧЕСКИЙ_КОД

Информация о лекарствах и устройствах, исследовательские документы

Изучает лекарственный продукт, регулируемый FDA США.

Нет

Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.

Нет

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. .