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CAMP Air: skuteczność i opłacalność u młodzieży miejskiej

17 września 2026 zaktualizowane przez: Jean-Marie Bruzzese, Columbia University

Skuteczność CAMP Air, internetowej interwencji przeciwko astmie, wśród młodzieży z miast z niekontrolowaną astmą

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.

Przegląd badań

Status

Zakończony

Warunki

Interwencja / Leczenie

Szczegółowy opis

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.

Typ studiów

Interwencyjne

Zapisy (Rzeczywisty)

374

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

    • New York
      • New York, New York, Stany Zjednoczone, 10032
        • High schools in the 5 boroughs of New York City

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

13 lat do 17 lat (Dziecko)

Akceptuje zdrowych ochotników

Nie

Płeć kwalifikująca się do nauki

Wszystko

Opis

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.

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Pojedynczy

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: 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.

Inne nazwy:
  • OBÓZ Powietrze
Aktywny komparator: 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.

Inne nazwy:
  • Astma Plus

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Mean score on the Asthma Control Questionnaire (ACQ-5)
Ramy czasowe: 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
Ramy czasowe: 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

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Mean score on the Asthma Symptom Prevention Index
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Współpracownicy

Śledczy

  • Główny śledczy: Jean-Marie Bruzzese, PhD, Columbia University

Publikacje i pomocne linki

Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.

Publikacje ogólne

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

8 listopada 2021

Zakończenie podstawowe (Rzeczywisty)

12 maja 2026

Ukończenie studiów (Rzeczywisty)

12 maja 2026

Daty rejestracji na studia

Pierwszy przesłany

12 października 2021

Pierwszy przesłany, który spełnia kryteria kontroli jakości

12 października 2021

Pierwszy wysłany (Rzeczywisty)

25 października 2021

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

21 września 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

17 września 2026

Ostatnia weryfikacja

1 września 2026

Więcej informacji

Terminy związane z tym badaniem

Inne numery identyfikacyjne badania

  • AAAT2274
  • 1R61HL151958-01A1 (Grant/umowa NIH USA)

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

TAK

Opis planu 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.

Ramy czasowe udostępniania IPD

Up to 7 years from the end of the study

Kryteria dostępu do udostępniania IPD

De-identified

Typ informacji pomocniczych dotyczących udostępniania IPD

  • PROTOKÓŁ BADANIA
  • SOK ROŚLINNY
  • ANALITYCZNY_KOD

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .