AIM2ACT
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StatusAccepting Candidates
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Age12 Years - 70 Years
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SexesAll
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Healthy VolunteersNo
Objective
The aim is to test the efficacy of AIM2ACT and long-term maintenance of treatment effects in a fully-powered randomized controlled trial with 160 early adolescents with poorly controlled persistent asthma, ages 12-15 years, and a caregiver
Details
Full study title | AIM2ACT: Applying Interactive Mobile Health to Asthma Care in Teens A Randomized Control Trial |
Protocol number | OCR40368 |
ClinicalTrials.gov ID | NCT04448002 |
Phase | N/A |
Eligibility
Inclusion criteria are:
Adolescent is 12-15 years old
Caregiver is between 18-70 years-old
Adolescent lives in the residence of caregiver
Adolescent and caregiver can speak and read English
(a) Adolescent has been diagnosed as having asthma, OR (b) Doctor has stated the adolescent has asthma, OR (c) Adolescent has had breathing problems in the past 12 months
Adolescent has had an active inhaled corticosteroid prescription for ≥ 4 weeks
(a) During the past 14 days (that is, during the past fourteen 24-hour periods that include daytime and nighttime), the adolescent has experienced one or more of the
Following: (i) Asthma symptoms such as wheezing, shortness of breath, or tightness in
the chest, or cough on more than 4 separate days; (ii) Woken up because of asthma
symptoms such as wheezing, shortness of breath, or tightness in the chest, or cough on
1 or more separate nights; (iii) Had to slow down or stop play or usual activities or
missed school because of asthma, wheezing, or tightness in the chest, or cough on more
than 4 separate days; (iv) Used any asthma rescue medicine (sometimes called a quick
relief medicine) on more than 4 separate days
OR (b) In the past year, adolescent has had one or more of the following: (i) 2 or more exacerbations requiring oral systemic corticosteroids; (ii) 2 or more emergency department visits; (iii) 1 hospitalization; (iv) 2 or more urgent medical care visits due to asthma
OR (c) Adolescent scores 19 or lower on the Asthma Control Test
Exclusion criteria are -
Families will be excluded if:
The family is currently involved in an asthma management intervention above and beyond usual care, OR
Adolescent is unable to complete study procedures independently.
Lead researcher
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David Fedele, PhD, ABPPPsychologist
Participate in a study
Here are some general steps to consider when participating in a research study:
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Step1
Contact the research team
Call or email the research team listed within the specific clinical trial or study to let them know that you're interested. A member of the research team, such as the researcher or study coordinator, will be available to tell you more about the study and to answer any questions or concerns you may have.
Primary contact
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Step2
Get screened to confirm eligibility
You may be asked to take part in prescreening to make sure you are eligible for a study. The prescreening process ensures it is safe for you to participate. During the prescreening process, you will be asked some questions and you may also be asked to schedule tests or procedures to confirm your eligibility.
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Step3
Provide your consent to participate
If you are eligible and want to join the clinical trial or study, a member of the research team will ask for your consent to participate. To give consent, you will be asked to read and sign a consent form for the study. This consent form explains the study's purpose, procedures, risks, benefits and provides other important information, such as the study team's contact information.
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Step4
Participate
If you decide to participate in a clinical trial or study, the research team will keep you informed of the study requirements and what you will need to do to throughout the study. For some trials or studies, your health care provider may work with the research team to ensure there are no conflicts with other medications or treatments.