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Smartphone Application for Asthma Management
N/A
Recruiting
Led By Amy Alman, PhD
Research Sponsored by University of South Florida
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Established mild, moderate, or severe persistent asthma with a diagnosis verified by clinic physicians
At least 12 and less than 18 years at enrollment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing a smartphone app designed to help manage asthma, specifically in adolescents. They will be measuring how well the app works, how often it is used, and how accepted it is.
Who is the study for?
This trial is for English-speaking adolescents aged 12-17 with mild to severe persistent asthma, who own an iPhone or Android device. They must be diagnosed by clinic physicians and live in the Tampa Bay area during the trial. It's not for those with other chronic lung diseases, certain disorders like cystic fibrosis, vision impairments that affect app use, mental or developmental disorders impacting self-management, or those involved in the app's development.
What is being tested?
The study tests a smartphone application designed to help teenagers manage their asthma better alongside standard care. Participants will either receive standard care alone or with the addition of this new app. The trial measures how well participants can stick to using the app and its impact on managing their asthma over six months.
What are the potential side effects?
Since this intervention involves a smartphone application rather than medication, traditional side effects are not applicable. However, users may experience technical issues or find it challenging to engage consistently with the app features.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My asthma is persistent and has been confirmed by a doctor.
Select...
I am between 12 and 17 years old.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Adherence to app reminders (proportion of app reminders)
Average app usage per day
Mean overall usability score obtained from the Health-ITUES
+3 moreSecondary study objectives
Change in ACT score from baseline to the 6-month end point
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Asthma SMARTExperimental Treatment1 Intervention
Subjects randomized to the intervention arm will be provided with the app to download to their personal iPhone or Android smartphone. Subjects will be asked to use the app every day for 6 months.
Group II: Standard of careActive Control1 Intervention
Subjects randomized to the standard-of-care arm will continue to receive regular care for their condition.
Find a Location
Who is running the clinical trial?
University of South FloridaLead Sponsor
427 Previous Clinical Trials
192,581 Total Patients Enrolled
9 Trials studying Asthma
633 Patients Enrolled for Asthma
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,944 Previous Clinical Trials
47,799,782 Total Patients Enrolled
282 Trials studying Asthma
114,373 Patients Enrolled for Asthma
Amy Alman, PhDPrincipal InvestigatorUniversity of South Florida
Marisa Couluris, DOPrincipal InvestigatorUniversity of South Florida
4 Previous Clinical Trials
29 Total Patients Enrolled
Paul Rosen, PhDPrincipal InvestigatorUniversity of Utah
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My asthma is persistent and has been confirmed by a doctor.I have a chronic lung disease or a condition like cystic fibrosis, neuromuscular disease, an immune system disorder, or severe vision problems that could make it hard for me to use a mobile app.I am between 12 and 17 years old.You have a mental or developmental disorder that makes it hard for you to take care of a long-term health condition.
Research Study Groups:
This trial has the following groups:- Group 1: Asthma SMART
- Group 2: Standard of care
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.