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ASMA Self-Management for Asthma
N/A
Waitlist Available
Led By Jean-Marie Bruzzese, PhD
Research Sponsored by Columbia University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Adolescents who are at least 13.0 at the time of consent
Teenager reports having a prior asthma diagnosis, and in the last 12 months has: (a) used prescribed asthma medication and (b) uncontrolled asthma, defined as: (i) symptoms 3+ days a week; (ii) night awakenings 3+ nights per month; (iii) 2+ ED visits; or (iv) 1+ hospitalization for asthma
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 1 year
Awards & highlights
Study Summary
This trial will test an asthma self-management intervention to see if it improves asthma in rural high school students with uncontrolled asthma. The investigators will also test the cost-effectiveness of the intervention and examine barriers and facilitators to its widespread implementation.
Who is the study for?
This trial is for rural high school students aged at least 13 who speak English, have been diagnosed with asthma, and show signs of uncontrolled asthma like frequent symptoms or emergency visits. It's not for those with other diseases affecting lung function.Check my eligibility
What is being tested?
The study tests 'Asthma Self-Management for Adolescents (ASMA)', an 8-week program in schools by Community Health Workers to see if it helps manage asthma better. The cost-effectiveness and implementation barriers will also be evaluated.See study design
What are the potential side effects?
Since ASMA is a non-medical intervention focusing on self-management education rather than drugs, no direct side effects are expected from the program itself.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 13 years old or older.
Select...
I am a teenager with asthma, using medication, and have had frequent symptoms or hospital visits.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of days with asthma-related activity limitations
Number of night awakenings due to asthma symptoms
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Asthma Self-Management for AdolescentsExperimental Treatment1 Intervention
Asthma Self-Management for Adolescents (ASMA) consists of three complementary components: (1) an 8- week intervention for students; (2) caregiver education; and (3) education for students' medical providers.
Group II: Attention ControlActive Control1 Intervention
In 3 group sessions and 5 one-on-one sessions, held at school during the school day, students will receive information about asthma and other health topics relevant to adolescents (e.g., nutrition, safety). They will learn to monitor their health by using diaries to record behaviors, such as what they eat, and/or their sleep patterns. Students will be referred to their medical providers for asthma and other health concerns; if they do not have a provider, they are given referrals in their community.
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Who is running the clinical trial?
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,833 Previous Clinical Trials
47,306,137 Total Patients Enrolled
276 Trials studying Asthma
112,192 Patients Enrolled for Asthma
NYU Langone HealthOTHER
1,367 Previous Clinical Trials
839,402 Total Patients Enrolled
10 Trials studying Asthma
3,251 Patients Enrolled for Asthma
Columbia UniversityLead Sponsor
1,431 Previous Clinical Trials
2,460,472 Total Patients Enrolled
20 Trials studying Asthma
4,760 Patients Enrolled for Asthma
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have other health conditions that affect my lungs.I am 13 years old or older.I am a teenager who speaks and understands English well.I am a teenager with asthma, using medication, and have had frequent symptoms or hospital visits.
Research Study Groups:
This trial has the following groups:- Group 1: Attention Control
- Group 2: Asthma Self-Management for Adolescents
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there still opportunities for individuals to participate in this clinical experiment?
"The clinical trial hosted on clinicaltrials.gov is not presently searching for participants, as the investigation was last updated in October of 2022. Nevertheless, there are still 322 medical studies actively recruiting enrollees at present."
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