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Behavioral Intervention
TASC Intervention for Asthma (TASC Trial)
N/A
Recruiting
Led By Rachelle R Ramsey, PhD
Research Sponsored by Children's Hospital Medical Center, Cincinnati
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patient age between 12-18 years
Patient is diagnosed with severe-persistent or moderate-persistent asthma per NAEPP asthma guidelines
Must not have
Active chronic disease apart from asthma or allergic disease (e.g. Bronchiectasis, pulmonary hypertension, and moderate or severe tracheomalacia)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights
Summary
This trial is testing a new intervention to help people with asthma better follow their treatment plan.
Who is the study for?
This trial is for adolescents aged 12-18 with moderate to severe persistent asthma, as defined by NAEPP guidelines. They must be on daily inhaled medication and fluent in English. It's not suitable for those with developmental disorders, other chronic diseases besides asthma or allergic disease, serious mental illness, cognitive deficits, or who receive school-administered daily controller medication.Check my eligibility
What is being tested?
The study is examining the effectiveness of a Technology-Assisted Stepped Care (TASC) intervention aimed at improving medication adherence among teenagers with asthma. Participants will either receive this new TASC intervention or continue with their usual treatment plan.See study design
What are the potential side effects?
Since the TASC intervention involves technology-assisted care rather than medications, traditional side effects are not expected. However, there may be indirect effects related to changes in treatment adherence that could affect asthma control.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 12 and 18 years old.
Select...
My asthma is diagnosed as severe or moderate persistent.
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I use daily asthma medication, including inhaled steroids and a long-acting bronchodilator.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I do not have chronic diseases except for asthma or allergies.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Inhaler Adherence Electronic Monitoring
Secondary outcome measures
Asthma Control Test (ACT)
Asthma Severity Score via TreatSmart
Attendance/Participation rates
+13 moreOther outcome measures
Adolescent Medication Barriers Scale (AMBS)
Asthma Responsibility Questionnaire (ARQ)
Behavioral Assessment (BASC-3)
+7 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: TASC InterventionExperimental Treatment1 Intervention
Step 1 of the intervention includes educational materials related to asthma. Step 2 includes electronic monitoring of adherence and a text messaging intervention personally tailored to the participant. Step 3 includes problem solving telehealth sessions with a trained clinician.
Group II: Treatment as UsualActive Control1 Intervention
Participants will not receive any intervention.
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Who is running the clinical trial?
Children's Hospital Medical Center, CincinnatiLead Sponsor
816 Previous Clinical Trials
6,575,098 Total Patients Enrolled
16 Trials studying Asthma
2,816 Patients Enrolled for Asthma
Rachelle R Ramsey, PhDPrincipal InvestigatorChildren's Hospital Medical Center, Cincinnati
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am between 12 and 18 years old.My asthma is diagnosed as severe or moderate persistent.You have been diagnosed with a pervasive developmental disorder.I do not have chronic diseases except for asthma or allergies.You have a serious mental illness like schizophrenia.You have trouble understanding things because of memory or thinking problems.I use daily asthma medication, including inhaled steroids and a long-acting bronchodilator.
Research Study Groups:
This trial has the following groups:- Group 1: TASC Intervention
- Group 2: Treatment as Usual
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.
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