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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

No Placebo-Only Group

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.

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.

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 below

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I am between 12 and 18 years old.

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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:

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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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Inhaler Adherence Electronic Monitoring

Secondary study objectives

Asthma Control Test (ACT)

Asthma Severity Score via TreatSmart

Attendance/Participation rates

+13 more

Other study objectives

Adolescent Medication Barriers Scale (AMBS)

Asthma Responsibility Questionnaire (ARQ)

Behavioral Assessment (BASC-3)

+7 more

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: 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.

0 / 4Eligibility criteria met