BREATHE-Peds Pilot- II III Trial and Post Trial
- Conditions
- Asthma in Children
- Registration Number
- NCT05832437
- Lead Sponsor
- Columbia University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria (Dyad participants):<br><br>Dyad (caregiver/child) participants will<br><br> 1. Early adolescents (10-14 years of age) or the caregiver of early adolescents (10-14<br> years of age)<br><br> 2. Have or the caregiver of a child that has clinician-diagnosed persistent asthma<br> (defined as being prescribed inhaled corticosteroids in the last 12 months)<br><br> 3. Receive asthma care at a partner FQHC and<br><br> 4. Child screens positive for uncontrolled asthma as measured by the Asthma Control<br> Questionnaire- 6 items (ACQ-6) and child or caregiver has erroneous beliefs as<br> measured by the Conventional and Alternative Management for Asthma (CAM-A) survey.<br><br>Inclusion Criterion (clinicians):<br><br> 1. Those who manage a panel of pediatric asthma patients at partner FQHC.<br><br>Exclusion Criteria (Dyad participants):<br><br> 1. Non-English speaking<br><br> 2. Serious mental health conditions that preclude completion of study procedures or<br> confound analyses or participation in a listening session
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Mean Asthma Control Questionnaire Score
- Secondary Outcome Measures
Name Time Method Mean Shared Decision Making-Questionnaire-9 Score;Mean Medication Adherence Report Scale - Asthma Score;Mean Asthma Quality of Life Questionnaire Score;Mean Asthma Impairment and Risk Questionnaire Score