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BREATHE-Peds intervention for Childhood Asthma
N/A
Recruiting
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
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 months post intervention
Awards & highlights
Study Summary
This trial will develop & test a decision-making tool to improve asthma self-management among minority early adolescents in urban health centers. Phase II & III involve a randomized trial.
Who is the study for?
This trial is for early adolescents aged 10-14 with clinician-diagnosed persistent asthma and their caregivers. Participants must be receiving care at a partner FQHC, have uncontrolled asthma as indicated by the ACQ-6, and hold certain beliefs about asthma management.Check my eligibility
What is being tested?
The BREATHE-Peds study is testing a shared decision-making intervention aimed at improving self-management of asthma in minority youths. The pilot phase involves focus groups to develop the intervention, followed by a randomized controlled trial to test its effectiveness.See study design
What are the potential side effects?
Since this trial focuses on an educational intervention rather than medication or medical procedures, there are no direct side effects associated with typical drug trials. However, participants may experience changes in how they manage their asthma.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 3 months post intervention
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 months post intervention
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Mean Asthma Control Questionnaire Score
Secondary outcome measures
Mean Asthma Impairment and Risk Questionnaire Score
Mean Asthma Quality of Life Questionnaire Score
Mean Medication Adherence Report Scale - Asthma Score
+1 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: BREATHE-Peds interventionExperimental Treatment1 Intervention
The patient's primary care provider (PCP) will deliver a brief intervention using motivational interviewing and shared decision making, in a one time 9-minute intervention integrated into an office visit for asthma. PCPs will follow a 4-step script tailored to erroneous asthma and inhaled corticosteroid (ICS) beliefs, as well as ACQ score, measured just prior to the office visit. PCPs will follow a 4-step script tailored to erroneous asthma and inhaled corticosteroid (ICS) beliefs, as well as ACQ score, measured just prior to the office visit.
Group II: Control InterventionActive Control1 Intervention
The patient's primary care provider (PCP) will deliver a 9-minute scripted intervention on credible nutrition and lifestyle information. The control intervention is designed to not be specific enough to change strategies related to asthma control.
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Who is running the clinical trial?
Columbia UniversityLead Sponsor
1,433 Previous Clinical Trials
2,446,959 Total Patients Enrolled
National Institute of Nursing Research (NINR)NIH
580 Previous Clinical Trials
10,376,261 Total Patients Enrolled
Jean-Marie Bruzzese, PhDPrincipal InvestigatorColumbia University
6 Previous Clinical Trials
1,650 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I manage a group of children with asthma at a partner health center.I can speak and understand English.I am a caregiver of a child with persistent asthma, as diagnosed by a doctor.I am either between 10-14 years old or I am the caregiver of someone who is.
Research Study Groups:
This trial has the following groups:- Group 1: BREATHE-Peds intervention
- Group 2: Control Intervention
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.
Is the enrollment criterion for this study restricted to individuals aged 25 and below?
"This clinical trial requires participants to be between 10 and 14 years of age, with no exceptions."
Answered by AI
How may I join the research study?
"The requirements for entry into this asthma trial are the following: participants must be of juvenile age (10-14) and show a history of childhood asthma. Approximately 300 enrollees will be admitted."
Answered by AI
How many participants are being welcomed into this trial?
"Affirmative. According to clinicaltrials.gov, this research initiative is actively looking for participants since its posting on May 1st 2023 and most recent update on April 25th 2023. This trial requires the enrolment of 300 individuals at 3 different sites."
Answered by AI
Are there available vacancies for participants in this trial?
"According to clinicaltrials.gov, this medical study is actively seeking enrolment from participants - it was first posted on May 1st 2023 and the most recent update occurred on April 25th 2023."
Answered by AI
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