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RI-AIR Program for Childhood Asthma (RI-AIR Trial)
N/A
Waitlist Available
Led By Elizabeth L McQuaid, PhD
Research Sponsored by Rhode Island Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Child's asthma status is not well-controlled or poorly controlled
Caregiver must speak English or Spanish.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up during active trial period at baseline, end of treatment (eot; which will occur between 1 to 2 months after baseline, depending on intervention assignment), 3 month follow-up after eot, 6 month follow-up, 9 month follow-up, 12 month follow-up
Awards & highlights
RI-AIR Trial Summary
This trial will test whether the RI-AIR ACIP intervention can help improve asthma outcomes for children. 434 children with asthma will participate in the program, which will involve education for the child and their parents, as well as follow-up visits. The goal is to see if children who participate in the program have better asthma outcomes.
Who is the study for?
This trial is for children aged 2-12 with poorly controlled asthma, living in a specific area. Caregivers must speak English or Spanish. Children with complex medical conditions needing on-site supervision are excluded.Check my eligibility
What is being tested?
The RI-AIR program aims to improve childhood asthma outcomes through tailored services based on electronic screening results. It includes school and home-based education and strategies over a year, with follow-ups every three months.See study design
What are the potential side effects?
Since the interventions involve educational programs and environmental strategies rather than medications, there are no direct side effects like those associated with drugs; however, individual experiences may vary.
RI-AIR Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My child's asthma is not under control.
Select...
My caregiver speaks English or Spanish.
Select...
My child has been diagnosed with asthma.
Select...
My child is between 2 and 12 years old.
RI-AIR Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ during active trial period at baseline, end of treatment (eot; which will occur between 1 to 2 months after baseline, depending on intervention assignment), 3 month follow-up after eot, 6 month follow-up, 9 month follow-up, 12 month follow-up
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~during active trial period at baseline, end of treatment (eot; which will occur between 1 to 2 months after baseline, depending on intervention assignment), 3 month follow-up after eot, 6 month follow-up, 9 month follow-up, 12 month follow-up
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in Asthma Control (Individual Level)
Change in Asthma Control (Individual-Level)
Secondary outcome measures
Change in Asthma Symptom Free Days (Individual-Level)
Change in Quality of Life related to Asthma as defined by the physical and emotional impact related to managing a child's asthma on the parent or caregiver (Individual-Level)
Change in caregivers' asthma self-efficacy, or their beliefs about how effectively they can manage their child's asthma (Individual-Level)
+4 moreRI-AIR Trial Design
3Treatment groups
Active Control
Group I: Standard CareActive Control1 Intervention
Cluster-based randomization in the Stepped Wedge Trial allows for comparison of Community Based Outcomes for clusters (communities defined by school catchment areas) who are not yet in the active trial phase and are receiving Standard of Care at that time.
Group II: CASE and HARP ProgramsActive Control2 Interventions
During the Active Trial Phase, families of children with asthma status that is defined as "poorly controlled" will complete the CASE and HARP programs. Outcomes for participants assigned to this arm (CASE and HARP) will be compared in a pre-post within subject comparison. Regardless of intervention arm assignment, children are expected show improvement in asthma outcomes. The stepped wedge trial design of the overall study allows for comparison of outcomes of communities in the pre-active trial baseline "control" period, active trial phase, and post-active trial phase follow-up period.
Group III: CASE Program onlyActive Control1 Intervention
During the Active Trial Phase, families of children with asthma status defined as "not well controlled" will complete the CASE program. Outcomes for participants assigned to the CASE program will be compared in a pre-post within subject comparison. Regardless of intervention arm assignment, children are expected show improvement in asthma outcomes. The stepped wedge trial design of the overall study allows for comparison of outcomes of communities in the pre-active trial baseline "control" period, active trial phase, and post-active trial phase follow-up period.
Find a Location
Who is running the clinical trial?
State of Rhode Island Department of HealthUNKNOWN
Central Falls School DistrictUNKNOWN
Cranston Public SchoolsUNKNOWN
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Eligibility Criteria:
This trial includes the following eligibility criteria:- My child's asthma is not under control.My caregiver speaks English or Spanish.My child has been diagnosed with asthma.My child is between 2 and 12 years old.My child needs constant medical care.
Research Study Groups:
This trial has the following groups:- Group 1: Standard Care
- Group 2: CASE and HARP Programs
- Group 3: CASE Program only
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 people aged 40+ eligible to join this medical trial?
"Those eligible for inclusion in this clinical trial must be between 2 and 12 years old."
Answered by AI
What are the eligibility criteria for participation in this clinical trial?
"This clinical trial requires 432 children aged between two and twelve who have a diagnosis of asthma."
Answered by AI
Is this trial still enrolling participants?
"Contrarily to what the information on clinicaltrials.gov states, this medical study no longer requires enrollment and has not done so since January 4th 2022. Nonetheless, there are 327 other trials actively looking for participants at present."
Answered by AI
What are the desired outcomes of this experiment?
"Over the course of 12 months, this trial's primary evaluation metric is Change in Asthma Control. Secondary metrics include caregiver report of Asthma Management Efficacy (measured through Parent Asthma Self-Efficacy Scale), parent report of school absences and electronic health record review for emergency department visits and hospital admissions."
Answered by AI
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