Pediatric AsthmaPR-AIRNCT05999032
The Puerto Rico Asthma Integrated Response Program ("PR-AIR")
A study testing CASE in person version (High Intensity Package), CASE-V remote version (Low Intensity Package) and CASE and HARP in person (High Intensity package) in people with Pediatric Asthma, run by Rhode Island Hospital at 2 sites in 2 countries.
Trial summary
The purpose of this study is to adapt and deliver an evidence-based multi-level intervention to reduce asthma disparities, and that promote and improve population health in the high-burden communities of San Juan, Puerto Rico. Read more about this study
- Who is it for?
- Ages 2 to 12 years
- Conditions the study is for
- Pediatric Asthma
- What is being tested?
- CASE in person version (High Intensity Package), CASE-V remote version (Low Intensity Package) and CASE and HARP in person (High Intensity package)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 480 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 16 Dec 2024to 31 Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children between the ages of 2 and 12 years old
- Children must reside in one of the identified catchment areas
- Children must meet the screening criteria as having not well controlled or poorly controlled asthma
Who cannot join
- 1. Children with complex medical conditions
Trial locations and contacts
2 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
2 sites in 2 countries
United States1 site
- Active, not recruiting
Rhode Island Hospital
Providence, Rhode Island, 02903
Puerto Rico1 site, 1 recruiting
- Recruiting
Medial Sciences Campus, University of Puerto Rico
San Juan, Puerto Rico, 00937
Ligia Chavez, PhD, 787-758-2525 ext. 1941, ligia.chavez@upr.edu
Keilyn Vale, MS, 787-758-2525 ext. 1994, keilyn.vale@upr.edu
About this study
The purpose of this study is to adapt and deliver an evidence-based multi-level intervention to reduce asthma disparities, and that promote and improve population health in the high-burden communities of San Juan, Puerto Rico.
The Puerto Rico-Asthma Integrated Response Program (PR-AIR) will be implemented and evaluated to address pediatric asthma disparities in San Juan, PR, an area of high asthma burden. This study unfolds in two phases: In Phase 1, the researchers will collaborate with community stakeholders to identify needs, barriers and facilitators of PR-AIR implementation. Phase 2 consists of an evaluation of low-intensity (virtual) and high-intensity (in-person) methods of PR-AIR implementation outcomes using the RE-AIM (Reach, Effectiveness, Adoption, Implementation, and Maintenance) framework and a mixed methods approach.
Read the detailed description
During the formative evaluation (Phase 1), the researchers will engage community stakeholders (primary caregivers of children with asthma, school personnel, asthma healthcare providers) to help identify, adapt and finalize strategies for PR-AIR implementation. The Consolidated Framework for Implementation Research (CFIR) will be used to identify barriers and facilitators of low-intensity and high-intensity implementation approaches, the Adaptome to guide intervention adaptation to the context of PR, and the CFIR-ERIC matching tool to identify strategies to support but low- and high-intensity implementation packages. Fifteen stakeholders will complete in-depth interviews early in Phase 1, and 16 will participate in two focus groups at the end of Phase 1 prior to the transition to Phase 2, in preparation for trial implementation. A collaborative of community stakeholders will be convened (the PR-AIR CC) to provide input throughout both phases of the trial.
In Phase 2 (Years 2-4) 480 urban children will be enrolled, ages 2-12 (expected retention for full protocol, n = 400) with asthma across 12 areas in San Juan with high asthma burden. Randomization is at the level of targeted geographic area, and data will be collected from groups in each of these areas over time. Individual-level (asthma control, QOL) and community-specific (ED use/hospitalizations, school absence) effectiveness outcomes will be evaluated. All families will participate in both a control (in our case, baseline period for the community indicators) and intervention (active trial). Each target area will begin with a low-intensity (virtual) implementation phase, and transition to a high-intensity implementation phase mid-year. Families enrolled in the first 5 months of the school year will receive the low-intensity intervention package, and those enrolled in the last 5 months of the school year will receive the high-intensity intervention package. Input will be collected throughout each year from community stakeholders about the trial, through in-depth interviews and surveys. Reach, Adoption, Implementation, and Maintenance will be measured using a mixed-methods approach at the end of each trial year (years 2 - 4). Repeated assessments will measure individual-level effectiveness outcomes (asthma control, QOL) at time points linked to the start of intervention participation; at enrollment, end of treatment (EOT; 1 - 2 months after baseline, depending on intervention assignment), and every 3 months for 1 year.
- Conditions
- Pediatric Asthma
- Being tested
- CASE in person version (High Intensity Package), CASE-V remote version (Low Intensity Package), CASE and HARP in person (High Intensity package), CASE-V and HARP-V remote version (Low Intensity package)
- Keywords
- Pediatric asthma, Community intervention program, Hybrid Type III, Effectiveness and implementation, Home-based intervention, School-based intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CASE in person version (High Intensity Package)Behavioural
Controlling Asthma in Schools Effectively (CASE) is a multi-level school-based asthma management program delivered by a Community Health Worker (CHW) that includes 1) staff training involving education on asthma management in school, 2) child-based asthma management education with an emphasis on control of symptoms in the school setting provided in a group setting during the school day, 3) caregiver education after school involving supporting children's asthma control in the school setting, 4), and provision of an Asthma Action Plan (AAP) to the school for child enrollees.
CASE-V remote version (Low Intensity Package)Behavioural
CASE-V, the low intensity version of CASE, includes similar child and caregiver-based asthma management education that is provided in a remote format with adaptation to integrate technological feature of Zoom. All CASE-V components (for staff, children, and parents) have been adapted to promote engagement (e.g., use of chat and polling function).
CASE and HARP in person (High Intensity package)Behavioural
Children with "poorly controlled" asthma will receive both the CASE and HARP programs. HARP is a home-visiting program that includes individualized asthma management education and strategies and supplies for environmental remediation. All 3 visits can be conducted by a CHW. The first includes a "walk-through" to identify triggers. Asthma education and self-management strategies are provided using a structured protocol and low-literacy flip-book (English or Spanish). Referrals and advocacy are offered to address asthma management barriers (e.g., communication with landlord/housing re: code violation). The 2nd and 3rd visits include delivery of supplies (e.g., HEPA vacuum, pest gels, mattress covers), instruction for use, review of AAP, and follow-up on environmental control recommendations provided during the 1st visit.
CASE-V and HARP-V remote version (Low Intensity package)Behavioural
HARP-V replicates the content delivered in HARP in a remote format. The first session includes a virtual "walk-through" in which the educator uses a structured script and checklist to guide the caregiver through the home and show specific components of the environment (e.g., carpeting, area under the kitchen sink, exhaust fan in bathroom) to identify asthma triggers. Asthma education and self-management strategies are provided using a structured protocol and slide overview based on the HARP flip-book. Supplies for environmental remediation are delivered prior to the 2nd visit. The 2nd and 3rd visit include instruction for use of supplies, review of AAP, and follow-up on recommendations and referrals.
| Study group | Role | What they receive |
|---|---|---|
| Low-Intensity (Virtual) Intervention Implementation | Active comparator | During low intensity implementation, families of children with poorly controlled asthma will be referred to the remote version of HARP (HARP-V) and will receive CASE remotely (CASE-V). Children with not well controlled asthma will receive only CASE-V remotely. Receives: Behavioral: CASE in person version (High Intensity Package); Behavioral: CASE-V remote version (Low Intensity Package) |
| High Intensity (in-Person) Intervention Implementation | Active comparator | During high intensity implementation, all interventions are administered in person.
Specifically, families of children with poorly controlled asthma will receive in-person versions of HARP and CASE. Children with not well controlled asthma will receive an in-person version of CASE only. Receives: Behavioral: CASE and HARP in person (High Intensity package); Behavioral: CASE-V and HARP-V remote version (Low Intensity package) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Child Asthma Control (Individual Level, ages 2-4 years)
Effectiveness of the intervention on child-level asthma control is measured using the Test for Respiratory and Asthma Control in Kids (TRACK). The TRACK is a 5-item measure assessing asthma symptoms and control in young children by caregiver report. Items assessing frequency of various asthma-related events (e.g., breathing problems, quick-relief medication use, etc.) are rated on a Likert-type scale from Not at all (scored 20) to Extremely (scored 0). Scores < 80 suggest child's asthma is not well controlled.
Measured: Asthma Control will be measured at baseline, End of Treatment (EOT; 1 - 2 months after baseline, depending on intervention assignment), and every 3 months for 1 year.
Change in Child Asthma Control (Individual Level, ages 5-11 years)
Effectiveness of the intervention on child-level asthma control is measured using the Childhood Asthma Control Test (cACT). Children answer 4 questions on a 0-3 scale, and caregivers answer 3 questions on a 0-5 scale related to the frequency child's asthma symptoms in the previous 4 weeks. Lower scores indicate worse symptoms. Scores of 19 or less suggest asthma is not well controlled.
Measured: Asthma Control will be measured at baseline, End of Treatment (EOT; 1 - 2 months after baseline, depending on intervention assignment), and every 3 months for 1 year.
Change in Child Asthma Control (Individual Level; ages 12 and up)
Effectiveness of the intervention on child-level asthma control is measured using the Asthma Control Test. Youth ages 12 and up complete 5-items related to their asthma on Likert-type scales ranging from 1-5, with lower scores indicating more severe symptoms. A cutoff score <19 indicates suboptimal asthma control; scores <=15 suggest poorly controlled asthma.
Measured: Asthma Control will be measured at baseline, End of Treatment (EOT; 1 - 2 months after baseline, depending on intervention assignment), and every 3 months for 1 year.
Health Care Utilization-ED visits (Community Level)
Health care utilization will be assessed by community-level rates of Emergency Department visits of children within the targeted geographic area. Obtaining utilization rates in this way will help the researchers to assess effectiveness of the intervention on the community level.
Measured: 12 months pre- and post-intervention year
Health Care Utilization-Hospitalizations (Community Level)
Effectiveness of the intervention on the community level. Health care utilization will be assessed by community-level rates of hospitalizations in children within the targeted geographic area.
Measured: 12 months pre- and post-intervention year
Health Care Utilization-Urgent Care Visits (Community Level)
Effectiveness of the intervention on the community level. Health care utilization will be assessed by community-level rates of urgent care visits in children within the targeted geographic area.
Measured: 12 months pre- and post-intervention year
Secondary outcomes (2)
Asthma-related Quality of Life (QoL) (Individual Level)
Effectiveness on child-level quality of life (QOL) will be measured by the Pediatric Asthma Quality of Life Questionnaire (PAQLQ). The instrument consists of 23 items related to limitation across three domains (activity limitation, symptoms and emotional function). Each item is rated 1-7 on a Likert scale, with lower numerical responses indicating greater impairment.
Measured: Asthma-related QOL will be measured at baseline, End of Treatment (EOT; 1 - 2 months after baseline, depending on intervention assignment), and every three months for 1 year.
School Absences (Community Level)
Community-level school absences will be assessed by attendance data (i.e., number of school absences) from the schools in the targeted area that correspond to each "step" in the wedge of the study design.
Measured: 12 months pre- and post-intervention year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2023
- Study start16 Dec 2024
- Primary completion30 Nov 2026 (estimated)
- Study completion31 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Pediatric AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 480 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rhode Island Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Puerto Rico
- Responsible party
- Sponsor
- Investigators
- Daphne Koinis Mitchell, PhD, Principal investigator, Rhode Island HospitalElizabeth L McQuaid, PhD, ABPP, Principal investigator, Rhode Island HospitalLigia Chavez, PhD, Principal investigator, University of Puerto Rico
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05999032
- Sponsor's protocol ID
- R01HL159701
- Acronym
- PR-AIR
- Status last verified
- Sep 2026
- First submitted
- 22 May 2023
- Last updated
- 4 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Following the NIH data sharing policy (2015), within one year of completion of the studies and dissemination of primary study results, public-use analysis datasets will be made available to the public, along with the final version of the study protocol, data dictionaries, and brief instructions. De-identification for the analysis datasets will follow published guidelines for "limited access data sets" funded by NHLBI (Geller et al., 2004).
Publications
Glasgow RE, Harden SM, Gaglio B, Rabin B, Smith ML, Porter GC, Ory MG, Estabrooks PA. RE-AIM Planning and Evaluation Framework: Adapting to New Science and Practice With a 20-Year Review. Front Public Health. 2019 Mar 29;7:64. doi: 10.3389/fpubh.2019.00064. eCollection 2019.
PubMed 30984733CFIR Research Team. Strategy Design [Web]. Consolidated Framework for Implementation Research; 2019 [Available from: https://cfirguide.org/choosing-strategies/ accessed 22 November 2019.
Chambers DA, Norton WE. The Adaptome: Advancing the Science of Intervention Adaptation. Am J Prev Med. 2016 Oct;51(4 Suppl 2):S124-31. doi: 10.1016/j.amepre.2016.05.011. Epub 2016 Jun 28.
PubMed 27371105Waltz TJ, Powell BJ, Fernandez ME, Abadie B, Damschroder LJ. Choosing implementation strategies to address contextual barriers: diversity in recommendations and future directions. Implement Sci. 2019 Apr 29;14(1):42. doi: 10.1186/s13012-019-0892-4.
PubMed 31036028Murphy KR, Zeiger RS, Kosinski M, Chipps B, Mellon M, Schatz M, Lampl K, Hanlon JT, Ramachandran S. Test for respiratory and asthma control in kids (TRACK): a caregiver-completed questionnaire for preschool-aged children. J Allergy Clin Immunol. 2009 Apr;123(4):833-9.e9. doi: 10.1016/j.jaci.2009.01.058.
PubMed 19348922Liu AH, Zeiger R, Sorkness C, Mahr T, Ostrom N, Burgess S, Rosenzweig JC, Manjunath R. Development and cross-sectional validation of the Childhood Asthma Control Test. J Allergy Clin Immunol. 2007 Apr;119(4):817-25. doi: 10.1016/j.jaci.2006.12.662. Epub 2007 Mar 13.
PubMed 17353040Nathan RA, Sorkness CA, Kosinski M, Schatz M, Li JT, Marcus P, Murray JJ, Pendergraft TB. Development of the asthma control test: a survey for assessing asthma control. J Allergy Clin Immunol. 2004 Jan;113(1):59-65. doi: 10.1016/j.jaci.2003.09.008.
PubMed 14713908Juniper EF, Guyatt GH, Feeny DH, Ferrie PJ, Griffith LE, Townsend M. Measuring quality of life in the parents of children with asthma. Qual Life Res. 1996 Feb;5(1):27-34. doi: 10.1007/BF00435966.
PubMed 8901364
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Puerto Rico Asthma Integrated Response Program ("PR-AIR")
- ClinicalTrials.gov ID
- NCT05999032
- Acronym / sponsor ID
- PR-AIR / R01HL159701
- Conditions
- Pediatric Asthma
- Keywords
- Pediatric asthma, Community intervention program, Hybrid Type III, Effectiveness and implementation, Home-based intervention, School-based intervention
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 480 participants (estimated)
- Lead sponsor
- Rhode Island HospitalUniversity, hospital or other
- Collaborators
- University of Puerto Rico
- Study start
- 16 Dec 2024 (actual)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 31 Jul 2027 (estimated)
- First posted
- 21 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to adapt and deliver an evidence-based multi-level intervention to reduce asthma disparities, and that promote and improve population health in the high-burden communities of San Juan, Puerto Rico.
The Puerto Rico-Asthma Integrated Response Program (PR-AIR) will be implemented and evaluated to address pediatric asthma disparities in San Juan, PR, an area of high asthma burden. This study unfolds in two phases: In Phase 1, the researchers will collaborate with community stakeholders to identify needs, barriers and facilitators of PR-AIR implementation. Phase 2 consists of an evaluation of low-intensity (virtual) and high-intensity (in-person) methods of PR-AIR implementation outcomes using the RE-AIM (Reach, Effectiveness, Adoption, Implementation, and Maintenance) framework and a mixed methods approach.
Detailed description
During the formative evaluation (Phase 1), the researchers will engage community stakeholders (primary caregivers of children with asthma, school personnel, asthma healthcare providers) to help identify, adapt and finalize strategies for PR-AIR implementation. The Consolidated Framework for Implementation Research (CFIR) will be used to identify barriers and facilitators of low-intensity and high-intensity implementation approaches, the Adaptome to guide intervention adaptation to the context of PR, and the CFIR-ERIC matching tool to identify strategies to support but low- and high-intensity implementation packages. Fifteen stakeholders will complete in-depth interviews early in Phase 1, and 16 will participate in two focus groups at the end of Phase 1 prior to the transition to Phase 2, in preparation for trial implementation. A collaborative of community stakeholders will be convened (the PR-AIR CC) to provide input throughout both phases of the trial.
In Phase 2 (Years 2-4) 480 urban children will be enrolled, ages 2-12 (expected retention for full protocol, n = 400) with asthma across 12 areas in San Juan with high asthma burden. Randomization is at the level of targeted geographic area, and data will be collected from groups in each of these areas over time. Individual-level (asthma control, QOL) and community-specific (ED use/hospitalizations, school absence) effectiveness outcomes will be evaluated. All families will participate in both a control (in our case, baseline period for the community indicators) and intervention (active trial). Each target area will begin with a low-intensity (virtual) implementation phase, and transition to a high-intensity implementation phase mid-year. Families enrolled in the first 5 months of the school year will receive the low-intensity intervention package, and those enrolled in the last 5 months of the school year will receive the high-intensity intervention package. Input will be collected throughout each year from community stakeholders about the trial, through in-depth interviews and surveys. Reach, Adoption, Implementation, and Maintenance will be measured using a mixed-methods approach at the end of each trial year (years 2 - 4). Repeated assessments will measure individual-level effectiveness outcomes (asthma control, QOL) at time points linked to the start of intervention participation; at enrollment, end of treatment (EOT; 1 - 2 months after baseline, depending on intervention assignment), and every 3 months for 1 year.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low-Intensity (Virtual) Intervention Implementation | Active comparator | Behavioral: CASE in person version (High Intensity Package), Behavioral: CASE-V remote version (Low Intensity Package)During low intensity implementation, families of children with poorly controlled asthma will be referred to the remote version of HARP (HARP-V) and will receive CASE remotely (CASE-V). Children with not well controlled asthma will receive only CASE-V remotely. |
| High Intensity (in-Person) Intervention Implementation | Active comparator | Behavioral: CASE and HARP in person (High Intensity package), Behavioral: CASE-V and HARP-V remote version (Low Intensity package)During high intensity implementation, all interventions are administered in person. Specifically, families of children with poorly controlled asthma will receive in-person versions of HARP and CASE. Children with not well controlled asthma will receive an in-person version of CASE only. |
Who may qualify
- Ages
- 2 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Children between the ages of 2 and 12 years old
- Children must reside in one of the identified catchment areas
- Children must meet the screening criteria as having not well controlled or poorly controlled asthma
Key exclusion criteria (1 listed)
- 1. Children with complex medical conditions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CASE in person version (High Intensity Package)Controlling Asthma in Schools Effectively (CASE) is a multi-level school-based asthma management program delivered by a Community Health Worker (CHW) that includes 1) staff training involving education on asthma management in school, 2) child-based asthma management education with an emphasis on control of symptoms in the school setting provided in a group setting during the school day, 3) caregiver education after school involving supporting children's asthma control in the school setting, 4), and provision of an Asthma Action Plan (AAP) to the school for child enrollees. | Behavioural | Low-Intensity (Virtual) Intervention Implementation |
| CASE-V remote version (Low Intensity Package)CASE-V, the low intensity version of CASE, includes similar child and caregiver-based asthma management education that is provided in a remote format with adaptation to integrate technological feature of Zoom. All CASE-V components (for staff, children, and parents) have been adapted to promote engagement (e.g., use of chat and polling function). | Behavioural | Low-Intensity (Virtual) Intervention Implementation |
| CASE and HARP in person (High Intensity package)Children with "poorly controlled" asthma will receive both the CASE and HARP programs. HARP is a home-visiting program that includes individualized asthma management education and strategies and supplies for environmental remediation. All 3 visits can be conducted by a CHW. The first includes a "walk-through" to identify triggers. Asthma education and self-management strategies are provided using a structured protocol and low-literacy flip-book (English or Spanish). Referrals and advocacy are offered to address asthma management barriers (e.g., communication with landlord/housing re: code violation). The 2nd and 3rd visits include delivery of supplies (e.g., HEPA vacuum, pest gels, mattress covers), instruction for use, review of AAP, and follow-up on environmental control recommendations provided during the 1st visit. | Behavioural | High Intensity (in-Person) Intervention Implementation |
| CASE-V and HARP-V remote version (Low Intensity package)HARP-V replicates the content delivered in HARP in a remote format. The first session includes a virtual "walk-through" in which the educator uses a structured script and checklist to guide the caregiver through the home and show specific components of the environment (e.g., carpeting, area under the kitchen sink, exhaust fan in bathroom) to identify asthma triggers. Asthma education and self-management strategies are provided using a structured protocol and slide overview based on the HARP flip-book. Supplies for environmental remediation are delivered prior to the 2nd visit. The 2nd and 3rd visit include instruction for use of supplies, review of AAP, and follow-up on recommendations and referrals. | Behavioural | High Intensity (in-Person) Intervention Implementation |
Primary outcome
Change in Child Asthma Control (Individual Level, ages 2-4 years)
Time frame: Asthma Control will be measured at baseline, End of Treatment (EOT; 1 - 2 months after baseline, depending on intervention assignment), and every 3 months for 1 year.
Effectiveness of the intervention on child-level asthma control is measured using the Test for Respiratory and Asthma Control in Kids (TRACK). The TRACK is a 5-item measure assessing asthma symptoms and control in young children by caregiver report. Items assessing frequency of various asthma-related events (e.g., breathing problems, quick-relief medication use, etc.) are rated on a Likert-type scale from Not at all (scored 20) to Extremely (scored 0). Scores < 80 suggest child's asthma is not well controlled.
Change in Child Asthma Control (Individual Level, ages 5-11 years)
Time frame: Asthma Control will be measured at baseline, End of Treatment (EOT; 1 - 2 months after baseline, depending on intervention assignment), and every 3 months for 1 year.
Effectiveness of the intervention on child-level asthma control is measured using the Childhood Asthma Control Test (cACT). Children answer 4 questions on a 0-3 scale, and caregivers answer 3 questions on a 0-5 scale related to the frequency child's asthma symptoms in the previous 4 weeks. Lower scores indicate worse symptoms. Scores of 19 or less suggest asthma is not well controlled.
Change in Child Asthma Control (Individual Level; ages 12 and up)
Time frame: Asthma Control will be measured at baseline, End of Treatment (EOT; 1 - 2 months after baseline, depending on intervention assignment), and every 3 months for 1 year.
Effectiveness of the intervention on child-level asthma control is measured using the Asthma Control Test. Youth ages 12 and up complete 5-items related to their asthma on Likert-type scales ranging from 1-5, with lower scores indicating more severe symptoms. A cutoff score <19 indicates suboptimal asthma control; scores <=15 suggest poorly controlled asthma.
Health Care Utilization-ED visits (Community Level)
Time frame: 12 months pre- and post-intervention year
Health care utilization will be assessed by community-level rates of Emergency Department visits of children within the targeted geographic area. Obtaining utilization rates in this way will help the researchers to assess effectiveness of the intervention on the community level.
Health Care Utilization-Hospitalizations (Community Level)
Time frame: 12 months pre- and post-intervention year
Effectiveness of the intervention on the community level. Health care utilization will be assessed by community-level rates of hospitalizations in children within the targeted geographic area.
Health Care Utilization-Urgent Care Visits (Community Level)
Time frame: 12 months pre- and post-intervention year
Effectiveness of the intervention on the community level. Health care utilization will be assessed by community-level rates of urgent care visits in children within the targeted geographic area.
2 secondary outcomes
Asthma-related Quality of Life (QoL) (Individual Level)
Time frame: Asthma-related QOL will be measured at baseline, End of Treatment (EOT; 1 - 2 months after baseline, depending on intervention assignment), and every three months for 1 year.
School Absences (Community Level)
Time frame: 12 months pre- and post-intervention year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2026.
- Background: PubMed 30984733Glasgow RE, Harden SM, Gaglio B, Rabin B, Smith ML, Porter GC, Ory MG, Estabrooks PA. RE-AIM Planning and Evaluation Framework: Adapting to New Science and Practice With a 20-Year Review. Front Public Health. 2019 Mar 29;7:64. doi: 10.3389/fpubh.2019.00064. eCollection 2019.
- BackgroundCFIR Research Team. Strategy Design [Web]. Consolidated Framework for Implementation Research; 2019 [Available from: https://cfirguide.org/choosing-strategies/ accessed 22 November 2019.
- Background: PubMed 27371105Chambers DA, Norton WE. The Adaptome: Advancing the Science of Intervention Adaptation. Am J Prev Med. 2016 Oct;51(4 Suppl 2):S124-31. doi: 10.1016/j.amepre.2016.05.011. Epub 2016 Jun 28.
- Background: PubMed 31036028Waltz TJ, Powell BJ, Fernandez ME, Abadie B, Damschroder LJ. Choosing implementation strategies to address contextual barriers: diversity in recommendations and future directions. Implement Sci. 2019 Apr 29;14(1):42. doi: 10.1186/s13012-019-0892-4.
- Background: PubMed 19348922Murphy KR, Zeiger RS, Kosinski M, Chipps B, Mellon M, Schatz M, Lampl K, Hanlon JT, Ramachandran S. Test for respiratory and asthma control in kids (TRACK): a caregiver-completed questionnaire for preschool-aged children. J Allergy Clin Immunol. 2009 Apr;123(4):833-9.e9. doi: 10.1016/j.jaci.2009.01.058.
- Background: PubMed 17353040Liu AH, Zeiger R, Sorkness C, Mahr T, Ostrom N, Burgess S, Rosenzweig JC, Manjunath R. Development and cross-sectional validation of the Childhood Asthma Control Test. J Allergy Clin Immunol. 2007 Apr;119(4):817-25. doi: 10.1016/j.jaci.2006.12.662. Epub 2007 Mar 13.
- Background: PubMed 14713908Nathan RA, Sorkness CA, Kosinski M, Schatz M, Li JT, Marcus P, Murray JJ, Pendergraft TB. Development of the asthma control test: a survey for assessing asthma control. J Allergy Clin Immunol. 2004 Jan;113(1):59-65. doi: 10.1016/j.jaci.2003.09.008.
- Background: PubMed 8901364Juniper EF, Guyatt GH, Feeny DH, Ferrie PJ, Griffith LE, Townsend M. Measuring quality of life in the parents of children with asthma. Qual Life Res. 1996 Feb;5(1):27-34. doi: 10.1007/BF00435966.
- Individual participant dataSharing planned: Yes. Following the NIH data sharing policy (2015), within one year of completion of the studies and dissemination of primary study results, public-use analysis datasets will be made available to the public, along with the final version of the study protocol, data dictionaries, and brief instructions. De-identification for the analysis datasets will follow published guidelines for "limited access data sets" funded by NHLBI (Geller et al., 2004).
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Asthma (Diagnosis)
Recruiting
Towards Digital Management of Paediatric Asthma
Pediatric Asthma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Daphne Koinis Mitchell, PhD principal investigator
Rhode Island Hospital
Elizabeth L McQuaid, PhD, ABPP principal investigator
Rhode Island Hospital
Ligia Chavez, PhD principal investigator
University of Puerto Rico
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CASE in person version (High Intensity Package), CASE-V remote version (Low Intensity Package) and CASE and HARP in person (High Intensity package) in people with Pediatric Asthma, run by Rhode Island Hospital at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Daphne Koinis Mitchell, PhD (401-793-8632, dkoinismitchell@lifespan.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Child Asthma Control (Individual Level, ages 2-4 years) (time frame: Asthma Control will be measured at baseline, End of Treatment (EOT; 1 - 2 months after baseline, depending on intervention assignment), and every 3 months for 1 year.). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05999032, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2026.