AsthmaABC-HSNCT01519453
Reducing Asthma Morbidity In High Risk Minority Preschool Children
A study testing Home Based Asthma Education in people with Asthma, run by Johns Hopkins University at 1 site in United States.
Trial summary
Low-income, minority children are disproportionately affected by asthma and can experience higher rates of asthma attacks, lower lung function, decreased physical activity, increases in school absenteeism, and higher rates of death. Read more about this study
- Who is it for?
- Ages 2 to 6 years
- Conditions the study is for
- Asthma
- What is being tested?
- Home Based Asthma Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 404 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2011to Mar 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Enrolled in Head Start
- Physician diagnosed asthma or reactive airway disease
- Resides in Baltimore City or Baltimore County
- English Speaking
Who cannot join
- Enrolled in another pulmonary research study
- Sibling enrolled in study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Reducing Asthma Morbidity in High Risk Minority Preschool Children (Asthma Basic Care (ABC) at Head Start)
Low-income, minority children are disproportionately affected by asthma and can experience higher rates of asthma attacks, lower lung function, decreased physical activity, increases in school absenteeism, and higher rates of death. The National Center for Children in Poverty suggests that effective interventions to improve asthma and reduce harm for high risk groups (like low-income minority children) must begin in early childhood. Previous research has shown that asthma education programs can be effective to improve overall asthma management in preschool children, but there has been limited sustainability of these programs in medical, educational, and social environments that serve young high risk children. One of the core missions of federally-funded Head Start programs is to provide preventive health services and screening to their low-income preschool students and would be an ideal setting in the community to disseminate an early asthma education program. The purpose of this study is to draw on our health and research partnership with Baltimore City Head Start programs to test the effectiveness of a home-based asthma education intervention combined with a Head Start level asthma education program compared to a Head Start level asthma education program alone.
Read the detailed description
Despite advances in asthma therapies and the wide-spread dissemination of asthma clinical guidelines, low-income, minority children have disproportionately high morbidity and mortality from asthma. The National Center for Children in Poverty has strongly argued that effective interventions to improve asthma health disparities and reduce harm must begin in early childhood. Previous efficacy studies have suggested that asthma education programs can be effective in improving overall management of asthma for preschool children. However, for these promising asthma intervention strategies to have sustainable public health impact for low-income, minority children they must be integrated within those medical, educational and social structures that serve these young high risk children, such as community clinics, schools and day care programs. Because one of the core missions of federally-funded Head Start programs is to provide preventive health services and screening to their low-income preschool students, Head Start represents an ideal community setting for disseminating early asthma education. The investigators propose to draw on our established health and research partnership with Head Start programs in Baltimore City to test the effectiveness of this home-based asthma education intervention with demonstrated efficacy, when delivered in the context of a Head Start-wide asthma education program. The investigators further propose to partner with Head Start to support and evaluate adoption, maintenance and dissemination of new knowledge gained from this project. Specifically the investigators hypothesize that participants receiving the ABC intervention combined with a HS-level asthma education will have more symptom free days at the 6-, 9-, and 12-month evaluation when compared with participants in the HS-level asthma education alone. The investigators plan to enroll of 406 children age 2-6 years old enrolled in Head Start with symptomatic asthma. Secondary outcome measures include other measures of asthma morbidity (i.e., hospitalizations, Emergency Department visits, oral steroid bursts, school absences, and caregiver quality of life). The investigators will also evaluate the mediating effects of outcomes expectancies, self-efficacy, asthma knowledge, motivation, and asthma management practices, as well as moderator effects, such as health literacy, caregiver depression, neighborhood cohesion, family management of asthma, and Head Start adoption and dissemination of an asthma education curriculum.
- Conditions
- Asthma
- Being tested
- Home Based Asthma Education
- Keywords
- Asthma, Preschool, Health Disparities, Implementation
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home Based Asthma EducationBehavioural
4 home based and 3 phone based sessions with community asthma outreach worker to provide families with asthma education
| Study group | Role | What they receive |
|---|---|---|
| Home Based Asthma Education | Experimental | Families will receive 4 home based and 3 phone based asthma education sessions with a community asthma outreach worker Receives: Behavioral: Home Based Asthma Education |
| Control | No intervention | There is no control arm specific intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Asthma Control as Determined by Test for Respiratory and Asthma Control in Kids Assessment Tool
The Test for Respiratory and Asthma Control in Kids test is an assessment tool consisting of 5 questions posed to caregivers and designed to assess respiratory and asthma control in patients between 12 months and 5 years. It addresses risk and impairment domains outlined in the Asthma Guidelines and is meant to be interpreted by medical professionals. A total score is calculated from 0-100 with scores less than 80 indicating the child's asthma may not be under control and scores of 80 or more indicating that a child's asthma seems to be under control.
Measured: Baseline, 3, 6, 9 and 12 months
Secondary outcomes (2)
Total Number of Emergency Department (ED) Visits [Child]
Aggregate number of ED visits for asthma in past 90 days for all participants.
Measured: Baseline, 3, 6, 9 and 12 months
Total Number of Hospitalizations [Child]
Aggregate number of hospitalizations due to asthma 12 months before randomization vs after randomization for all participants.
Measured: Baseline and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2012 (estimated)
- Study startSep 2011
- Primary completionNov 2017
- Study completionMar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 404 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Cynthia Rand, Ph.D., Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01519453
- Sponsor's protocol ID
- NA_00046455
- Other IDs
- HL-107223
- Acronym
- ABC-HS
- Status last verified
- Apr 2021
- First submitted
- 24 Jan 2012
- Last updated
- 11 May 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We will not be sharing individual participant data with other researchers
Publications
Callaghan-Koru JA, Riekert KA, Ruvalcaba E, Rand CS, Eakin MN. Home Medication Readiness for Preschool Children With Asthma. Pediatrics. 2018 Sep;142(3):e20180829. doi: 10.1542/peds.2018-0829. Epub 2018 Aug 7.
PubMed 30087197Ruvalcaba E, Chung SE, Rand C, Riekert KA, Eakin M. Evaluating the implementation of a multicomponent asthma education program for Head Start staff. J Asthma. 2019 Feb;56(2):218-226. doi: 10.1080/02770903.2018.1443467. Epub 2018 Mar 15.
PubMed 29543493Sadreameli SC, Riekert KA, Matsui EC, Rand CS, Eakin MN. Family Caregiver Marginalization is Associated With Decreased Primary and Subspecialty Asthma Care in Head Start Children. Acad Pediatr. 2018 Nov-Dec;18(8):905-911. doi: 10.1016/j.acap.2018.04.135. Epub 2018 May 3.
PubMed 29730244Eakin MN, Zaeh S, Eckmann T, Ruvalcaba E, Rand CS, Hilliard ME, Riekert KA. Effectiveness of a Home- and School-Based Asthma Educational Program for Head Start Children With Asthma: A Randomized Clinical Trial. JAMA Pediatr. 2020 Dec 1;174(12):1191-1198. doi: 10.1001/jamapediatrics.2020.3375.
PubMed 33016987Lu MA, Eckmann T, Ruvalcaba E, McQuaid EL, Rand CS, Riekert KA, Eakin MN. Family management of asthma in Head Start preschool children. Ann Allergy Asthma Immunol. 2022 Feb;128(2):178-183. doi: 10.1016/j.anai.2021.11.002. Epub 2021 Nov 10.
PubMed 34774736
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing Asthma Morbidity in High Risk Minority Preschool Children (Asthma Basic Care (ABC) at Head Start)
- ClinicalTrials.gov ID
- NCT01519453
- Acronym / sponsor ID
- ABC-HS / NA_00046455
- Conditions
- Asthma
- Keywords
- Asthma, Preschool, Health Disparities, Implementation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 404 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Study start
- Sep 2011
- Primary completion
- Nov 2017 (actual)
- Study completion
- Mar 2018 (actual)
- First posted
- 27 Jan 2012 (estimated)
- Results
- Posted 23 Apr 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Low-income, minority children are disproportionately affected by asthma and can experience higher rates of asthma attacks, lower lung function, decreased physical activity, increases in school absenteeism, and higher rates of death. The National Center for Children in Poverty suggests that effective interventions to improve asthma and reduce harm for high risk groups (like low-income minority children) must begin in early childhood. Previous research has shown that asthma education programs can be effective to improve overall asthma management in preschool children, but there has been limited sustainability of these programs in medical, educational, and social environments that serve young high risk children. One of the core missions of federally-funded Head Start programs is to provide preventive health services and screening to their low-income preschool students and would be an ideal setting in the community to disseminate an early asthma education program. The purpose of this study is to draw on our health and research partnership with Baltimore City Head Start programs to test the effectiveness of a home-based asthma education intervention combined with a Head Start level asthma education program compared to a Head Start level asthma education program alone.
Detailed description
Despite advances in asthma therapies and the wide-spread dissemination of asthma clinical guidelines, low-income, minority children have disproportionately high morbidity and mortality from asthma. The National Center for Children in Poverty has strongly argued that effective interventions to improve asthma health disparities and reduce harm must begin in early childhood. Previous efficacy studies have suggested that asthma education programs can be effective in improving overall management of asthma for preschool children. However, for these promising asthma intervention strategies to have sustainable public health impact for low-income, minority children they must be integrated within those medical, educational and social structures that serve these young high risk children, such as community clinics, schools and day care programs. Because one of the core missions of federally-funded Head Start programs is to provide preventive health services and screening to their low-income preschool students, Head Start represents an ideal community setting for disseminating early asthma education. The investigators propose to draw on our established health and research partnership with Head Start programs in Baltimore City to test the effectiveness of this home-based asthma education intervention with demonstrated efficacy, when delivered in the context of a Head Start-wide asthma education program. The investigators further propose to partner with Head Start to support and evaluate adoption, maintenance and dissemination of new knowledge gained from this project. Specifically the investigators hypothesize that participants receiving the ABC intervention combined with a HS-level asthma education will have more symptom free days at the 6-, 9-, and 12-month evaluation when compared with participants in the HS-level asthma education alone. The investigators plan to enroll of 406 children age 2-6 years old enrolled in Head Start with symptomatic asthma. Secondary outcome measures include other measures of asthma morbidity (i.e., hospitalizations, Emergency Department visits, oral steroid bursts, school absences, and caregiver quality of life). The investigators will also evaluate the mediating effects of outcomes expectancies, self-efficacy, asthma knowledge, motivation, and asthma management practices, as well as moderator effects, such as health literacy, caregiver depression, neighborhood cohesion, family management of asthma, and Head Start adoption and dissemination of an asthma education curriculum.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Home Based Asthma Education | Experimental | Behavioral: Home Based Asthma EducationFamilies will receive 4 home based and 3 phone based asthma education sessions with a community asthma outreach worker |
| Control | No intervention | –There is no control arm specific intervention |
Who may qualify
- Ages
- 2 to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Enrolled in Head Start
- Physician diagnosed asthma or reactive airway disease
- Resides in Baltimore City or Baltimore County
- English Speaking
Key exclusion criteria (2 listed)
- Enrolled in another pulmonary research study
- Sibling enrolled in study
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 |
|---|---|---|
| Home Based Asthma Education4 home based and 3 phone based sessions with community asthma outreach worker to provide families with asthma education | Behavioural | Home Based Asthma Education |
Primary outcome
Asthma Control as Determined by Test for Respiratory and Asthma Control in Kids Assessment Tool
Time frame: Baseline, 3, 6, 9 and 12 months
The Test for Respiratory and Asthma Control in Kids test is an assessment tool consisting of 5 questions posed to caregivers and designed to assess respiratory and asthma control in patients between 12 months and 5 years. It addresses risk and impairment domains outlined in the Asthma Guidelines and is meant to be interpreted by medical professionals. A total score is calculated from 0-100 with scores less than 80 indicating the child's asthma may not be under control and scores of 80 or more indicating that a child's asthma seems to be under control.
2 secondary outcomes
Total Number of Emergency Department (ED) Visits [Child]
Time frame: Baseline, 3, 6, 9 and 12 months
Total Number of Hospitalizations [Child]
Time frame: Baseline and 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 30087197Callaghan-Koru JA, Riekert KA, Ruvalcaba E, Rand CS, Eakin MN. Home Medication Readiness for Preschool Children With Asthma. Pediatrics. 2018 Sep;142(3):e20180829. doi: 10.1542/peds.2018-0829. Epub 2018 Aug 7.
- Background: PubMed 29543493Ruvalcaba E, Chung SE, Rand C, Riekert KA, Eakin M. Evaluating the implementation of a multicomponent asthma education program for Head Start staff. J Asthma. 2019 Feb;56(2):218-226. doi: 10.1080/02770903.2018.1443467. Epub 2018 Mar 15.
- Background: PubMed 29730244Sadreameli SC, Riekert KA, Matsui EC, Rand CS, Eakin MN. Family Caregiver Marginalization is Associated With Decreased Primary and Subspecialty Asthma Care in Head Start Children. Acad Pediatr. 2018 Nov-Dec;18(8):905-911. doi: 10.1016/j.acap.2018.04.135. Epub 2018 May 3.
- Results publication: PubMed 33016987Eakin MN, Zaeh S, Eckmann T, Ruvalcaba E, Rand CS, Hilliard ME, Riekert KA. Effectiveness of a Home- and School-Based Asthma Educational Program for Head Start Children With Asthma: A Randomized Clinical Trial. JAMA Pediatr. 2020 Dec 1;174(12):1191-1198. doi: 10.1001/jamapediatrics.2020.3375.
- Derived from this study: PubMed 34774736Lu MA, Eckmann T, Ruvalcaba E, McQuaid EL, Rand CS, Riekert KA, Eakin MN. Family management of asthma in Head Start preschool children. Ann Allergy Asthma Immunol. 2022 Feb;128(2):178-183. doi: 10.1016/j.anai.2021.11.002. Epub 2021 Nov 10.
- Individual participant dataSharing planned: No. We will not be sharing individual participant data with other researchers
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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. This study is not recruiting at the moment.
Cynthia Rand, Ph.D. principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Home Based Asthma Education in people with Asthma, run by Johns Hopkins University at 1 site in United States.
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 4 inclusion and 2 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: finished, as of the sponsor's last update on 11 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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?
Yes. Results are posted in the registry (first posted 23 Apr 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Asthma Control as Determined by Test for Respiratory and Asthma Control in Kids Assessment Tool (time frame: Baseline, 3, 6, 9 and 12 months). 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 NCT01519453, which also lists 5 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 11 May 2021.