AsthmaNCT00094276
Intervention for Improving Asthma Care for Minority Children in Head Start
A study testing Facilitated Asthma Communication Intervention (FACI) and Breathmobile intervention in people with Asthma and Lung Diseases, run by Johns Hopkins University at 1 site in United States.
Trial summary
This study will evaluate two interventions that are designed to reduce asthma morbidity and improve asthma care of children in Head Start in urban Baltimore. Read more about this study
- Who is it for?
- Ages 2 to 6 years
- Conditions the study is for
- Asthma, Lung Diseases
- What is being tested?
- Facilitated Asthma Communication Intervention (FACI) and Breathmobile intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 336 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2004to Jun 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Diagnosis of asthma or reactive airway disease (RAD) OR
- Experienced asthma symptoms within 1 month prior to study entry
- Treated for asthma in the emergency department within 6 months prior to study entry
- Asthma symptoms include day or nighttime wheezing, shortness of breath and cough, or use of rescue medicine (e.g., albuterol or ventolin)
Who cannot join
- Currently participating in another asthma education research study
Trial locations and contacts
1 site in 1 country.
United States1 site
Johns Hopkins University School of Medicine
Baltimore, Maryland, 21224
About this study
Official title: Improving Asthma Care for Minority Children in Head Start
This study will evaluate two interventions that are designed to reduce asthma morbidity and improve asthma care of children in Head Start in urban Baltimore.
Read the detailed description
BACKGROUND:
Asthma-related morbidity and mortality are disproportionately high among low-income African American children. The effects of asthma are particularly harsh in very young children and their families, resulting in high rates of emergency department care, hospitalization, decreased quality of life, and the risk of fatal asthma. Research suggests that the contributing factors to this high morbidity include under-use of asthma primary preventive care, sub-optimal medical management, and inappropriate asthma management behaviors. Despite the importance of early and regular asthma preventive care for children, this goal has proved elusive. Head Start programs offer an ideal venue for accessing high-risk, low-income preschool children and improving asthma morbidity. The study will test the hypothesis that removing barriers to preventive asthma care and facilitating communication between parents and primary care providers (PCP) are necessary prerequisites to optimally influence caregiver's asthma management practices. The study will remove barriers by the use of Breathmobile, a community-based service that is specifically designed to deliver asthma screening and special consultation directly to families and children in high-risk neighborhoods. In addition, the study will evaluate a caregiver/PCP communication intervention designed to facilitate communication between parents and PCPs about a child's asthma severity and recommended therapy.
DESIGN NARRATIVE:
This two times two modified factorial study design will compare the following in their effectiveness in reducing asthma morbidity and improving asthma management: a Breathmobile intervention combined with a Facilitated Asthma Communication intervention (FACI); a FACI alone; the Breathmobile intervention alone; or a control group. A total of 360 Head Start students ages 2 to 6 with symptomatic doctor-diagnosed asthma will be recruited. The primary study outcome measure will be the number of symptom-free days over a period of 12 months. Secondary outcomes include health care utilization (i.e., emergency department visits, hospitalizations, and primary care visits), asthma medications, parent asthma-related quality of life, parent asthma management practices, and cost-effectiveness. The study will test the hypothesis that a FACI combined with the Breathmobile intervention will be the most effective in improving parent and PCP management of the child's asthma and in reducing asthma morbidity.
- Conditions
- Asthma, Lung Diseases
- Being tested
- Facilitated Asthma Communication Intervention (FACI), Breathmobile intervention
- Medical subject headings
- Asthma, Lung Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Facilitated Asthma Communication Intervention (FACI)Behavioural
A caregiver/PCP communication intervention designed to facilitate communication between parents and PCPs about a child's asthma severity and recommended therapy.
Breathmobile interventionBehavioural
A community-based service that is specifically designed to deliver asthma screening and special consultation directly to families and children in high-risk neighborhoods.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Breathmobile intervention combined with a Facilitated Asthma Communication intervention (FACI) Receives: Behavioral: Facilitated Asthma Communication Intervention (FACI); Behavioral: Breathmobile intervention |
| 2 | Active comparator | FACI intervention Receives: Behavioral: Facilitated Asthma Communication Intervention (FACI) |
| 3 | Active comparator | Breathmobile intervention Receives: Behavioral: Breathmobile intervention |
| 4 | No intervention | Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Symptom-free days
Measured: Measured at baseline, 6 months and 12 months
Secondary outcomes (5)
Health care utilization (i.e., emergency department visits, hospitalizations, and primary care visits)
Measured: Measured at baseline, 6 months and 12 months
Asthma medications
Measured: Measured at baseline, 6 months and 12 months
Parent asthma-related quality of life
Measured: Measured at baseline, 6 months and 12 months
Parent asthma management practices
Measured: Measured at baseline, 6 months and 12 months
Cost-effectiveness
Measured: Measured at 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2004 (estimated)
- Study startSep 2004
- Primary completionJun 2009
- Study completionJun 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 336 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Cynthia S. Rand, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00094276
- Sponsor's protocol ID
- 168
- Other IDs
- R01HL073833-01
- Status last verified
- Apr 2018
- First submitted
- 15 Oct 2004
- Last updated
- 25 Apr 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Asthma Care for Minority Children in Head Start
- ClinicalTrials.gov ID
- NCT00094276
- Acronym / sponsor ID
- 168
- Conditions
- Asthma, Lung Diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 336 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Sep 2004
- Primary completion
- Jun 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 15 Oct 2004 (estimated)
- 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.
This study will evaluate two interventions that are designed to reduce asthma morbidity and improve asthma care of children in Head Start in urban Baltimore.
Detailed description
BACKGROUND:
Asthma-related morbidity and mortality are disproportionately high among low-income African American children. The effects of asthma are particularly harsh in very young children and their families, resulting in high rates of emergency department care, hospitalization, decreased quality of life, and the risk of fatal asthma. Research suggests that the contributing factors to this high morbidity include under-use of asthma primary preventive care, sub-optimal medical management, and inappropriate asthma management behaviors. Despite the importance of early and regular asthma preventive care for children, this goal has proved elusive. Head Start programs offer an ideal venue for accessing high-risk, low-income preschool children and improving asthma morbidity. The study will test the hypothesis that removing barriers to preventive asthma care and facilitating communication between parents and primary care providers (PCP) are necessary prerequisites to optimally influence caregiver's asthma management practices. The study will remove barriers by the use of Breathmobile, a community-based service that is specifically designed to deliver asthma screening and special consultation directly to families and children in high-risk neighborhoods. In addition, the study will evaluate a caregiver/PCP communication intervention designed to facilitate communication between parents and PCPs about a child's asthma severity and recommended therapy.
DESIGN NARRATIVE:
This two times two modified factorial study design will compare the following in their effectiveness in reducing asthma morbidity and improving asthma management: a Breathmobile intervention combined with a Facilitated Asthma Communication intervention (FACI); a FACI alone; the Breathmobile intervention alone; or a control group. A total of 360 Head Start students ages 2 to 6 with symptomatic doctor-diagnosed asthma will be recruited. The primary study outcome measure will be the number of symptom-free days over a period of 12 months. Secondary outcomes include health care utilization (i.e., emergency department visits, hospitalizations, and primary care visits), asthma medications, parent asthma-related quality of life, parent asthma management practices, and cost-effectiveness. The study will test the hypothesis that a FACI combined with the Breathmobile intervention will be the most effective in improving parent and PCP management of the child's asthma and in reducing asthma morbidity.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: Facilitated Asthma Communication Intervention (FACI), Behavioral: Breathmobile interventionBreathmobile intervention combined with a Facilitated Asthma Communication intervention (FACI) |
| 2 | Active comparator | Behavioral: Facilitated Asthma Communication Intervention (FACI)FACI intervention |
| 3 | Active comparator | Behavioral: Breathmobile interventionBreathmobile intervention |
| 4 | No intervention | –Control group |
Who may qualify
- Ages
- 2 to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Diagnosis of asthma or reactive airway disease (RAD) OR
- Experienced asthma symptoms within 1 month prior to study entry
- Treated for asthma in the emergency department within 6 months prior to study entry
- Asthma symptoms include day or nighttime wheezing, shortness of breath and cough, or use of rescue medicine (e.g., albuterol or ventolin)
Key exclusion criteria (1 listed)
- Currently participating in another asthma education research 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 |
|---|---|---|
| Facilitated Asthma Communication Intervention (FACI)A caregiver/PCP communication intervention designed to facilitate communication between parents and PCPs about a child's asthma severity and recommended therapy. | Behavioural | 1, 2 |
| Breathmobile interventionA community-based service that is specifically designed to deliver asthma screening and special consultation directly to families and children in high-risk neighborhoods. | Behavioural | 1, 3 |
Primary outcome
Symptom-free days
Time frame: Measured at baseline, 6 months and 12 months
5 secondary outcomes
Health care utilization (i.e., emergency department visits, hospitalizations, and primary care visits)
Time frame: Measured at baseline, 6 months and 12 months
Asthma medications
Time frame: Measured at baseline, 6 months and 12 months
Parent asthma-related quality of life
Time frame: Measured at baseline, 6 months and 12 months
Parent asthma management practices
Time frame: Measured at baseline, 6 months and 12 months
Cost-effectiveness
Time frame: Measured at 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2018.
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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 S. Rand 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 Facilitated Asthma Communication Intervention (FACI) and Breathmobile intervention in people with Asthma and Lung Diseases, 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 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: finished, as of the sponsor's last update on 25 Apr 2018. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Symptom-free days (time frame: Measured at baseline, 6 months and 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Apr 2018.