Asthma in ChildrenFIPANCT03302962
Factors Influencing Pediatric Asthma
A study testing Intensive Asthma Education in people with Asthma in Children, run by Missouri Breaks Industries Research, Inc. at 1 site in United States.
Trial summary
Asthma is a chronic lung disease with serious morbidity and potential mortality. Multiple physiologic, environmental and social conditions impact the prevalence and severity of asthma. Read more about this study
- Who is it for?
- Ages 6 to 17 years
- Conditions the study is for
- Asthma in Children
- What is being tested?
- Intensive Asthma Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 324 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Mar 2013to 25 May 2017
- 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 6 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Cases must be "American Indian" (eligibile for care within the Indian Health Service); and at least 2 of the following 3 criteria:
- a diagnosis of asthma on at least 2 occasions by more than one provider during the past 2 years.
- refills of asthma treatment medications on at least 2 occasions during the past 2 years.
- Improvement of spirometry FEV1 of 20% with use of albuterol MDI or nebulizer.
- Controls meet the same demographic criteria as cases, but must also meet all of the following criteria.
- No diagnosis of asthma by any provider during the past 2 years.
- No prescriptions of any asthma meds during the past 2 years.
- FEV1 on spirometry greater than 80% of predicted value Exclusion Criteria:
Who cannot join
- Birthweight less than 2500 grams
- Neonatal ventilator treatment
- Hospitalization at birth greater than 15 days.
- Congenital heart anomaly requiring surgery
- Diagnosis of cystic fibrosis
- Congenital lung, diaphragm, chest wall, or airway anomaly
- Diagnosis of pneumonia, pertussis, or tuberculosis within the past year
- Congenital muscular disorder
Trial locations and contacts
1 site in 1 country.
United States1 site
Missouri Breaks Industries Research Inc.
Eagle Butte, South Dakota, 57625
About this study
Asthma is a chronic lung disease with serious morbidity and potential mortality. Multiple physiologic, environmental and social conditions impact the prevalence and severity of asthma. Even when diagnosed, effective control can be impeded by improper use of medication, not understanding or being unable to avoid environmental triggers, lack of continuity in follow-up care, and lack of an asthma action plan. American Indians are especially at-risk for health problems related to asthma. American Indians have the highest asthma rate among single-race groups; 18.5% of American Indians are diagnosed with asthma, while only 11% are diagnosed with asthma in the general population but little is known about why this is true. Asthma is a prototypic example of the interaction of biologic, environmental and psychosocial influences on disease and this study investigated the possible improvement in asthma control from an intensive educational intervention.
Read the detailed description
The primary aim of this study was to test the hypothesis that intensive patient education regarding self-directed, stepped care will result in reduced morbidity and medical care utilization, while increasing quality of life.
One half (54) of the identified cases will be randomized to receive the previously established "BREATHE" study educational program, emphasizing patient-centered, self management of asthma. Periodic follow-up through personal contact and surveillance of IHS RPMS or other medical provider records was conducted.
- Conditions
- Asthma in Children
- Being tested
- Intensive Asthma Education
- Keywords
- asthma, pediatric, american indian, children
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intensive Asthma EducationBehavioural
One half (54) of the identified cases were randomized to receive the previously established "BREATHE" study educational program, emphasizing patient-centered, self management of asthma. Periodic follow-up through personal contact and surveillance of IHS RPMS or other medical provider records was conducted.
| Study group | Role | What they receive |
|---|---|---|
| Intensive Asthma Education | Experimental | One half (54) of the identified cases were randomized to receive the previously established "BREATHE" study educational program, emphasizing patient-centered, self management of asthma. Periodic follow-up through personal contact and surveillance of IHS RPMS or other medical provider records was conducted. Receives: Behavioral: Intensive Asthma Education |
| Routine Asthma Education Literature | No intervention | The remaining 54 cases were randomized to the "control" arm and received written materials related to patient-centered asthma control. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Chart Review of ED Visits
Emergency room visits for pulmonary complaints
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2017
- Study start14 Mar 2013
- Primary completion25 May 2017
- Study completion25 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Asthma in ChildrenStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 324 participants (actual)
Sponsor and investigators
- Lead sponsor
- Missouri Breaks Industries Research, Inc.
- Sponsor type
- University, hospital or other
- Collaborators
- Sanford Research
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03302962
- Sponsor's protocol ID
- 1U54MD008164-01
- Acronym
- FIPA
- Status last verified
- Oct 2017
- First submitted
- 29 Sep 2017
- Last updated
- 5 Oct 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: This study was conducted by permission of the Cheyenne River Sioux Tribe and data sharing is allowed only with their permission. Any investigators wishing to access data from the study should contact Missouri Breaks Industries Research Inc for information on application procedures.
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Factors Influencing Pediatric Asthma
- ClinicalTrials.gov ID
- NCT03302962
- Acronym / sponsor ID
- FIPA / 1U54MD008164-01
- Conditions
- Asthma in Children
- Keywords
- asthma, pediatric, american indian, children
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 324 participants (actual)
- Lead sponsor
- Missouri Breaks Industries Research, Inc.University, hospital or other
- Collaborators
- Sanford Research
- Study start
- 14 Mar 2013 (actual)
- Primary completion
- 25 May 2017 (actual)
- Study completion
- 25 May 2017 (actual)
- First posted
- 5 Oct 2017 (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.
Asthma is a chronic lung disease with serious morbidity and potential mortality. Multiple physiologic, environmental and social conditions impact the prevalence and severity of asthma. Even when diagnosed, effective control can be impeded by improper use of medication, not understanding or being unable to avoid environmental triggers, lack of continuity in follow-up care, and lack of an asthma action plan. American Indians are especially at-risk for health problems related to asthma. American Indians have the highest asthma rate among single-race groups; 18.5% of American Indians are diagnosed with asthma, while only 11% are diagnosed with asthma in the general population but little is known about why this is true. Asthma is a prototypic example of the interaction of biologic, environmental and psychosocial influences on disease and this study investigated the possible improvement in asthma control from an intensive educational intervention.
Detailed description
The primary aim of this study was to test the hypothesis that intensive patient education regarding self-directed, stepped care will result in reduced morbidity and medical care utilization, while increasing quality of life.
One half (54) of the identified cases will be randomized to receive the previously established "BREATHE" study educational program, emphasizing patient-centered, self management of asthma. Periodic follow-up through personal contact and surveillance of IHS RPMS or other medical provider records was conducted.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intensive Asthma Education | Experimental | Behavioral: Intensive Asthma EducationOne half (54) of the identified cases were randomized to receive the previously established "BREATHE" study educational program, emphasizing patient-centered, self management of asthma. Periodic follow-up through personal contact and surveillance of IHS RPMS or other medical provider records was conducted. |
| Routine Asthma Education Literature | No intervention | –The remaining 54 cases were randomized to the "control" arm and received written materials related to patient-centered asthma control. |
Who may qualify
- Ages
- 6 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- Cases must be "American Indian" (eligibile for care within the Indian Health Service); and at least 2 of the following 3 criteria:
- Controls meet the same demographic criteria as cases, but must also meet all of the following criteria.
Key exclusion criteria (8 listed)
- Birthweight less than 2500 grams
- Neonatal ventilator treatment
- Hospitalization at birth greater than 15 days.
- Congenital heart anomaly requiring surgery
- Diagnosis of cystic fibrosis
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 |
|---|---|---|
| Intensive Asthma EducationOne half (54) of the identified cases were randomized to receive the previously established "BREATHE" study educational program, emphasizing patient-centered, self management of asthma. Periodic follow-up through personal contact and surveillance of IHS RPMS or other medical provider records was conducted. | Behavioural | Intensive Asthma Education |
Primary outcome
Chart Review of ED Visits
Time frame: 3 years
Emergency room visits for pulmonary complaints
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 5 Oct 2017.
- Individual participant dataSharing planned: No. This study was conducted by permission of the Cheyenne River Sioux Tribe and data sharing is allowed only with their permission. Any investigators wishing to access data from the study should contact Missouri Breaks Industries Research Inc for information on application procedures.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intensive Asthma Education in people with Asthma in Children, run by Missouri Breaks Industries Research, Inc. 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 8 inclusion and 8 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 5 Oct 2017. 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?
Chart Review of ED Visits (time frame: 3 years). 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 5 Oct 2017.