AsthmaNCT00377663
Internet-Based Program to Improve Asthma Management in Children
A study testing AsthmaNet in people with Asthma, run by Seattle Children's Hospital at 1 site in United States.
Trial summary
Asthma is a respiratory condition that affects millions of children. It can be controlled, however, with the proper medications and treatment. AsthmaNet, an internet-based asthma management system, aims to improve the asthma care of children by providing their parents and doctors with appropriate tools and feedback… Read more about this study
- Who is it for?
- Ages 2 to 10 years
- Conditions the study is for
- Asthma
- What is being tested?
- AsthmaNet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2007to Aug 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 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Asthma
- Receives asthma care at a clinic in Western Washington
- Has access to the internet at home
Who cannot join
- Does not speak or read English
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Internet-Based Patient-Centered Asthma Management System
Asthma is a respiratory condition that affects millions of children. It can be controlled, however, with the proper medications and treatment. AsthmaNet, an internet-based asthma management system, aims to improve the asthma care of children by providing their parents and doctors with appropriate tools and feedback related to asthma management. The purpose of this study is to evaluate the effectiveness of AsthmaNet at improving quality of care and controlling asthma symptoms in children.
Read the detailed description
In the United States, almost 9 million children have been diagnosed with asthma. It is a leading cause of hospitalization, chronic disease, and school absenteeism. With the proper treatment, most children with asthma are able to lead a normal life. However, if asthma is not adequately controlled, it can be a life-threatening disease. It is important for parents to work with their child's doctor to develop a comprehensive treatment plan that minimizes asthma symptoms. AsthmaNet, an interactive web-based system, aims to improve the quality of care for children with asthma by enhancing parents' asthma care skills and encouraging parents to discuss their child's asthma care with their doctor. AsthmaNet provides evidence-based guidelines, asthma management tools, and individually tailored feedback to both parents and physicians to improve communication and enhance asthma management skills and behaviors. The goal of this study is to evaluate the effectiveness of AsthmaNet at increasing medication and treatment adherence in children with asthma.
This 1-year study will enroll young children with asthma. Participants will be randomly assigned to either use the AsthmaNet web site or not use the web site. The web site will provide parents of children in the AsthmaNet group with individualized clinical information regarding their child's asthma care and with decision-making aids that they can share with their child's doctor. The web site will also prompt parents to make additional doctor appointments, as needed, to discuss their child's condition. All children will attend regularly scheduled doctor's appointments for asthma and receive their usual care; there are no additional study visits specifically for this study. Study researchers will review medical records to analyze medication usage and asthma symptoms. Participants in the AsthmaNet group will complete questionnaires on a monthly basis to assess asthma status; the control group will complete questionnaires at Month 6 and Year 1.
- Conditions
- Asthma
- Being tested
- AsthmaNet
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AsthmaNetBehavioural
The AsthmaNet Web site will provide parents of children in the AsthmaNet group with individualized clinical information regarding their child's asthma care and with decision-making aids that they can share with their child's doctor. The web site will also prompt parents to make additional doctor appointments, as needed, to discuss their child's condition.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Participants will use the AsthmaNet web site. Receives: Behavioral: AsthmaNet |
| 2 | No intervention | Participants will not use the AsthmaNet Web site. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Appropriate use of asthma controller medications
Measured: Measured at Year 1
Number of asthma symptom days
Measured: Measured at Year 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2006 (estimated)
- Study startJul 2007
- Primary completionAug 2009
- Study completionAug 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by Seattle Children's HospitalThe 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
- Participant
- Enrolment
- 600 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seattle Children's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Dimitri Christakis, Seattle Children's Hospital
- Investigators
- Dimitri A. Christakis, MD, MPH, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00377663
- Sponsor's protocol ID
- 431
- Other IDs
- R01HL079402-01A2
- Status last verified
- Mar 2014
- First submitted
- 14 Sep 2006
- Last updated
- 26 Mar 2014
- Results posted
- No
Publications
Christakis DA, Garrison MM, Lozano P, Meischke H, Zhou C, Zimmerman FJ. Improving parental adherence with asthma treatment guidelines: a randomized controlled trial of an interactive website. Acad Pediatr. 2012 Jul-Aug;12(4):302-11. doi: 10.1016/j.acap.2012.03.006. Epub 2012 Jun 11.
PubMed 22694878
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Internet-Based Patient-Centered Asthma Management System
- ClinicalTrials.gov ID
- NCT00377663
- Acronym / sponsor ID
- 431
- Conditions
- Asthma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 600 participants (actual)
- Lead sponsor
- Seattle Children's HospitalUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Jul 2007
- Primary completion
- Aug 2009 (actual)
- Study completion
- Aug 2009 (actual)
- First posted
- 18 Sep 2006 (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.
Asthma is a respiratory condition that affects millions of children. It can be controlled, however, with the proper medications and treatment. AsthmaNet, an internet-based asthma management system, aims to improve the asthma care of children by providing their parents and doctors with appropriate tools and feedback related to asthma management. The purpose of this study is to evaluate the effectiveness of AsthmaNet at improving quality of care and controlling asthma symptoms in children.
Detailed description
In the United States, almost 9 million children have been diagnosed with asthma. It is a leading cause of hospitalization, chronic disease, and school absenteeism. With the proper treatment, most children with asthma are able to lead a normal life. However, if asthma is not adequately controlled, it can be a life-threatening disease. It is important for parents to work with their child's doctor to develop a comprehensive treatment plan that minimizes asthma symptoms. AsthmaNet, an interactive web-based system, aims to improve the quality of care for children with asthma by enhancing parents' asthma care skills and encouraging parents to discuss their child's asthma care with their doctor. AsthmaNet provides evidence-based guidelines, asthma management tools, and individually tailored feedback to both parents and physicians to improve communication and enhance asthma management skills and behaviors. The goal of this study is to evaluate the effectiveness of AsthmaNet at increasing medication and treatment adherence in children with asthma.
This 1-year study will enroll young children with asthma. Participants will be randomly assigned to either use the AsthmaNet web site or not use the web site. The web site will provide parents of children in the AsthmaNet group with individualized clinical information regarding their child's asthma care and with decision-making aids that they can share with their child's doctor. The web site will also prompt parents to make additional doctor appointments, as needed, to discuss their child's condition. All children will attend regularly scheduled doctor's appointments for asthma and receive their usual care; there are no additional study visits specifically for this study. Study researchers will review medical records to analyze medication usage and asthma symptoms. Participants in the AsthmaNet group will complete questionnaires on a monthly basis to assess asthma status; the control group will complete questionnaires at Month 6 and Year 1.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: AsthmaNetParticipants will use the AsthmaNet web site. |
| 2 | No intervention | –Participants will not use the AsthmaNet Web site. |
Who may qualify
- Ages
- 2 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Asthma
- Receives asthma care at a clinic in Western Washington
- Has access to the internet at home
Key exclusion criteria (1 listed)
- Does not speak or read English
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 |
|---|---|---|
| AsthmaNetThe AsthmaNet Web site will provide parents of children in the AsthmaNet group with individualized clinical information regarding their child's asthma care and with decision-making aids that they can share with their child's doctor. The web site will also prompt parents to make additional doctor appointments, as needed, to discuss their child's condition. | Behavioural | 1 |
Primary outcome
Appropriate use of asthma controller medications
Time frame: Measured at Year 1
Number of asthma symptom days
Time frame: Measured at Year 1
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 26 Mar 2014.
- Derived from this study: PubMed 22694878Christakis DA, Garrison MM, Lozano P, Meischke H, Zhou C, Zimmerman FJ. Improving parental adherence with asthma treatment guidelines: a randomized controlled trial of an interactive website. Acad Pediatr. 2012 Jul-Aug;12(4):302-11. doi: 10.1016/j.acap.2012.03.006. Epub 2012 Jun 11.
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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. This study is not recruiting at the moment.
Dimitri A. Christakis, MD, MPH principal investigator
University of Washington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AsthmaNet in people with Asthma, run by Seattle Children's Hospital 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 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: finished, as of the sponsor's last update on 26 Mar 2014. 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?
Appropriate use of asthma controller medications (time frame: Measured at Year 1). The study lists 2 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 NCT00377663, which also lists 1 linked publication.
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 26 Mar 2014.