Mild, Moderate and Severe Persistent Asthma as Defined by NHLBI-2 GuidelinesNCT00282516
Asthma In-Home Monitoring (AIM) Trial
A study testing In-home telemonitoring of pediatric patients with persistent asthma in people with Mild, Moderate and Severe Persistent Asthma as Defined by NHLBI-2 Guidelines, run by Tripler Army Medical Center at 1 site in United States.
Trial summary
OBJECTIVE: Determine whether home asthma telemonitoring using store-and-forward technology improves outcomes when compared to in-person, office-based visits. Read more about this study
- Who is it for?
- Ages 6 to 17 years
- Conditions the study is for
- Mild, Moderate and Severe Persistent Asthma as Defined by NHLBI-2 Guidelines
- What is being tested?
- In-home telemonitoring of pediatric patients with persistent asthma
- Type of treatment
- Surgery or procedure
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2003to Apr 2004
- 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
- Diagnosis of persistent asthma as defined using the NHLBI Expert Panel Report -2 guidelines Assignment of severity classification will be made at the beginning of the study based on severity of disease off therapy.
- Dependent of active duty or retired US military personnel
- 6 to 17 years of age
- Not moving from Oahu for 12 months after entry into study
- Ability to receive cable modem hook-up in home
- Willingness to learn to record and send MDI + spacer technique and peak flow two times week
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- Willing to attend asthma education follow-up visits either in person or electronically at 2- weeks, 6- weeks, 3-months and 6-month intervals after initiation into the study.
- Willing to complete survey at the end of study period.
- Willing to sign informed, written consent
Who cannot join
- Diagnosis of mild intermittent asthma as defined by Expert Panel Report -2 guidelines.
- <6 and >17 years of age
- Family leaving Oahu within 12 months
- Inability to receive cable modem hook-up in home
- Unwilling or unable to learn to record and send MDI + spacer technique and peak flow and/or to attend asthma education follow-up visits either in person or electronically at initiation into study and at 2- weeks, 6- weeks, 3-months and 6 month intervals.
- Unwilling to complete survey at the end of study period.
- Patients or parents who decline to participate.
- Patients with other chronic pulmonary disease (cystic fibrosis, bronchopulmonary dysplasia)
Trial locations and contacts
1 site in 1 country.
United States1 site
Tripler Army Medical Center
Tripler AMC, Hawaii, 96859-5000
About this study
Official title: "Internet-based Home Monitoring and Education of Children With Asthma is Comparable to Ideal, Office-based Care: Results of a One-year, Asthma In-Home Monitoring (AIM) Trial"
OBJECTIVE: Determine whether home asthma telemonitoring using store-and-forward technology improves outcomes when compared to in-person, office-based visits.
Read the detailed description
OBJECTIVE: Determine whether home asthma telemonitoring using store-and-forward technology improves outcomes when compared to in-person, office-based visits.
METHODS: 120 patients 6-17 yrs with persistent asthma were randomized into two groups: office or virtual. Both groups followed the same ambulatory clinical pathway for 12 months. Office patients received traditional in-person education and case management. Virtual patients received computers, Internet connection, and in-home Web-based case management and received education via the study web site. They also recorded and forwarded a video of peak flow and inhaler use to their case manager two times a week for 6 weeks then once a week thereafter and submitted daily asthma diaries electronically via the web site. Virtual patients were seen in-person only 3 times. Regimen adherence was assessed by monitoring therapeutic (controller medication use, video medication use) and diagnostic (asthma symptom diary and peak flow submitted electronically) outcomes. Disease control outcome measures included quality of life, utilization of services, and symptom control.
RESULTS: 120 volunteers (45 females) were enrolled. The groups were clinically comparable: office 22 females, 38 males 9.0 + 3.0 yrs (mean + SD) virtual 23 females, 37 males, 10.2 + 3.1 yrs. Virtual patients had higher metered-dose inhaler/valved holding chamber score than the office group at 52 weeks (94% vs 89%, p < 0.05), a higher adherence to daily asthma symptom diary submission (35.4% vs 20.8 %, p < 0.01), less participant time (636 vs 713 patient months, p < 0.05), and were older (10.2 + 3.1 years virtual, 9.0 + 3.0 office, p < 0.05). Caregivers in both groups perceived an increase in quality of life (p<0.05) and an increase in asthma knowledge scores from baseline (p < 0.01). There were no other outcome differences in therapeutic or disease control or outcome measures.
CONCLUSION: Virtual patients achieved excellent asthma therapeutic and disease control outcomes. When compared to idealized office-based care they were more adherent to diary submission and had better inhaler scores at 52 weeks than office-based patients. Store-and-forward telemedicine technology and case management provides an additional tool to assist in the management of children with persistent asthma.
- Being tested
- In-home telemonitoring of pediatric patients with persistent asthma
- Keywords
- asthma, telemedicine, case management, clinic, children, pediatric
- Medical subject headings
- Lymphoma, Follicular, Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
In-home telemonitoring of pediatric patients with persistent asthmaProcedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2006 (estimated)
- Study startApr 2003
- Primary completionApr 2004
- Study completionApr 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild, Moderate and Severe Persistent Asthma as Defined by NHLBI-2 GuidelinesStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tripler Army Medical Center
- Sponsor type
- US federal agency
- Collaborators
- U.S. Army Medical Research Acquisition Activity
- Responsible party
- Sponsor
- Investigators
- Charles W Callahan, DO, Principal investigator, Chief, Department of Pediatrics, Tripler Army Medical CenterDebora S Chan, PharmD, Study director, Department of Pediatrics, Tripler Army Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00282516
- Sponsor's protocol ID
- 28H01
- Status last verified
- Feb 2025
- First submitted
- 25 Jan 2006
- Last updated
- 10 Feb 2025
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Internet-based Home Monitoring and Education of Children With Asthma is Comparable to Ideal, Office-based Care: Results of a One-year, Asthma In-Home Monitoring (AIM) Trial"
- ClinicalTrials.gov ID
- NCT00282516
- Acronym / sponsor ID
- 28H01
- Keywords
- asthma, telemedicine, case management, clinic, children, pediatric
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Tripler Army Medical CenterUS federal agency
- Collaborators
- U.S. Army Medical Research Acquisition Activity
- Study start
- Apr 2003
- Primary completion
- Apr 2004 (actual)
- Study completion
- Apr 2004
- First posted
- 26 Jan 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.
OBJECTIVE: Determine whether home asthma telemonitoring using store-and-forward technology improves outcomes when compared to in-person, office-based visits.
Detailed description
OBJECTIVE: Determine whether home asthma telemonitoring using store-and-forward technology improves outcomes when compared to in-person, office-based visits.
METHODS: 120 patients 6-17 yrs with persistent asthma were randomized into two groups: office or virtual. Both groups followed the same ambulatory clinical pathway for 12 months. Office patients received traditional in-person education and case management. Virtual patients received computers, Internet connection, and in-home Web-based case management and received education via the study web site. They also recorded and forwarded a video of peak flow and inhaler use to their case manager two times a week for 6 weeks then once a week thereafter and submitted daily asthma diaries electronically via the web site. Virtual patients were seen in-person only 3 times. Regimen adherence was assessed by monitoring therapeutic (controller medication use, video medication use) and diagnostic (asthma symptom diary and peak flow submitted electronically) outcomes. Disease control outcome measures included quality of life, utilization of services, and symptom control.
RESULTS: 120 volunteers (45 females) were enrolled. The groups were clinically comparable: office 22 females, 38 males 9.0 + 3.0 yrs (mean + SD) virtual 23 females, 37 males, 10.2 + 3.1 yrs. Virtual patients had higher metered-dose inhaler/valved holding chamber score than the office group at 52 weeks (94% vs 89%, p < 0.05), a higher adherence to daily asthma symptom diary submission (35.4% vs 20.8 %, p < 0.01), less participant time (636 vs 713 patient months, p < 0.05), and were older (10.2 + 3.1 years virtual, 9.0 + 3.0 office, p < 0.05). Caregivers in both groups perceived an increase in quality of life (p<0.05) and an increase in asthma knowledge scores from baseline (p < 0.01). There were no other outcome differences in therapeutic or disease control or outcome measures.
CONCLUSION: Virtual patients achieved excellent asthma therapeutic and disease control outcomes. When compared to idealized office-based care they were more adherent to diary submission and had better inhaler scores at 52 weeks than office-based patients. Store-and-forward telemedicine technology and case management provides an additional tool to assist in the management of children with persistent asthma.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 6 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
- Diagnosis of persistent asthma as defined using the NHLBI Expert Panel Report -2 guidelines Assignment of severity classification will be made at the beginning of the study based on severity of disease off therapy.
- Dependent of active duty or retired US military personnel
- 6 to 17 years of age
- Not moving from Oahu for 12 months after entry into study
- Ability to receive cable modem hook-up in home
Key exclusion criteria (8 listed)
- Diagnosis of mild intermittent asthma as defined by Expert Panel Report -2 guidelines.
- <6 and >17 years of age
- Family leaving Oahu within 12 months
- Inability to receive cable modem hook-up in home
- Unwilling or unable to learn to record and send MDI + spacer technique and peak flow and/or to attend asthma education follow-up visits either in person or electronically at initiation into study and at 2- weeks, 6- weeks, 3-months and 6 month intervals.
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 |
|---|---|---|
| In-home telemonitoring of pediatric patients with persistent asthma | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
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 10 Feb 2025.
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.
Charles W Callahan, DO principal investigator
Chief, Department of Pediatrics, Tripler Army Medical Center
Debora S Chan, PharmD study director
Department of Pediatrics, Tripler Army Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing In-home telemonitoring of pediatric patients with persistent asthma in people with Mild, Moderate and Severe Persistent Asthma as Defined by NHLBI-2 Guidelines, run by Tripler Army Medical Center 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 9 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 10 Feb 2025. 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.
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 10 Feb 2025.