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CompletedNCT00282516Updated Feb 10, 2025

Asthma In-Home Monitoring (AIM) Trial

An interventional study of In-home telemonitoring of pediatric patients with persistent asthma in Mild, Moderate and Severe Persistent Asthma as Defined by NHLBI-2 Guidelines, sponsored by Tripler Army Medical Center. Completed at 1 site in United States. Open to participants aged 6 Years to 17 Years. Per ClinicalTrials.gov, last updated 2025-02-10.

Sponsored by Tripler Army Medical Center · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
120
Allocation
Randomized
Ages
6 Years to 17 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Mild, Moderate and Severe Persistent Asthma as Defined by NHLBI-2 Guidelines

Keywords

  • asthma
  • telemedicine
  • case management
  • clinic
  • children
  • pediatric
03

In context

Lymphoma, Follicular

1,891 studies on the registry are indexed under Lymphoma, Follicular; 290 are open to participants now.

This study's enrollment of 120 is above the median of 48 across 1,503 interventional studies indexed under Lymphoma, Follicular.

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Lead sponsor

Tripler Army Medical Center is the lead sponsor of 11 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
6 Years to 17 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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
  • 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

Exclusion criteria

Exclusion Criteria:

  • 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)
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
120 participants (actual)

Interventions

  • ProcedureIn-home telemonitoring of pediatric patients with persistent asthma
06

Study locations

1 site
  • Tripler Army Medical Center
    Tripler AMC, Hawaii 96859-5000, United States
07

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Apr 2003, a primary completion of Apr 2004 and a completion of Apr 2004. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 25, 2006
First posted
Jan 26, 2006
Start
Apr 2003
Primary completionActual
Apr 2004
Completion
Apr 2004
Last update
Feb 10, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 10, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
08

Registry details

Key details

Study ID
NCT00282516
Lead sponsor
Tripler Army Medical Center
Collaborators
U.S. Army Medical Research Acquisition Activity
Responsible party
Sponsor
First posted
Jan 26, 2006
Start date
Apr 2003
Primary completion
Apr 2004
Completion
Apr 2004
Last update
Feb 10, 2025

Study contacts

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
View the source record on ClinicalTrials.gov ↗

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