Asthma In-Home Monitoring (AIM) Trial
|ClinicalTrials.gov Identifier: NCT00282516|
Recruitment Status : Unknown
Verified January 2006 by Tripler Army Medical Center.
Recruitment status was: Active, not recruiting
First Posted : January 26, 2006
Last Update Posted : January 26, 2006
|Condition or disease||Intervention/treatment||Phase|
|Mild, Moderate and Severe Persistent Asthma as Defined by NHLBI-2 Guidelines||Procedure: In-home telemonitoring of pediatric patients with persistent asthma||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Enrollment :||120 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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”|
|Study Start Date :||April 2003|
|Study Completion Date :||February 2005|
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00282516
|United States, Hawaii|
|Tripler Army Medical Center|
|Tripler AMC, Hawaii, United States, 96859-5000|
|Principal Investigator:||Charles W Callahan, DO||Chief, Department of Pediatrics, Tripler Army Medical Center|
|Study Director:||Debora S Chan, PharmD||Department of Pediatrics, Tripler Army Medical Center|