Ignite Creation Date:
2024-05-05 @ 4:38 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00282516
Status:
UNKNOWN
Last Update Posted:
2006-01-26
First Post:
2006-01-25
Brief Title:
Asthma In-Home Monitoring AIM Trial
Sponsor:
Tripler Army Medical Center
Organization:
Tripler Army Medical Center
Study Overview
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
Status:
UNKNOWN
Status Verified Date:
2006-01
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 90 30 yrs mean SD virtual 23 females 37 males 102 31 yrs Virtual patients had higher metered-dose inhalervalved holding chamber score than the office group at 52 weeks 94 vs 89 p 005 a higher adherence to daily asthma symptom diary submission 354 vs 208 p 001 less participant time 636 vs 713 patient months p 005 and were older 102 31 years virtual 90 30 office p 005 Caregivers in both groups perceived an increase in quality of life p005 and an increase in asthma knowledge scores from baseline p 001 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
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 90 30 yrs mean SD virtual 23 females 37 males 102 31 yrs Virtual patients had higher metered-dose inhalervalved holding chamber score than the office group at 52 weeks 94 vs 89 p 005 a higher adherence to daily asthma symptom diary submission 354 vs 208 p 001 less participant time 636 vs 713 patient months p 005 and were older 102 31 years virtual 90 30 office p 005 Caregivers in both groups perceived an increase in quality of life p005 and an increase in asthma knowledge scores from baseline p 001 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None