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Asthma In-Home Monitoring (AIM) Trial

Primary Purpose

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

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
In-home telemonitoring of pediatric patients with persistent asthma
Sponsored by
Tripler Army Medical Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional educational/counseling/training trial for Mild, Moderate and Severe Persistent Asthma as Defined by NHLBI-2 Guidelines focused on measuring asthma, telemedicine, case management, clinic, children, pediatric

Eligibility Criteria

6 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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: 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)

Sites / Locations

  • Tripler Army Medical Center

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
January 25, 2006
Last Updated
January 25, 2006
Sponsor
Tripler Army Medical Center
Collaborators
U.S. Army Medical Research Acquisition Activity
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1. Study Identification

Unique Protocol Identification Number
NCT00282516
Brief Title
Asthma In-Home Monitoring (AIM) Trial
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 Type
Interventional

2. Study Status

Record Verification Date
January 2006
Overall Recruitment Status
Unknown status
Study Start Date
April 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
February 2005 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Tripler Army Medical Center
Collaborators
U.S. Army Medical Research Acquisition Activity

4. Oversight

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mild, Moderate and Severe Persistent Asthma as Defined by NHLBI-2 Guidelines
Keywords
asthma, telemedicine, case management, clinic, children, pediatric

7. Study Design

Primary Purpose
Educational/Counseling/Training
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (false)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
In-home telemonitoring of pediatric patients with persistent asthma

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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: 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Charles W Callahan, DO
Organizational Affiliation
Chief, Department of Pediatrics, Tripler Army Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Debora S Chan, PharmD
Organizational Affiliation
Department of Pediatrics, Tripler Army Medical Center
Official's Role
Study Director
Facility Information:
Facility Name
Tripler Army Medical Center
City
Tripler AMC
State/Province
Hawaii
ZIP/Postal Code
96859-5000
Country
United States

12. IPD Sharing Statement

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Asthma In-Home Monitoring (AIM) Trial

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