Asthma In-Home Monitoring (AIM) Trial

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2006 by Tripler Army Medical Center.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
U.S. Army Medical Research Acquisition Activity
Information provided by:
Tripler Army Medical Center
ClinicalTrials.gov Identifier:
NCT00282516
First received: January 25, 2006
Last updated: NA
Last verified: January 2006
History: No changes posted
  Purpose

OBJECTIVE: Determine whether home asthma telemonitoring using store-and-forward technology improves outcomes when compared to in-person, office-based visits.


Condition Intervention
Mild, Moderate and Severe Persistent Asthma as Defined by NHLBI-2 Guidelines
Procedure: In-home telemonitoring of pediatric patients with persistent asthma

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Educational/Counseling/Training
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”

Resource links provided by NLM:


Further study details as provided by Tripler Army Medical Center:

Estimated Enrollment: 120
Study Start Date: April 2003
Estimated Study Completion Date: February 2005
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.

  Eligibility

Ages Eligible for Study:   6 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00282516

Locations
United States, Hawaii
Tripler Army Medical Center
Tripler AMC, Hawaii, United States, 96859-5000
Sponsors and Collaborators
Tripler Army Medical Center
U.S. Army Medical Research Acquisition Activity
Investigators
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
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00282516     History of Changes
Other Study ID Numbers: 28H01
Study First Received: January 25, 2006
Last Updated: January 25, 2006
Health Authority: United States: Federal Government
United States: Institutional Review Board
United States: US Army Medical Research Acquisition Activity
United States: Department of the Army

Keywords provided by Tripler Army Medical Center:
asthma
telemedicine
case management
clinic
children
pediatric

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on August 28, 2014