Ignite Creation Date:
2024-05-05 @ 12:04 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00232557
Status:
COMPLETED
Last Update Posted:
2015-04-24
First Post:
2005-09-30
Brief Title:
Telecommunications System in Asthma
Sponsor:
US Department of Veterans Affairs
Organization:
VA Office of Research and Development
Study Overview
Official Title:
Effectiveness of a Telecommunications System in Asthma Management
Status:
COMPLETED
Status Verified Date:
2013-10
Last Known Status:
None
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:
This project is investigating whether application of a telecommunications system to the care of adult patients with asthma will improve self-management by enhancing compliance with preventive medication regimens and fostering the use of peak-flow-based action plans
Detailed Description:
BackgroundRationale
Asthma is one of the most common chronic diseases of adults affecting 6 of the US adult population and accounting for substantial morbidity and mortality Despite the availability of effective therapy for asthma morbidity and mortality have increased over the last several decades Asthma specialty care case management and patient education are means for improving the quality of asthma care and patient outcomes but cost and inconvenience limit the degree to which these are used in asthma care nationally The principal aim of this study is to evaluate the impact of an inexpensive telephone-based home education and disease monitoring system on asthma medication adherence and clinical outcomes in adult patients with asthma
Objectives
We hypothesize that application of TLC to the care of adult patients with asthma will improve self-management by enhancing compliance with preventive medication regimens and fostering the use of peak flow-based action plans This in turn will improve asthma control thus reducing acute health care utilization and improving quality of life QOL
Methods
A randomized controlled trial will be conducted with adult asthma patients identified from the VA Boston Healthcare System comprised of the Boston West Roxbury and Brockton VA Medical Centers and their associated satellite clinics Patients will be randomized to either the TLC-Asthma group or an attention placebo control group Outcome measurements will include medication adherence QOL utilization of urgent care services oral corticosteroid use
Asthma is one of the most common chronic diseases of adults affecting 6 of the US adult population and accounting for substantial morbidity and mortality Despite the availability of effective therapy for asthma morbidity and mortality have increased over the last several decades Asthma specialty care case management and patient education are means for improving the quality of asthma care and patient outcomes but cost and inconvenience limit the degree to which these are used in asthma care nationally The principal aim of this study is to evaluate the impact of an inexpensive telephone-based home education and disease monitoring system on asthma medication adherence and clinical outcomes in adult patients with asthma
Objectives
We hypothesize that application of TLC to the care of adult patients with asthma will improve self-management by enhancing compliance with preventive medication regimens and fostering the use of peak flow-based action plans This in turn will improve asthma control thus reducing acute health care utilization and improving quality of life QOL
Methods
A randomized controlled trial will be conducted with adult asthma patients identified from the VA Boston Healthcare System comprised of the Boston West Roxbury and Brockton VA Medical Centers and their associated satellite clinics Patients will be randomized to either the TLC-Asthma group or an attention placebo control group Outcome measurements will include medication adherence QOL utilization of urgent care services oral corticosteroid use
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