Telecommunications System in Asthma
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|ClinicalTrials.gov Identifier: NCT00232557|
Recruitment Status : Completed
First Posted : October 4, 2005
Results First Posted : February 13, 2014
Last Update Posted : April 24, 2015
|Condition or disease||Intervention/treatment||Phase|
|Asthma||Device: TLC-Asthma Device: TLC-health education||Phase 3|
Asthma is one of the most common chronic diseases of adults, affecting 6% of the U.S. 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.
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).
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||136 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Effectiveness of a Telecommunications System in Asthma Management|
|Study Start Date :||August 2004|
|Primary Completion Date :||July 2009|
|Study Completion Date :||December 2009|
Telephone-based home education and asthma monitoring
Telephone-linked communication (TLC) designed to improve asthma self-management by enhancing compliance with preventive medication regimens
Active Comparator: TLC-health education
Telephone-based home education
Device: TLC-health education
A telephone-linked communication system (TLC) to provide general health education.
- Participants With Unscheduled Asthma-related Visits [ Time Frame: 1 year ]Number of participants found to have any unscheduled office visits, emergency room visits, or hospitalizations that are related to asthma during one year.
- Participants With Oral Corticosteroid Use [ Time Frame: 1 year ]Number of participants found to have any use of oral corticosteroids related to asthma during one year
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00232557
|United States, Massachusetts|
|VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA|
|Boston, Massachusetts, United States, 02130|
|Principal Investigator:||David William Sparrow, DSc||VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA|