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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.
Background/Rationale:
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.
Objective(s):
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TLC-Asthma | Experimental | Telephone-based home education and asthma monitoring |
|
| TLC-health education | Active Comparator | Telephone-based home education |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TLC-Asthma | Device | Telephone-linked communication (TLC) designed to improve asthma self-management by enhancing compliance with preventive medication regimens |
|
| Measure | Description | Time Frame |
|---|---|---|
| Participants With Unscheduled Asthma-related Visits | Number of participants found to have any unscheduled office visits, emergency room visits, or hospitalizations that are related to asthma during one year. | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Participants With Oral Corticosteroid Use | Number of participants found to have any use of oral corticosteroids related to asthma during one year | 1 year |
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Inclusion Criteria:
Exclusion Criteria:
N/A
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| Name | Affiliation | Role |
|---|---|---|
| David William Sparrow, DSc | VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA | Boston | Massachusetts | 02130 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | TLC-Asthma | A telephone-linked communication (TLC) system to improve asthma self-management by enhancing compliance with preventive medication regimens |
| FG001 | TLC-health Education | A TLC system for providing general health education |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Subject with baseline examination
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| ID | Title | Description |
|---|---|---|
| BG000 | TLC-Asthma | A telephone-linked communication (TLC) system to improve asthma self-management by enhancing compliance with preventive medication regimens |
| BG001 | TLC-health Education |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Participants With Unscheduled Asthma-related Visits | Number of participants found to have any unscheduled office visits, emergency room visits, or hospitalizations that are related to asthma during one year. | Posted | Number | participants | 1 year |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Arm 1 | A telephone-linked communication (TLC) system to improve asthma self-management by enhancing compliance with preventive medication regimens |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. David Sparrow | VA Boston Healthcare System | 857-364-6407 | david.sparrow@va.gov |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| D010349 | Patient Compliance |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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| TLC-health education | Device | A telephone-linked communication system (TLC) to provide general health education. |
|
A TLC system for providing general health education
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Units | Counts |
|---|
| Participants |
|
|
| Secondary | Participants With Oral Corticosteroid Use | Number of participants found to have any use of oral corticosteroids related to asthma during one year | Posted | Number | participants | 1 year |
|
|
|
| 0 |
| 71 |
| 0 |
| 71 |
| EG001 | Arm 2 | A TLC system for providing general health education | 0 | 65 | 0 | 65 |
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| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D010342 | Patient Acceptance of Health Care |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |