Asthma
Conditions
Keywords
Asthma, Disease Management, Telecommunications, Health Services, Quality of Life, Patient Compliance
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
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.
Interventions
DEVICETLC-Asthma
Telephone-linked communication (TLC) designed to improve asthma self-management by enhancing compliance with preventive medication regimens
DEVICETLC-health education
A telephone-linked communication system (TLC) to provide general health education.
Sponsors
US Department of Veterans Affairs
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Physician diagnosis of asthma * Receiving treatment with one or more daily controller (i.e., preventive) medications * Age = 18 years * Less than 30 pack years of cigarette smoking * FEVi greater than 50% of predicted * FEVi bronchodilator response of at least 12% * Ability to use a telephone without assistance
Exclusion criteria
N/A
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Participants With Unscheduled Asthma-related Visits | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Participants With Oral Corticosteroid Use | 1 year | Number of participants found to have any use of oral corticosteroids related to asthma during one year |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| TLC-Asthma A telephone-linked communication (TLC) system to improve asthma self-management by enhancing compliance with preventive medication regimens | 71 |
| TLC-health Education A TLC system for providing general health education | 65 |
| Total | 136 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 3 | 5 |
Baseline characteristics
| Characteristic | TLC-Asthma | TLC-health Education | Total |
|---|---|---|---|
| Age, Continuous | 61.6 years STANDARD_DEVIATION 13.9 | 62.8 years STANDARD_DEVIATION 14.3 | 61.9 years STANDARD_DEVIATION 14.3 |
| Sex: Female, Male Female | 10 Participants | 4 Participants | 14 Participants |
| Sex: Female, Male Male | 61 Participants | 61 Participants | 122 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 71 | 0 / 65 |
| serious Total, serious adverse events | 0 / 71 | 0 / 65 |
Outcome results
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.
Time frame: 1 year
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| TLC-Asthma | Participants With Unscheduled Asthma-related Visits | 29 participants |
| TLC-health Education | Participants With Unscheduled Asthma-related Visits | 26 participants |
Secondary
Participants With Oral Corticosteroid Use
Number of participants found to have any use of oral corticosteroids related to asthma during one year
Time frame: 1 year
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| TLC-Asthma | Participants With Oral Corticosteroid Use | 14 participants |
| TLC-health Education | Participants With Oral Corticosteroid Use | 19 participants |