Trial Outcomes & Findings for Telecommunications System in Asthma (NCT NCT00232557)
NCT ID: NCT00232557
Last Updated: 2015-04-24
Results Overview
Number of participants found to have any unscheduled office visits, emergency room visits, or hospitalizations that are related to asthma during one year.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
136 participants
Primary outcome timeframe
1 year
Results posted on
2015-04-24
Participant Flow
Participant milestones
| Measure |
TLC-Asthma
A telephone-linked communication (TLC) system to improve asthma self-management by enhancing compliance with preventive medication regimens
|
TLC-health Education
A TLC system for providing general health education
|
|---|---|---|
|
Overall Study
STARTED
|
71
|
65
|
|
Overall Study
COMPLETED
|
68
|
60
|
|
Overall Study
NOT COMPLETED
|
3
|
5
|
Reasons for withdrawal
| Measure |
TLC-Asthma
A telephone-linked communication (TLC) system to improve asthma self-management by enhancing compliance with preventive medication regimens
|
TLC-health Education
A TLC system for providing general health education
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
3
|
5
|
Baseline Characteristics
Telecommunications System in Asthma
Baseline characteristics by cohort
| Measure |
TLC-Asthma
n=71 Participants
A telephone-linked communication (TLC) system to improve asthma self-management by enhancing compliance with preventive medication regimens
|
TLC-health Education
n=65 Participants
A TLC system for providing general health education
|
Total
n=136 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
61.6 years
STANDARD_DEVIATION 13.9 • n=99 Participants
|
62.8 years
STANDARD_DEVIATION 14.3 • n=107 Participants
|
61.9 years
STANDARD_DEVIATION 14.3 • n=206 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
14 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
61 Participants
n=99 Participants
|
61 Participants
n=107 Participants
|
122 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 1 yearNumber of participants found to have any unscheduled office visits, emergency room visits, or hospitalizations that are related to asthma during one year.
Outcome measures
| Measure |
TLC-Asthma
n=71 Participants
A telephone-linked communication (TLC) system to improve asthma self-management by enhancing compliance with preventive medication regimens
|
TLC-health Education
n=65 Participants
A TLC system for providing general health education
|
|---|---|---|
|
Participants With Unscheduled Asthma-related Visits
|
29 participants
|
26 participants
|
SECONDARY outcome
Timeframe: 1 yearNumber of participants found to have any use of oral corticosteroids related to asthma during one year
Outcome measures
| Measure |
TLC-Asthma
n=71 Participants
A telephone-linked communication (TLC) system to improve asthma self-management by enhancing compliance with preventive medication regimens
|
TLC-health Education
n=65 Participants
A TLC system for providing general health education
|
|---|---|---|
|
Participants With Oral Corticosteroid Use
|
14 participants
|
19 participants
|
Adverse Events
Arm 1
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Arm 2
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place