Trial Outcomes & Findings for Randomized Prospective Trial of a Mobile Health Application for Asthma Self-Management (NCT NCT02333630)
NCT ID: NCT02333630
Last Updated: 2020-03-11
Results Overview
Number of emergency room visits for asthma 6 months following study enrollment and randomization
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
200 participants
Primary outcome timeframe
6 months
Results posted on
2020-03-11
Participant Flow
Participant milestones
| Measure |
AsthmaCare Intervention
Participants randomized to this arm will have the AsthmaCare app downloaded to their mobile device at time of study recruitment. They will have access to AsthmaCare indefinitely after enrollment.
AsthmaCare mobile health application: Personalized, interactive mobile health application designed to send daily medication reminders and assist with self management
|
Control Group
Participants randomized to this arm will receive a link to a website containing asthma education videos and information. They will be able to access this link at their discretion.
Asthma education: A website with links to written asthma education and videos
|
|---|---|---|
|
Overall Study
STARTED
|
100
|
100
|
|
Overall Study
COMPLETED
|
95
|
98
|
|
Overall Study
NOT COMPLETED
|
5
|
2
|
Reasons for withdrawal
| Measure |
AsthmaCare Intervention
Participants randomized to this arm will have the AsthmaCare app downloaded to their mobile device at time of study recruitment. They will have access to AsthmaCare indefinitely after enrollment.
AsthmaCare mobile health application: Personalized, interactive mobile health application designed to send daily medication reminders and assist with self management
|
Control Group
Participants randomized to this arm will receive a link to a website containing asthma education videos and information. They will be able to access this link at their discretion.
Asthma education: A website with links to written asthma education and videos
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
5
|
2
|
Baseline Characteristics
Randomized Prospective Trial of a Mobile Health Application for Asthma Self-Management
Baseline characteristics by cohort
| Measure |
AsthmaCare Intervention
n=98 Participants
Participants randomized to this arm will have the AsthmaCare app downloaded to their mobile device at time of study recruitment. They will have access to AsthmaCare indefinitely after enrollment.
AsthmaCare mobile health application: Personalized, interactive mobile health application designed to send daily medication reminders and assist with self management
|
Control Group
n=95 Participants
Participants randomized to this arm will receive a link to a website containing asthma education videos and information. They will be able to access this link at their discretion.
Asthma education: A website with links to written asthma education and videos
|
Total
n=193 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
7.84 years
STANDARD_DEVIATION 5 • n=5 Participants
|
6.24 years
STANDARD_DEVIATION 4.2 • n=7 Participants
|
6.80 years
STANDARD_DEVIATION 5.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
44 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
80 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
54 Participants
n=5 Participants
|
59 Participants
n=7 Participants
|
113 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
77 Participants
n=5 Participants
|
69 Participants
n=7 Participants
|
146 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
14 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
7 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
98 participants
n=5 Participants
|
95 participants
n=7 Participants
|
193 participants
n=5 Participants
|
|
Insurance Provider
Medicaid
|
86 Participants
n=5 Participants
|
93 Participants
n=7 Participants
|
179 Participants
n=5 Participants
|
|
Insurance Provider
Commercial
|
5 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Insurance Provider
Self pay
|
7 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Controller medications
Low dose ICS
|
30 Participants
n=5 Participants
|
41 Participants
n=7 Participants
|
71 Participants
n=5 Participants
|
|
Controller medications
Medium dose ICS
|
28 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
48 Participants
n=5 Participants
|
|
Controller medications
ICS and LABA
|
10 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Controller medications
Montelukast
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Controller medications
ICS and montelukast
|
17 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
|
Controller medications
ICS/LABA and montelukast
|
12 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Health Care Utilization for Asthma Exacerbations During 6 Months Prior to Enrollment
ED visits
|
0.35 visits
STANDARD_DEVIATION 0.56 • n=5 Participants
|
0.29 visits
STANDARD_DEVIATION 0.56 • n=7 Participants
|
0.32 visits
STANDARD_DEVIATION 0.55 • n=5 Participants
|
|
Health Care Utilization for Asthma Exacerbations During 6 Months Prior to Enrollment
Urgent Care visits
|
0.3 visits
STANDARD_DEVIATION 0.68 • n=5 Participants
|
0.26 visits
STANDARD_DEVIATION 0.57 • n=7 Participants
|
0.28 visits
STANDARD_DEVIATION 0.62 • n=5 Participants
|
|
Health Care Utilization for Asthma Exacerbations During 6 Months Prior to Enrollment
Hospitalizations
|
0.17 visits
STANDARD_DEVIATION 0.46 • n=5 Participants
|
0.2 visits
STANDARD_DEVIATION 0.5 • n=7 Participants
|
0.19 visits
STANDARD_DEVIATION 0.48 • n=5 Participants
|
PRIMARY outcome
Timeframe: 6 monthsNumber of emergency room visits for asthma 6 months following study enrollment and randomization
Outcome measures
| Measure |
AsthmaCare Intervention
n=98 Participants
Participants randomized to this arm will have the AsthmaCare app downloaded to their mobile device at time of study recruitment. They will have access to AsthmaCare indefinitely after enrollment.
AsthmaCare mobile health application: Personalized, interactive mobile health application designed to send daily medication reminders and assist with self management
|
Control Group
n=95 Participants
Participants randomized to this arm will receive a link to a website containing asthma education videos and information. They will be able to access this link at their discretion.
Asthma education: A website with links to written asthma education and videos
|
|---|---|---|
|
Number of Emergency Room Visits Secondary to Asthma Exacerbation
|
0.31 visits
Standard Deviation 0.6
|
0.33 visits
Standard Deviation 0.74
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: Data were not collected for this outcome measure
Number of prednisone courses prescribed for asthma exacerbations during 6 month study time frame
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 6 monthsNumber of hospitalizations for asthma exacerbation during 6 month study duration
Outcome measures
| Measure |
AsthmaCare Intervention
n=98 Participants
Participants randomized to this arm will have the AsthmaCare app downloaded to their mobile device at time of study recruitment. They will have access to AsthmaCare indefinitely after enrollment.
AsthmaCare mobile health application: Personalized, interactive mobile health application designed to send daily medication reminders and assist with self management
|
Control Group
n=95 Participants
Participants randomized to this arm will receive a link to a website containing asthma education videos and information. They will be able to access this link at their discretion.
Asthma education: A website with links to written asthma education and videos
|
|---|---|---|
|
Hospitalizations
|
0.14 visits
Standard Deviation 0.38
|
0.1 visits
Standard Deviation 0.33
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: Data were not collected for this measure
Analytics from within the mobile application will be measured to determine the frequency and usage patterns of the mobile health application by users during the study period
Outcome measures
Outcome data not reported
Adverse Events
AsthmaCare Intervention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control Group
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