Trial Outcomes & Findings for Asthma Controller Adherence After Hospitalization (NCT NCT02615743)
NCT ID: NCT02615743
Last Updated: 2019-04-16
Results Overview
The number and percentage of patients that continue to use the monitoring device throughout the month will be compared between the intervention and control groups.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
41 participants
Primary outcome timeframe
30 days
Results posted on
2019-04-16
Participant Flow
Children were the participants enrolled in the study, parents/caregivers were not.
Participant milestones
| Measure |
Intervention Group
Caregivers of Intervention arm participants will receive daily text message reminders about asthma controller medication use, as well as an electronic monitoring device to track their medication usage for 60 days following hospital discharge. All participants will also complete a 30-minute survey at the time of enrollment and 2 brief telephone followups at 30 and 60 days.
The text message will remind them to give their child their controller medication and provide a helpful information on asthma controller use.
An electronic monitor will be affixed to subjects' inhaled steroid canister and families will be instructed to use the inhaler as directed by their physician. The canister monitor, the Propeller sensor (Propeller, Madison, Wisconsin) is an FDA-approved, portable device which affixes to the top of most metered dose inhaler canisters. The devices records the number and time of each inhaler actuation and transmits this information to either a smart phone or cellular modem.
|
Control Group
Caregivers of control arm participants will receive an electronic monitoring device to track their medication usage for 60 days following hospital discharge. All participants will also complete a 30-minute survey at the time of enrollment and 2 brief telephone followups at 30 and 60 days.
An electronic monitor will be affixed to subjects' inhaled steroid canister and families will be instructed to use the inhaler as directed by their physician. Subjects will not receive daily text messages.The canister monitor, the Propeller sensor (Propeller, Madison, Wisconsin) is an FDA-approved, portable device which affixes to the top of most metered dose inhaler canisters. The devices records the number and time of each inhaler actuation and transmits this information to either a smart phone or cellular modem.
|
|---|---|---|
|
Overall Study
STARTED
|
21
|
20
|
|
Overall Study
COMPLETED
|
15
|
17
|
|
Overall Study
NOT COMPLETED
|
6
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Asthma Controller Adherence After Hospitalization
Baseline characteristics by cohort
| Measure |
Intervention Group
n=21 Participants
Caregivers of intervention participants will receive daily text message reminders about asthma controller medication use and an electronic monitoring device to track their medication use for 60 days following hospital discharge. All caregivers of participants will also complete a 30-minute survey at the time of enrollment and 2 brief telephone followups at 30 and 60 days.
The text message will remind them to give their child their controller medication and provide a helpful information on asthma controller use.
An electronic monitor will be affixed to subjects' inhaled steroid canister and families will be instructed to use the inhaler as directed by their physician. The canister monitor, the Propeller sensor (Propeller, Madison, Wisconsin) is an FDA-approved, portable device which affixes to the top of most metered dose inhaler canisters. The devices records the number and time of each inhaler actuation and transmits this information to either a smart phone or cellular modem.
|
Control Group
n=20 Participants
Caregivers of control arm participants will receive an electronic monitoring device to track their medication usage for 60 days following hospital discharge. All caregivers of participants will also complete a 30-minute survey at the time of enrollment and 2 brief telephone followups at 30 and 60 days.
An electronic monitor will be affixed to subjects' inhaled steroid canister and families will be instructed to use the inhaler as directed by their physician. Subjects will not receive daily text messages.The canister monitor, the Propeller sensor (Propeller, Madison, Wisconsin) is an FDA-approved, portable device which affixes to the top of most metered dose inhaler canisters. The devices records the number and time of each inhaler actuation and transmits this information to either a smart phone or cellular modem.
|
Total
n=41 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
6.1 years
STANDARD_DEVIATION 2.1 • n=93 Participants
|
5.8 years
STANDARD_DEVIATION 2.1 • n=4 Participants
|
5.9 years
STANDARD_DEVIATION 2.1 • n=27 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=93 Participants
|
10 Participants
n=4 Participants
|
19 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=93 Participants
|
10 Participants
n=4 Participants
|
22 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Black
|
20 Participants
n=93 Participants
|
15 Participants
n=4 Participants
|
35 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
6 Participants
n=27 Participants
|
|
Primary Caregiver Education
High School or less
|
14 primary caregiver of participant
n=93 Participants
|
7 primary caregiver of participant
n=4 Participants
|
21 primary caregiver of participant
n=27 Participants
|
|
Primary Caregiver Education
Some College and above
|
7 primary caregiver of participant
n=93 Participants
|
13 primary caregiver of participant
n=4 Participants
|
20 primary caregiver of participant
n=27 Participants
|
|
Family Income Level
<$30,000
|
15 Participants
n=93 Participants
|
12 Participants
n=4 Participants
|
27 Participants
n=27 Participants
|
|
Family Income Level
>$30,000
|
6 Participants
n=93 Participants
|
8 Participants
n=4 Participants
|
14 Participants
n=27 Participants
|
|
Child Health Insurance
private
|
1 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
5 Participants
n=27 Participants
|
|
Child Health Insurance
public
|
20 Participants
n=93 Participants
|
16 Participants
n=4 Participants
|
36 Participants
n=27 Participants
|
|
Baseline Caregiver Asthma Knowledge Questionnaire
|
93 percentage score
STANDARD_DEVIATION 8.7 • n=93 Participants
|
92 percentage score
STANDARD_DEVIATION 8.4 • n=4 Participants
|
93 percentage score
STANDARD_DEVIATION 8.5 • n=27 Participants
|
|
Baseline child Asthma Control Test
|
17.8 units on a scale
STANDARD_DEVIATION 4.3 • n=93 Participants
|
17.2 units on a scale
STANDARD_DEVIATION 4.7 • n=4 Participants
|
17.3 units on a scale
STANDARD_DEVIATION 4.4 • n=27 Participants
|
|
Baseline prior adherence (caregiver-reported), mean (std)
|
65 percentage of medication taken
STANDARD_DEVIATION 23 • n=93 Participants
|
62 percentage of medication taken
STANDARD_DEVIATION 25 • n=4 Participants
|
64 percentage of medication taken
STANDARD_DEVIATION 24 • n=27 Participants
|
|
Baseline adherence intent , mean (std)
|
80 percentage of intended medication
STANDARD_DEVIATION 23 • n=93 Participants
|
85 percentage of intended medication
STANDARD_DEVIATION 21 • n=4 Participants
|
85 percentage of intended medication
STANDARD_DEVIATION 21 • n=27 Participants
|
|
Prior asthma-related emergency department visits in year before enrollment, mean (std)
|
1.0 visits
STANDARD_DEVIATION 1.5 • n=93 Participants
|
1.0 visits
STANDARD_DEVIATION 1.6 • n=4 Participants
|
1.0 visits
STANDARD_DEVIATION 1.5 • n=27 Participants
|
|
Prior asthma-related hospitalizations in year before enrollment, mean (std)
|
0.3 hospitalizations
STANDARD_DEVIATION 0.6 • n=93 Participants
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0.5 hospitalizations
STANDARD_DEVIATION 0.8 • n=4 Participants
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0.4 hospitalizations
STANDARD_DEVIATION 0.7 • n=27 Participants
|
PRIMARY outcome
Timeframe: 30 daysThe number and percentage of patients that continue to use the monitoring device throughout the month will be compared between the intervention and control groups.
Outcome measures
| Measure |
Intervention Group
n=21 Participants
Caregivers of intervention participants will receive daily text message reminders about asthma controller medication use and an electronic monitoring device to track their medication use for 60 days following hospital discharge. All caregivers of participants will also complete a 30-minute survey at the time of enrollment and 2 brief telephone followups at 30 and 60 days.
The text message will remind them to give their child their controller medication and provide a helpful information on asthma controller use.
An electronic monitor will be affixed to subjects' inhaled steroid canister and families will be instructed to use the inhaler as directed by their physician. The canister monitor, the Propeller sensor (Propeller, Madison, Wisconsin) is an FDA-approved, portable device which affixes to the top of most metered dose inhaler canisters. The devices records the number and time of each inhaler actuation and transmits this information to either a smart phone or cellular modem.
|
Control Group
n=20 Participants
Caregivers of control arm participants will receive an electronic monitoring device to track their medication usage for 60 days following hospital discharge. All caregivers of participants will also complete a 30-minute survey at the time of enrollment and 2 brief telephone followups at 30 and 60 days.
An electronic monitor will be affixed to subjects' inhaled steroid canister and families will be instructed to use the inhaler as directed by their physician. Subjects will not receive daily text messages.The canister monitor, the Propeller sensor (Propeller, Madison, Wisconsin) is an FDA-approved, portable device which affixes to the top of most metered dose inhaler canisters. The devices records the number and time of each inhaler actuation and transmits this information to either a smart phone or cellular modem.
|
|---|---|---|
|
Comparison of Number and Percentage of Patients That Use Monitoring Device Over 30 Days (Feasibility)
|
15 Participants
|
17 Participants
|
PRIMARY outcome
Timeframe: 30 days (intervention group) 60 days (control group)Population: There were 6 participants missing from the intervention group due to loss to followup. There were only 5 caregivers of participants in the control group who agreed to receive daily text messages.
The rating of the monitoring device will be compared between groups based on responses to a questionnaire asking about acceptability and preferences to determine if there is a difference in the "favorability" We determined this by the number of participants who found text message reminders helpful to avoid missing doses. After 30 days caregivers of control group participants were given the option to receive daily text messages; they were asked about acceptability 30 days later.
Outcome measures
| Measure |
Intervention Group
n=15 Participants
Caregivers of intervention participants will receive daily text message reminders about asthma controller medication use and an electronic monitoring device to track their medication use for 60 days following hospital discharge. All caregivers of participants will also complete a 30-minute survey at the time of enrollment and 2 brief telephone followups at 30 and 60 days.
The text message will remind them to give their child their controller medication and provide a helpful information on asthma controller use.
An electronic monitor will be affixed to subjects' inhaled steroid canister and families will be instructed to use the inhaler as directed by their physician. The canister monitor, the Propeller sensor (Propeller, Madison, Wisconsin) is an FDA-approved, portable device which affixes to the top of most metered dose inhaler canisters. The devices records the number and time of each inhaler actuation and transmits this information to either a smart phone or cellular modem.
|
Control Group
n=5 Participants
Caregivers of control arm participants will receive an electronic monitoring device to track their medication usage for 60 days following hospital discharge. All caregivers of participants will also complete a 30-minute survey at the time of enrollment and 2 brief telephone followups at 30 and 60 days.
An electronic monitor will be affixed to subjects' inhaled steroid canister and families will be instructed to use the inhaler as directed by their physician. Subjects will not receive daily text messages.The canister monitor, the Propeller sensor (Propeller, Madison, Wisconsin) is an FDA-approved, portable device which affixes to the top of most metered dose inhaler canisters. The devices records the number and time of each inhaler actuation and transmits this information to either a smart phone or cellular modem.
|
|---|---|---|
|
Acceptability
|
15 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: 30 daysPopulation: There are only 15 participants in the intervention group and 17 in the control group due to loss to follow up.
Percent adherence will be calculated as observed medication actuations from electronic adherence monitors over expected use (the latter is = prescribed daily regimen number of observation days)
Outcome measures
| Measure |
Intervention Group
n=15 Participants
Caregivers of intervention participants will receive daily text message reminders about asthma controller medication use and an electronic monitoring device to track their medication use for 60 days following hospital discharge. All caregivers of participants will also complete a 30-minute survey at the time of enrollment and 2 brief telephone followups at 30 and 60 days.
The text message will remind them to give their child their controller medication and provide a helpful information on asthma controller use.
An electronic monitor will be affixed to subjects' inhaled steroid canister and families will be instructed to use the inhaler as directed by their physician. The canister monitor, the Propeller sensor (Propeller, Madison, Wisconsin) is an FDA-approved, portable device which affixes to the top of most metered dose inhaler canisters. The devices records the number and time of each inhaler actuation and transmits this information to either a smart phone or cellular modem.
|
Control Group
n=17 Participants
Caregivers of control arm participants will receive an electronic monitoring device to track their medication usage for 60 days following hospital discharge. All caregivers of participants will also complete a 30-minute survey at the time of enrollment and 2 brief telephone followups at 30 and 60 days.
An electronic monitor will be affixed to subjects' inhaled steroid canister and families will be instructed to use the inhaler as directed by their physician. Subjects will not receive daily text messages.The canister monitor, the Propeller sensor (Propeller, Madison, Wisconsin) is an FDA-approved, portable device which affixes to the top of most metered dose inhaler canisters. The devices records the number and time of each inhaler actuation and transmits this information to either a smart phone or cellular modem.
|
|---|---|---|
|
Adherence
|
34 percent adherence
Interval 18.0 to 50.0
|
40 percent adherence
Interval 25.0 to 55.0
|
SECONDARY outcome
Timeframe: 30 daysPopulation: There are only 15 participants in the intervention group and 17 in the control group due to loss to follow up.
The difference in the change of cACT score from first study visit to the third study visit will be compared between the two study groups. Asthma Control Test (ACT) provides a numerical score to determine if asthma symptoms are well controlled. The scores range from 5 (poor control of asthma) to 25 (complete control of asthma), with higher scores reflecting greater asthma control. An ACT score \>19 indicates well controlled asthma.
Outcome measures
| Measure |
Intervention Group
n=15 Participants
Caregivers of intervention participants will receive daily text message reminders about asthma controller medication use and an electronic monitoring device to track their medication use for 60 days following hospital discharge. All caregivers of participants will also complete a 30-minute survey at the time of enrollment and 2 brief telephone followups at 30 and 60 days.
The text message will remind them to give their child their controller medication and provide a helpful information on asthma controller use.
An electronic monitor will be affixed to subjects' inhaled steroid canister and families will be instructed to use the inhaler as directed by their physician. The canister monitor, the Propeller sensor (Propeller, Madison, Wisconsin) is an FDA-approved, portable device which affixes to the top of most metered dose inhaler canisters. The devices records the number and time of each inhaler actuation and transmits this information to either a smart phone or cellular modem.
|
Control Group
n=17 Participants
Caregivers of control arm participants will receive an electronic monitoring device to track their medication usage for 60 days following hospital discharge. All caregivers of participants will also complete a 30-minute survey at the time of enrollment and 2 brief telephone followups at 30 and 60 days.
An electronic monitor will be affixed to subjects' inhaled steroid canister and families will be instructed to use the inhaler as directed by their physician. Subjects will not receive daily text messages.The canister monitor, the Propeller sensor (Propeller, Madison, Wisconsin) is an FDA-approved, portable device which affixes to the top of most metered dose inhaler canisters. The devices records the number and time of each inhaler actuation and transmits this information to either a smart phone or cellular modem.
|
|---|---|---|
|
Change in Child Asthma Control Tool Score (cACT) From Baseline to End of Intervention Period.
|
1.0 units on a scale
Standard Deviation 2.8
|
3.1 units on a scale
Standard Deviation 3.0
|
Adverse Events
Intervention Group
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
Dr. Chen Kenyon, Faculty PolicyLab and Assistant Professor University of Pennsylvania
Children's Hospital of Philadelphia
Phone: 267-426-6339
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place