Trial Outcomes & Findings for The Tailored Adherence Incentives for Childhood Asthma Medications (TAICAM) Trial (NCT NCT03907410)
NCT ID: NCT03907410
Last Updated: 2024-03-18
Results Overview
Calculated as the mean daily proportion of prescribed doses taken by study month by study arm. Days that reflect \>1 were truncated to 1.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
125 participants
Primary outcome timeframe
6 months
Results posted on
2024-03-18
Participant Flow
125 participants were initially enrolled into the 1 month study run-in period, in which they were needed to successfully (1) synchronize their electronic study sensor with the caregivers smartphone (via Bluetooth) and the Way to Health study platform (via wireless or cellular data) and (2) respond to an automated text message from the Way to Health study platform.
19 participants did not successfully complete the run-in period and, thus, were not randomized. 106 study participants were randomized in a 2:1:2 schema. The caregiver-child dyad was one unit. If the caregiver withdrew from the study, the child also withdrew from the study. Medication adherence was only collected from the child, but caregivers were included in the dyad-language given that they were interacting with certain parts of the intervention employed.
Participant milestones
| Measure |
Arm 1: Incentives, Plus Reminders & Feedback (IRF)
There will be a run-in period to determine eligibility for randomization and collect baseline adherence data (Month 0).
During the "Experiment" period (Months 1-3), Arm 1 will receive the IRF intervention.
During the "Observation" period (Months 4-6), all the arms will have continued daily ICS monitoring to assess enduring effects of each arm - no IRF.
Nominal Financial Incentives: The nominal financial incentives will consist of fixed-ratio incentives for each inhaled corticosteroids (ICS) actuation (25 cents for children on 4 daily ICS doses and 50 cents for children on 2 daily doses), with a maximum of $1 per day.
Daily Adherence Reminders/Adherence Performance Feedback: Study participants will receive automated daily text message or push notification reminders and automated weekly feedback summarizing their adherence performance through Way to Health, a mobile health, electronic monitoring platform.
|
Arm 2: Reminders & Feedback ONLY
There will be a run-in period to determine eligibility for randomization and collect baseline adherence data (Month 0).
During the "Experiment" period (Months 1-3), Arm 2 will receive ONLY reminders and feedback, without nominal financial incentives.
During the "Observation" period (Months 4-6), all three arms will have continued daily ICS monitoring to assess enduring effects of each arm - no IRF.
Daily Adherence Reminders/Adherence Performance Feedback: Study participants will receive automated daily text message or push notification reminders and automated weekly feedback summarizing their adherence performance through Way to Health, a mobile health, electronic monitoring platform.
|
Arm 3 (Control)
There will be a run-in period to determine eligibility for randomization and collect baseline adherence data (Month 0).
During the "Experiment" period (Months 1-3), Arm 3 will not receive any component of the IRF intervention.
During the "Observation" period (Months 4-6), all three arms will have continued daily ICS monitoring to assess enduring effects of each arm - no IRF.
|
|---|---|---|---|
|
Overall Study
STARTED
|
42
|
22
|
42
|
|
Overall Study
COMPLETED
|
38
|
21
|
40
|
|
Overall Study
NOT COMPLETED
|
4
|
1
|
2
|
Reasons for withdrawal
| Measure |
Arm 1: Incentives, Plus Reminders & Feedback (IRF)
There will be a run-in period to determine eligibility for randomization and collect baseline adherence data (Month 0).
During the "Experiment" period (Months 1-3), Arm 1 will receive the IRF intervention.
During the "Observation" period (Months 4-6), all the arms will have continued daily ICS monitoring to assess enduring effects of each arm - no IRF.
Nominal Financial Incentives: The nominal financial incentives will consist of fixed-ratio incentives for each inhaled corticosteroids (ICS) actuation (25 cents for children on 4 daily ICS doses and 50 cents for children on 2 daily doses), with a maximum of $1 per day.
Daily Adherence Reminders/Adherence Performance Feedback: Study participants will receive automated daily text message or push notification reminders and automated weekly feedback summarizing their adherence performance through Way to Health, a mobile health, electronic monitoring platform.
|
Arm 2: Reminders & Feedback ONLY
There will be a run-in period to determine eligibility for randomization and collect baseline adherence data (Month 0).
During the "Experiment" period (Months 1-3), Arm 2 will receive ONLY reminders and feedback, without nominal financial incentives.
During the "Observation" period (Months 4-6), all three arms will have continued daily ICS monitoring to assess enduring effects of each arm - no IRF.
Daily Adherence Reminders/Adherence Performance Feedback: Study participants will receive automated daily text message or push notification reminders and automated weekly feedback summarizing their adherence performance through Way to Health, a mobile health, electronic monitoring platform.
|
Arm 3 (Control)
There will be a run-in period to determine eligibility for randomization and collect baseline adherence data (Month 0).
During the "Experiment" period (Months 1-3), Arm 3 will not receive any component of the IRF intervention.
During the "Observation" period (Months 4-6), all three arms will have continued daily ICS monitoring to assess enduring effects of each arm - no IRF.
|
|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
4
|
1
|
1
|
|
Overall Study
Lost to follow-up and research burden
|
0
|
0
|
1
|
Baseline Characteristics
The Tailored Adherence Incentives for Childhood Asthma Medications (TAICAM) Trial
Baseline characteristics by cohort
| Measure |
Arm 1: Incentives, Plus Reminders & Feedback (IRF)
n=38 Participants
There will be a run-in period to determine eligibility for randomization and collect baseline adherence data (Month 0).
During the "Experiment" period (Months 1-3), Arm 1 will receive the IRF intervention.
During the "Observation" period (Months 4-6), all the arms will have continued daily ICS monitoring to assess enduring effects of each arm - no IRF.
Nominal Financial Incentives: The nominal financial incentives will consist of fixed-ratio incentives for each inhaled corticosteroids (ICS) actuation (25 cents for children on 4 daily ICS doses and 50 cents for children on 2 daily doses), with a maximum of $1 per day.
Daily Adherence Reminders/Adherence Performance Feedback: Study participants will receive automated daily text message or push notification reminders and automated weekly feedback summarizing their adherence performance through Way to Health, a mobile health, electronic monitoring platform.
|
Arm 2: Reminders & Feedback ONLY
n=21 Participants
There will be a run-in period to determine eligibility for randomization and collect baseline adherence data (Month 0).
During the "Experiment" period (Months 1-3), Arm 2 will receive ONLY reminders and feedback, without nominal financial incentives.
During the "Observation" period (Months 4-6), all three arms will have continued daily ICS monitoring to assess enduring effects of each arm - no IRF.
Daily Adherence Reminders/Adherence Performance Feedback: Study participants will receive automated daily text message or push notification reminders and automated weekly feedback summarizing their adherence performance through Way to Health, a mobile health, electronic monitoring platform.
|
Arm 3 (Control)
n=40 Participants
There will be a run-in period to determine eligibility for randomization and collect baseline adherence data (Month 0).
During the "Experiment" period (Months 1-3), Arm 3 will not receive any component of the IRF intervention.
During the "Observation" period (Months 4-6), all three arms will have continued daily ICS monitoring to assess enduring effects of each arm - no IRF.
|
Total
n=99 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Customized
Child Age Group · 5-7 years
|
12 Participants
n=93 Participants
|
10 Participants
n=4 Participants
|
18 Participants
n=27 Participants
|
40 Participants
n=483 Participants
|
|
Age, Customized
Child Age Group · 8-11 years
|
26 Participants
n=93 Participants
|
11 Participants
n=4 Participants
|
22 Participants
n=27 Participants
|
59 Participants
n=483 Participants
|
|
Age, Customized
Mean Caregiver Age
|
34.2 years
STANDARD_DEVIATION 5.9 • n=93 Participants
|
34.1 years
STANDARD_DEVIATION 5.6 • n=4 Participants
|
33.5 years
STANDARD_DEVIATION 6.7 • n=27 Participants
|
33.8 years
STANDARD_DEVIATION 6.2 • n=483 Participants
|
|
Sex: Female, Male
Child Sex · Female
|
18 Participants
n=93 Participants
|
9 Participants
n=4 Participants
|
16 Participants
n=27 Participants
|
43 Participants
n=483 Participants
|
|
Sex: Female, Male
Child Sex · Male
|
20 Participants
n=93 Participants
|
12 Participants
n=4 Participants
|
24 Participants
n=27 Participants
|
56 Participants
n=483 Participants
|
|
Race/Ethnicity, Customized
Child Race · Black
|
31 Participants
n=93 Participants
|
17 Participants
n=4 Participants
|
33 Participants
n=27 Participants
|
81 Participants
n=483 Participants
|
|
Race/Ethnicity, Customized
Child Race · Non-Black
|
7 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
7 Participants
n=27 Participants
|
18 Participants
n=483 Participants
|
|
Region of Enrollment
United States
|
38 participants
n=93 Participants
|
21 participants
n=4 Participants
|
40 participants
n=27 Participants
|
99 participants
n=483 Participants
|
|
Run-in Period ICS Adherence
|
56 % of doses taken
STANDARD_DEVIATION 26 • n=93 Participants
|
50 % of doses taken
STANDARD_DEVIATION 29 • n=4 Participants
|
52 % of doses taken
STANDARD_DEVIATION 30 • n=27 Participants
|
53 % of doses taken
STANDARD_DEVIATION 28 • n=483 Participants
|
PRIMARY outcome
Timeframe: 6 monthsCalculated as the mean daily proportion of prescribed doses taken by study month by study arm. Days that reflect \>1 were truncated to 1.
Outcome measures
| Measure |
Arm 1
n=38 Participants
Full intervention group
|
Arm 2
n=21 Participants
Hybrid intervention group
|
Arm 3
n=40 Participants
Active control group
|
|---|---|---|---|
|
Mean Monthly Adherence to Inhaled Corticosteroid Regimen (Unadjusted)
Month 3
|
0.55 proportion of prescribed doses taken
Interval 0.49 to 0.6
|
0.44 proportion of prescribed doses taken
Interval 0.37 to 0.51
|
0.39 proportion of prescribed doses taken
Interval 0.34 to 0.45
|
|
Mean Monthly Adherence to Inhaled Corticosteroid Regimen (Unadjusted)
Month 4
|
0.44 proportion of prescribed doses taken
Interval 0.39 to 0.48
|
0.40 proportion of prescribed doses taken
Interval 0.32 to 0.47
|
0.45 proportion of prescribed doses taken
Interval 0.39 to 0.5
|
|
Mean Monthly Adherence to Inhaled Corticosteroid Regimen (Unadjusted)
Month 5
|
0.35 proportion of prescribed doses taken
Interval 0.29 to 0.4
|
0.30 proportion of prescribed doses taken
Interval 0.23 to 0.37
|
0.41 proportion of prescribed doses taken
Interval 0.35 to 0.46
|
|
Mean Monthly Adherence to Inhaled Corticosteroid Regimen (Unadjusted)
Month 6
|
0.38 proportion of prescribed doses taken
Interval 0.34 to 0.42
|
0.34 proportion of prescribed doses taken
Interval 0.28 to 0.4
|
0.48 proportion of prescribed doses taken
Interval 0.43 to 0.53
|
|
Mean Monthly Adherence to Inhaled Corticosteroid Regimen (Unadjusted)
Month 0
|
0.56 proportion of prescribed doses taken
Interval 0.52 to 0.61
|
0.50 proportion of prescribed doses taken
Interval 0.44 to 0.57
|
0.52 proportion of prescribed doses taken
Interval 0.47 to 0.57
|
|
Mean Monthly Adherence to Inhaled Corticosteroid Regimen (Unadjusted)
Month 1
|
0.61 proportion of prescribed doses taken
Interval 0.57 to 0.66
|
0.48 proportion of prescribed doses taken
Interval 0.41 to 0.54
|
0.47 proportion of prescribed doses taken
Interval 0.41 to 0.52
|
|
Mean Monthly Adherence to Inhaled Corticosteroid Regimen (Unadjusted)
Month 2
|
0.56 proportion of prescribed doses taken
Interval 0.52 to 0.61
|
0.45 proportion of prescribed doses taken
Interval 0.38 to 0.51
|
0.38 proportion of prescribed doses taken
Interval 0.33 to 0.43
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: The total cohort of 99 participants were analyzed to assign participants to one adherence group based on their adherence to the inhaled corticosteroid medication over the study interval. As pre-specified in the study protocol, this outcome measure represents group-based modeling of adherence patterns agnostic of study arm.
Group-based trajectory modeling derived of adherence patterns - not reported by study arm. This secondary outcome was included in the event that there was no difference in adherence between study arms to help identify participant characteristics that were associated with different adherence patterns. The unit of measure is the percentage of participants that fall into each adherence category (low, medium, and high adherence) over a 6-month time period.
Outcome measures
| Measure |
Arm 1
n=99 Participants
Full intervention group
|
Arm 2
n=99 Participants
Hybrid intervention group
|
Arm 3
n=99 Participants
Active control group
|
|---|---|---|---|
|
Adherence Trajectory
|
20.2 percentage of study participants
|
41.5 percentage of study participants
|
38.2 percentage of study participants
|
SECONDARY outcome
Timeframe: months 2, 4,7, 12Population: The number analyzed in the study visits differ as some participants did not complete all study visits.
Assess the change in total cACT score or parental portion of the cACT from baseline to the second, third, fourth, and fifth study visits. The Child Asthma Control Tool (cACT) score ranges from 0 (poor control) to 27 (complete control) and was assessed at study visits 1 and 3 only. The parental portion of the cACT ranges from 0-15 and was assessed at all study visits. The greater the value, the better the control. The larger the difference (larger magnitude) of the value in the differences between the scores, the greater the improvement in controlling the child's asthma diagnosis.
Outcome measures
| Measure |
Arm 1
n=38 Participants
Full intervention group
|
Arm 2
n=21 Participants
Hybrid intervention group
|
Arm 3
n=40 Participants
Active control group
|
|---|---|---|---|
|
Changes in Child Asthma Control Tool (cACT) Score
Study Visit 2* (only parental portion of ACT collected: Range 0-15) - Month 2
|
1.73 score on a scale
Standard Deviation 0.64
|
2.86 score on a scale
Standard Deviation 0.73
|
2.16 score on a scale
Standard Deviation 0.71
|
|
Changes in Child Asthma Control Tool (cACT) Score
Study Visit 3 - Month 4
|
2.19 score on a scale
Standard Deviation 0.96
|
3.63 score on a scale
Standard Deviation 1.15
|
1.85 score on a scale
Standard Deviation 1.36
|
|
Changes in Child Asthma Control Tool (cACT) Score
Study Visit 4* (only parental portion of ACT collected: Range 0-15) - Month 7
|
2.29 score on a scale
Standard Deviation 0.62
|
2.33 score on a scale
Standard Deviation 0.86
|
2.36 score on a scale
Standard Deviation 0.72
|
|
Changes in Child Asthma Control Tool (cACT) Score
Study Visit 5* (only parental portion of ACT collected: Range 0-15) - Month 12
|
1.75 score on a scale
Standard Deviation 0.61
|
2.41 score on a scale
Standard Deviation 0.71
|
1.74 score on a scale
Standard Deviation 0.79
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: The oral steroid course outcome was a secondary outcome added when we expanded inclusion criteria during the Coronavirus pandemic, so it is only reported for a proportion of participants.
Calculate and compare the number of asthma-related emergency room visits, hospitalizations and oral steroid courses between study arms.
Outcome measures
| Measure |
Arm 1
n=38 Participants
Full intervention group
|
Arm 2
n=21 Participants
Hybrid intervention group
|
Arm 3
n=40 Participants
Active control group
|
|---|---|---|---|
|
Number of Asthma-related Emergency Room Visits, Hospitalizations and Oral Steroid Courses
2 hospitalizations
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Asthma-related Emergency Room Visits, Hospitalizations and Oral Steroid Courses
3 hospitalizations
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Asthma-related Emergency Room Visits, Hospitalizations and Oral Steroid Courses
0 emergency department visits
|
31 Participants
|
14 Participants
|
27 Participants
|
|
Number of Asthma-related Emergency Room Visits, Hospitalizations and Oral Steroid Courses
1 emergency department visit
|
4 Participants
|
6 Participants
|
8 Participants
|
|
Number of Asthma-related Emergency Room Visits, Hospitalizations and Oral Steroid Courses
2 oral steroid courses
|
1 Participants
|
3 Participants
|
1 Participants
|
|
Number of Asthma-related Emergency Room Visits, Hospitalizations and Oral Steroid Courses
3 oral steroid courses
|
2 Participants
|
1 Participants
|
2 Participants
|
|
Number of Asthma-related Emergency Room Visits, Hospitalizations and Oral Steroid Courses
4 oral steroid courses
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Asthma-related Emergency Room Visits, Hospitalizations and Oral Steroid Courses
0 hospitalizations
|
32 Participants
|
17 Participants
|
34 Participants
|
|
Number of Asthma-related Emergency Room Visits, Hospitalizations and Oral Steroid Courses
1 hospitalization
|
5 Participants
|
3 Participants
|
5 Participants
|
|
Number of Asthma-related Emergency Room Visits, Hospitalizations and Oral Steroid Courses
2 emergency department visits
|
3 Participants
|
0 Participants
|
2 Participants
|
|
Number of Asthma-related Emergency Room Visits, Hospitalizations and Oral Steroid Courses
3 emergency department visits
|
0 Participants
|
1 Participants
|
3 Participants
|
|
Number of Asthma-related Emergency Room Visits, Hospitalizations and Oral Steroid Courses
0 oral steroid courses
|
21 Participants
|
4 Participants
|
13 Participants
|
|
Number of Asthma-related Emergency Room Visits, Hospitalizations and Oral Steroid Courses
1 oral steroid course
|
6 Participants
|
4 Participants
|
8 Participants
|
|
Number of Asthma-related Emergency Room Visits, Hospitalizations and Oral Steroid Courses
5 or more oral steroid courses
|
0 Participants
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: This secondary outcome will not be analyzed because this data was not collected for reasons related to the onset of the COVID-19 pandemic.
Calculate the costs associated with emergency room utilization, hospital utilization and oral steroid course prescriptions between study arms.
Outcome measures
Outcome data not reported
Adverse Events
Arm 1: Incentives, Plus Reminders & Feedback (IRF)
Serious events: 6 serious events
Other events: 17 other events
Deaths: 0 deaths
Arm 2: Reminders & Feedback ONLY
Serious events: 4 serious events
Other events: 13 other events
Deaths: 0 deaths
Arm 3 (Control)
Serious events: 6 serious events
Other events: 22 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm 1: Incentives, Plus Reminders & Feedback (IRF)
n=38 participants at risk
There will be a run-in period to determine eligibility for randomization and collect baseline adherence data (Month 0).
During the "Experiment" period (Months 1-3), Arm 1 will receive the IRF intervention.
During the "Observation" period (Months 4-6), all the arms will have continued daily ICS monitoring to assess enduring effects of each arm - no IRF.
Nominal Financial Incentives: The nominal financial incentives will consist of fixed-ratio incentives for each inhaled corticosteroids (ICS) actuation (25 cents for children on 4 daily ICS doses and 50 cents for children on 2 daily doses), with a maximum of $1 per day.
Daily Adherence Reminders/Adherence Performance Feedback: Study participants will receive automated daily text message or push notification reminders and automated weekly feedback summarizing their adherence performance through Way to Health, a mobile health, electronic monitoring platform.
|
Arm 2: Reminders & Feedback ONLY
n=21 participants at risk
There will be a run-in period to determine eligibility for randomization and collect baseline adherence data (Month 0).
During the "Experiment" period (Months 1-3), Arm 2 will receive ONLY reminders and feedback, without nominal financial incentives.
During the "Observation" period (Months 4-6), all three arms will have continued daily ICS monitoring to assess enduring effects of each arm - no IRF.
Daily Adherence Reminders/Adherence Performance Feedback: Study participants will receive automated daily text message or push notification reminders and automated weekly feedback summarizing their adherence performance through Way to Health, a mobile health, electronic monitoring platform.
|
Arm 3 (Control)
n=40 participants at risk
There will be a run-in period to determine eligibility for randomization and collect baseline adherence data (Month 0).
During the "Experiment" period (Months 1-3), Arm 3 will not receive any component of the IRF intervention.
During the "Observation" period (Months 4-6), all three arms will have continued daily ICS monitoring to assess enduring effects of each arm - no IRF.
|
|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Asthma Exacerbation or Increased Asthma Symptoms
|
15.8%
6/38 • Adverse events were collected for the entirety of the participant's study period (12 months).
Adverse events were only analyzed for the children involved in this study. The numbers differ with the number of individuals at risk for an adverse event due to participants that were lost to follow up, meaning that the participant had less than 14 days of electronic monitoring data following randomization, removing them from the study.
|
19.0%
4/21 • Adverse events were collected for the entirety of the participant's study period (12 months).
Adverse events were only analyzed for the children involved in this study. The numbers differ with the number of individuals at risk for an adverse event due to participants that were lost to follow up, meaning that the participant had less than 14 days of electronic monitoring data following randomization, removing them from the study.
|
12.5%
5/40 • Adverse events were collected for the entirety of the participant's study period (12 months).
Adverse events were only analyzed for the children involved in this study. The numbers differ with the number of individuals at risk for an adverse event due to participants that were lost to follow up, meaning that the participant had less than 14 days of electronic monitoring data following randomization, removing them from the study.
|
|
Gastrointestinal disorders
Abdominal Pain
|
2.6%
1/38 • Adverse events were collected for the entirety of the participant's study period (12 months).
Adverse events were only analyzed for the children involved in this study. The numbers differ with the number of individuals at risk for an adverse event due to participants that were lost to follow up, meaning that the participant had less than 14 days of electronic monitoring data following randomization, removing them from the study.
|
0.00%
0/21 • Adverse events were collected for the entirety of the participant's study period (12 months).
Adverse events were only analyzed for the children involved in this study. The numbers differ with the number of individuals at risk for an adverse event due to participants that were lost to follow up, meaning that the participant had less than 14 days of electronic monitoring data following randomization, removing them from the study.
|
0.00%
0/40 • Adverse events were collected for the entirety of the participant's study period (12 months).
Adverse events were only analyzed for the children involved in this study. The numbers differ with the number of individuals at risk for an adverse event due to participants that were lost to follow up, meaning that the participant had less than 14 days of electronic monitoring data following randomization, removing them from the study.
|
|
Nervous system disorders
Risk for Neurologic Deterioration
|
0.00%
0/38 • Adverse events were collected for the entirety of the participant's study period (12 months).
Adverse events were only analyzed for the children involved in this study. The numbers differ with the number of individuals at risk for an adverse event due to participants that were lost to follow up, meaning that the participant had less than 14 days of electronic monitoring data following randomization, removing them from the study.
|
0.00%
0/21 • Adverse events were collected for the entirety of the participant's study period (12 months).
Adverse events were only analyzed for the children involved in this study. The numbers differ with the number of individuals at risk for an adverse event due to participants that were lost to follow up, meaning that the participant had less than 14 days of electronic monitoring data following randomization, removing them from the study.
|
2.5%
1/40 • Adverse events were collected for the entirety of the participant's study period (12 months).
Adverse events were only analyzed for the children involved in this study. The numbers differ with the number of individuals at risk for an adverse event due to participants that were lost to follow up, meaning that the participant had less than 14 days of electronic monitoring data following randomization, removing them from the study.
|
Other adverse events
| Measure |
Arm 1: Incentives, Plus Reminders & Feedback (IRF)
n=38 participants at risk
There will be a run-in period to determine eligibility for randomization and collect baseline adherence data (Month 0).
During the "Experiment" period (Months 1-3), Arm 1 will receive the IRF intervention.
During the "Observation" period (Months 4-6), all the arms will have continued daily ICS monitoring to assess enduring effects of each arm - no IRF.
Nominal Financial Incentives: The nominal financial incentives will consist of fixed-ratio incentives for each inhaled corticosteroids (ICS) actuation (25 cents for children on 4 daily ICS doses and 50 cents for children on 2 daily doses), with a maximum of $1 per day.
Daily Adherence Reminders/Adherence Performance Feedback: Study participants will receive automated daily text message or push notification reminders and automated weekly feedback summarizing their adherence performance through Way to Health, a mobile health, electronic monitoring platform.
|
Arm 2: Reminders & Feedback ONLY
n=21 participants at risk
There will be a run-in period to determine eligibility for randomization and collect baseline adherence data (Month 0).
During the "Experiment" period (Months 1-3), Arm 2 will receive ONLY reminders and feedback, without nominal financial incentives.
During the "Observation" period (Months 4-6), all three arms will have continued daily ICS monitoring to assess enduring effects of each arm - no IRF.
Daily Adherence Reminders/Adherence Performance Feedback: Study participants will receive automated daily text message or push notification reminders and automated weekly feedback summarizing their adherence performance through Way to Health, a mobile health, electronic monitoring platform.
|
Arm 3 (Control)
n=40 participants at risk
There will be a run-in period to determine eligibility for randomization and collect baseline adherence data (Month 0).
During the "Experiment" period (Months 1-3), Arm 3 will not receive any component of the IRF intervention.
During the "Observation" period (Months 4-6), all three arms will have continued daily ICS monitoring to assess enduring effects of each arm - no IRF.
|
|---|---|---|---|
|
Injury, poisoning and procedural complications
Concerns for glass ingestion
|
2.6%
1/38 • Adverse events were collected for the entirety of the participant's study period (12 months).
Adverse events were only analyzed for the children involved in this study. The numbers differ with the number of individuals at risk for an adverse event due to participants that were lost to follow up, meaning that the participant had less than 14 days of electronic monitoring data following randomization, removing them from the study.
|
0.00%
0/21 • Adverse events were collected for the entirety of the participant's study period (12 months).
Adverse events were only analyzed for the children involved in this study. The numbers differ with the number of individuals at risk for an adverse event due to participants that were lost to follow up, meaning that the participant had less than 14 days of electronic monitoring data following randomization, removing them from the study.
|
0.00%
0/40 • Adverse events were collected for the entirety of the participant's study period (12 months).
Adverse events were only analyzed for the children involved in this study. The numbers differ with the number of individuals at risk for an adverse event due to participants that were lost to follow up, meaning that the participant had less than 14 days of electronic monitoring data following randomization, removing them from the study.
|
|
Infections and infestations
Viral Infection
|
2.6%
1/38 • Adverse events were collected for the entirety of the participant's study period (12 months).
Adverse events were only analyzed for the children involved in this study. The numbers differ with the number of individuals at risk for an adverse event due to participants that were lost to follow up, meaning that the participant had less than 14 days of electronic monitoring data following randomization, removing them from the study.
|
0.00%
0/21 • Adverse events were collected for the entirety of the participant's study period (12 months).
Adverse events were only analyzed for the children involved in this study. The numbers differ with the number of individuals at risk for an adverse event due to participants that were lost to follow up, meaning that the participant had less than 14 days of electronic monitoring data following randomization, removing them from the study.
|
2.5%
1/40 • Adverse events were collected for the entirety of the participant's study period (12 months).
Adverse events were only analyzed for the children involved in this study. The numbers differ with the number of individuals at risk for an adverse event due to participants that were lost to follow up, meaning that the participant had less than 14 days of electronic monitoring data following randomization, removing them from the study.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma Exacerbation or Increased Asthma Symptoms
|
23.7%
9/38 • Adverse events were collected for the entirety of the participant's study period (12 months).
Adverse events were only analyzed for the children involved in this study. The numbers differ with the number of individuals at risk for an adverse event due to participants that were lost to follow up, meaning that the participant had less than 14 days of electronic monitoring data following randomization, removing them from the study.
|
38.1%
8/21 • Adverse events were collected for the entirety of the participant's study period (12 months).
Adverse events were only analyzed for the children involved in this study. The numbers differ with the number of individuals at risk for an adverse event due to participants that were lost to follow up, meaning that the participant had less than 14 days of electronic monitoring data following randomization, removing them from the study.
|
32.5%
13/40 • Adverse events were collected for the entirety of the participant's study period (12 months).
Adverse events were only analyzed for the children involved in this study. The numbers differ with the number of individuals at risk for an adverse event due to participants that were lost to follow up, meaning that the participant had less than 14 days of electronic monitoring data following randomization, removing them from the study.
|
|
Injury, poisoning and procedural complications
Joint/Extremity Pain or Fracture
|
10.5%
4/38 • Adverse events were collected for the entirety of the participant's study period (12 months).
Adverse events were only analyzed for the children involved in this study. The numbers differ with the number of individuals at risk for an adverse event due to participants that were lost to follow up, meaning that the participant had less than 14 days of electronic monitoring data following randomization, removing them from the study.
|
9.5%
2/21 • Adverse events were collected for the entirety of the participant's study period (12 months).
Adverse events were only analyzed for the children involved in this study. The numbers differ with the number of individuals at risk for an adverse event due to participants that were lost to follow up, meaning that the participant had less than 14 days of electronic monitoring data following randomization, removing them from the study.
|
10.0%
4/40 • Adverse events were collected for the entirety of the participant's study period (12 months).
Adverse events were only analyzed for the children involved in this study. The numbers differ with the number of individuals at risk for an adverse event due to participants that were lost to follow up, meaning that the participant had less than 14 days of electronic monitoring data following randomization, removing them from the study.
|
|
Infections and infestations
Hordeolum Externum
|
0.00%
0/38 • Adverse events were collected for the entirety of the participant's study period (12 months).
Adverse events were only analyzed for the children involved in this study. The numbers differ with the number of individuals at risk for an adverse event due to participants that were lost to follow up, meaning that the participant had less than 14 days of electronic monitoring data following randomization, removing them from the study.
|
4.8%
1/21 • Adverse events were collected for the entirety of the participant's study period (12 months).
Adverse events were only analyzed for the children involved in this study. The numbers differ with the number of individuals at risk for an adverse event due to participants that were lost to follow up, meaning that the participant had less than 14 days of electronic monitoring data following randomization, removing them from the study.
|
0.00%
0/40 • Adverse events were collected for the entirety of the participant's study period (12 months).
Adverse events were only analyzed for the children involved in this study. The numbers differ with the number of individuals at risk for an adverse event due to participants that were lost to follow up, meaning that the participant had less than 14 days of electronic monitoring data following randomization, removing them from the study.
|
|
Cardiac disorders
Chest Pain
|
0.00%
0/38 • Adverse events were collected for the entirety of the participant's study period (12 months).
Adverse events were only analyzed for the children involved in this study. The numbers differ with the number of individuals at risk for an adverse event due to participants that were lost to follow up, meaning that the participant had less than 14 days of electronic monitoring data following randomization, removing them from the study.
|
0.00%
0/21 • Adverse events were collected for the entirety of the participant's study period (12 months).
Adverse events were only analyzed for the children involved in this study. The numbers differ with the number of individuals at risk for an adverse event due to participants that were lost to follow up, meaning that the participant had less than 14 days of electronic monitoring data following randomization, removing them from the study.
|
2.5%
1/40 • Adverse events were collected for the entirety of the participant's study period (12 months).
Adverse events were only analyzed for the children involved in this study. The numbers differ with the number of individuals at risk for an adverse event due to participants that were lost to follow up, meaning that the participant had less than 14 days of electronic monitoring data following randomization, removing them from the study.
|
|
Gastrointestinal disorders
Constipation
|
2.6%
1/38 • Adverse events were collected for the entirety of the participant's study period (12 months).
Adverse events were only analyzed for the children involved in this study. The numbers differ with the number of individuals at risk for an adverse event due to participants that were lost to follow up, meaning that the participant had less than 14 days of electronic monitoring data following randomization, removing them from the study.
|
4.8%
1/21 • Adverse events were collected for the entirety of the participant's study period (12 months).
Adverse events were only analyzed for the children involved in this study. The numbers differ with the number of individuals at risk for an adverse event due to participants that were lost to follow up, meaning that the participant had less than 14 days of electronic monitoring data following randomization, removing them from the study.
|
0.00%
0/40 • Adverse events were collected for the entirety of the participant's study period (12 months).
Adverse events were only analyzed for the children involved in this study. The numbers differ with the number of individuals at risk for an adverse event due to participants that were lost to follow up, meaning that the participant had less than 14 days of electronic monitoring data following randomization, removing them from the study.
|
|
Infections and infestations
Otitis Externa
|
0.00%
0/38 • Adverse events were collected for the entirety of the participant's study period (12 months).
Adverse events were only analyzed for the children involved in this study. The numbers differ with the number of individuals at risk for an adverse event due to participants that were lost to follow up, meaning that the participant had less than 14 days of electronic monitoring data following randomization, removing them from the study.
|
4.8%
1/21 • Adverse events were collected for the entirety of the participant's study period (12 months).
Adverse events were only analyzed for the children involved in this study. The numbers differ with the number of individuals at risk for an adverse event due to participants that were lost to follow up, meaning that the participant had less than 14 days of electronic monitoring data following randomization, removing them from the study.
|
0.00%
0/40 • Adverse events were collected for the entirety of the participant's study period (12 months).
Adverse events were only analyzed for the children involved in this study. The numbers differ with the number of individuals at risk for an adverse event due to participants that were lost to follow up, meaning that the participant had less than 14 days of electronic monitoring data following randomization, removing them from the study.
|
|
Nervous system disorders
Seizures
|
0.00%
0/38 • Adverse events were collected for the entirety of the participant's study period (12 months).
Adverse events were only analyzed for the children involved in this study. The numbers differ with the number of individuals at risk for an adverse event due to participants that were lost to follow up, meaning that the participant had less than 14 days of electronic monitoring data following randomization, removing them from the study.
|
0.00%
0/21 • Adverse events were collected for the entirety of the participant's study period (12 months).
Adverse events were only analyzed for the children involved in this study. The numbers differ with the number of individuals at risk for an adverse event due to participants that were lost to follow up, meaning that the participant had less than 14 days of electronic monitoring data following randomization, removing them from the study.
|
2.5%
1/40 • Adverse events were collected for the entirety of the participant's study period (12 months).
Adverse events were only analyzed for the children involved in this study. The numbers differ with the number of individuals at risk for an adverse event due to participants that were lost to follow up, meaning that the participant had less than 14 days of electronic monitoring data following randomization, removing them from the study.
|
|
Infections and infestations
Flu
|
0.00%
0/38 • Adverse events were collected for the entirety of the participant's study period (12 months).
Adverse events were only analyzed for the children involved in this study. The numbers differ with the number of individuals at risk for an adverse event due to participants that were lost to follow up, meaning that the participant had less than 14 days of electronic monitoring data following randomization, removing them from the study.
|
0.00%
0/21 • Adverse events were collected for the entirety of the participant's study period (12 months).
Adverse events were only analyzed for the children involved in this study. The numbers differ with the number of individuals at risk for an adverse event due to participants that were lost to follow up, meaning that the participant had less than 14 days of electronic monitoring data following randomization, removing them from the study.
|
2.5%
1/40 • Adverse events were collected for the entirety of the participant's study period (12 months).
Adverse events were only analyzed for the children involved in this study. The numbers differ with the number of individuals at risk for an adverse event due to participants that were lost to follow up, meaning that the participant had less than 14 days of electronic monitoring data following randomization, removing them from the study.
|
|
Skin and subcutaneous tissue disorders
Balantitis Xerotica Obliterans
|
0.00%
0/38 • Adverse events were collected for the entirety of the participant's study period (12 months).
Adverse events were only analyzed for the children involved in this study. The numbers differ with the number of individuals at risk for an adverse event due to participants that were lost to follow up, meaning that the participant had less than 14 days of electronic monitoring data following randomization, removing them from the study.
|
0.00%
0/21 • Adverse events were collected for the entirety of the participant's study period (12 months).
Adverse events were only analyzed for the children involved in this study. The numbers differ with the number of individuals at risk for an adverse event due to participants that were lost to follow up, meaning that the participant had less than 14 days of electronic monitoring data following randomization, removing them from the study.
|
2.5%
1/40 • Adverse events were collected for the entirety of the participant's study period (12 months).
Adverse events were only analyzed for the children involved in this study. The numbers differ with the number of individuals at risk for an adverse event due to participants that were lost to follow up, meaning that the participant had less than 14 days of electronic monitoring data following randomization, removing them from the study.
|
|
General disorders
Tooth Pain/Dental Cavities
|
2.6%
1/38 • Adverse events were collected for the entirety of the participant's study period (12 months).
Adverse events were only analyzed for the children involved in this study. The numbers differ with the number of individuals at risk for an adverse event due to participants that were lost to follow up, meaning that the participant had less than 14 days of electronic monitoring data following randomization, removing them from the study.
|
0.00%
0/21 • Adverse events were collected for the entirety of the participant's study period (12 months).
Adverse events were only analyzed for the children involved in this study. The numbers differ with the number of individuals at risk for an adverse event due to participants that were lost to follow up, meaning that the participant had less than 14 days of electronic monitoring data following randomization, removing them from the study.
|
0.00%
0/40 • Adverse events were collected for the entirety of the participant's study period (12 months).
Adverse events were only analyzed for the children involved in this study. The numbers differ with the number of individuals at risk for an adverse event due to participants that were lost to follow up, meaning that the participant had less than 14 days of electronic monitoring data following randomization, removing them from the study.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place