Trial Outcomes & Findings for Using Technology-Assisted Stepped Care Intervention to Improve Adherence in Adolescents With Asthma (NCT NCT04365556)
NCT ID: NCT04365556
Last Updated: 2025-09-18
Results Overview
The electronic monitoring system records every dose, or "puff", the patient takes and sends it to a corresponding online database that is accessible to study staff. 30 day adherence is calculated by doses taken divided by doses prescribed and is capped at 100%. Percent Change refers to the change in percent adherence at baseline compared to end of study.
COMPLETED
NA
72 participants
30 days
2025-09-18
Participant Flow
Adolescents were recruited through the CCHMC Asthma Center. Eligible adolescents were also identified through electronic medical records and approached during outpatient medical visits. Dates of recruitment: 11/19/2019 - 9/23/2023
Participant milestones
| Measure |
TASC Intervention
Step 1 of the intervention includes educational materials related to asthma. Step 2 includes electronic monitoring of adherence and a text messaging intervention personally tailored to the participant. Step 3 includes problem solving telehealth sessions with a trained clinician.
TASC Intervention: All participants receive Step 1 of the intervention. Participants who have adherence below or at 68% will step up to Step 2 or Step 3 after the third or fourth month in the study.
|
Treatment as Usual
Participants will not receive any intervention.
|
|---|---|---|
|
Overall Study
STARTED
|
37
|
35
|
|
Overall Study
COMPLETED
|
33
|
33
|
|
Overall Study
NOT COMPLETED
|
4
|
2
|
Reasons for withdrawal
| Measure |
TASC Intervention
Step 1 of the intervention includes educational materials related to asthma. Step 2 includes electronic monitoring of adherence and a text messaging intervention personally tailored to the participant. Step 3 includes problem solving telehealth sessions with a trained clinician.
TASC Intervention: All participants receive Step 1 of the intervention. Participants who have adherence below or at 68% will step up to Step 2 or Step 3 after the third or fourth month in the study.
|
Treatment as Usual
Participants will not receive any intervention.
|
|---|---|---|
|
Overall Study
No longer eligible due to treatment plan
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
3
|
2
|
Baseline Characteristics
Using Technology-Assisted Stepped Care Intervention to Improve Adherence in Adolescents With Asthma
Baseline characteristics by cohort
| Measure |
TASC Intervention
n=37 Participants
Step 1 of the intervention includes educational materials related to asthma. Step 2 includes electronic monitoring of adherence and a text messaging intervention personally tailored to the participant. Step 3 includes problem solving telehealth sessions with a trained clinician.
TASC Intervention: All participants receive Step 1 of the intervention. Participants who have adherence below or at 68% will step up to Step 2 or Step 3 after the third or fourth month in the study.
|
Treatment as Usual
n=35 Participants
Participants will not receive any intervention.
|
Total
n=72 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
37 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
72 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
14.67 years
STANDARD_DEVIATION 1.84 • n=5 Participants
|
15.18 years
STANDARD_DEVIATION 2.15 • n=7 Participants
|
14.92 years
STANDARD_DEVIATION 1.99 • n=5 Participants
|
|
Sex: Female, Male
Female
|
22 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
35 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
68 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 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
|
16 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
21 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 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
|
37 participants
n=5 Participants
|
35 participants
n=7 Participants
|
72 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 30 daysPopulation: Intention to treat
The electronic monitoring system records every dose, or "puff", the patient takes and sends it to a corresponding online database that is accessible to study staff. 30 day adherence is calculated by doses taken divided by doses prescribed and is capped at 100%. Percent Change refers to the change in percent adherence at baseline compared to end of study.
Outcome measures
| Measure |
TASC Intervention
n=36 Participants
Step 1 of the intervention includes educational materials related to asthma. Step 2 includes electronic monitoring of adherence and a text messaging intervention personally tailored to the participant. Step 3 includes problem solving telehealth sessions with a trained clinician.
TASC Intervention: All participants receive Step 1 of the intervention. Participants who have adherence below or at 68% will step up to Step 2 or Step 3 after the third or fourth month in the study.
|
Treatment as Usual
n=34 Participants
Participants will not receive any intervention.
|
|---|---|---|
|
Percent Change in Inhaler Adherence Via Electronic Monitoring
|
14.05 percent
Standard Deviation .30
|
13.43 percent
Standard Deviation .22
|
SECONDARY outcome
Timeframe: 2 monthsPopulation: Intention to treat
The outcome measures the change in asthma severity (i.e., baseline, post) based on the participant's symptom burden, health care utilization, systemic corticosteroid use, and current medication use over the past month. The scale ranges from 0 to 20 with lower scores indicating less severe asthma.
Outcome measures
| Measure |
TASC Intervention
n=37 Participants
Step 1 of the intervention includes educational materials related to asthma. Step 2 includes electronic monitoring of adherence and a text messaging intervention personally tailored to the participant. Step 3 includes problem solving telehealth sessions with a trained clinician.
TASC Intervention: All participants receive Step 1 of the intervention. Participants who have adherence below or at 68% will step up to Step 2 or Step 3 after the third or fourth month in the study.
|
Treatment as Usual
n=34 Participants
Participants will not receive any intervention.
|
|---|---|---|
|
Change in Composite Asthma Severity Index
|
-0.92 score on a scale
Standard Deviation 3.09
|
-0.34 score on a scale
Standard Deviation 3.2
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: Only the TASC intervention arm completed this measure of intervention feasibility and therefore the Treatment as Usual arm is not included.
A measure of format, content, length, skills and acceptability of the intervention will be given to participants in the form of a questionnaire at the end of each step and the end of the study. The feasibility section is on a scale of 1 to 5, 1 being the worst and 5 being the best.
Outcome measures
| Measure |
TASC Intervention
n=33 Participants
Step 1 of the intervention includes educational materials related to asthma. Step 2 includes electronic monitoring of adherence and a text messaging intervention personally tailored to the participant. Step 3 includes problem solving telehealth sessions with a trained clinician.
TASC Intervention: All participants receive Step 1 of the intervention. Participants who have adherence below or at 68% will step up to Step 2 or Step 3 after the third or fourth month in the study.
|
Treatment as Usual
Participants will not receive any intervention.
|
|---|---|---|
|
Feasibility Questionnaire
|
4.30 score on a scale
Standard Deviation .50
|
—
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: Only the TASC intervention arm completed this measure of intervention feasibility and therefore the Treatment as Usual arm is not included.
A 10 item, Likert scale giving a global view of usability will be given to participants in the form of a questionnaire at the end of each step and at the end of the study. The scale ranges from 'Strongly Disagree' to 'Strongly Agree, with half of the items reverse scored. Scores range from 0-100 with higher scores indicating better usability.
Outcome measures
| Measure |
TASC Intervention
n=33 Participants
Step 1 of the intervention includes educational materials related to asthma. Step 2 includes electronic monitoring of adherence and a text messaging intervention personally tailored to the participant. Step 3 includes problem solving telehealth sessions with a trained clinician.
TASC Intervention: All participants receive Step 1 of the intervention. Participants who have adherence below or at 68% will step up to Step 2 or Step 3 after the third or fourth month in the study.
|
Treatment as Usual
Participants will not receive any intervention.
|
|---|---|---|
|
Usability: Questionnaire
|
75.83 score on a scale
Standard Deviation 13.57
|
—
|
Adverse Events
TASC Intervention
Treatment as Usual
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Rachelle Ramsey
Cincinnati Children's Hospital Medical Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place