Trial Outcomes & Findings for Medication Adherence With Telehealthcare Medication Therapy Management (NCT NCT03978936)
NCT ID: NCT03978936
Last Updated: 2026-06-26
Results Overview
Proportion of daily adherence over the follow-up period recorded using the digital sensor on the ICS inhaler (adherence outcome) Daily ICS adherence was calculated as a proportion of sensor-recorded inhalations to the number expected based on prescribed daily dose. For primary analyses, an adherent day was defined as completion of at least 75% of prescribed inhalations, with adherence capped at 100%. The time frame of 12 months includes a run-in period prior to randomization.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
375 participants
Primary outcome timeframe
Up to 12 months
Results posted on
2026-06-26
Participant Flow
375 participants enrolled into the study. 54 declined to participate. 321 participants were randomized to MTM-EAM (n=166) or EAM (n=155). 162 randomized into MTM-EAM contributed adherence outcomes data and 164 contributed to the efficacy outcomes. 149 randomized into EAM contributed adherence outcomes and 155 to the efficacy outcomes.
Participant milestones
| Measure |
MTM-EAM
Medication Therapy Management Video Telehealthcare plus Electronic Adherence Self-Management \[MTM-EAM\]
Medication Therapy Management (MTM) Video Telehealthcare: MTM is an individualized approach to "optimize medication use for improved patient outcomes" and is designed to "empower patients to take an active role in managing patients' medications" thus, providing a favorable strategy for addressing adherence issues. Five core elements define MTM: complete medication therapy review (CMR), creation of a personal medication list (PML), development of a medication action plan (MAP), intervention and/or referral for drug therapy problems, and documentation and follow-up
Electronic Adherence Self-Management (EAM): Participants will have a sensor which monitors their adherence to medication use
|
EAM Only
Electronic Adherence Self-Management \[EAM\] only
Electronic Adherence Self-Management (EAM): Participants will have a sensor which monitors their adherence to medication use
|
|---|---|---|
|
Overall Study
STARTED
|
166
|
155
|
|
Overall Study
COMPLETED
|
130
|
109
|
|
Overall Study
NOT COMPLETED
|
36
|
46
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The number of participants with baseline prescription data for the controller inhalations
Baseline characteristics by cohort
| Measure |
MTM-EAM
n=166 Participants
Medication Therapy Management Video Telehealthcare plus Electronic Adherence Self-Management \[MTM-EAM\]
Medication Therapy Management (MTM) Video Telehealthcare: MTM is an individualized approach to "optimize medication use for improved patient outcomes" and is designed to "empower patients to take an active role in managing patients' medications" thus, providing a favorable strategy for addressing adherence issues. Five core elements define MTM: complete medication therapy review (CMR), creation of a personal medication list (PML), development of a medication action plan (MAP), intervention and/or referral for drug therapy problems, and documentation and follow-up
Electronic Adherence Self-Management (EAM): Participants will have a sensor which monitors their adherence to medication use
|
EAM Only
n=155 Participants
Electronic Adherence Self-Management \[EAM\] only
Electronic Adherence Self-Management (EAM): Participants will have a sensor which monitors their adherence to medication use
|
Total
n=321 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
23 years
n=166 Participants
|
23 years
n=155 Participants
|
23 years
n=321 Participants
|
|
Sex: Female, Male
Female
|
111 Participants
n=166 Participants
|
100 Participants
n=155 Participants
|
211 Participants
n=321 Participants
|
|
Sex: Female, Male
Male
|
55 Participants
n=166 Participants
|
55 Participants
n=155 Participants
|
110 Participants
n=321 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
25 Participants
n=166 Participants
|
30 Participants
n=155 Participants
|
55 Participants
n=321 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
141 Participants
n=166 Participants
|
125 Participants
n=155 Participants
|
266 Participants
n=321 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=166 Participants
|
0 Participants
n=155 Participants
|
0 Participants
n=321 Participants
|
|
Race/Ethnicity, Customized
White
|
103 Participants
n=166 Participants
|
104 Participants
n=155 Participants
|
207 Participants
n=321 Participants
|
|
Race/Ethnicity, Customized
Black
|
46 Participants
n=166 Participants
|
39 Participants
n=155 Participants
|
85 Participants
n=321 Participants
|
|
Race/Ethnicity, Customized
Asian
|
6 Participants
n=166 Participants
|
3 Participants
n=155 Participants
|
9 Participants
n=321 Participants
|
|
Race/Ethnicity, Customized
Other single races
|
2 Participants
n=166 Participants
|
1 Participants
n=155 Participants
|
3 Participants
n=321 Participants
|
|
Race/Ethnicity, Customized
More than one race
|
2 Participants
n=166 Participants
|
1 Participants
n=155 Participants
|
3 Participants
n=321 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
7 Participants
n=166 Participants
|
7 Participants
n=155 Participants
|
14 Participants
n=321 Participants
|
|
Participants with controller inhalations prescribed per day
1 inhalation
|
36 Participants
n=162 Participants • The number of participants with baseline prescription data for the controller inhalations
|
25 Participants
n=149 Participants • The number of participants with baseline prescription data for the controller inhalations
|
61 Participants
n=311 Participants • The number of participants with baseline prescription data for the controller inhalations
|
|
Participants with controller inhalations prescribed per day
2 inhalations
|
45 Participants
n=162 Participants • The number of participants with baseline prescription data for the controller inhalations
|
34 Participants
n=149 Participants • The number of participants with baseline prescription data for the controller inhalations
|
79 Participants
n=311 Participants • The number of participants with baseline prescription data for the controller inhalations
|
|
Participants with controller inhalations prescribed per day
4 inhalations
|
80 Participants
n=162 Participants • The number of participants with baseline prescription data for the controller inhalations
|
90 Participants
n=149 Participants • The number of participants with baseline prescription data for the controller inhalations
|
170 Participants
n=311 Participants • The number of participants with baseline prescription data for the controller inhalations
|
|
Participants with controller inhalations prescribed per day
Greater than 4 inhalations
|
1 Participants
n=162 Participants • The number of participants with baseline prescription data for the controller inhalations
|
0 Participants
n=149 Participants • The number of participants with baseline prescription data for the controller inhalations
|
1 Participants
n=311 Participants • The number of participants with baseline prescription data for the controller inhalations
|
PRIMARY outcome
Timeframe: Up to 12 monthsPopulation: Participants with data collected
Proportion of daily adherence over the follow-up period recorded using the digital sensor on the ICS inhaler (adherence outcome) Daily ICS adherence was calculated as a proportion of sensor-recorded inhalations to the number expected based on prescribed daily dose. For primary analyses, an adherent day was defined as completion of at least 75% of prescribed inhalations, with adherence capped at 100%. The time frame of 12 months includes a run-in period prior to randomization.
Outcome measures
| Measure |
MTM-EAM
n=162 Participants
Medication Therapy Management Video Telehealthcare plus Electronic Adherence Self-Management \[MTM-EAM\]
|
EAM Only
n=149 Participants
Electronic Adherence Self-Management \[EAM\] only
|
|---|---|---|
|
Proportion of ICS Inhaler Adherent Days
Months 5 to 11 Adherence
|
0.187 Proportion of adherent days
Interval 0.138 to 0.235
|
0.107 Proportion of adherent days
Interval 0.077 to 0.138
|
|
Proportion of ICS Inhaler Adherent Days
Baseline Adherence
|
0.276 Proportion of adherent days
Interval 0.222 to 0.331
|
0.271 Proportion of adherent days
Interval 0.215 to 0.328
|
|
Proportion of ICS Inhaler Adherent Days
Randomization to Month 2 Adherence
|
0.350 Proportion of adherent days
Interval 0.287 to 0.412
|
0.281 Proportion of adherent days
Interval 0.228 to 0.334
|
|
Proportion of ICS Inhaler Adherent Days
Months 2 to 5 Adherence
|
0.258 Proportion of adherent days
Interval 0.207 to 0.31
|
0.185 Proportion of adherent days
Interval 0.146 to 0.224
|
PRIMARY outcome
Timeframe: Up to 12 monthsPopulation: Only 319 MATCH participants (164 MTM vs. 155 EAM) had exacerbation follow-up data.
Percent cumulative incidence of first asthma severe exacerbation (efficacy outcome). Percent cumulative incidence of first severe asthma exacerbation was defined as a worsening of asthma requiring: (1) use of systemic corticosteroids for at least three days, (2) an emergency department visit requiring systemic corticosteroid treatment, (3) hospitalization due to asthma, or (4) death from any cause. Exacerbations were identified using biweekly My Asthma surveys, in which participants reported health-care use, medication changes, and impacts on work or school.
Outcome measures
| Measure |
MTM-EAM
n=164 Participants
Medication Therapy Management Video Telehealthcare plus Electronic Adherence Self-Management \[MTM-EAM\]
|
EAM Only
n=155 Participants
Electronic Adherence Self-Management \[EAM\] only
|
|---|---|---|
|
Percent Cumulative Incidence Severe Exacerbation
|
29.1 Percent cumulative incidence
Interval 20.9 to 36.4
|
26.2 Percent cumulative incidence
Interval 18.6 to 33.0
|
Adverse Events
MTM-EAM
Serious events: 6 serious events
Other events: 83 other events
Deaths: 0 deaths
EAM Only
Serious events: 14 serious events
Other events: 77 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
MTM-EAM
n=166 participants at risk
Medication Therapy Management Video Telehealthcare plus Electronic Adherence Self-Management \[MTM-EAM\]
|
EAM Only
n=155 participants at risk
Electronic Adherence Self-Management \[EAM\] only
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Asthma exacerbation
|
1.8%
3/166 • Enrollment until end of follow-up, up to 1 year.
|
1.9%
3/155 • Enrollment until end of follow-up, up to 1 year.
|
|
Respiratory, thoracic and mediastinal disorders
Difficulty breathing
|
0.00%
0/166 • Enrollment until end of follow-up, up to 1 year.
|
1.3%
2/155 • Enrollment until end of follow-up, up to 1 year.
|
|
General disorders
Surgery
|
0.60%
1/166 • Enrollment until end of follow-up, up to 1 year.
|
1.9%
3/155 • Enrollment until end of follow-up, up to 1 year.
|
|
Respiratory, thoracic and mediastinal disorders
COVID
|
0.00%
0/166 • Enrollment until end of follow-up, up to 1 year.
|
0.65%
1/155 • Enrollment until end of follow-up, up to 1 year.
|
|
Nervous system disorders
Seizure
|
0.00%
0/166 • Enrollment until end of follow-up, up to 1 year.
|
0.65%
1/155 • Enrollment until end of follow-up, up to 1 year.
|
|
Cardiac disorders
Heart failure
|
0.60%
1/166 • Enrollment until end of follow-up, up to 1 year.
|
0.00%
0/155 • Enrollment until end of follow-up, up to 1 year.
|
|
Psychiatric disorders
Altered mental status
|
0.00%
0/166 • Enrollment until end of follow-up, up to 1 year.
|
1.9%
3/155 • Enrollment until end of follow-up, up to 1 year.
|
|
Immune system disorders
Lupus flareup
|
0.00%
0/166 • Enrollment until end of follow-up, up to 1 year.
|
0.65%
1/155 • Enrollment until end of follow-up, up to 1 year.
|
|
Gastrointestinal disorders
Constipation
|
0.60%
1/166 • Enrollment until end of follow-up, up to 1 year.
|
0.00%
0/155 • Enrollment until end of follow-up, up to 1 year.
|
Other adverse events
| Measure |
MTM-EAM
n=166 participants at risk
Medication Therapy Management Video Telehealthcare plus Electronic Adherence Self-Management \[MTM-EAM\]
|
EAM Only
n=155 participants at risk
Electronic Adherence Self-Management \[EAM\] only
|
|---|---|---|
|
Psychiatric disorders
Depression
|
34.3%
57/166 • Enrollment until end of follow-up, up to 1 year.
|
29.0%
45/155 • Enrollment until end of follow-up, up to 1 year.
|
|
General disorders
Medical issue
|
15.7%
26/166 • Enrollment until end of follow-up, up to 1 year.
|
20.6%
32/155 • Enrollment until end of follow-up, up to 1 year.
|
Additional Information
Kathryn Blake, Pharm D
Department of Biomedical Research, Nemours Children's Health
Phone: 904-697-3806
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place