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Telecommunication Enhanced Asthma Management

Telecommunication Enhanced Asthma Management

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00958932
Acronym
TEAM
Enrollment
1187
Registered
2009-08-14
Start date
2009-09-30
Completion date
2013-05-31
Last updated
2024-04-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma

Brief summary

The primary aim of this project is to conduct a randomized practical clinical trial within a large health maintenance organization to test a telephone intervention designed to improve adherence to daily asthma medications and thereby improve asthma outcomes. The investigators hypothesize that adherence with inhaled corticosteroid medications in the TEAM intervention group will be greater than in the usual care group.

Detailed description

Asthma affects more than 15 million people in the United States. Inhaled corticosteroids (ICS), the ranking treatment-of-choice, are safe and highly efficacious in controlled trials, but adherence to ICS medications in real-world settings is poor in all patient groups, especially low-income and minority patients who experience the most morbidity from asthma. Children and adults with asthma take less than half of their prescribed ICS medication. One study found that only 44% of ICS prescriptions for children with asthma were filled. Even the most effective medications have little value if not taken as prescribed. Decreasing use of ICS has been repeatedly linked to poor asthma control and increasing health care utilization. We will conduct a randomized, practical clinical trial to test the impact of a communication enhancement program for parents of 3-12 year old children with asthma in the largest health maintenance organization (HMO) within Colorado. Research in this setting has the significant advantage of not only establishing the utility of a behavior-changing strategy, but at the same time demonstrating that the strategy can be applied in a large healthcare system and sustained over time. The proposed intervention will be referred to here as the Telecommunication Enhanced Adherence Management (TEAM) program. This proposal builds upon ongoing efforts within Kaiser Permanente of Colorado (KPCO), the participating HMO, to use automated telecommunication technology to prevent diabetes, reduce cardiac risk, reduce calorie consumption, and increase exercise adherence, with the introduction of an intervention to increase adherence with daily ICS therapy. Speech Recognition (SR), the telecommunication technology used in this trial, has not previously been employed to promote adherence in a population of children treated for asthma within a large HMO. TEAM creates a theory-based enhanced communication program using SR with support from asthma care manager nurses. The Asthma Care Manager program already exists within KPCO, but with SR the frequency and quality of communication with parents is expected to improve significantly, resulting in more ICS medication refills, better persistence in ICS use, and improved asthma outcomes. Through SR calls, parents will be reminded and motivated about the importance of continued daily use of ICS medications, asked about their child's recent asthma symptoms, and given the opportunity to receive a call back from an asthma care manager or to place a request for a medication refill.

Interventions

The TEAM intervention is a program to increase communication with families, provide feedback to families about their refill adherence, assess asthma symptoms, deliver health communication messages, encourage parents to ask questions of asthma care managers, and facilitate refilling ICS prescription. Speech recognition calls will be tailored to specific situations including new or re-issued ICS prescriptions, failure to fill an initial prescription, failure to refill, or failure to refill following an ED visit, hospitalization, or oral steroid burst resulting from an asthma exacerbation.

Sponsors

Kaiser Permanente
CollaboratorOTHER
National Jewish Health
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)

Eligibility

Sex/Gender
ALL
Age
3 Years to 12 Years
Healthy volunteers
No

Inclusion criteria

* 3-12 year old children with asthma requiring daily corticosteroid

Exclusion criteria

* sibling already in study * physician excludes from participation * non English Speaking

Design outcomes

Primary

MeasureTime frameDescription
Medication Adherence12 monthsThe primary outcome of this study, adherence, was expressed as a mean proportion of days covered (PDC) over 24 months. The PDC was calculated as the total number of ICS days supplied divided by the period for which the medication was prescribed. Calculation of the PDC was adjusted to account for the supply that would extend beyond the end of the study period. Comparisons were adjusted for baseline PDC, which was calculated as the ratio of number of days a patient had possession of medication divided by the number of days enrolled 1 year prior to randomization.

Secondary

MeasureTime frameDescription
Emergency Care Visits Per Person-YearPer one year of person-timeAsthma-related emergency care events were compared between the two study groups. In health insurance data, individual records often do not cover the entire period of study because people may leave the insurance network seeking new coverage, or after moving, etc. However, this partial data is still usable when pooled to calculate numbers of events of interest per person-year. For example, one person may only be in the study for six months, and they may log an emergency room. Another person may be in the study for 18 months and log no visits. Put together, the two participants log two person years of data (6 months + 18 months = 24 months = 2 person-years in the study) and between the two of them they log one emergency room visit, which results in an outcome of 0.5 emergency care visits, on average, per person-year of data available. This measure of central tendency is calculated for the two study groups to permit comparison.

Countries

United States

Participant flow

Participants by arm

ArmCount
Speech Recognition (TEAM Intervention)
Speech recognition: The TEAM intervention is a program to increase communication with families, provide feedback to families about their refill adherence, assess asthma symptoms, deliver health communication messages, encourage parents to ask questions of asthma care managers, and facilitate refilling ICS prescription. Speech recognition calls will be tailored to specific situations including new or re-issued ICS prescriptions, failure to fill an initial prescription, failure to refill, or failure to refill following an ED visit, hospitalization, or oral steroid burst resulting from an asthma exacerbation.
590
Speech Recognition (Usual Care)
Speech recognition: Automated, speech recognition telephone calls
597
Total1,187

Baseline characteristics

CharacteristicTotalSpeech Recognition (TEAM Intervention)Speech Recognition (Usual Care)
Age, Continuous8.2 years
STANDARD_DEVIATION 2.2
8.1 years
STANDARD_DEVIATION 2.6
8.2 years
STANDARD_DEVIATION 2.2
Ethnicity (NIH/OMB)
Hispanic or Latino
292 Participants146 Participants146 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
880 Participants431 Participants449 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
15 Participants13 Participants2 Participants
Race (NIH/OMB)
American Indian or Alaska Native
17 Participants8 Participants9 Participants
Race (NIH/OMB)
Asian
40 Participants17 Participants23 Participants
Race (NIH/OMB)
Black or African American
154 Participants80 Participants74 Participants
Race (NIH/OMB)
More than one race
285 Participants139 Participants146 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
7 Participants3 Participants4 Participants
Race (NIH/OMB)
Unknown or Not Reported
15 Participants13 Participants2 Participants
Race (NIH/OMB)
White
669 Participants330 Participants339 Participants
Region of Enrollment
United States
1187 participants590 participants597 participants
Sex: Female, Male
Female
424 Participants229 Participants195 Participants
Sex: Female, Male
Male
763 Participants361 Participants402 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
0 / 5900 / 597
serious
Total, serious adverse events
0 / 5900 / 597

Outcome results

Primary

Medication Adherence

The primary outcome of this study, adherence, was expressed as a mean proportion of days covered (PDC) over 24 months. The PDC was calculated as the total number of ICS days supplied divided by the period for which the medication was prescribed. Calculation of the PDC was adjusted to account for the supply that would extend beyond the end of the study period. Comparisons were adjusted for baseline PDC, which was calculated as the ratio of number of days a patient had possession of medication divided by the number of days enrolled 1 year prior to randomization.

Time frame: 12 months

Population: The 899 participants remaining in the final analysis represent those who remained in the insurance network at 24 months post-randomization.

ArmMeasureValue (MEAN)
Speech Recognition (TEAM Intervention)Medication Adherence.445 Proportion of Days Covered
Speech Recognition (Usual Care)Medication Adherence.355 Proportion of Days Covered
Secondary

Emergency Care Visits Per Person-Year

Asthma-related emergency care events were compared between the two study groups. In health insurance data, individual records often do not cover the entire period of study because people may leave the insurance network seeking new coverage, or after moving, etc. However, this partial data is still usable when pooled to calculate numbers of events of interest per person-year. For example, one person may only be in the study for six months, and they may log an emergency room. Another person may be in the study for 18 months and log no visits. Put together, the two participants log two person years of data (6 months + 18 months = 24 months = 2 person-years in the study) and between the two of them they log one emergency room visit, which results in an outcome of 0.5 emergency care visits, on average, per person-year of data available. This measure of central tendency is calculated for the two study groups to permit comparison.

Time frame: Per one year of person-time

ArmMeasureValue (NUMBER)
Speech Recognition (TEAM Intervention)Emergency Care Visits Per Person-Year0.06 Number of visits per person-year
Speech Recognition (Usual Care)Emergency Care Visits Per Person-Year0.04 Number of visits per person-year

Source: ClinicalTrials.gov · Data processed: Mar 5, 2026