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Telecommunication Enhanced Asthma Management (TEAM)

Primary Purpose

Asthma

Status
Unknown status
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Speech recognition
Speech recognition
Sponsored by
National Jewish Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Asthma

Eligibility Criteria

3 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Sites / Locations

  • National Jewish Health

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Speech recognition (TEAM intervention)

Speech recognition (Usual care)

Arm Description

Outcomes

Primary Outcome Measures

Medication adherence

Secondary Outcome Measures

urgent care visits

Full Information

First Posted
August 13, 2009
Last Updated
July 19, 2011
Sponsor
National Jewish Health
Collaborators
Kaiser Permanente
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1. Study Identification

Unique Protocol Identification Number
NCT00958932
Brief Title
Telecommunication Enhanced Asthma Management
Acronym
TEAM
Official Title
Telecommunication Enhanced Asthma Management
Study Type
Interventional

2. Study Status

Record Verification Date
July 2011
Overall Recruitment Status
Unknown status
Study Start Date
September 2009 (undefined)
Primary Completion Date
May 2012 (Anticipated)
Study Completion Date
May 2012 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
National Jewish Health
Collaborators
Kaiser Permanente

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
1000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Speech recognition (TEAM intervention)
Arm Type
Experimental
Arm Title
Speech recognition (Usual care)
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
Speech recognition
Other Intervention Name(s)
usual care
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Speech recognition
Other Intervention Name(s)
usual care
Intervention Description
Automated, speech recognition telephone calls
Primary Outcome Measure Information:
Title
Medication adherence
Time Frame
12 months
Secondary Outcome Measure Information:
Title
urgent care visits
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 3-12 year old children with asthma requiring daily corticosteroid
Facility Information:
Facility Name
National Jewish Health
City
Denver
State/Province
Colorado
ZIP/Postal Code
80206
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
25664620
Citation
Bender BG, Cvietusa PJ, Goodrich GK, Lowe R, Nuanes HA, Rand C, Shetterly S, Tacinas C, Vollmer WM, Wagner N, Wamboldt FS, Xu S, Magid DJ. Pragmatic trial of health care technologies to improve adherence to pediatric asthma treatment: a randomized clinical trial. JAMA Pediatr. 2015 Apr;169(4):317-23. doi: 10.1001/jamapediatrics.2014.3280.
Results Reference
derived

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Telecommunication Enhanced Asthma Management

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