Telecommunication Enhanced Asthma Management
TEAM
1 other identifier
interventional
1,187
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable asthma
Started Sep 2009
Longer than P75 for not_applicable asthma
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 13, 2009
CompletedFirst Posted
Study publicly available on registry
August 14, 2009
CompletedStudy Start
First participant enrolled
September 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2013
CompletedResults Posted
Study results publicly available
April 4, 2024
CompletedApril 4, 2024
March 1, 2024
3.7 years
August 13, 2009
September 23, 2014
March 29, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
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.
12 months
Secondary Outcomes (1)
Emergency Care Visits Per Person-Year
Per one year of person-time
Study Arms (2)
Speech recognition (TEAM intervention)
EXPERIMENTALParents randomized to the intervention received speech recognition phone calls if their child's medication refill was overdue.
Control
NO INTERVENTIONUsual care
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.
Eligibility Criteria
You may qualify if:
- year old children with asthma requiring daily corticosteroid
You may not qualify if:
- sibling already in study
- physician excludes from participation
- non English Speaking
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- National Jewish Healthlead
- Kaiser Permanentecollaborator
Study Sites (1)
National Jewish Health
Denver, Colorado, 80206, United States
Related Publications (2)
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.
PMID: 25664620BACKGROUNDBender BG, Cvietusa PJ, Goodrich GK, King DK, Shoup JA. Adapting adaptive design methods to accelerate adoption of a digital asthma management intervention. Transl Behav Med. 2023 Apr 3;13(3):149-155. doi: 10.1093/tbm/ibac093.
PMID: 36689336DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
A potential limitation to this study is that the most poorly adherent patients may have been excluded from the study since eligible patients were required to have made at least 1 Inhaled Corticosteroid fill in the 6 months prior to enrollment. An additional limitation may be non-applicability of the intervention to practices without an Electronic Health Record (EHR) or with an EHR that is different from the one used at Kaiser Permanente Colorado (KPCO).
Results Point of Contact
- Title
- Dr. Bruce Bender
- Organization
- National Jewish Health
Study Officials
- PRINCIPAL INVESTIGATOR
Bruce G Bender, PhD
National Jewish Health
Publication Agreements
- PI is Sponsor Employee
- Yes
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Pediatrics
Study Record Dates
First Submitted
August 13, 2009
First Posted
August 14, 2009
Study Start
September 1, 2009
Primary Completion
May 1, 2013
Study Completion
May 1, 2013
Last Updated
April 4, 2024
Results First Posted
April 4, 2024
Record last verified: 2024-03