Barriers to Adherence to Asthma Controller Meds in Low In... | NCT00967720

Studies
Barriers to Adherence to Asthma Controller Meds in Low Income Urban Minority Adolescents

NCT00967720

Sponsor

Rush University Medical Center

Status

Completed

Last Update Posted

Nov 21, 2017Actual

Enrollment

4Actual

Phase

Not provided

Conditions

Asthma

Interventions

Not provided

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2008

Primary Completion Date

Aug 2009Actual

Completion Date

Aug 2009Actual

First Submitted Date

Aug 26, 2009

First Submission Date that Met QC Criteria

Aug 26, 2009

First Posted Date

Aug 28, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 17, 2017

Last Update Posted Date

Nov 21, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Poor adherence to appropriate asthma medications is an important risk factor contributing to high asthma morbidity and mortality in urban African American adolescents. As part of the ADEPT (Adolescent Disease Empowerment and Persistency Technology) for Asthma Pilot 2 study, a focus group was developed specifically to explore existing barriers to adherence among inner city African American adolescent asthmatics.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

4Actual

Label	Type	Description	Intervention Names
Barriers, Adherence, Asthma

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Focus groups explored whether a new communication medium improved adherence to asthma controller medications and to examine existing barriers to adherence among four urban African American adolescents with uncontrolled moderate persistent asthma

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

12-18 years of age
self identify as African American
have persistent asthma
read at a minimum fourth grade reading level
be on a prescribed daily inhaled corticosteroid medication for asthma

Exclusion Criteria:

candidate refusal or presence of other co-morbidities

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

12 Years

Maximum Age

15 Years

Standard Ages

Child

Study Population

four low income urban adolescents with uncontrolled moderate persistent asthma

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Giselle S Mosnaim, MD	Rush University Medical Center	Principal Investigator

Locations

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D001249	Asthma

Ancestor Terms

ID	Term
D001982	Bronchial Diseases
D012140	Respiratory Tract Diseases
D008173	Lung Diseases, Obstructive
D008171	Lung Diseases

Browse Leaves

Not provided

Browse Branches

Not provided