Viewing Study NCT00217776



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Last Modification Date: 2024-10-26 @ 9:19 AM
Study NCT ID: NCT00217776
Status: COMPLETED
Last Update Posted: 2013-01-17
First Post: 2005-09-19

Brief Title: School-based Approaches to Help Pre-teens Manage Asthma
Sponsor: University of Michigan
Organization: University of Michigan

Study Overview

Official Title: None
Status: COMPLETED
Status Verified Date: 2013-01
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: DMSP
Brief Summary: This random trial will deploy 2 interventions and a control group with eleven and twelve year old low income African American students in middle schools in Detroit MI The goals are to determine if 1 a self-management program focused on pre-teen capabilities designed for middle schools produces desired outcomes and 2 if the program enhanced by a peer component improves upon outcomes Outcomes of interest are symptom experience quality of life self-management and school grades
Detailed Description: BACKGROUND

To date no data provide information on the effects of middle school based interventions for pre-teens with asthma or the advantages of an approach that recognizes the importance of peer influence on pre-teens asthma behavior Interventions to reach low income minority populations are particularly needed

DESIGN NARRATIVE

If only one primary outcome is to be specified it would be asthma morbidity as evident in asthma symptoms Data to assess outcomes will be collected at baseline and 12 and 24 months post program through parent interviews and student surveys

Additional primary outcomes listed in the protocol include Asthma related quality of life disease management behavior and academic performance

Secondary outcomes include peer support school attendance physical activity health care use and smoking behavior

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None
Secondary IDs
Secondary ID Type Domain Link
R01HL068654-04 NIH None httpsreporternihgovquickSearchR01HL068654-04