Universal Screening for Tuberculosis and Anemia With the CHICA System
2 other identifiers
interventional
2,239
1 country
1
Brief Summary
The CHICA system is a clinical decision support system that uses adaptive turnaround documents to provide point-of-care information to clinicians. The investigators will be studying whether it can help in the diagnosis and treatment of tuberculosis and iron deficiency anemia.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2007
Typical duration for not_applicable
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
Study Start
First participant enrolled
October 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2010
CompletedFirst Submitted
Initial submission to the registry
March 23, 2011
CompletedFirst Posted
Study publicly available on registry
March 25, 2011
CompletedResults Posted
Study results publicly available
December 18, 2015
CompletedDecember 2, 2016
October 1, 2016
1.8 years
March 23, 2011
November 17, 2015
October 21, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of Patients Screened Positive for One of the Disorders
six months
Secondary Outcomes (1)
Percentage of Patients Diagnosed With One of the Disorders
six months
Study Arms (2)
CHICA Diagnosis Module
ACTIVE COMPARATORThis arm had the CHICA screening module turned on
CHICA Placebo
PLACEBO COMPARATORThis arm had CHICA but no additional module
Interventions
The CHICA module helped to screen and diagnose patients with tuberculosis or iron deficiency anemia
Eligibility Criteria
You may qualify if:
- Age 3 to 11 years old and seen in a study clinic
You may not qualify if:
- None
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Indiana Universitylead
- National Library of Medicine (NLM)collaborator
Study Sites (1)
Children's Health Services Research
Indianapolis, Indiana, 46202, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Aaron Carroll
- Organization
- Indiana University School of Medicine
Study Officials
- PRINCIPAL INVESTIGATOR
Aaron E Carroll, MD, MS
IUSM
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Pediatrics
Study Record Dates
First Submitted
March 23, 2011
First Posted
March 25, 2011
Study Start
October 1, 2007
Primary Completion
July 1, 2009
Study Completion
September 1, 2010
Last Updated
December 2, 2016
Results First Posted
December 18, 2015
Record last verified: 2016-10