NCT01322841

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,239

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2007

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2007

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2009

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2010

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

March 23, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 25, 2011

Completed
4.7 years until next milestone

Results Posted

Study results publicly available

December 18, 2015

Completed
Last Updated

December 2, 2016

Status Verified

October 1, 2016

Enrollment Period

1.8 years

First QC Date

March 23, 2011

Results QC Date

November 17, 2015

Last Update Submit

October 21, 2016

Conditions

Keywords

CHICAclinical decision support

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 COMPARATOR

This arm had the CHICA screening module turned on

Other: CHICA Diagnosis Module

CHICA Placebo

PLACEBO COMPARATOR

This arm had CHICA but no additional module

Other: CHICA Placebo

Interventions

The CHICA module helped to screen and diagnose patients with tuberculosis or iron deficiency anemia

CHICA Diagnosis Module

This was CHICA without the screening module

CHICA Placebo

Eligibility Criteria

Age3 Years - 11 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

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

Study Sites (1)

Children's Health Services Research

Indianapolis, Indiana, 46202, United States

Location

MeSH Terms

Conditions

TuberculosisAnemia, Iron-Deficiency

Condition Hierarchy (Ancestors)

Mycobacterium InfectionsActinomycetales InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfectionsAnemia, HypochromicAnemiaHematologic DiseasesHemic and Lymphatic DiseasesIron DeficienciesIron Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Results Point of Contact

Title
Aaron Carroll
Organization
Indiana University School of Medicine

Study Officials

  • Aaron E Carroll, MD, MS

    IUSM

    PRINCIPAL INVESTIGATOR

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

Locations