Universal Screening for Tuberculosis and Anemia With the CHICA System

October 21, 2016 updated by: Aaron Carroll, Indiana University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The CHICA system is a clinical decision support system that uses adaptive turnaround documents to provide point-of-care information to clinicians. We will be studying whether it can help in the diagnosis and treatment of tuberculosis and iron deficiency anemia.

Study Type

Interventional

Enrollment (Actual)

2239

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Children's Health Services Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years to 11 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

Age 3 to 11 years old and seen in a study clinic

Exclusion Criteria:

None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: CHICA Diagnosis Module
This arm had the CHICA screening module turned on
Other: CHICA Diagnosis Module
The CHICA module helped to screen and diagnose patients with tuberculosis or iron deficiency anemia
Placebo Comparator: CHICA Placebo
This arm had CHICA but no additional module
Other: CHICA Placebo
This was CHICA without the screening module

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percentage of Patients Screened Positive for One of the Disorders
Time Frame: six months
six months

Secondary Outcome Measures

Outcome Measure
Time Frame
Percentage of Patients Diagnosed With One of the Disorders
Time Frame: six months
six months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Indiana University

Collaborators

National Library of Medicine (NLM)

Investigators

  • Principal Investigator: Aaron E Carroll, MD, MS, IUSM

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2007

Primary Completion (Actual)

July 1, 2009

Study Completion (Actual)

September 1, 2010

Study Registration Dates

First Submitted

March 23, 2011

First Submitted That Met QC Criteria

March 24, 2011

First Posted (Estimate)

March 25, 2011

Study Record Updates

Last Update Posted (Estimate)

December 2, 2016

Last Update Submitted That Met QC Criteria

October 21, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHICA_Screening
  • 5K22LM009160 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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