Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

Universal Screening for Tuberculosis and Anemia With the CHICA System

This study has been completed.
Sponsor:
Collaborator:
National Library of Medicine (NLM)
Information provided by (Responsible Party):
Aaron Carroll, Indiana University
ClinicalTrials.gov Identifier:
NCT01322841
First received: March 23, 2011
Last updated: January 22, 2016
Last verified: January 2016
Results First Received: November 17, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Investigator);   Primary Purpose: Diagnostic
Conditions: Tuberculosis
Iron Deficiency Anemia
Interventions: Other: CHICA Screening Module
Other: CHICA Screening Control

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
CHICA Screening Module

This arm had the CHICA screening module turned on

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

CHICA Screening Control

This arm had CHICA but no additional module

CHICA Placebo: This was CHICA without the screening module


Participant Flow:   Overall Study
    CHICA Screening Module     CHICA Screening Control  
STARTED     1116     1123  
COMPLETED     1116     1123  
NOT COMPLETED     0     0  



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
CHICA Screening Module

This arm had the CHICA screening module turned on

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

CHICA Screening Control

This arm had CHICA but no additional module

CHICA Placebo: This was CHICA without the screening module

Total Total of all reporting groups

Baseline Measures
    CHICA Screening Module     CHICA Screening Control     Total  
Number of Participants  
[units: participants]
  1116     1123     2239  
Age  
[units: participants]
     
<=18 years     1116     1123     2239  
Between 18 and 65 years     0     0     0  
>=65 years     0     0     0  
Gender  
[units: participants]
     
Female     538     542     1080  
Male     578     581     1159  
Race (NIH/OMB)  
[units: participants]
     
American Indian or Alaska Native     2     0     2  
Asian     0     0     0  
Native Hawaiian or Other Pacific Islander     21     27     48  
Black or African American     394     397     791  
White     679     662     1341  
More than one race     0     0     0  
Unknown or Not Reported     20     37     57  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Percentage of Patients Screened Positive for One of the Disorders   [ Time Frame: six months ]

2.  Secondary:   Percentage of Patients Diagnosed With One of the Disorders   [ Time Frame: six months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
  Hide More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Aaron Carroll
Organization: Indiana University School of Medicine
phone: 3172789616
e-mail: aaecarro@iu.edu



Responsible Party: Aaron Carroll, Indiana University
ClinicalTrials.gov Identifier: NCT01322841     History of Changes
Other Study ID Numbers: CHICA_Screening
5K22LM009160 ( US NIH Grant/Contract Award Number )
Study First Received: March 23, 2011
Results First Received: November 17, 2015
Last Updated: January 22, 2016
Health Authority: United States: Institutional Review Board