TuberculosisNCT01322841
Universal Screening for Tuberculosis and Anemia With the CHICA System
A study testing CHICA Diagnosis Module in people with Tuberculosis and Iron Deficiency Anemia, run by Indiana University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 to 11 yearsHealthy volunteers can take part
- Conditions the study is for
- Tuberculosis, Iron Deficiency Anemia
- What is being tested?
- CHICA Diagnosis Module
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 2,239 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2007to Sep 2010
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 11 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Age 3 to 11 years old and seen in a study clinic
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Health Services Research
Indianapolis, Indiana, 46202
About this study
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.
Read the 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.
- Conditions
- Tuberculosis, Iron Deficiency Anemia
- Being tested
- CHICA Diagnosis Module, CHICA Placebo
- Keywords
- CHICA, clinical decision support
- Medical subject headings
- Tuberculosis, Anemia, Iron-Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CHICA Diagnosis ModuleOther
The CHICA module helped to screen and diagnose patients with tuberculosis or iron deficiency anemia
CHICA PlaceboOther
This was CHICA without the screening module
| Study group | Role | What they receive |
|---|---|---|
| CHICA Diagnosis Module | Active comparator | This arm had the CHICA screening module turned on Receives: Other: CHICA Diagnosis Module |
| CHICA Placebo | Placebo comparator | This arm had CHICA but no additional module Receives: Other: CHICA Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Patients Screened Positive for One of the Disorders
Measured: six months
Secondary outcomes (1)
Percentage of Patients Diagnosed With One of the Disorders
Measured: six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2011 (estimated)
- Study startOct 2007
- Primary completionJul 2009
- Study completionSep 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for TuberculosisStudies of the same condition, open and under way.
- More trials run by Indiana UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 2,239 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Collaborators
- National Library of Medicine (NLM)
- Responsible party
- Principal investigator, Aaron Carroll, Indiana University
- Investigators
- Aaron E Carroll, MD, MS, Principal investigator, IUSM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01322841
- Sponsor's protocol ID
- CHICA_Screening
- Other IDs
- 5K22LM009160
- Status last verified
- Oct 2016
- First submitted
- 23 Mar 2011
- Last updated
- 2 Dec 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Universal Screening for Tuberculosis and Anemia With the CHICA System
- ClinicalTrials.gov ID
- NCT01322841
- Acronym / sponsor ID
- CHICA_Screening
- Conditions
- Tuberculosis, Iron Deficiency Anemia
- Keywords
- CHICA, clinical decision support
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,239 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Collaborators
- National Library of Medicine (NLM)
- Study start
- Oct 2007
- Primary completion
- Jul 2009 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 25 Mar 2011 (estimated)
- Results
- Posted 18 Dec 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CHICA Diagnosis Module | Active comparator | Other: CHICA Diagnosis ModuleThis arm had the CHICA screening module turned on |
| CHICA Placebo | Placebo comparator | Other: CHICA PlaceboThis arm had CHICA but no additional module |
Who may qualify
- Ages
- 3 to 11 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Age 3 to 11 years old and seen in a study clinic
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CHICA Diagnosis ModuleThe CHICA module helped to screen and diagnose patients with tuberculosis or iron deficiency anemia | Other | CHICA Diagnosis Module |
| CHICA PlaceboThis was CHICA without the screening module | Other | CHICA Placebo |
Primary outcome
Percentage of Patients Screened Positive for One of the Disorders
Time frame: six months
1 secondary outcome
Percentage of Patients Diagnosed With One of the Disorders
Time frame: six months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aaron E Carroll, MD, MS principal investigator
IUSM
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CHICA Diagnosis Module in people with Tuberculosis and Iron Deficiency Anemia, run by Indiana University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Dec 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Patients Screened Positive for One of the Disorders (time frame: six months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2016.