Cigarette SmokingNCT01334216
Using Computers to Assist in Parental Smoking Cessation in a Pediatric Setting
A study testing CHICA Smoking Cessation Module in people with Cigarette Smoking, 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 to support parents in their efforts to quit smoking. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cigarette Smoking
- What is being tested?
- CHICA Smoking Cessation Module
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 362 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2008to Jun 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Parent of child in our clinics who reported cigarette smoking
Who cannot join
- Not smoking
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 to support parents in their efforts to quit smoking.
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. The investigators will be studying in a randomized controlled trial whether it can help to support parents in their efforts to quit smoking.
- Conditions
- Cigarette Smoking
- Being tested
- CHICA Smoking Cessation Module, CHICA Placebo
- Keywords
- smoking, quitting, tobacco, Parental
- Medical subject headings
- Cigarette Smoking, Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CHICA Smoking Cessation ModuleOther
The CHICA module helped to screen parents for smoking and assist them in quitting.
CHICA PlaceboOther
This was CHICA without the study module.
| Study group | Role | What they receive |
|---|---|---|
| CHICA Smoking Cessation Module | Active comparator | This arm had the CHICA smoking cessation module turned on Receives: Other: CHICA Smoking Cessation Module |
| CHICA Placebo | Placebo comparator | This arm had CHICA without the smoking cessation module Receives: Other: CHICA Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Parental Smoking Quit Rate
This is the number of participants who quit smoking
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2011 (estimated)
- Study startJul 2008
- Primary completionJun 2010
- Study completionJun 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 Cigarette SmokingStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 362 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stephen Downs, Indiana University
- Investigators
- Stephen M Downs, MD, MS, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01334216
- Sponsor's protocol ID
- CHICA_Smoking_Cessation_Study
- Status last verified
- Aug 2017
- First submitted
- 11 Apr 2011
- Last updated
- 13 Sep 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Computers to Assist in Parental Smoking Cessation in a Pediatric Setting
- ClinicalTrials.gov ID
- NCT01334216
- Acronym / sponsor ID
- CHICA_Smoking_Cessation_Study
- Conditions
- Cigarette Smoking
- Keywords
- smoking, quitting, tobacco, Parental
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 362 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Study start
- Jul 2008
- Primary completion
- Jun 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 13 Apr 2011 (estimated)
- Results
- Posted 14 Mar 2017
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 to support parents in their efforts to quit smoking.
Detailed description
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 in a randomized controlled trial whether it can help to support parents in their efforts to quit smoking.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CHICA Smoking Cessation Module | Active comparator | Other: CHICA Smoking Cessation ModuleThis arm had the CHICA smoking cessation module turned on |
| CHICA Placebo | Placebo comparator | Other: CHICA PlaceboThis arm had CHICA without the smoking cessation module |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Parent of child in our clinics who reported cigarette smoking
Key exclusion criteria (1 listed)
- Not smoking
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 Smoking Cessation ModuleThe CHICA module helped to screen parents for smoking and assist them in quitting. | Other | CHICA Smoking Cessation Module |
| CHICA PlaceboThis was CHICA without the study module. | Other | CHICA Placebo |
Primary outcome
Parental Smoking Quit Rate
Time frame: one year
This is the number of participants who quit smoking
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Cigarette Smoking
Enrolling by invitationObservational study
Using Smartwatches to Monitor Smoking in Real-life Situations
Smoking
Not yet recruitingPhase 3
iCanQuit Smoking Cessation Among Hispanic Adults
Cigarette Smoking-Related Carcinoma
RecruitingEarly Phase 1
Role of Inflammation in Vascular Phenotype Associated With E-cigarette Use
Electronic Cigarette Use, Endothelial Dysfunction
Not yet recruiting
Studying Different Ways of Using Oral Nicotine Pouches to Understand the Effect on Nicotine Delivery, Appeal, and Side Effects Among Adult Cigarette Smokers
Cigarette Smoking-Related Carcinoma
Not yet recruiting
Flavored Electronic Nicotine Delivery Systems to Lower Smoking and Exposure to Tobacco Toxicants Among Cigarette Smokers Interested in Quitting, REFLECT Trial
Tobacco Cessation, Electronic Nicotine Delivery Systems
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.
Stephen M Downs, MD, MS principal investigator
Indiana University
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 Smoking Cessation Module in people with Cigarette Smoking, 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 13 Sep 2017. 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 14 Mar 2017). 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?
Parental Smoking Quit Rate (time frame: one year). 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 13 Sep 2017.