SmokingCTQNCT01299896
Connect to Quit for Smoking
A study testing Coordinated Care in people with Smoking and Smoking Cessation, run by University of Pittsburgh at 1 site in United States.
Trial summary
The purpose of this research study is to examine the effectiveness of an intervention designed to reduce smoking in low income veterans within a regional United States Veterans Administration(VA) health care system. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Smoking, Smoking Cessation
- What is being tested?
- Coordinated Care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 633 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2011to Feb 2015
- 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
- Male or female 18 years or older
- Veterans seen by a primary care physician within the VAPHS
- Household income not more than $36,000 annually
- Smoke at least 1 cigarette per day
Who cannot join
- Smokeless tobacco (snuff or chew) users
- Non-cigarette (e.g., pipe) smokers
- Non-English speaking patients
- Can not be enrolled in another smoking cessation related clinical trial at the time of enrollment
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Pittsburgh Healthcare System
Pittsburgh, Pennsylvania, 15206
About this study
Official title: Connect to Quit: Coordinated Care for Smoking Cessation Among Low Income Veterans
The purpose of this research study is to examine the effectiveness of an intervention designed to reduce smoking in low income veterans within a regional United States Veterans Administration(VA) health care system. A proactive, personalized, coordinated system of care "Connect to Quit (CTQ)" is rooted in the Chronic Care Model. CTQ treats smoking as a chronic condition, like hypertension or diabetes, that requires long term treatment with appropriate combinations of behavioral therapy and pharmacotherapy. CTQ will be evaluated in the context of three (3) VA Pittsburgh Healthcare System (VAPHS) medical practices.
Read the detailed description
Approximately 40 Primary Care Providers (PCPs), including non-physicians, in the VAPHS and their patients will be recruited and randomized to either Connect to Quit (CTQ) or Usual Care (UC), existing Veterans Health Administration (VHA) services. After PCPs are enrolled, we will begin recruiting their patients who meet eligibility criteria. The desire to quit smoking is not required for participation in the study, as the point of CTQ is to engage smokers at every level of readiness to quit. Target enrollment is 660 participants, approximately 330 in each treatment arm. Participants will be followed for a minimum of 2 years and a maximum of 4. Investigators will measure abstinence (biochemically-validated, 30 day point-prevalence) throughout the study, assessed every 6 months.
- Conditions
- Smoking, Smoking Cessation
- Being tested
- Coordinated Care, Usual Care
- Keywords
- Cigarette Smoking, Smoking, Tobacco, Tobacco Smoking, Smoking Cessation, Tobacco Dependence
- Medical subject headings
- Smoking, Smoking Cessation, Cigarette Smoking, Tobacco Smoking, Tobacco Use Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coordinated CareOther
Also called Smoking, Tobacco, Tobacco Smoking, Smoking Cessation, Tobacco, Intervention
CTQ coordinators will contact the participants for various information sessions about the participant's smoking. These participants will also receive our Connecting to Quit newsletter quarterly.
Usual CareOther
Also called Smoking, Tobacco, Tobacco Smoking, Smoking Cessation, Tobacco, Intervention
Standard therapy to help participants with smoking cessation.
| Study group | Role | What they receive |
|---|---|---|
| Usual Care | Active comparator | Participants will continue to receive all the care currently offered in the VAPHS, including medications for smoking cessation and use of the in-person or telephone counseling options for quit smoking classes. For veterans with a co-pay, incurred fees with be reimbursed. Receives: Other: Usual Care |
| Coordinated Care | Active comparator | A CTQ Coordinator will coordinate the delivery of smoking related care. Receives: Other: Coordinated Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effectiveness of CTQ vs UC
We will measure abstinence of CTQ smokers vs those in Usual Care (UC). We will biochemically-validate (defined as salivary cotinine <10ng/ml) self reported abstinence (30 day point-prevalence) at the end of 2 years.
Measured: Two (2) year period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2011 (estimated)
- Study startMar 2011
- Primary completionFeb 2015
- Study completionFeb 2015
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 SmokingStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 633 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Hilary A. Tindle, MD, MPH, Principal investigator, Vanderbilt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01299896
- Sponsor's protocol ID
- 02936
- Other IDs
- R01CA141596
- Acronym
- CTQ
- Status last verified
- Feb 2016
- First submitted
- 27 Jan 2011
- Last updated
- 22 Mar 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Connect to Quit: Coordinated Care for Smoking Cessation Among Low Income Veterans
- ClinicalTrials.gov ID
- NCT01299896
- Acronym / sponsor ID
- CTQ / 02936
- Conditions
- Smoking, Smoking Cessation
- Keywords
- Cigarette Smoking, Smoking, Tobacco, Tobacco Smoking, Smoking Cessation, Tobacco Dependence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 633 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Cancer Institute (NCI)
- Study start
- Mar 2011
- Primary completion
- Feb 2015 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 18 Feb 2011 (estimated)
- Results
- Posted 24 Feb 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this research study is to examine the effectiveness of an intervention designed to reduce smoking in low income veterans within a regional United States Veterans Administration(VA) health care system. A proactive, personalized, coordinated system of care "Connect to Quit (CTQ)" is rooted in the Chronic Care Model. CTQ treats smoking as a chronic condition, like hypertension or diabetes, that requires long term treatment with appropriate combinations of behavioral therapy and pharmacotherapy. CTQ will be evaluated in the context of three (3) VA Pittsburgh Healthcare System (VAPHS) medical practices.
Detailed description
Approximately 40 Primary Care Providers (PCPs), including non-physicians, in the VAPHS and their patients will be recruited and randomized to either Connect to Quit (CTQ) or Usual Care (UC), existing Veterans Health Administration (VHA) services. After PCPs are enrolled, we will begin recruiting their patients who meet eligibility criteria. The desire to quit smoking is not required for participation in the study, as the point of CTQ is to engage smokers at every level of readiness to quit. Target enrollment is 660 participants, approximately 330 in each treatment arm. Participants will be followed for a minimum of 2 years and a maximum of 4. Investigators will measure abstinence (biochemically-validated, 30 day point-prevalence) throughout the study, assessed every 6 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual Care | Active comparator | Other: Usual CareParticipants will continue to receive all the care currently offered in the VAPHS, including medications for smoking cessation and use of the in-person or telephone counseling options for quit smoking classes. For veterans with a co-pay, incurred fees with be reimbursed. |
| Coordinated Care | Active comparator | Other: Coordinated CareA CTQ Coordinator will coordinate the delivery of smoking related care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male or female 18 years or older
- Veterans seen by a primary care physician within the VAPHS
- Household income not more than $36,000 annually
- Smoke at least 1 cigarette per day
Key exclusion criteria (4 listed)
- Smokeless tobacco (snuff or chew) users
- Non-cigarette (e.g., pipe) smokers
- Non-English speaking patients
- Can not be enrolled in another smoking cessation related clinical trial at the time of enrollment
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 |
|---|---|---|
| Coordinated CareAlso: Smoking, Tobacco, Tobacco Smoking, Smoking Cessation, Tobacco, InterventionCTQ coordinators will contact the participants for various information sessions about the participant's smoking. These participants will also receive our Connecting to Quit newsletter quarterly. | Other | Coordinated Care |
| Usual CareAlso: Smoking, Tobacco, Tobacco Smoking, Smoking Cessation, Tobacco, InterventionStandard therapy to help participants with smoking cessation. | Other | Usual Care |
Primary outcome
Effectiveness of CTQ vs UC
Time frame: Two (2) year period
We will measure abstinence of CTQ smokers vs those in Usual Care (UC). We will biochemically-validate (defined as salivary cotinine <10ng/ml) self reported abstinence (30 day point-prevalence) at the end of 2 years.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Smoking
Not yet recruiting
New Smoking Cessation Intervention in Primary Care - a Randomized Controlled Trial
Smoking Cessation, Smoking Cessation Counselling
Enrolling by invitationObservational study
Using Smartwatches to Monitor Smoking in Real-life Situations
Smoking
Recruiting
Feasibility and Uptake of Low-Dose CT Lung Cancer Screening in Kuwait
Lung Cancer, Lung Neoplasms
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
Contingency Management to Promote Smoking Cessation Study
Smoking Cessation
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.
Hilary A. Tindle, MD, MPH principal investigator
Vanderbilt 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 Coordinated Care in people with Smoking and Smoking Cessation, run by University of Pittsburgh 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 4 inclusion and 4 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 22 Mar 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. 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 24 Feb 2016). 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?
Effectiveness of CTQ vs UC (time frame: Two (2) year period). 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 22 Mar 2016.