Smoking CessationTEQNCT00888992
Technology-Enhanced Quitline Services to Prevent Smoking Relapse
A study testing Quitline Service + 10 automated monitoring calls and Quitline service + 20 automated monitoring calls in people with Smoking Cessation, run by Indiana University at 1 site in United States.
Trial summary
The purpose of this study is to see if automated telephone monitoring will enhance existing quitline services, such as Alere Wellbeing's Quit For Life program, and help people 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
- Smoking Cessation
- What is being tested?
- Quitline Service + 10 automated monitoring calls and Quitline service + 20 automated monitoring calls
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,785 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2010to Mar 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- 18 years or older
- Enrolled in Free \& Clear, Inc. services
- Self-reported abstinence for at least 24 hours at the quit date call
- Able to read and speak English
- Personal access to a touch-tone telephone or cellular telephone
Who cannot join
- Have not stopped smoking for 24 hours
- Currently incarcerated
- Currently participating in any other smoking cessation research
- Live in same household as another study participant
- Participated in the Alere Wellbeing Quit for Life Program within the last 6 months
- Were previously enrolled in this study even if they repeat the smoking cessation program during the accrual period
- Hearing impaired enrollees receiving Free \& Clear services via telecommunications devices for the deaf (TDD) will be excluded from the study as the IVR technology currently does not have this capability
Trial locations and contacts
1 site in 1 country.
United States1 site
Alere Wellbeing (formally known as Free & Clear, Inc.)
Seattle, Washington, 98104
About this study
The purpose of this study is to see if automated telephone monitoring will enhance existing quitline services, such as Alere Wellbeing's Quit For Life program, and help people quit smoking. If successful, this intervention could be incorporated into existing quitline protocols and delivered to millions of people who are trying to quit smoking.
- Conditions
- Smoking Cessation
- Being tested
- Quitline Service + 10 automated monitoring calls, Quitline service + 20 automated monitoring calls
- Keywords
- Smoking, Cessation, Quitline, Counseling
- Medical subject headings
- Smoking Cessation, Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quitline Service + 10 automated monitoring callsBehavioural
This group will receive the usual care provided in Alere Wellbeing's Quit For Life® program. The program includes 5 telephone counseling calls. In addition, participants receive 10 automated telephone monitoring calls to help them stay off cigarettes. The automated call schedule will be two calls per a week for 2 weeks, then once a week for 6 weeks. Participants whose answers indicate that they may be having trouble quitting smoking will be automatically connected to a Quit Coach for individualized relapse prevention counseling.
Quitline service + 20 automated monitoring callsBehavioural
This group will receive the usual care provided in Alere Wellbeing's Quit For Life® program. The program includes 5 telephone counseling calls. In addition, participants receive 20 automated telephone monitoring calls to help them stay off cigarettes. The automated call schedule will be one automated call a day for 2 weeks, then once a week for 6 weeks. Participants whose answers indicate that they may be having trouble quitting smoking will be automatically connected to a Quit Coach for individualized relapse prevention counseling.
| Study group | Role | What they receive |
|---|---|---|
| Group A | No intervention | Receive the usual care provided in Alere Wellbeing's Quit For Life® program. The program includes 5 telephone counseling calls. |
| Group B | Experimental | Not described Receives: Behavioral: Quitline Service + 10 automated monitoring calls |
| Group C | Experimental | Not described Receives: Behavioral: Quitline service + 20 automated monitoring calls |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participant smoking status.
Measured: 6 and 12 month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2009 (estimated)
- Study startApr 2010
- Primary completionJan 2013
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Smoking CessationStudies of the same condition, open and under way.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,785 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Collaborators
- Consumer Wellness Solutions, Kaiser Foundation Hospitals, Center for Health Research, University of Washington
- Responsible party
- Sponsor
- Investigators
- Anna M McDaniel, PhD RN FAAN, Principal investigator, Indiana UniversitySusan Zbikowski, PhD, Principal investigator, Consumer Wellness SolutionsKatie Witkiewitz, PhD, Principal investigator, University of New MexicoJeffery Fellows, PhD, Principal investigator, Kaiser Permanente
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00888992
- Sponsor's protocol ID
- 0812-77B
- Other IDs
- 1R01CA138936-01
- Acronym
- TEQ
- Status last verified
- Apr 2015
- First submitted
- 27 Apr 2009
- Last updated
- 3 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
McDaniel AM, Vickerman KA, Stump TE, Monahan PO, Fellows JL, Weaver MT, Carlini BH, Champion VL, Zbikowski SM. A randomised controlled trial to prevent smoking relapse among recently quit smokers enrolled in employer and health plan sponsored quitlines. BMJ Open. 2015 Jun 29;5(6):e007260. doi: 10.1136/bmjopen-2014-007260.
PubMed 26124508
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Technology-Enhanced Quitline Services to Prevent Smoking Relapse
- ClinicalTrials.gov ID
- NCT00888992
- Acronym / sponsor ID
- TEQ / 0812-77B
- Conditions
- Smoking Cessation
- Keywords
- Smoking, Cessation, Quitline, Counseling
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,785 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Collaborators
- Consumer Wellness Solutions, Kaiser Foundation Hospitals, Center for Health Research, University of Washington
- Study start
- Apr 2010
- Primary completion
- Jan 2013 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 28 Apr 2009 (estimated)
- Results
- Not posted in the source record
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 study is to see if automated telephone monitoring will enhance existing quitline services, such as Alere Wellbeing's Quit For Life program, and help people quit smoking. If successful, this intervention could be incorporated into existing quitline protocols and delivered to millions of people who are trying to quit smoking.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A | No intervention | –Receive the usual care provided in Alere Wellbeing's Quit For Life® program. The program includes 5 telephone counseling calls. |
| Group B | Experimental | Behavioral: Quitline Service + 10 automated monitoring calls |
| Group C | Experimental | Behavioral: Quitline service + 20 automated monitoring calls |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 18 years or older
- Enrolled in Free \& Clear, Inc. services
- Self-reported abstinence for at least 24 hours at the quit date call
- Able to read and speak English
- Personal access to a touch-tone telephone or cellular telephone
Key exclusion criteria (7 listed)
- Have not stopped smoking for 24 hours
- Currently incarcerated
- Currently participating in any other smoking cessation research
- Live in same household as another study participant
- Participated in the Alere Wellbeing Quit for Life Program within the last 6 months
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 |
|---|---|---|
| Quitline Service + 10 automated monitoring callsThis group will receive the usual care provided in Alere Wellbeing's Quit For Life® program. The program includes 5 telephone counseling calls. In addition, participants receive 10 automated telephone monitoring calls to help them stay off cigarettes. The automated call schedule will be two calls per a week for 2 weeks, then once a week for 6 weeks. Participants whose answers indicate that they may be having trouble quitting smoking will be automatically connected to a Quit Coach for individualized relapse prevention counseling. | Behavioural | Group B |
| Quitline service + 20 automated monitoring callsThis group will receive the usual care provided in Alere Wellbeing's Quit For Life® program. The program includes 5 telephone counseling calls. In addition, participants receive 20 automated telephone monitoring calls to help them stay off cigarettes. The automated call schedule will be one automated call a day for 2 weeks, then once a week for 6 weeks. Participants whose answers indicate that they may be having trouble quitting smoking will be automatically connected to a Quit Coach for individualized relapse prevention counseling. | Behavioural | Group C |
Primary outcome
Participant smoking status.
Time frame: 6 and 12 month follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2015.
- Derived from this study: PubMed 26124508McDaniel AM, Vickerman KA, Stump TE, Monahan PO, Fellows JL, Weaver MT, Carlini BH, Champion VL, Zbikowski SM. A randomised controlled trial to prevent smoking relapse among recently quit smokers enrolled in employer and health plan sponsored quitlines. BMJ Open. 2015 Jun 29;5(6):e007260. doi: 10.1136/bmjopen-2014-007260.
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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.
Anna M McDaniel, PhD RN FAAN principal investigator
Indiana University
Susan Zbikowski, PhD principal investigator
Consumer Wellness Solutions
Katie Witkiewitz, PhD principal investigator
University of New Mexico
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Quitline Service + 10 automated monitoring calls and Quitline service + 20 automated monitoring calls in people with Smoking Cessation, 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 5 inclusion and 7 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 3 Apr 2015. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Participant smoking status. (time frame: 6 and 12 month follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00888992, which also lists 1 linked publication.
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 3 Apr 2015.