SmokingQ2NCT00992264

'Questions About Quitting' Smoking Cessation Trial

A study testing Message Tone, Navigation and Proactive Outreach in people with Smoking, run by Kaiser Permanente at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Smoking
What is being tested?: Message Tone, Navigation and Proactive Outreach
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 1,865 participants
Where: 1 siteUnited States
Study dates: May 2010to Nov 2013
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
No healthy volunteers
Adult, Older adult

Who may be able to join

Member of Group Health Cooperative
Currently Smoking at Least 5 Cigarettes/Day
Access to Email and the Internet
Read and Write English
18 years or older
Not currently receiving tobacco cessation treatment
Capable of participating in online and phone surveys

Who cannot join

Persons will be excluded if they do not meet above criteria

Trial locations and contacts

1 site in 1 country.

United States1 site

Group Health Research Institute
Seattle, Washington, 98101

Other trials in United States

About this study

Official title: Optimizing an Online Motivational Tobacco Cessation Program

The current study tested the effectiveness of four potentially important tailoring factors (decisional framework, self-efficacy, navigation autonomy, and proactive outreach) in the context of an online motivational intervention for smoking cessation. A fifth factor was originally planned by dropped during intervention development due to confounds with the other planned factors. Information learned from this study will inform how to best design an online interventions for smoking cessation. Participants were recruited from a large, regional U.S. health plan. Using a full factorial design to screen for important main effects and 2-way interactions, participants were randomized to receive one of 16 different experimental factor combinations and followed for one year to assess program impact on smokers' use of empirically-validated cessation treatment and abstinence.

Read the detailed description

The current study is a factorial screening experiment, consistent with the Multiphase Optimization Strategy. Participants were randomly assigned to one of 16 different combinations of the 4 experimental factors. Each factor was explored on 2 contrasting levels. Each contrasting factor level was then compared to the other, resulting in 4 analytic arms. Within each arm, all participants (n = 1865) were analyzed to determine the relative effect of each contrasting factor level on the primary and secondary outcomes of interest.

Conditions: Smoking
Being tested: Message Tone, Navigation, Proactive Outreach, Testimonials
Keywords: Cigarette Smoking, Health Behavior, Intervention Studies, Personal Communication
Medical subject headings: Smoking, Cigarette Smoking, Health Behavior, Communication

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Message ToneBehavioural
All participants receive an tailored, online smoking cessation program. Participants in this intervention group either receive content written in a prescriptive tone or a motivational tone.
NavigationBehavioural
Persons in this arm either have their ability to navigate the site dictated for them based on their readiness to quit smoking or they are able to freely navigate through the website.
Proactive OutreachBehavioural
Persons receive periodic, proactively delivered email reminders to visit the intervention website.
TestimonialsBehavioural
People receive a personally-tailored testimonial as part of their online smoking cessation program.

Study groups in NCT00992264
Study group	Role	What they receive
Message Tone	Experimental	Prescriptive or Motivational Persons are randomized to receive intervention content written in either a prescriptive or motivational tone. Receives: Behavioral: Message Tone
Testimonials	Experimental	Persons are randomized to receive a personally tailored testimonial or not. Receives: Behavioral: Testimonials
Navigation	Experimental	Dictated or Non-Dictated Persons are randomly assigned to be able to freely navigate the website or to have their navigation of the website pre-determined based on their baseline readiness to quit smoking. Receives: Behavioral: Navigation
Proactive Outreach	Experimental	Email or No-Email communication Persons are randomized to receive periodic email reminders to return to the intervention website or not. Receives: Behavioral: Proactive Outreach

What is being measured

The primary outcome is the main question the study is designed to answer.

Smoking Abstinence
7 day point prevalent abstinence
Measured: 12 months
Treatment Utilization for Smoking Cessation
confirmed use of pharmacotherapy or enrollment in health plan-sponsored counseling program
Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 2010Nov 2013

First posted9 Oct 2009 (estimated)
Study startMay 2010
Primary completionNov 2012
Study completionNov 2013

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.
Publications (4)Papers the sponsor has linked to this study.
Other trials for SmokingStudies 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: Treatment
Allocation: Randomised
Intervention model: Factorial
Masking: Single blind
Who is masked: Participant
Enrolment: 1,865 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00992264
Sponsor's protocol ID: R01CA138598
Acronym: Q2
Status last verified: Oct 2017
First submitted: 7 Oct 2009
Last updated: 13 Oct 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

McClure JB, Derry H, Riggs KR, Westbrook EW, St John J, Shortreed SM, Bogart A, An LC. Questions about quitting (Q2): design and methods of a Multiphase Optimization Strategy (MOST) randomized screening experiment for an online, motivational smoking cessation intervention. Contemp Clin Trials. 2012 Sep;33(5):1094-102. doi: 10.1016/j.cct.2012.06.009. Epub 2012 Jul 4.
PubMed 22771577
McClure JB, Shortreed SM, Bogart A, Derry H, Riggs K, St John J, Nair V, An L. The effect of program design on engagement with an internet-based smoking intervention: randomized factorial trial. J Med Internet Res. 2013 Mar 25;15(3):e69. doi: 10.2196/jmir.2508.
PubMed 23529377
McClure JB, Peterson D, Derry H, Riggs K, Saint-Johnson J, Nair V, An L, Shortreed SM. Exploring the "active ingredients" of an online smoking intervention: a randomized factorial trial. Nicotine Tob Res. 2014 Aug;16(8):1129-39. doi: 10.1093/ntr/ntu057. Epub 2014 Apr 11.
PubMed 24727369
Shortreed SM, Bogart A, McClure JB. Using multiple imputations to accommodate time-outs in online interventions. J Med Internet Res. 2013 Nov 21;15(11):e252. doi: 10.2196/jmir.2781.
PubMed 24263289

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Early Withdrawal Exposure and Negative Affect Withdrawal (NAW) Regulation Training for Smoking Cessation
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All Smoking trials

Study at a glance

From the registry record, last updated by the sponsor on 13 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Optimizing an Online Motivational Tobacco Cessation Program
ClinicalTrials.gov ID: NCT00992264
Acronym / sponsor ID: Q2 / R01CA138598
Conditions: Smoking
Keywords: Cigarette Smoking, Health Behavior, Intervention Studies, Personal Communication
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,865 participants (actual)
Lead sponsor: Kaiser PermanenteUniversity, hospital or other
Collaborators: University of Michigan
Study start: May 2010
Primary completion: Nov 2012 (actual)
Study completion: Nov 2013 (actual)
First posted: 9 Oct 2009 (estimated)
Results: Posted 15 Aug 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Factorial
Masking: Single blind (participant)
Number of arms: 4

Arm	Type	Receives
Message Tone	Experimental	Behavioral: Message TonePrescriptive or Motivational Persons are randomized to receive intervention content written in either a prescriptive or motivational tone.
Testimonials	Experimental	Behavioral: TestimonialsPersons are randomized to receive a personally tailored testimonial or not.
Navigation	Experimental	Behavioral: NavigationDictated or Non-Dictated Persons are randomly assigned to be able to freely navigate the website or to have their navigation of the website pre-determined based on their baseline readiness to quit smoking.
Proactive Outreach	Experimental	Behavioral: Proactive OutreachEmail or No-Email communication Persons are randomized to receive periodic email reminders to return to the intervention website or not.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

Member of Group Health Cooperative
Currently Smoking at Least 5 Cigarettes/Day
Access to Email and the Internet
Read and Write English
18 years or older

Key exclusion criteria (1 listed)

Persons will be excluded if they do not meet above criteria

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
Message ToneAll participants receive an tailored, online smoking cessation program. Participants in this intervention group either receive content written in a prescriptive tone or a motivational tone.	Behavioural	Message Tone
NavigationPersons in this arm either have their ability to navigate the site dictated for them based on their readiness to quit smoking or they are able to freely navigate through the website.	Behavioural	Navigation
Proactive OutreachPersons receive periodic, proactively delivered email reminders to visit the intervention website.	Behavioural	Proactive Outreach
TestimonialsPeople receive a personally-tailored testimonial as part of their online smoking cessation program.	Behavioural	Testimonials

Primary outcome

Smoking Abstinence
Time frame: 12 months
7 day point prevalent abstinence
Treatment Utilization for Smoking Cessation
Time frame: 12 months
confirmed use of pharmacotherapy or enrollment in health plan-sponsored counseling program

Results and safety

Results posted to the registry on 15 Aug 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Randomization Arm 1	116	116
Randomization Arm 2	116	116
Randomization Arm 3	117	117
Randomization Arm 4	117	117
Randomization Arm 5	117	117
Randomization Arm 6	117	117
Randomization Arm 7	116	116
Randomization Arm 8	117	117
Randomization Arm 9	116	116
Randomization Arm 10	116	116
Randomization Arm 11	117	117
Randomization Arm 12	117	117
Randomization Arm 13	116	116
Randomization Arm 14	117	117
Randomization Arm 15	117	117
Randomization Arm 16	116	116

Primary outcome: Smoking Abstinence

Time frame: 12 months. Number. Unit: percentage of abstinent participants

Measure	Message Tone: Prescriptive n = 1865	Testimonials n = 1865	Navigation: Dictated n = 1865	Proactive Outreach n = 1865
Smoking prevalence: 'active' intervention grp	13.0	13.8	14.5	13.3
smoking prevalence: comparison group	14.5	13.6	13.0	14.2

Message Tone: Prescriptive: Odds Ratio (OR): 0.88 (95% CI 0.51 to 1.51)
Testimonials: Odds Ratio (OR): 1.12 (95% CI 0.66 to 1.91)
Navigation: Dictated: Odds Ratio (OR): 1.19 (95% CI 0.70 to 2.02)

Population analysed: Missing data imputed, so all enrolled participants were included in the final intent to treat analytic sample.

Primary outcome: Treatment Utilization for Smoking Cessation

Time frame: 12 months. Number. Unit: % of participants using adjunct treatmen

Measure	Message Tone: Prescriptive n = 1838	Testimonials n = 1838	Navigation: Dictated n = 1838	Proactive Emails n = 1838
Treatment utilization: % in active intervention	26.1	25.3	26.0	23.7
treatment utilization: % in comparison group	25.8	26.6	25.9	28.2

Message Tone: Prescriptive vs Testimonials: Odds Ratio, log: 0.94 (95% CI 0.62 to 1.43)
Testimonials: Odds Ratio (OR): 0.70 (95% CI 0.46 to 1.07)
Navigation: Dictated: Odds Ratio (OR): 0.78 (95% CI 0.51 to 1.18)

Population analysed: Twenty-seven participants were excluded for not being enrolled in the health plan during the study period and not having access to the provided adjunct treatment.

Adverse events

Time frame: Adverse events were monitored from May 2010 until November 2012, the time during which participants were actively enrolled in this trial.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Message Tone	0 of 1,865 (0%)	0 of 1,865 (0%)	Not reported
Testimonials	0 of 1,865 (0%)	0 of 1,865 (0%)	Not reported
Navigation	0 of 1,865 (0%)	0 of 1,865 (0%)	Not reported
Proactive Outreach	0 of 1,865 (0%)	0 of 1,865 (0%)	Not reported

Limitations and caveats (from the sponsor): The study was powered to detect differences between each factor level of 5% or more.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 22771577McClure JB, Derry H, Riggs KR, Westbrook EW, St John J, Shortreed SM, Bogart A, An LC. Questions about quitting (Q2): design and methods of a Multiphase Optimization Strategy (MOST) randomized screening experiment for an online, motivational smoking cessation intervention. Contemp Clin Trials. 2012 Sep;33(5):1094-102. doi: 10.1016/j.cct.2012.06.009. Epub 2012 Jul 4.
Results publication: PubMed 23529377McClure JB, Shortreed SM, Bogart A, Derry H, Riggs K, St John J, Nair V, An L. The effect of program design on engagement with an internet-based smoking intervention: randomized factorial trial. J Med Internet Res. 2013 Mar 25;15(3):e69. doi: 10.2196/jmir.2508.
Results publication: PubMed 24727369McClure JB, Peterson D, Derry H, Riggs K, Saint-Johnson J, Nair V, An L, Shortreed SM. Exploring the "active ingredients" of an online smoking intervention: a randomized factorial trial. Nicotine Tob Res. 2014 Aug;16(8):1129-39. doi: 10.1093/ntr/ntu057. Epub 2014 Apr 11.
Derived from this study: PubMed 24263289Shortreed SM, Bogart A, McClure JB. Using multiple imputations to accommodate time-outs in online interventions. J Med Internet Res. 2013 Nov 21;15(11):e252. doi: 10.2196/jmir.2781.

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Impact of Multidisciplinary Care, Structured and Targeted on the COPD Patient's Clinical Pathway.
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Comparing the Efficacy of a Conversational Agent (QuitBot) Versus Standard Health Education on Smoking Cessation Among Medical Students; A Randomized Controlled Trial.
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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.

Jennifer B McClure, PhD principal investigator

Group Health Research Institute

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Message Tone, Navigation and Proactive Outreach in people with Smoking, run by Kaiser Permanente 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 7 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 Oct 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. 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 15 Aug 2014). 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?

Smoking Abstinence (time frame: 12 months). The study lists 2 primary outcomes in all. 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 NCT00992264, which also lists 4 linked publications.

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 Oct 2017.