SmokingNCT01326234
Computer-Based Program to Facilitate Readiness and Motivation for Smoking Cessation
A study testing Personalized Feedback and Treatment as Usual in people with Smoking, run by University of Oklahoma.
Trial summary
The current study seeks to use a computer-based program to target parents of children who smoke. Parents will be randomly assigned to either receive personalized feedback about their smoking behaviors or not. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Smoking
- What is being tested?
- Personalized Feedback and Treatment as Usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jun 2010to Nov 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- the parent or caregiver reports active cigarette use
- the parent or caregiver speaks English as their primary language
Who cannot join
- the parent or caregiver is actively attempting smoking cessation
- the parent or caregiver reads below the 8th grade level
- the parent or caregiver does not have email or web access
About this study
Official title: Further Development and Testing of an Interactive Computer-Based Program to Facilitate Readiness and Motivation for Smoking Cessation
The current study seeks to use a computer-based program to target parents of children who smoke. Parents will be randomly assigned to either receive personalized feedback about their smoking behaviors or not. One month after gathering their baseline information, all participants will be asked to complete follow-up questionnaires online assessing their smoking behaviors.
Read the detailed description
Tobacco use is widely recognized as the most preventable cause of cancer in the United States. Furthermore, tobacco use is responsible for 30% of all cancer-related deaths in the United States. Although practice guidelines recommend that clinicians address tobacco use during all outpatient clinic visits, the realities of the clinic setting make this difficult for overworked and overstretched clinical personnel. A computer-based intervention may enhance patient care by decreasing this burden and priming patients and families for a discussion about smoking cessation with their physician. Previous research has demonstrated the feasibility of developing and implementing an interactive computer-based program to facilitate smoking cessation in the outpatient clinic setting. The program can be self-administered, presents minimal burden to existing staff, and meets the Public Health Service practice guidelines. Furthermore, this intervention was found to be effective at increasing readiness to change in parental smoking behavior. The overall objective of this proposal is to further develop the program and test this interactive computer-based program to facilitate motivation and readiness to cease tobacco use and engage in parental smoking cessation services. The current computer program focuses on the assessment of the participant's smoking behavior and the delivery of personalized feedback regarding their smoking behavior. Modifications to the new program will include the removal of the carbon monoxide testing, inclusion of all baseline and follow-up assessment into the computer-based program (creating a single, stand-alone package that further reduces staff burden), and the inclusion of a link directly to the Oklahoma Tobacco Settlement Endowment Trust "click to call" option (allowing patients to immediately self-refer for cessation support). Parents of children presenting to a general pediatric outpatient clinic, who self-report as current smokers, will be recruited for a randomized controlled trial to assess the effectiveness of the revised computer-based program. It is proposed that exposure to this brief intervention will result in increasing smokers' readiness to cease tobacco use and engage in smoking cessation services. The successful completion of the proposed project will result in the development of a smoking cessation intervention that can be easily and consistently delivered, in a host of different settings, with little burden to existing staff. The successful development of such an intervention directly relates to the OTRC Mission and Goals and specifically fits with two of the OTRC's primary research areas: prevention and cessation of tobacco use and tobacco-related health disparities in Oklahoma's diverse populations and reduction of secondhand smoke exposure.
- Conditions
- Smoking
- Being tested
- Personalized Feedback, Treatment as Usual
- Keywords
- Smoking, Motivation, Cessation
- Medical subject headings
- Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Personalized FeedbackBehavioural
The interactive program will provide assessment and personalized feedback on the participants' level of nicotine dependence, daily cigarette consumption, money spent on cigarettes, behavioral consequences of smoking, individual medical consequences of smoking, and family members' medical consequences of secondhand smoke.
Treatment as UsualBehavioural
Practitioners are able to provide normal care with regard to smoking; participants will complete the Treatment Fidelity Questionnaire to assess whether any smoking cessation interventions occurred
| Study group | Role | What they receive |
|---|---|---|
| Personalized Feedback | Active comparator | The interactive program will provide assessment and personalized feedback on the participants' level of nicotine dependence, daily cigarette consumption, money spent on cigarettes, behavioral consequences of smoking, individual medical consequences of smoking, and family members' medical consequences of secondhand smoke. Receives: Behavioral: Personalized Feedback |
| Treatment as Usual | Sham comparator | Practitioners are able to provide normal care with regard to smoking; participants will complete the Treatment Fidelity Questionnaire to assess whether any smoking cessation interventions occurred. Receives: Behavioral: Treatment as Usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stage of Change
The Stages of Change Algorithm (SCA; DiClemente et al., 1991) will be used to categorize participants' individual stage of change in regards to smoking cessation. Participants will be asked, "Are you thinking of quitting smoking?" and then placed into one of the following stages: (1) Precontemplation, "No, I am not seriously considering quitting within the next 6 months"; (2) Contemplation, "Yes, I am seriously considering quitting within the next 6 months"; or (3) Preparation, "Yes, I am seriously planning to quit within the next 30 days."
Measured: Baseline, 1- Mo Follow-up
Secondary outcomes (3)
Readiness to Quit
The Contemplation Ladder (CL; Biener \& Abrams, 1991) is a one-item instrument that provides a continuous measure of an individual's readiness to consider smoking cessation. Participants view a ladder with rungs and text ranging from 0 "No thought of quitting," to 5 "Think I should quit but am not ready," to 10 "Taking action to quit (e.g., cutting down, enrolling in a program).
Measured: Baseline, 1-Mo Follow-up
Personal Importance, Confidence, and Motivation to Stop Smoking
Participant perception of importance, confidence, and motivation to cease tobacco use will each be measured by an 11-point rating scale, ranging from 0 (not at all) to 10 (very). Based on the stages of change model of behavior change and motivational interviewing, these three constructs are considered instrumental in assessing behavior change. The proposed format for assessing these key constructs is consistent with the typical assessment strategy used while conducting motivational interviewing (Miller \& Rollnick, 2002).
Measured: Baseline; 1-Mo Follow-up
Quit Behaviors
At baseline, all participants will be asked whether they have: (1)previously quit smoking; (2)previously engaged in a quit attempt; (3) methods used to quit smoking; and (4) the length of any previous cessation periods. Additionally, during the follow-up participants will be asked whether they done any of the following since completing the program: (1) quit smoking; (2) engaged in a quit attempt; and (3) methods used to quit smoking; and (4) the length of the current smoking cessation period.
Measured: Baseline; 1-Mo follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2011 (estimated)
- Study startJun 2010
- Primary completionNov 2014
- Study completionNov 2014
Why it stopped: Due to staff changes the study never started.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SmokingStudies of the same condition, open and under way.
- More trials run by University of OklahomaThe 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oklahoma
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stephen Gillaspy, University of Oklahoma
- Investigators
- Stephen R Gillaspy, PhD, Principal investigator, University of Oklahoma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01326234
- Sponsor's protocol ID
- 1694
- Status last verified
- Apr 2017
- First submitted
- 8 Mar 2011
- Last updated
- 20 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Further Development and Testing of an Interactive Computer-Based Program to Facilitate Readiness and Motivation for Smoking Cessation
- ClinicalTrials.gov ID
- NCT01326234
- Acronym / sponsor ID
- 1694
- Conditions
- Smoking
- Keywords
- Smoking, Motivation, Cessation
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Due to staff changes the study never started.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of OklahomaUniversity, hospital or other
- Study start
- Jun 2010
- Primary completion
- Nov 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 30 Mar 2011 (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 current study seeks to use a computer-based program to target parents of children who smoke. Parents will be randomly assigned to either receive personalized feedback about their smoking behaviors or not. One month after gathering their baseline information, all participants will be asked to complete follow-up questionnaires online assessing their smoking behaviors.
Detailed description
Tobacco use is widely recognized as the most preventable cause of cancer in the United States. Furthermore, tobacco use is responsible for 30% of all cancer-related deaths in the United States. Although practice guidelines recommend that clinicians address tobacco use during all outpatient clinic visits, the realities of the clinic setting make this difficult for overworked and overstretched clinical personnel. A computer-based intervention may enhance patient care by decreasing this burden and priming patients and families for a discussion about smoking cessation with their physician. Previous research has demonstrated the feasibility of developing and implementing an interactive computer-based program to facilitate smoking cessation in the outpatient clinic setting. The program can be self-administered, presents minimal burden to existing staff, and meets the Public Health Service practice guidelines. Furthermore, this intervention was found to be effective at increasing readiness to change in parental smoking behavior. The overall objective of this proposal is to further develop the program and test this interactive computer-based program to facilitate motivation and readiness to cease tobacco use and engage in parental smoking cessation services. The current computer program focuses on the assessment of the participant's smoking behavior and the delivery of personalized feedback regarding their smoking behavior. Modifications to the new program will include the removal of the carbon monoxide testing, inclusion of all baseline and follow-up assessment into the computer-based program (creating a single, stand-alone package that further reduces staff burden), and the inclusion of a link directly to the Oklahoma Tobacco Settlement Endowment Trust "click to call" option (allowing patients to immediately self-refer for cessation support). Parents of children presenting to a general pediatric outpatient clinic, who self-report as current smokers, will be recruited for a randomized controlled trial to assess the effectiveness of the revised computer-based program. It is proposed that exposure to this brief intervention will result in increasing smokers' readiness to cease tobacco use and engage in smoking cessation services. The successful completion of the proposed project will result in the development of a smoking cessation intervention that can be easily and consistently delivered, in a host of different settings, with little burden to existing staff. The successful development of such an intervention directly relates to the OTRC Mission and Goals and specifically fits with two of the OTRC's primary research areas: prevention and cessation of tobacco use and tobacco-related health disparities in Oklahoma's diverse populations and reduction of secondhand smoke exposure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Personalized Feedback | Active comparator | Behavioral: Personalized FeedbackThe interactive program will provide assessment and personalized feedback on the participants' level of nicotine dependence, daily cigarette consumption, money spent on cigarettes, behavioral consequences of smoking, individual medical consequences of smoking, and family members' medical consequences of secondhand smoke. |
| Treatment as Usual | Sham comparator | Behavioral: Treatment as UsualPractitioners are able to provide normal care with regard to smoking; participants will complete the Treatment Fidelity Questionnaire to assess whether any smoking cessation interventions occurred. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- the parent or caregiver reports active cigarette use
- the parent or caregiver speaks English as their primary language
Key exclusion criteria (3 listed)
- the parent or caregiver is actively attempting smoking cessation
- the parent or caregiver reads below the 8th grade level
- the parent or caregiver does not have email or web access
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 |
|---|---|---|
| Personalized FeedbackThe interactive program will provide assessment and personalized feedback on the participants' level of nicotine dependence, daily cigarette consumption, money spent on cigarettes, behavioral consequences of smoking, individual medical consequences of smoking, and family members' medical consequences of secondhand smoke. | Behavioural | Personalized Feedback |
| Treatment as UsualPractitioners are able to provide normal care with regard to smoking; participants will complete the Treatment Fidelity Questionnaire to assess whether any smoking cessation interventions occurred | Behavioural | Treatment as Usual |
Primary outcome
Stage of Change
Time frame: Baseline, 1- Mo Follow-up
The Stages of Change Algorithm (SCA; DiClemente et al., 1991) will be used to categorize participants' individual stage of change in regards to smoking cessation. Participants will be asked, "Are you thinking of quitting smoking?" and then placed into one of the following stages: (1) Precontemplation, "No, I am not seriously considering quitting within the next 6 months"; (2) Contemplation, "Yes, I am seriously considering quitting within the next 6 months"; or (3) Preparation, "Yes, I am seriously planning to quit within the next 30 days."
3 secondary outcomes
Readiness to Quit
Time frame: Baseline, 1-Mo Follow-up
Personal Importance, Confidence, and Motivation to Stop Smoking
Time frame: Baseline; 1-Mo Follow-up
Quit Behaviors
Time frame: Baseline; 1-Mo follow-up
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2017.
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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.
Stephen R Gillaspy, PhD principal investigator
University of Oklahoma
Questions about this trial
What is this clinical trial studying?
A study testing Personalized Feedback and Treatment as Usual in people with Smoking, run by University of Oklahoma.
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 2 inclusion and 3 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: withdrawn, as of the sponsor's last update on 20 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Stage of Change (time frame: Baseline, 1- Mo Follow-up). 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 20 Apr 2017.