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Tobacco UseNCT01311830

Enhancing Smoker Utilization of the Minnesota Quitline Through Support Persons

A study testing Telephone Counseling and Written Materials in people with Tobacco Use, run by Mayo Clinic 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

This study will develop an intervention for adults who want to support a smoker. The goal of the intervention is for the support person to motivate \& encourage their smoker to call the state Quitline funded by Minnesota ClearWay. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Tobacco Use
What is being tested?
Telephone Counseling and Written Materials
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
534 participants
Where
1 siteUnited States
Study dates
Sep 2007to Apr 2010
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

  • reside in Minnesota
  • be 18 years of age or older
  • provide written informed consent
  • be a never or former cigarette smoker (no cigarette smoking in the past 6 months)
  • be interested in supporting a current cigarette smoker (has smoked a total of >1 cigarettes during the past 7 days) who is 18 years of age or older and who resides in Minnesota
  • be able and willing to participate in all aspects of the study
Show all 9Show fewer
  • have access to a working telephone
  • have current and anticipated contact (any combination of face-to-face, telephone, or electronic mail) with the smoker on at least 3 days a week for the 26 week study duration.
  • Individuals will be excluded if another support person from the same household has enrolled.

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Mayo Clinic

    Rochester, Minnesota, 55905

Other trials in United States

About this study

This study will develop an intervention for adults who want to support a smoker. The goal of the intervention is for the support person to motivate \& encourage their smoker to call the state Quitline funded by Minnesota ClearWay. The study will examine the efficacy of a telephone based intervention for support persons compared to a self-help intervention (written materials only).

Read the detailed description

To have the greatest impact on the public health, interventions need to reach as large a proportion of the smoking population as possible. A significant science base now exists that demonstrates the effectiveness of tobacco quitlines. While the provision of telephone counseling has improved the reach of treatment services to smokers, research is needed to enhance their utilization or reach. In 2001, ClearWay Minnesota (formerly known as MPAAT [Minnesota Partnership for Action Against Tobacco) funded the QUITPLAN Helpline, a telephone-based tobacco cessation counseling service for Minnesotans. Consistent with findings from other quitlines, the QUITPLAN Helpline has reached only 1.5% of smokers in Minnesota. Nonsmokers have a substantial potential role in tobacco control efforts. They represent 82% of the adult population of Minnesota. A novel approach to increasing smoker utilization of effective cessation services is by focusing on nonsmokers who want to help a smoker, i.e., support persons or proxies. Numerous studies provide evidence for the role of extra-treatment social support in smoking cessation. The current study builds on our previous work which indicated the feasibility and potential efficacy of directly recruiting and providing intervention for support persons. Cohen?s theory of social support and health is the conceptual basis for the proposed intervention.

In the first phase of this study, we will pilot the intervention to obtain support person feedback in refining the telephone counseling and other study procedures. We will recruit 30 nonsmoking adult support persons for the pilot to complete the 3-session telephone counseling intervention. Assessments will be completed by mail at baseline and week 4. In phase 2, after refining the intervention, we will use a randomized, two-group design to examine the effect of a 3-session telephone-based intervention versus a self-help intervention (written materials) for nonsmoking adult support persons on increasing their smokers? utilization of the ClearWay Minnesota funded QUITPLAN Helpline. Repeated mailed assessments will be completed by support persons at baseline (week 0) and follow-up at weeks 4 and 26. This study, funded by ClearWay Minnesota, addresses their funding priority area to ?Increase the Availability and Use of Individual Cessation Services.? The Primary Aims of phase 2 are (1) To determine if providing the telephone-based intervention for nonsmoking adult support persons results in a greater proportion of their smokers who call the QUITPLAN Helpline compared to the self-help intervention over the 26 week study period; and (2) To compare treatment groups on change in supportive behaviors provided (Support Provided Measure score) from baseline to week 4. Secondary Aims are to compare the smoker's readiness to quit and utilization of cessation service in the two groups.

We will recruit 564 (30 phase 1, 534 phase 2) nonsmoking adult support persons throughout the entire state of Minnesota using mass media and outreach approaches. They must be interested in supporting a current cigarette smoker who is 18 years of age or older and a resident of Minnesota. In phase 2, support persons will be randomly assigned to receive written self-help materials only (N=237; control group) or to receive the same written materials plus three, 15-20minute telephone-based sessions (N=237; experimental group) stratified according to whether or not the support person lives in the same residence as their smoker. The written materials will be mailed to the support person?s home. These materials will include a QUITPLAN Helpline toll-free number developed specifically for this study and a study reference code that reflects the support person's group assignment and includes the support person?s study ID number (e.g., BLUE 012) that the smoker should provide to the QUITPLAN Helpline intake staff if and when he/she decides to call. The primary dependent variable will be the proportion of support persons? smokers who call the QUITPLAN Helpline anytime during the interval from randomization through week 26, documented by the QUITPLAN Helpline intake staff. (using the study reference code).

The chi-square test will be used to examine treatment differences on the proportion of support persons whose smokers called the QUITPLAN Helpline at least once between randomization into the study and week 26 (Primary Aim 1). Additionally, the two groups will be compared on the time of the smoker?s first call using the Kaplan-Meier method with a log rank test. Support persons whose smoker does not call the Helpline will be censored at week 26. The mean change in Support Provided Measure total score at weeks 4 and 26 will be compared between treatment groups using a two-sample t-test (Primary Aim 2). For each dependent variable, a secondary analysis, using logistic regression or analysis of covariance as appropriate, will be performed to assess treatment effects adjusting for any baseline characteristics that are found to differ between groups.

Conditions
Tobacco Use
Being tested
Telephone Counseling, Written Materials
Medical subject headings
Tobacco Use

What participants receive

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

  • Telephone CounselingBehavioural

  • Written MaterialsBehavioural

Study groups in NCT01311830
Study groupRoleWhat they receive
Telephone CounselingActive comparatorNot described
Receives: Behavioral: Telephone Counseling
Written MaterialsPlacebo comparatorNot described
Receives: Behavioral: Written Materials

What is being measured

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

  1. proportion of smokers in each group who call the Minnesota Quitline, and changes in supportive behaviors among the support persons as measured by the Support Provided Measure.

    Measured: 6 months

Secondary outcomes (1)
  1. quit attempts and changes in readiness to quit among the smokers

    Measured: 6 months

Timeline

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

  1. First posted10 Mar 2011 (estimated)
  2. Study startSep 2007
  3. Primary completionApr 2010
  4. Study completionApr 2010

Resources

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
534 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01311830
Sponsor's protocol ID
06-005379
Status last verified
Mar 2011
First submitted
8 Mar 2011
Last updated
23 Mar 2011
Results posted
No
Data monitoring committee
No

Publications

  • Patten CA, Smith CM, Brockman TA, Decker PA, Hughes CA, Nadeau AM, Sinicrope PS, Offord KP, Lichtenstein E, Zhu SH. Support-person promotion of a smoking quitline: a randomized controlled trial. Am J Prev Med. 2011 Jul;41(1):17-23. doi: 10.1016/j.amepre.2011.03.012.

    PubMed 21665059

Questions about this trial

What is this clinical trial studying?

A study testing Telephone Counseling and Written Materials in people with Tobacco Use, run by Mayo Clinic 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 9 inclusion and 0 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 23 Mar 2011. 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?

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?

proportion of smokers in each group who call the Minnesota Quitline, and changes in supportive behaviors among the support persons as measured by the Support Provided Measure. (time frame: 6 months). 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 NCT01311830, 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 23 Mar 2011.

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