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.
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
- Type of treatment
- Lifestyle or therapy programme
- 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.
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 group | Role | What they receive |
|---|---|---|
| Telephone Counseling | Active comparator | Not described Receives: Behavioral: Telephone Counseling |
| Written Materials | Placebo comparator | Not described Receives: Behavioral: Written Materials |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
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.
- First posted10 Mar 2011 (estimated)
- Study startSep 2007
- Primary completionApr 2010
- Study completionApr 2010
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 Tobacco UseStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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
- 534 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- ClearWay Minnesota
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
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing Smoker Utilization of the Minnesota Quitline Through Support Persons
- ClinicalTrials.gov ID
- NCT01311830
- Acronym / sponsor ID
- 06-005379
- Conditions
- Tobacco Use
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 534 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- ClearWay Minnesota
- Study start
- Sep 2007
- Primary completion
- Apr 2010 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 10 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.
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).
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Telephone Counseling | Active comparator | Behavioral: Telephone Counseling |
| Written Materials | Placebo comparator | Behavioral: Written Materials |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Telephone Counseling | Behavioural | Telephone Counseling |
| Written Materials | Behavioural | Written Materials |
Primary outcome
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
1 secondary outcome
quit attempts and changes in readiness to quit among the smokers
Time frame: 6 months
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 23 Mar 2011.
- Derived from this study: PubMed 21665059Patten 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.
Related trials for Tobacco Use
Active, not recruiting
Symptoms and Functions in Patients With COPD and Chronic Bronchitis Switching From CIG to THS
COPD, Smoking
Recruiting
Effectiveness of Volitional Help Sheets as an Adjunct to Treatment to Promote Behavior Change: A Pilot Study on Smoking
Tobacco Dependence
Not yet recruiting
Impacto 2.0: Mobile Smoking Cessation Across Texas
Cigarette Smoking, Smoking Cessation
Active, not recruiting
Vaping Cessation Using the Ottawa Model for Smoking Cessation Among E-Cigarette Users
Tobacco Smoking, Vaping
Not yet recruitingEarly Phase 1
Lung Health and Breath Biomarkers: Acute Effects of Inhaled Cannabis
Cannabis Use, Tobacco
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
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.