Tobacco CessationClearWay #4NCT01331226
Support Person Intervention to Promote a Smoking Helpline
A study testing telephone counseling 3 sessions, telephone counseling 1 session and written materials only in people with Tobacco Cessation, run by Mayo Clinic at 1 site in United States.
Trial summary
This study is designed to examine if a telephone-based intervention delivered to a support person (i.e., friend, spouse of a smoker) increases the smoker's use of the Minnesota helpline. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Tobacco Cessation
- What is being tested?
- telephone counseling 3 sessions, telephone counseling 1 session and written materials only
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,020 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2011to Apr 2015
- 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
- The support person must
- 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)
- want to support a current cigarette smoker (has smoked a total of >1 cigarettes during the past 7 days) who is 18 years of age or older, resides in Minnesota, and has not been enrolled in a helpline or any other cessation program in the last 3 months
Show all 9Show fewer
- be able and willing to participate in all aspects of the study
- have access to a working telephone
- have current and anticipated contact (any combination of face-to-face, telephone, text messaging, or electronic mail) with the smoker on at least 3 days a week for the 30 week study duration.
Who cannot join
- Support persons will be excluded if another support person from the same household has enrolled.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Support Person Effectiveness Study to Promote Smoker Utilization of the QUITPLAN Helpline
This study is designed to examine if a telephone-based intervention delivered to a support person (i.e., friend, spouse of a smoker) increases the smoker's use of the Minnesota helpline. In addition, the study will examine if the rate of smoker calls to the helpline is greater if the support person receives 3 intervention calls, 1 intervention call, or no calls (written materials only, control condition).
Read the detailed description
We will conduct a randomized clinical trial within the ongoing service of the QUITPLAN® Helpline. Our primary aim is to examine the efficacy of two levels of telephone counseling for support persons (1 or 3 sessions) compared with a control condition on the proportion of smokers who call the Helpline over the 7 month follow-up period. We hypothesize a dose response relationship between number of telephone sessions provided to the support persons and smoker calls to the Helpline. Additional aims are to examine smoker quit attempts and cessation, and cost-effectiveness of the interventions.
Nonsmoking adult support persons (N=1020) residing in Minnesota will be enrolled and randomly assigned to one of three study conditions: (1) control condition -written self-help materials, (2) written materials plus one telephone session, or (3) written materials plus three telephone sessions. Outcome assessments will be completed by support persons and smokers at post-treatment (week 4) and at 7 month follow-up.
This design will allow for evaluation of whether results from our previous trial (Patten et al., in press, AJPM) can be replicated when the intervention is implemented within a "real-world" setting. That is all support person intervention calls will be delivered by the Helpline. Moreover, we will examine the potential efficacy and cost-effectiveness of a streamlined version of the intervention (i.e., 1 call). Furthermore, the proposed study will provide new data on quit attempts and cessation among the smokers. Ultimately, positive findings from this line of research could serve as the basis for expanding the range of helpline services to nonsmokers.
- Conditions
- Tobacco Cessation
- Being tested
- telephone counseling 3 sessions, telephone counseling 1 session, written materials only
- Medical subject headings
- Tobacco Use Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
telephone counseling 3 sessionsBehavioural
3 sessions of telephone counseling
telephone counseling 1 sessionBehavioural
1 session of telephone counseling
written materials onlyBehavioural
written materials only
| Study group | Role | What they receive |
|---|---|---|
| 3 session telephone counseling | Experimental | Not described Receives: Behavioral: telephone counseling 3 sessions |
| 1 session telephone counseling | Experimental | Not described Receives: Behavioral: telephone counseling 1 session |
| written materials | Active comparator | Not described Receives: Behavioral: written materials only |
What is being measured
The primary outcome is the main question the study is designed to answer.
helpline utilization
smoker calls to the helpline
Measured: At 7 month follow-up
Secondary outcomes (1)
smoker quit attempts and cessation
Measured: 7 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 posted7 Apr 2011 (estimated)
- Study startJul 2011
- Primary completionApr 2015
- Study completionApr 2015
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 CessationStudies 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
- 1,020 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christi Patten, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01331226
- Sponsor's protocol ID
- 11-001796
- Other IDs
- 10-008318
- Acronym
- ClearWay #4
- Status last verified
- Apr 2015
- First submitted
- 6 Apr 2011
- Last updated
- 10 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Patten CA, Boyle R, Tinkelman D, Brockman TA, Lukowski A, Decker PA, D'Silva J, Lichtenstein E, Zhu SH. Linking smokers to a quitline: randomized controlled effectiveness trial of a support person intervention that targets non-smokers. Health Educ Res. 2017 Aug 1;32(4):318-331. doi: 10.1093/her/cyx050.
PubMed 28854569
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Support Person Effectiveness Study to Promote Smoker Utilization of the QUITPLAN Helpline
- ClinicalTrials.gov ID
- NCT01331226
- Acronym / sponsor ID
- ClearWay #4 / 11-001796
- Conditions
- Tobacco Cessation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,020 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- Jul 2011
- Primary completion
- Apr 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 7 Apr 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 is designed to examine if a telephone-based intervention delivered to a support person (i.e., friend, spouse of a smoker) increases the smoker's use of the Minnesota helpline. In addition, the study will examine if the rate of smoker calls to the helpline is greater if the support person receives 3 intervention calls, 1 intervention call, or no calls (written materials only, control condition).
Detailed description
We will conduct a randomized clinical trial within the ongoing service of the QUITPLAN® Helpline. Our primary aim is to examine the efficacy of two levels of telephone counseling for support persons (1 or 3 sessions) compared with a control condition on the proportion of smokers who call the Helpline over the 7 month follow-up period. We hypothesize a dose response relationship between number of telephone sessions provided to the support persons and smoker calls to the Helpline. Additional aims are to examine smoker quit attempts and cessation, and cost-effectiveness of the interventions.
Nonsmoking adult support persons (N=1020) residing in Minnesota will be enrolled and randomly assigned to one of three study conditions: (1) control condition -written self-help materials, (2) written materials plus one telephone session, or (3) written materials plus three telephone sessions. Outcome assessments will be completed by support persons and smokers at post-treatment (week 4) and at 7 month follow-up.
This design will allow for evaluation of whether results from our previous trial (Patten et al., in press, AJPM) can be replicated when the intervention is implemented within a "real-world" setting. That is all support person intervention calls will be delivered by the Helpline. Moreover, we will examine the potential efficacy and cost-effectiveness of a streamlined version of the intervention (i.e., 1 call). Furthermore, the proposed study will provide new data on quit attempts and cessation among the smokers. Ultimately, positive findings from this line of research could serve as the basis for expanding the range of helpline services to nonsmokers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 3 session telephone counseling | Experimental | Behavioral: telephone counseling 3 sessions |
| 1 session telephone counseling | Experimental | Behavioral: telephone counseling 1 session |
| written materials | Active comparator | Behavioral: written materials only |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- The support person must
Key exclusion criteria (1 listed)
- Support persons will be excluded if another support person from the same household has enrolled.
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 3 sessions3 sessions of telephone counseling | Behavioural | 3 session telephone counseling |
| telephone counseling 1 session1 session of telephone counseling | Behavioural | 1 session telephone counseling |
| written materials onlywritten materials only | Behavioural | written materials |
Primary outcome
helpline utilization
Time frame: At 7 month follow-up
smoker calls to the helpline
1 secondary outcome
smoker quit attempts and cessation
Time frame: 7 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 10 Apr 2015.
- Derived from this study: PubMed 28854569Patten CA, Boyle R, Tinkelman D, Brockman TA, Lukowski A, Decker PA, D'Silva J, Lichtenstein E, Zhu SH. Linking smokers to a quitline: randomized controlled effectiveness trial of a support person intervention that targets non-smokers. Health Educ Res. 2017 Aug 1;32(4):318-331. doi: 10.1093/her/cyx050.
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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.
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 3 sessions, telephone counseling 1 session and written materials only in people with Tobacco Cessation, 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 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 10 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?
helpline utilization (time frame: At 7 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 NCT01331226, 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 10 Apr 2015.