Tobacco CessationNCT03096145
Support Person Intervention to Promote a Smoking Helpline Among Under Resourced Smokers
A study testing Telephone counseling 1 session, Mobile texting and Health incentive in people with Tobacco Cessation, run by Mayo Clinic at 1 site in United States.
Trial summary
This pilot study is being done to adapt an effective 1 session phone coaching intervention for nonsmoking support persons to a low income population. This study will also pilot new intervention components including text messaging and health incentives. 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 1 session, Mobile texting and Health incentive
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2017to 24 Aug 2019
- 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
Nonsmoker Inclusion Criteria:
- Minnesota resident
- 18 years of age or older
- Is a never smoker or former smoker (no cigarette smoking in past 6 months)
- Has a low income defined as receiving state funded health insurance including medical assistance (e.g., Medicaid) or MinnesotaCare
- Has access to a working cellular telephone with text messaging capabilities
- Has a mailing address/P.O. box
- Have regular contact with a current smoker is at least 18 years of age, resides in MN
- Provided verbal consent
Nonsmoker Exclusion Criteria:
- Their smoker does not provide written informed consent
Smoker Study Inclusion Criteria:
- Minnesota resident
- 18 years of age or older
- Has a low income defined as receiving state funded health insurance including medical assistance (e.g., Medicaid) or MinnesotaCare
- Has access to a working phone
- Has a mailing address/P.O. box
- Has smoked at least 1 cigarette in the past 30 days (to include both light/intermittent as well as daily/frequent smokers thus enhancing generalizability)
- Has not participated in a stop smoking program in the past 3 months including receiving pharmacotherapy for smoking cessation
- Provided written informed consent
Smoker Exclusion Criteria:
- Their nonsmoker does not provide verbal consent
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Official title: Pilot Study Phase - Nonsmoker Interventions to Increase Use of Quitline Services Among Racially Diverse Low Income Smokers
This pilot study is being done to adapt an effective 1 session phone coaching intervention for nonsmoking support persons to a low income population. This study will also pilot new intervention components including text messaging and health incentives. The goal of the intervention is for support persons to prompt their smoker to use quitline services. To see if these methods are effective, smokers in this study will be asked to complete assessments about their quit attempts and smoking status. The study will also evaluate if the smokers use quitline services or not. The preliminary findings will be used to provide data for an R01 NIH grant submission.
Read the detailed description
This is a proposal to conduct a pilot study to adapt an effective 1 session phone coaching intervention for nonsmoking support persons to a low income population. The study will also pilot new intervention components including text messaging and health incentives. The goal of the intervention is for support persons to prompt their smoker to use quitline services. The study will also build on prior work by enrolling smokers for assessments of quit attempts and smoking abstinence. The study uses a non-randomized, single group design. Thirty nonsmoker-smoker dyads will be enrolled in three waves of 10 each. The nonsmokers will receive different intervention components depending on the time of their enrollment. Nonsmokers will complete assessments at baseline and at 1 month follow-up. Smokers will be enrolled for assessments only at baseline and 3 month follow-up. The vendor for the Minnesota state quitline, Alere Wellbeing Inc. (a sole subsidiary of Optum) will track if smokers use quitline services over 3 months of follow-up. The aims of this pilot study are to: (1) Assess the feasibility of enrolling low income, racially diverse nonsmoker-smoker dyads; (2) Adapt and refine the support person intervention components to a low income population with feedback from the nonsmoker participants; and (3) Assess the feasibility of obtaining assessments from the smokers on quit attempts and smoking abstinence outcomes. The preliminary findings will be used to provide data for an R01 NIH grant submission.
- Conditions
- Tobacco Cessation
- Being tested
- Telephone counseling 1 session, Mobile texting, Health incentive
- Keywords
- tobacco, quitlines, social support, mobile support
- 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 1 sessionBehavioural
1 call coaching session for nonsmokers that will be piloted and adapted in this study
Mobile textingBehavioural
nonsmokers will receive 3-5 text messages for 4 weeks
Health incentiveBehavioural
Smokers receive a $25 gift card if they call the quitline
| Study group | Role | What they receive |
|---|---|---|
| Behavioral Intervention | Experimental | Behavioral: telephone counseling 1 sessions, mobile texting, and health incentive Receives: Behavioral: Telephone counseling 1 session; Behavioral: Mobile texting; Behavioral: Health incentive |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of low-income nonsmoker-smoker dyads at 1 month follow-up
feasibility of retaining low-income nonsmoker-smoker dyads at the 1 month follow-up
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2017
- Study start1 May 2017
- Primary completion22 May 2018
- Study completion24 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christi Patten, Mayo Clinic
- Investigators
- Christi A Patten, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03096145
- Sponsor's protocol ID
- 16-006338
- Status last verified
- Dec 2019
- First submitted
- 25 Mar 2017
- Last updated
- 11 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study Phase - Nonsmoker Interventions to Increase Use of Quitline Services Among Racially Diverse Low Income Smokers
- ClinicalTrials.gov ID
- NCT03096145
- Acronym / sponsor ID
- 16-006338
- Conditions
- Tobacco Cessation
- Keywords
- tobacco, quitlines, social support, mobile support
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 1 May 2017 (actual)
- Primary completion
- 22 May 2018 (actual)
- Study completion
- 24 Aug 2019 (actual)
- First posted
- 30 Mar 2017 (actual)
- 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 pilot study is being done to adapt an effective 1 session phone coaching intervention for nonsmoking support persons to a low income population. This study will also pilot new intervention components including text messaging and health incentives. The goal of the intervention is for support persons to prompt their smoker to use quitline services. To see if these methods are effective, smokers in this study will be asked to complete assessments about their quit attempts and smoking status. The study will also evaluate if the smokers use quitline services or not. The preliminary findings will be used to provide data for an R01 NIH grant submission.
Detailed description
This is a proposal to conduct a pilot study to adapt an effective 1 session phone coaching intervention for nonsmoking support persons to a low income population. The study will also pilot new intervention components including text messaging and health incentives. The goal of the intervention is for support persons to prompt their smoker to use quitline services. The study will also build on prior work by enrolling smokers for assessments of quit attempts and smoking abstinence. The study uses a non-randomized, single group design. Thirty nonsmoker-smoker dyads will be enrolled in three waves of 10 each. The nonsmokers will receive different intervention components depending on the time of their enrollment. Nonsmokers will complete assessments at baseline and at 1 month follow-up. Smokers will be enrolled for assessments only at baseline and 3 month follow-up. The vendor for the Minnesota state quitline, Alere Wellbeing Inc. (a sole subsidiary of Optum) will track if smokers use quitline services over 3 months of follow-up. The aims of this pilot study are to: (1) Assess the feasibility of enrolling low income, racially diverse nonsmoker-smoker dyads; (2) Adapt and refine the support person intervention components to a low income population with feedback from the nonsmoker participants; and (3) Assess the feasibility of obtaining assessments from the smokers on quit attempts and smoking abstinence outcomes. The preliminary findings will be used to provide data for an R01 NIH grant submission.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Behavioral Intervention | Experimental | Behavioral: Telephone counseling 1 session, Behavioral: Mobile texting, Behavioral: Health incentiveBehavioral: telephone counseling 1 sessions, mobile texting, and health incentive |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
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 1 session1 call coaching session for nonsmokers that will be piloted and adapted in this study | Behavioural | Behavioral Intervention |
| Mobile textingnonsmokers will receive 3-5 text messages for 4 weeks | Behavioural | Behavioral Intervention |
| Health incentiveSmokers receive a $25 gift card if they call the quitline | Behavioural | Behavioral Intervention |
Primary outcome
Number of low-income nonsmoker-smoker dyads at 1 month follow-up
Time frame: 1 month
feasibility of retaining low-income nonsmoker-smoker dyads at the 1 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 11 Dec 2019.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
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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.
Christi A Patten principal investigator
Mayo Clinic
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 1 session, Mobile texting and Health incentive 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?
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 11 Dec 2019. 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?
Number of low-income nonsmoker-smoker dyads at 1 month follow-up (time frame: 1 month). 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 11 Dec 2019.