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Support Person Intervention to Promote a Smoking Helpline Among Under Resourced Smokers

NCT ID: NCT03096145

Last Updated: 2019-12-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-05-01

Study Completion Date

2019-08-24

Brief Summary

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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

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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

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Tobacco Cessation

Keywords

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tobacco quitlines social support mobile support

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Behavioral Intervention

Behavioral: telephone counseling 1 sessions, mobile texting, and health incentive

Group Type EXPERIMENTAL

Telephone counseling 1 session

Intervention Type BEHAVIORAL

1 call coaching session for nonsmokers that will be piloted and adapted in this study

Mobile texting

Intervention Type BEHAVIORAL

nonsmokers will receive 3-5 text messages for 4 weeks

Health incentive

Intervention Type BEHAVIORAL

Smokers receive a $25 gift card if they call the quitline

Interventions

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Telephone counseling 1 session

1 call coaching session for nonsmokers that will be piloted and adapted in this study

Intervention Type BEHAVIORAL

Mobile texting

nonsmokers will receive 3-5 text messages for 4 weeks

Intervention Type BEHAVIORAL

Health incentive

Smokers receive a $25 gift card if they call the quitline

Intervention Type BEHAVIORAL

Eligibility Criteria

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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


* 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

Exclusion Criteria

* Their smoker does not provide written informed consent


* Their nonsmoker does not provide verbal consent
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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Christi Patten

Professor of Psychology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Christi A Patten

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

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Mayo Clinic in Rochester

Rochester, Minnesota, United States

Site Status

Countries

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United States

Related Links

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https://www.mayo.edu/research/clinical-trials

Mayo Clinic Clinical Trials

Other Identifiers

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16-006338

Identifier Type: -

Identifier Source: org_study_id