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

December 9, 2019 updated by: Christi Patten, Mayo Clinic

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic in Rochester

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Behavioral Intervention
Behavioral: telephone counseling 1 sessions, mobile texting, and health incentive
Behavioral: Telephone counseling 1 session
1 call coaching session for nonsmokers that will be piloted and adapted in this study
Behavioral: Mobile texting
nonsmokers will receive 3-5 text messages for 4 weeks
Behavioral: Health incentive
Smokers receive a $25 gift card if they call the quitline

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Investigators

  • Principal Investigator: Christi A Patten, Mayo Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2017

Primary Completion (Actual)

May 22, 2018

Study Completion (Actual)

August 24, 2019

Study Registration Dates

First Submitted

March 25, 2017

First Submitted That Met QC Criteria

March 29, 2017

First Posted (Actual)

March 30, 2017

Study Record Updates

Last Update Posted (Actual)

December 11, 2019

Last Update Submitted That Met QC Criteria

December 9, 2019

Last Verified

December 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 16-006338

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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