NCT03096145

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 25, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 30, 2017

Completed
1 month until next milestone

Study Start

First participant enrolled

May 1, 2017

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 22, 2018

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 24, 2019

Completed
Last Updated

December 11, 2019

Status Verified

December 1, 2019

Enrollment Period

1.1 years

First QC Date

March 25, 2017

Last Update Submit

December 9, 2019

Conditions

Keywords

tobaccoquitlinessocial supportmobile support

Outcome Measures

Primary Outcomes (1)

  • 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

    1 month

Study Arms (1)

Behavioral Intervention

EXPERIMENTAL

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

Behavioral: Telephone counseling 1 sessionBehavioral: Mobile textingBehavioral: Health incentive

Interventions

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

Behavioral Intervention
Mobile textingBEHAVIORAL

nonsmokers will receive 3-5 text messages for 4 weeks

Behavioral Intervention

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

Behavioral Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Minnesota resident
  • 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

You may not qualify if:

  • Their smoker does not provide written informed consent
  • Minnesota resident
  • 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
  • Their nonsmoker does not provide verbal consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

MeSH Terms

Conditions

Tobacco Use Cessation

Condition Hierarchy (Ancestors)

Health BehaviorBehavior

Study Officials

  • Christi A Patten

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Psychology

Study Record Dates

First Submitted

March 25, 2017

First Posted

March 30, 2017

Study Start

May 1, 2017

Primary Completion

May 22, 2018

Study Completion

August 24, 2019

Last Updated

December 11, 2019

Record last verified: 2019-12

Locations