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

Tobacco Cessation Clinical Trial

Official title:

Pilot Study Phase - Nonsmoker Interventions to Increase Use of Quitline Services Among Racially Diverse Low Income Smokers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03096145
• Other study ID #: 16-006338
• Status: Completed
• Phase: N/A
• Start date: May 1, 2017
• Est. completion date: August 24, 2019

Study information

• Verified date: December 2019
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: August 24, 2019
• Est. primary completion date: May 22, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Tobacco Cessation

Intervention

Behavioral:
• Telephone counseling 1 session
1 call coaching session for nonsmokers that will be piloted and adapted in this study
• Mobile texting
nonsmokers will receive 3-5 text messages for 4 weeks
• Health incentive
Smokers receive a $25 gift card if they call the quitline

Locations

Country	Name	City	State
United States	Mayo Clinic in Rochester	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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

External Links

•   Mayo Clinic Clinical Trials