Recruiting

Smoking Cessation

Sponsor:

Minneapolis Veterans Affairs Medical Center

Code:

NCT04840108

Conditions

Smoking Cessation

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Support Person Coaching Intervention

Support Person Written Materials

Study Details

Brief summary:

This is a proposal to conduct a pilot study to assess the feasibility of recruitment of Veteran smoker and support person (SP) dyads and study procedures in preparation for a large randomized pragmatic trial.

Conditions

Smoking Cessation

Study ID

NCT04840108

Start date

Apr 12, 2021

Status verified date

Nov, 2023

Completion date

Dec 1, 2024

Anticipated

Primary completion date

Sep 1, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Veteran: Veteran has to be current tobacco user (past month) and and has smoked greater than 1 cigarette in the past 30 days, aged 18 years or older, cigarettes are the main tobacco product being used, are able to identify a support person to volunteer in the study with them who they have contact with (of any form) at least 3 times per week, and the Veteran has to have access to a smartphone or tablet device.
  • Support Person: Has to be 18 years or older, willing to participate in the study and support the Veteran smoker, and have access to any type of phone they are able to complete the screener and coaching intervention call with.

Exclusion Criteria:

  • Veteran: Does not use cigarettes as may tobacco use, does not smoke, is younger than 18 years of age, does not have a support person to have participate with them in the study, does not have access to a smartphone or tablet device.
  • Support Person: Does not have access to a phone, is not willing to support the Veteran and participate in the study, or is younger than 18 years of age.

Study Design

Enrollment

64 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

experimental: Support Person Coaching Intervention

Support persons in the intervention arm will receive existing written materials on effective social support strategies for smoking cessation. Materials will be sent via postal mail. Support persons in this arm will also complete a one-session coaching intervention (15-25 minutes) delivered virtually by research staff via phone.

active comparator: Support Person Written Materials

Support persons in the intervention arm will receive existing written materials on effective social support strategies for smoking cessation. Materials will be sent via postal mail.

Interventions

Support Person Coaching Intervention

The intervention condition will include, for the SPs, a manualized, 1-session coaching intervention delivered by a research coach. The call will be delivered by phone using VA-permitted remote audio or video communication technology (e.g., doximity dialer, Zoom, or VA Video Connect if a Veteran). Coaches will use behavior change strategies delivered with a MI style.

Support Person Written Materials

Support persons will receive existing written materials on effective social support strategies for smoking cessation. Materials will be sent via postal mail.

Primary outcome measure

  • Recruitment Feasibility [ Time Frame: Duration of project, one year ]

Central Contacts and Locations

Central contacts

Mariah C Branson, BA

(612) 467-4920mariah.branson@va.gov

Steven Fu, MD, MSCE

(612) 467-2582steven.fu@va.gov

Locations

Minneapolis Veterans Administration Health Care System

Recruiting

Minneapolis, Minnesota, United States, 55417

Contacts

Mariah C Branson, BA

612-467-4920mariah.branson@va.gov

Steven S Fu, MD, MSCE

(612) 467-2582steven.fu@va.gov

Principal Investigator:

Steven S Fu, MD, MSCE

More Information

Sponsor

Minneapolis Veterans Affairs Medical Center

Last update posted

Mar 19, 2024

Last verified

Nov, 2023

Keywords

  • Smoking cessation
  • Support Person

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Minneapolis Veterans Affairs Medical Center on 2024-03-19.