NCT05194917

Brief Summary

The purpose of this research is to evaluate messages that motivate older smokers to make quit attempts using evidence based smoking treatments (EBSTs). 200 participants will be recruited nationally (within the United States) primarily via social media advertisements. Participation will include up to 2 interviews by telephone and receiving flyers via mail.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
201

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2023

Shorter than P25 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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 5, 2022

Completed
13 days until next milestone

First Posted

Study publicly available on registry

January 18, 2022

Completed
1.6 years until next milestone

Study Start

First participant enrolled

August 15, 2023

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 29, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 29, 2024

Completed
1 year until next milestone

Results Posted

Study results publicly available

March 7, 2025

Completed
Last Updated

March 7, 2025

Status Verified

March 1, 2025

Enrollment Period

7 months

First QC Date

January 5, 2022

Results QC Date

February 12, 2025

Last Update Submit

March 4, 2025

Conditions

Keywords

older smokermotivational intervention

Outcome Measures

Primary Outcomes (1)

  • Change in Motivation to Quit Within the Next 30 Days

    Motivation to Quit within the next 30 days is measured on a 10-point likert scale from 1 (not at all motivated) to 10 (extremely motivated); higher numbers indicate more motivation to quit.

    baseline (during wave 1), up to 6 months (during wave 2)

Study Arms (4)

Older Smoker Motivational Intervention

EXPERIMENTAL

Message package focused on the link between smoking and dementia

Other: Older Smoker Motivational Intervention

Control Motivational Message 1

ACTIVE COMPARATOR

CDC TIPS from former smokers campaign

Other: Control Motivational Message

Control Treatment as Usual

NO INTERVENTION

No intervention

Control Motivational Message 2

ACTIVE COMPARATOR

American Lung Association campaign

Other: Control Motivational Message

Interventions

OSMI identified in Aim 2 of the study, motivational interventions will be delivered via mailer with QR video code.

Also known as: OSMI
Older Smoker Motivational Intervention

One control motivational message with a standard health- and EBST access-related content (i.e., "Quitting smoking is the best thing you can do for your health. Call 1-800-QUIT-NOW for help."), motivational interventions will be delivered via mailer with QR video code.

Control Motivational Message 1Control Motivational Message 2

Eligibility Criteria

Age50 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ages 50-80
  • can read and write English
  • current smoker

You may not qualify if:

  • current diagnosis of dementia or mild cognitive impairment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Wisconsin

Madison, Wisconsin, 53705, United States

Location

MeSH Terms

Conditions

Smoking Cessation

Condition Hierarchy (Ancestors)

Health BehaviorBehavior

Results Point of Contact

Title
Dr. Adrienne Johnson
Organization
University of Wisconsin School of Medicine and Public Health Center for Tobacco Research and Intervention

Study Officials

  • Adrienne L Johnson, PhD

    UW School of Medicine and Public Health

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 5, 2022

First Posted

January 18, 2022

Study Start

August 15, 2023

Primary Completion

February 29, 2024

Study Completion

February 29, 2024

Last Updated

March 7, 2025

Results First Posted

March 7, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations