Motivating Change in Aging Smokers

Aim-3: Alzheimer's Disease and Related Dementias Prevention Messaging to Increase Smoking Cessation Attempts in Older Adult Smokers

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.

Study Overview

• Status: Completed
• Conditions: Smoking Cessation
• Intervention / Treatment: Other: Older Smoker Motivational Intervention; Other: Control Motivational Message

Detailed Description

Overview. This study will use a pre-post design to assess feasibility and preliminary effectiveness of a developed Older Smoker Motivational Intervention (OSMI) presented in a large primary care clinic. Participants will be randomized to one of four messaging interventions; 1) active control (CDC TIPS from former smokers campaign), 2) active control (American Lung Association campaign), 3) treatment condition including message package focused on the link between smoking and dementia, 4) no intervention control. The messaging intervention will be delivered via mail, which will include a QR code link that will allow participants to view associated motivational video. Participants will then complete the first of 2 telephone survey assessments (lasting ~30 minutes). Participants will then receive three mailers over the next couple of months and will schedule their follow-up call approximately 2.5 months later. At one to two weeks, one month, and two months after this call they will be mailed the corresponding message to their group (no intervention group will not be sent a message package). Follow up telephone assessments will occur within approximately 1-2 weeks following intervention exposure marked by date the intervention mailer was sent.

Participants. Older adults from the community (N=200) who are ages 50-80, self-report being a current smoker, do not hold a current diagnosis of dementia or Mild Cognitive Impairment (MCI), can read and write in English will be eligible to participate, located within the United States.

Setting/Recruitment. Participants will be recruited nationally (within the United States) primarily via social media advertisements. Should these efforts fail, the investigators will use flyers and television advertisements. Those interested in participating in the study will call the provided contact information to enroll in the study directly with University of Wisconsin Center for Tobacco Research and Intervention (UW-CTRI) staff. Upon contacting UW-CTRI, the investigators will confirm their location via their provided address. All data collected for this study will be stored an a secure departmental server (electronic data) or in a locked file cabinet in a locked room at UW-CTRI (physical copies of data). Audio files of recordings will be stored on a secure departmental server.

Procedure and Assessments. Upon study initiation 200 participants will be recruited for the study and provide informed consent. After consent they will be randomized to one of the 4 study conditions (active control1, active control 2, no intervention, treatment condition). They will then complete the first of 2 telephone survey assessments (lasting ~25 minutes). Participants will then be informed they will receive three mailers over the next couple of months and will schedule their follow-up call approximately 2.5 months later. At two weeks, one month, and two months after this call they will be mailed the corresponding message to their group (no intervention group will not be sent a message package). Follow up telephone assessments will occur within approximately 1-2 weeks following intervention exposure marked by date the intervention mailer was sent. Up to 20 participants randomized to the intervention condition will complete an additional brief qualitative interview following their second telephone survey assessment (lasting ~20 minutes). The qualitative interview will focus on the perceived impact of the message, preferred number of message exposures, preferred modality of message receipt, and suggested improvement to message content. Health Believe Model (HBM)1 constructs assessed include: perceived severity, perceived benefits (i.e., efficacy of EBSTs; impact of quitting on Alzheimer's disease and related dementias (ADRD) risk), perceived barriers (i.e., knowledge of how to access EBSTs in healthcare setting), and self-efficacy (i.e., confidence in ability to quit in the next 30 days).

Analyses. The investigators will evaluate preliminary effectiveness by descriptively comparing primary (1) and secondary (2) outcomes longitudinally (baseline vs. follow up) within participants, as well as cross-sectionally comparing follow-up data by treatment randomization groups (Intervention Message vs. Control Message; Intervention Message vs. Treatment as Usual (TAU); TAU vs. Control Message). The investigators will assess feasibility during follow-up via receipt and comprehension of messages. The HBM1 outcomes will be compared longitudinally within participant to identify potential mechanisms of action for the interventions and identify potential changes to the interventions prior to a larger randomized controlled trial (RCT). Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) domains preliminarily assessed will include (1) Reach: comprehension of motivational and access message; (2) Efficacy on smoking-cessation related beliefs and intentions (i.e., motivation to quit, quit attempts, and use of EBSTs when quitting); and (3) Implementation of the novel OSMI will be assess via qualitative interviews with participants.

• Study Type: Interventional
• Enrollment (Actual): 201
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Wisconsin
    • Madison, Wisconsin, United States, 53705
      • University of Wisconsin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

• current diagnosis of dementia or mild cognitive impairment

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Older Smoker Motivational Intervention; Message package focused on the link between smoking and dementia	Other: Older Smoker Motivational Intervention; OSMI identified in Aim 2 of the study, motivational interventions will be delivered via mailer with QR video code.; Other Names: OSMI
Active Comparator: Control Motivational Message 1; CDC TIPS from former smokers campaign	Other: Control Motivational Message; 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.
No Intervention: Control Treatment as Usual; No intervention
Active Comparator: Control Motivational Message 2; American Lung Association campaign	Other: Control Motivational Message; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)

Collaborators and Investigators

• Sponsor: University of Wisconsin, Madison
• Collaborators: National Institute on Aging (NIA)
• Investigators: Principal Investigator: Adrienne L Johnson, PhD, UW School of Medicine and Public Health

Study record dates

Study Major Dates

• Study Start (Actual): August 15, 2023
• Primary Completion (Actual): February 29, 2024
• Study Completion (Actual): February 29, 2024

Study Registration Dates

• First Submitted: January 5, 2022
• First Submitted That Met QC Criteria: January 5, 2022
• First Posted (Actual): January 18, 2022

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 4, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: older smoker; motivational intervention
• Other Study ID Numbers: 2023-0650; K23AG067929 (U.S. NIH Grant/Contract); A534252 (Other Identifier: UW Madison)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No