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Smoking CessationNCT05194917

Motivating Change in Aging Smokers

A study testing Older Smoker Motivational Intervention in people with Smoking Cessation, run by University of Wisconsin, Madison at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 50 to 80 yearsHealthy volunteers can take part
Conditions the study is for
Smoking Cessation
What is being tested?
Older Smoker Motivational Intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
201 participants
Where
1 siteUnited States
Study dates
15 Aug 2023to 29 Feb 2024
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 to 80 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • current diagnosis of dementia or mild cognitive impairment

Trial locations and contacts

1 site in 1 country.

United States1 site
  • University of Wisconsin

    Madison, Wisconsin, 53705

Other trials in United States

About this study

Official title: 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.

Read the 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.

Being tested
Older Smoker Motivational Intervention, Control Motivational Message
Keywords
older smoker, motivational intervention
Medical subject headings
Smoking Cessation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Older Smoker Motivational InterventionOther

    Also called OSMI

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

  • Control Motivational MessageOther

    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.

Study groups in NCT05194917
Study groupRoleWhat they receive
Older Smoker Motivational InterventionExperimentalMessage package focused on the link between smoking and dementia
Receives: Other: Older Smoker Motivational Intervention
Control Motivational Message 1Active comparatorCDC TIPS from former smokers campaign
Receives: Other: Control Motivational Message
Control Treatment as UsualNo interventionNo intervention
Control Motivational Message 2Active comparatorAmerican Lung Association campaign
Receives: Other: Control Motivational Message

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Jan 2022
  2. Study start15 Aug 2023
  3. Primary completion29 Feb 2024
  4. Study completion29 Feb 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
201 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05194917
Sponsor's protocol ID
2023-0650
Other IDs
K23AG067929, A534252
Status last verified
Mar 2025
First submitted
5 Jan 2022
Last updated
7 Mar 2025
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Older Smoker Motivational Intervention in people with Smoking Cessation, run by University of Wisconsin, Madison at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 7 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Motivation to Quit Within the Next 30 Days (time frame: baseline (during wave 1), up to 6 months (during wave 2)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2025.

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