Clinical trial NCT05194917: Motivating Change in Aging Smokers
Official title: Aim-3: Alzheimer's Disease and Related Dementias Prevention Messaging to Increase Smoking Cessation Attempts in Older Adult Smokers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Smoking Cessation
Keywords: older smoker
motivational intervention
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2022-01-18
Enrollment: 201
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* current diagnosis of dementia or mild cognitive impairment

Primary outcomes:
measure: Change in Motivation to Quit Within the Next 30 Days
timeFrame: baseline (during wave 1), up to 6 months (during wave 2)
Secondary outcomes:
Other outcomes:
Locations:
city: Madison
country: United States
facility: University of Wisconsin
state: Wisconsin
Study officials:
affiliation: UW School of Medicine and Public Health
name: Adrienne L Johnson, PhD
role: PRINCIPAL_INVESTIGATOR
References: