Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05194917 |
| Other study ID # |
2023-0650 |
| Secondary ID |
K23AG067929A5342 |
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
August 15, 2023 |
| Est. completion date |
February 29, 2024 |
Study information
| Verified date |
April 2024 |
| Source |
University of Wisconsin, Madison |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical 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.
Participation will include up to 2 interviews by telephone and receiving flyers via mail.
Description:
Overview. This study will use a pre-post design to assess feasibility and preliminary
effectiveness of a developed 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 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 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. 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 RCT. 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.
