Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03405129 |
| Other study ID # |
8814 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
October 17, 2018 |
| Est. completion date |
May 18, 2022 |
Study information
| Verified date |
May 2023 |
| Source |
University of Oklahoma |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Smoking is the leading preventable cause of death and disease in the United States. Although
most smokers report that they would like to quit smoking at some point in the future, only
20% are ready to quit within the next 30 days. Importantly, studies have indicated that
interventions can increase motivation and/or readiness for cessation among smokers who are
not yet ready to quit and these types of intervention can increase smoking cessation
attempts. Smartphone apps that offer daily information about the benefits of quitting and
motivational/supportive messages that aim to increase cessation self-efficacy may increase
the likelihood of initiating a smoking cessation attempt. Previous research has indicated
that smoking cessation smartphone applications are feasible and well-liked by smokers who are
already committed to quitting smoking. However, there are no empirically supported smartphone
apps that provide dynamic smoking cessation content that is automatically matched to a
smoker's current readiness to quit. This type of dynamically tailored intervention could
overcome many of the barriers that have hampered the widespread use of traditional
empirically supported smoking cessation treatments. The current pilot study (N=150) is a
3-armed randomized controlled smoking cessation induction trial that will determine the
initial utility of a novel smartphone based intervention compared with an attention control
group among smokers who are not yet ready to quit. The two intervention groups (Group 1:
Phoenix App Only; Group 2: Phoenix App + Nicotine Replacement Therapy [NRT]) will receive
targeted smoking cessation messaging that is matched to a participant's readiness to quit,
while the attention control group (i.e., Factoid) will receive messages that are not related
to smoking cessation.
Description:
Description of Study Visit and Follow-Up:
Screening and Baseline Assessment Visit. Individuals who complete the online screener (i.e.,
REDCap) and meet initial study inclusion criteria will be invited to complete the in person
screener and baseline visit at the Tobacco Treatment Research Program (TTRP). Potential
participants will be provided with detailed information about the study and given the
opportunity to have their questions answered within a private room to ensure confidentiality.
Study staff will review the consent form with interested participants, who will be screened
for eligibility on-site in a private room in the clinic. Participant eligibility for the
current study will not influence eligibility for treatment at the TTRP. The Rapid Estimate of
Adult Literacy in Medicine-Short Form (REALM45) will be administered to ensure that all
participants are able to read at > sixth grade level (i.e., required to complete EMA and
self-report questionnaires). Participants will also be asked to read aloud from the Informed
Consent form. Expired carbon monoxide (CO) will be measured with a Vitalograph BreathCO
carbon monoxide monitor and a Bedfont iCO carbon monoxide monitor. The purpose of using both
monitors is to validate the Bedfont iCO device. Participants will be questioned in person to
verify the information they provided during the REDCap screening process. Race/ethnicity,
sex, cigarettes smoked per day, education, and readiness to quit smoking will be used to
randomize participants to the Phoenix, Phoenix + NRT, or Factoid groups using adaptive
randomization software. Participants will complete the assessment portion of the baseline
visit on a laptop/tablet computer; and weight, and height will be measured in a private room
to ensure confidentiality.
Participants will be instructed that the app will prompt and deliver two messages per day and
that they should click the "Set New Quit Date" button when/if they want to set a smoking
cessation quit date. They will be informed that the app will offer smoking cessation
resources after they set a quit date.
Week 26 Follow-Up Phone Call. All participants will be asked to complete a brief 10-15 minute
follow-up interview over the phone. Participants will be asked about their current smoking
status, their opinions about the smartphone app, and how the app could be improved for future
studies.
