Clinical Trial of an Automated Smartphone Based Smoking Cessation Treatment
Status: | Active, not recruiting |
---|---|
Conditions: | Smoking Cessation |
Therapuetic Areas: | Pulmonary / Respiratory Diseases |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 2/24/2019 |
Start Date: | May 30, 2017 |
End Date: | August 2019 |
Pilot Randomized Clinical Trial of an Automated Smartphone Based Smoking Cessation Treatment
The primary long-term objective of this research is to reduce smoking relapse through the use
of automated mobile smoking cessation interventions that tailor content (e.g., treatment
messages/materials) in real-time based upon currently present symptoms. The primary
short-term objective of this pilot study is to determine the initial utility of a novel
smartphone based smoking cessation intervention compared with standard in-person smoking
cessation clinic care and the free National Cancer Institute (NCI) QuitGuide smoking
cessation application. The current pilot study is a 3 armed randomized clinical trial that
aims to determine the initial utility of a novel smartphone based smoking cessation
intervention compared with standard in-person smoking cessation clinic care and the free NCI
QuitGuide smoking cessation application.
of automated mobile smoking cessation interventions that tailor content (e.g., treatment
messages/materials) in real-time based upon currently present symptoms. The primary
short-term objective of this pilot study is to determine the initial utility of a novel
smartphone based smoking cessation intervention compared with standard in-person smoking
cessation clinic care and the free National Cancer Institute (NCI) QuitGuide smoking
cessation application. The current pilot study is a 3 armed randomized clinical trial that
aims to determine the initial utility of a novel smartphone based smoking cessation
intervention compared with standard in-person smoking cessation clinic care and the free NCI
QuitGuide smoking cessation application.
Description of Study Visits.
Screening and Baseline Assessment (Visit 1). Individuals attending the orientation visit of
the Tobacco Treatment Research Clinic (TTRC) 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, and they will be screened for eligibility on-site in a private room in the
clinic. Participants will be questioned about their 1) age, 2) current level of smoking, 3)
willingness to quit smoking, and 4) willingness/ability to attend 4 sessions (including the
first visit). Participants will be randomized to treatment as usual (TAU), QuitGuide, or
Smart-T groups and advised of their group assignment. Participants will complete the
assessment portion of visit 1. Participants will complete self-report questionnaires on a
laptop/tablet computer; and weight, and height will be measured in a private room to ensure
confidentiality. Participants will be loaned an Android smartphone and instructed regarding
the use of the phone as well as the ecological momentary assessment (EMA) procedures.
Quit Day (Visit 2). Participants will complete self-report questionnaires on a laptop/tablet
computer; and expired CO and weight will be measured in a private room to ensure
confidentiality. Participants will compensated completion of the in-person assessments. All
questions about study phones will be appropriately addressed and answered. Participants who
do not attend will be contacted by phone to obtain their self-reported smoking status.
4 Weeks Post-Quit (Visit 3). Participants will complete self-report questionnaires on a
laptop/tablet computer; and expired CO and weight will be measured in a private room to
ensure confidentiality. Participants will be compensated for the completion of the in-person
assessments, which will take approximately 45-60 minutes to complete. When participants
return the phone they will be compensated according to the compensation schedule described
above. Participants who do not attend will be contacted by phone to obtain their
self-reported smoking status and to request that the study phone be returned by mail or
in-person at the next visit.
12 Weeks Post-Quit (Visit 4; Follow-Up). Participants will complete self-report
questionnaires on a laptop/tablet computer; and expired CO and weight will be measured in a
private room to ensure confidentiality. Participants will be compensated for the completion
of the in-person assessments, which will take approximately 60 minutes to complete.
Participants who do not attend will be contacted by phone to obtain their self-reported
smoking status.
Screening and Baseline Assessment (Visit 1). Individuals attending the orientation visit of
the Tobacco Treatment Research Clinic (TTRC) 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, and they will be screened for eligibility on-site in a private room in the
clinic. Participants will be questioned about their 1) age, 2) current level of smoking, 3)
willingness to quit smoking, and 4) willingness/ability to attend 4 sessions (including the
first visit). Participants will be randomized to treatment as usual (TAU), QuitGuide, or
Smart-T groups and advised of their group assignment. Participants will complete the
assessment portion of visit 1. Participants will complete self-report questionnaires on a
laptop/tablet computer; and weight, and height will be measured in a private room to ensure
confidentiality. Participants will be loaned an Android smartphone and instructed regarding
the use of the phone as well as the ecological momentary assessment (EMA) procedures.
Quit Day (Visit 2). Participants will complete self-report questionnaires on a laptop/tablet
computer; and expired CO and weight will be measured in a private room to ensure
confidentiality. Participants will compensated completion of the in-person assessments. All
questions about study phones will be appropriately addressed and answered. Participants who
do not attend will be contacted by phone to obtain their self-reported smoking status.
4 Weeks Post-Quit (Visit 3). Participants will complete self-report questionnaires on a
laptop/tablet computer; and expired CO and weight will be measured in a private room to
ensure confidentiality. Participants will be compensated for the completion of the in-person
assessments, which will take approximately 45-60 minutes to complete. When participants
return the phone they will be compensated according to the compensation schedule described
above. Participants who do not attend will be contacted by phone to obtain their
self-reported smoking status and to request that the study phone be returned by mail or
in-person at the next visit.
12 Weeks Post-Quit (Visit 4; Follow-Up). Participants will complete self-report
questionnaires on a laptop/tablet computer; and expired CO and weight will be measured in a
private room to ensure confidentiality. Participants will be compensated for the completion
of the in-person assessments, which will take approximately 60 minutes to complete.
Participants who do not attend will be contacted by phone to obtain their self-reported
smoking status.
Inclusion Criteria:
1. earn a score ≥ 4 on the Short REALM indicating > 6th grade English literacy level,
2. are willing to quit smoking 7 days from their first visit,
3. are ≥ 18 years of age,
4. have an expired carbon monoxide (CO) level > 7 ppm suggestive of current smoking,
5. are currently smoking ≥ 5 cigarettes per day,
6. are willing and able to attend 4 assessment sessions (i.e., baseline, quit day [1 week
after baseline], 4 weeks post-quit, 12 weeks post-quit), and
7. have no contraindications for over the counter NRT (i.e., individuals with
uncontrolled blood pressure, history of myocardial infarction within the past two
weeks, or current pregnancy, breastfeeding, or plans to become pregnant during the
study period will be excluded).
Exclusion Criteria:
1. cannot read, speak, and understand English
2. are < 18 years of age
We found this trial at
1
site
1100 N Lindsay Ave
Oklahoma City, Oklahoma 73104
Oklahoma City, Oklahoma 73104
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