Smoking CessationNCT03517397
Mobile Contingency Management for Smoking Cessation (R01 Supplement) (PrevailGO)
A study testing Mobile Contingency Management in people with Smoking Cessation, run by University of Oklahoma at 1 site in United States.
Trial summary
Smoking prevalence rates are disproportionately high among individuals living below the poverty threshold, those living in rural areas, and Oklahomans. Nearly 1.3 million Oklahomans live in rural areas and the prevalence of poverty is elevated relative to the U.S. Read more about this study
- Who is it for?
- Ages 18 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Smoking Cessation
- What is being tested?
- Mobile Contingency Management
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Aug 2018to 15 May 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- currently uninsured or receiving Medicaid benefits
- earn a score ≥ 4 on the REALM indicating > 6th grade English literacy level
- willing to quit smoking 7 days from their first visit
- 18-64 years of age
- expired CO level ≥ 8 ppm suggestive of current smoking
- currently smoking ≥ 5 cigarettes per day
- own or have access to a computer (to remotely complete study questionnaires).
Who cannot join
- pregnant or breastfeeding
- have uncontrolled hypertension
- had a myocardial infarction within the past two weeks
- have an allergy to adhesive tape
- are unwilling to use nicotine replacement therapy.
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Oklahoma Health Sciences Center, Tobacco Treatment Research Program
Oklahoma City, Oklahoma, 73104
About this study
Official title: Mobile Contingency Management for Smoking Cessation Among Socioeconomically Disadvantaged Adults
Smoking prevalence rates are disproportionately high among individuals living below the poverty threshold, those living in rural areas, and Oklahomans. Nearly 1.3 million Oklahomans live in rural areas and the prevalence of poverty is elevated relative to the U.S. Our preliminary work has indicated that offering small escalating financial incentives for smoking abstinence (i.e., Contingency Management [CM]) dramatically increases short-term cessation rates among socioeconomically disadvantaged smokers when incentives are included as an adjunct to clinic-based smoking cessation treatment. However, other approaches are needed for socioeconomically disadvantaged individuals who are unable to attend clinic visits due to rural residence or other limitations. Internet and mobile phone-based CM approaches have been developed to reduce or eliminate the need for in-person visits. The goal of the current project is to improve upon existing mobile CM approaches by fully automating the process to make financial incentives interventions for smoking cessation feasible and accessible to individuals across the state. The aims of the proposed project are to 1) develop a fully automated, mobile phone-based CM approach to remotely verify smoking abstinence, confirm participant identity, and deliver financial incentives for smoking cessation, and 2) evaluate the feasibility and preliminary effectiveness of using fully automated mobile CM as an adjunct to telephone counseling and nicotine replacement therapy among 20 socioeconomically disadvantaged adults. The current project extends the scope of the parent study by increasing the reach of the CM approach to socioeconomically disadvantaged individuals who may be unable to attend in-person visits.
Read the detailed description
Tobacco Cessation Treatment. Participants referred to the Tobacco Treatment Research Program (TTRP) for smoking cessation treatment who are interested and eligible for the current study will be offered weekly telephone counseling/support sessions led by a staff counselor. Six unique sessions covering the following topics will be offered: 1) quit planning 2) the impact of tobacco on health/benefits of quitting, 2) stress management strategies, 3) making positive lifestyle changes, 4) developing coping skills, and 5) relapse prevention. The counselor will check in with participants each week about the difficulties and successes they have experienced, and plan for any challenging situations that are anticipated. Advice and support will be provided as needed. A two-week supply of nicotine replacement therapy (patches and gum) will be offered during the first session for medically eligible participants. Additional patches and gum will be mailed out for participants who wish to continue using pharmacotherapy (for up to 12 weeks).
Financial Incentives. Participants will be provided with a smartphone that has the PrevailGO EMA app preloaded, as well as a Smokerlyzer iCO monitor. Participants will be randomly prompted 4 times daily during waking hours to complete smartphone-based EMAs. During random prompts, participants who self-report abstinence will be asked to provide a CO breath sample on 5 randomly selected days out of the week. Participants will be prompted to provide a CO breath sample at the last random assessment of the day, Participants will be reminded 2 additional times on the same day during their normal waking hours to provide a CO breath sample if they miss the initial assessment. A gift card credit may be earned following a self-report of abstinence during the past 24 hours combined with a breath CO sample of ≤ 6 ppm.
Recruitment/Screening (Visit 1, Part 1; Screening). Individuals who are referred to the TTRP for smoking cessation treatment and report that they are uninsured or receiving Medicaid benefits will be sent an informational handout with their TTRP information packet (prior to their first visit). Participants will be reminded of all future in-person appointments via telephone, mail, email, and/or text. Additionally, research staff may attempt to collect smoking cessation status with each reminder. Participants with transportation difficulties living in the Oklahoma City metro area may be scheduled for pick-up and drop-off for key visits with SendaRide through their secure dashboard. At the first visit, study staff will inquire about their interest in finding out more about the study. 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. Participant eligibility for the current study will not influence eligibility for the TTRP. The Rapid Estimate of Adult Literacy in Medicine (REALM; see Appendix A) 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). Expired carbon monoxide (CO) will be measured and participants will be questioned about their 1) insurance status 2) age, 3) current level of smoking, 4) willingness to quit smoking, 5) willingness/ability to complete 6 weekly counseling sessions (including the first visit), 6) pregnancy/breastfeeding status, 7) computer/internet access, and 8) contraindications for nicotine replacement therapy. Expired CO will be measured. Eligible participants may complete the assessment portion of the visit.
Pre-Quit (Visit 1, Part 2; Assessment). Participants will complete self-report questionnaires on a laptop computer; weight and height will be measured in a private room to ensure confidentiality. Visit 1 will be 1 of 2 in-person visits. Participants will be provided with an Android smartphone and a Smokerlyzer iCO breathe monitor. They will be instructed regarding the use of the phone (participants may make personal calls), the EMA procedures, and use of the portable CO monitor. Participants will receive 4 random prompts and 1 daily diary prompt (in the morning) during the normal waking hours each day for five consecutive weeks. Participants will be instructed to quit smoking at bedtime or 10:00 pm (whichever occurs first) 7 days after enrollment.
Quit Day. Participants will remotely complete web-based self-report questionnaires and provide a smartphone-based CO measurement.
One Week Post-Quit. Participants will remotely complete web-based self-report questionnaires and provide a smartphone-based CO measurement.
Two Weeks Post-Quit. Participants will remotely complete web-based self-report questionnaires and provide a smartphone-based CO measurement.
Three Weeks Post-Quit. Participants will remotely complete web-based self-report questionnaires and provide a smartphone-based CO measurement.
Four Weeks Post-Quit. Participants will remotely complete web-based self-report questionnaires and provide a smartphone-based CO measurement.
Eight Weeks Post-Quit. Participants will remotely complete web-based self-report questionnaires and provide a smartphone-based CO measurement.
Twelve Weeks Post-Quit. Participants will return to the TTRP and complete self-report questionnaires on a tablet or laptop computer and provide a CO measurement.
- Conditions
- Smoking Cessation
- Being tested
- Mobile Contingency Management
- Keywords
- Smoking Cessation, Socioeconomic Disadvantage, Contingency Management, Financial Incentives, Mobile Health, Biochemical Verification
- Medical subject headings
- Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mobile Contingency ManagementBehavioural
Participants will be offered 6 counseling sessions, nicotine replacement therapy, and a smartphone app that remotely verifies participant identity and smoking abstinence and automatically credits a gift card account for evidence of smoking abstinence.
| Study group | Role | What they receive |
|---|---|---|
| Mobile Contingency Management | Experimental | Not described Receives: Behavioral: Mobile Contingency Management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biochemically-verified smoking cessation
Self-reported abstinence over the past 7 days in conjunction with a carbon monoxide value < 6 ppm
Measured: 12 weeks post-quit date
Treatment Participants
Treatment sessions completed (1-6)
Measured: 5 weeks post-enrollment
Follow-Up Completion Rate
The number of people who provide self-reports of smoking status and biochemical verification of smoking cessation.
Measured: 12 weeks post-quit date
Secondary outcomes (2)
Device Loss
The total number of phones and iCO monitors lost.
Measured: 13 weeks post-enrollment
Completion of Ecological Momentary Assessment
Percentage of ecological momentary assessments completed
Measured: 5 weeks post-enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2018
- Study start15 Aug 2018
- Primary completion15 May 2019
- Study completion15 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Smoking CessationStudies of the same condition, open and under way.
- More trials run by University of OklahomaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oklahoma
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Darla E. Kendzor, PhD, Principal investigator, The University of Oklahoma Health Sciences Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03517397
- Sponsor's protocol ID
- 7210
- Other IDs
- R01CA197314
- Status last verified
- Mar 2024
- First submitted
- 30 Mar 2018
- Last updated
- 29 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kendzor DE, Businelle MS, Waring JJC, Mathews AJ, Geller DW, Barton JM, Alexander AC, Hebert ET, Ra CK, Vidrine DJ. Automated Mobile Delivery of Financial Incentives for Smoking Cessation Among Socioeconomically Disadvantaged Adults: Feasibility Study. JMIR Mhealth Uhealth. 2020 Apr 15;8(4):e15960. doi: 10.2196/15960.
PubMed 32293568
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mobile Contingency Management for Smoking Cessation Among Socioeconomically Disadvantaged Adults
- ClinicalTrials.gov ID
- NCT03517397
- Acronym / sponsor ID
- 7210
- Conditions
- Smoking Cessation
- Keywords
- Smoking Cessation, Socioeconomic Disadvantage, Contingency Management, Financial Incentives, Mobile Health, Biochemical Verification
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of OklahomaUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 15 Aug 2018 (actual)
- Primary completion
- 15 May 2019 (actual)
- Study completion
- 15 May 2019 (actual)
- First posted
- 7 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Smoking prevalence rates are disproportionately high among individuals living below the poverty threshold, those living in rural areas, and Oklahomans. Nearly 1.3 million Oklahomans live in rural areas and the prevalence of poverty is elevated relative to the U.S. Our preliminary work has indicated that offering small escalating financial incentives for smoking abstinence (i.e., Contingency Management [CM]) dramatically increases short-term cessation rates among socioeconomically disadvantaged smokers when incentives are included as an adjunct to clinic-based smoking cessation treatment. However, other approaches are needed for socioeconomically disadvantaged individuals who are unable to attend clinic visits due to rural residence or other limitations. Internet and mobile phone-based CM approaches have been developed to reduce or eliminate the need for in-person visits. The goal of the current project is to improve upon existing mobile CM approaches by fully automating the process to make financial incentives interventions for smoking cessation feasible and accessible to individuals across the state. The aims of the proposed project are to 1) develop a fully automated, mobile phone-based CM approach to remotely verify smoking abstinence, confirm participant identity, and deliver financial incentives for smoking cessation, and 2) evaluate the feasibility and preliminary effectiveness of using fully automated mobile CM as an adjunct to telephone counseling and nicotine replacement therapy among 20 socioeconomically disadvantaged adults. The current project extends the scope of the parent study by increasing the reach of the CM approach to socioeconomically disadvantaged individuals who may be unable to attend in-person visits.
Detailed description
Tobacco Cessation Treatment. Participants referred to the Tobacco Treatment Research Program (TTRP) for smoking cessation treatment who are interested and eligible for the current study will be offered weekly telephone counseling/support sessions led by a staff counselor. Six unique sessions covering the following topics will be offered: 1) quit planning 2) the impact of tobacco on health/benefits of quitting, 2) stress management strategies, 3) making positive lifestyle changes, 4) developing coping skills, and 5) relapse prevention. The counselor will check in with participants each week about the difficulties and successes they have experienced, and plan for any challenging situations that are anticipated. Advice and support will be provided as needed. A two-week supply of nicotine replacement therapy (patches and gum) will be offered during the first session for medically eligible participants. Additional patches and gum will be mailed out for participants who wish to continue using pharmacotherapy (for up to 12 weeks).
Financial Incentives. Participants will be provided with a smartphone that has the PrevailGO EMA app preloaded, as well as a Smokerlyzer iCO monitor. Participants will be randomly prompted 4 times daily during waking hours to complete smartphone-based EMAs. During random prompts, participants who self-report abstinence will be asked to provide a CO breath sample on 5 randomly selected days out of the week. Participants will be prompted to provide a CO breath sample at the last random assessment of the day, Participants will be reminded 2 additional times on the same day during their normal waking hours to provide a CO breath sample if they miss the initial assessment. A gift card credit may be earned following a self-report of abstinence during the past 24 hours combined with a breath CO sample of ≤ 6 ppm.
Recruitment/Screening (Visit 1, Part 1; Screening). Individuals who are referred to the TTRP for smoking cessation treatment and report that they are uninsured or receiving Medicaid benefits will be sent an informational handout with their TTRP information packet (prior to their first visit). Participants will be reminded of all future in-person appointments via telephone, mail, email, and/or text. Additionally, research staff may attempt to collect smoking cessation status with each reminder. Participants with transportation difficulties living in the Oklahoma City metro area may be scheduled for pick-up and drop-off for key visits with SendaRide through their secure dashboard. At the first visit, study staff will inquire about their interest in finding out more about the study. 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. Participant eligibility for the current study will not influence eligibility for the TTRP. The Rapid Estimate of Adult Literacy in Medicine (REALM; see Appendix A) 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). Expired carbon monoxide (CO) will be measured and participants will be questioned about their 1) insurance status 2) age, 3) current level of smoking, 4) willingness to quit smoking, 5) willingness/ability to complete 6 weekly counseling sessions (including the first visit), 6) pregnancy/breastfeeding status, 7) computer/internet access, and 8) contraindications for nicotine replacement therapy. Expired CO will be measured. Eligible participants may complete the assessment portion of the visit.
Pre-Quit (Visit 1, Part 2; Assessment). Participants will complete self-report questionnaires on a laptop computer; weight and height will be measured in a private room to ensure confidentiality. Visit 1 will be 1 of 2 in-person visits. Participants will be provided with an Android smartphone and a Smokerlyzer iCO breathe monitor. They will be instructed regarding the use of the phone (participants may make personal calls), the EMA procedures, and use of the portable CO monitor. Participants will receive 4 random prompts and 1 daily diary prompt (in the morning) during the normal waking hours each day for five consecutive weeks. Participants will be instructed to quit smoking at bedtime or 10:00 pm (whichever occurs first) 7 days after enrollment.
Quit Day. Participants will remotely complete web-based self-report questionnaires and provide a smartphone-based CO measurement.
One Week Post-Quit. Participants will remotely complete web-based self-report questionnaires and provide a smartphone-based CO measurement.
Two Weeks Post-Quit. Participants will remotely complete web-based self-report questionnaires and provide a smartphone-based CO measurement.
Three Weeks Post-Quit. Participants will remotely complete web-based self-report questionnaires and provide a smartphone-based CO measurement.
Four Weeks Post-Quit. Participants will remotely complete web-based self-report questionnaires and provide a smartphone-based CO measurement.
Eight Weeks Post-Quit. Participants will remotely complete web-based self-report questionnaires and provide a smartphone-based CO measurement.
Twelve Weeks Post-Quit. Participants will return to the TTRP and complete self-report questionnaires on a tablet or laptop computer and provide a CO measurement.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mobile Contingency Management | Experimental | Behavioral: Mobile Contingency Management |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- currently uninsured or receiving Medicaid benefits
- earn a score ≥ 4 on the REALM indicating > 6th grade English literacy level
- willing to quit smoking 7 days from their first visit
- 18-64 years of age
- expired CO level ≥ 8 ppm suggestive of current smoking
Key exclusion criteria (5 listed)
- pregnant or breastfeeding
- have uncontrolled hypertension
- had a myocardial infarction within the past two weeks
- have an allergy to adhesive tape
- are unwilling to use nicotine replacement therapy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mobile Contingency ManagementParticipants will be offered 6 counseling sessions, nicotine replacement therapy, and a smartphone app that remotely verifies participant identity and smoking abstinence and automatically credits a gift card account for evidence of smoking abstinence. | Behavioural | Mobile Contingency Management |
Primary outcome
Biochemically-verified smoking cessation
Time frame: 12 weeks post-quit date
Self-reported abstinence over the past 7 days in conjunction with a carbon monoxide value < 6 ppm
Treatment Participants
Time frame: 5 weeks post-enrollment
Treatment sessions completed (1-6)
Follow-Up Completion Rate
Time frame: 12 weeks post-quit date
The number of people who provide self-reports of smoking status and biochemical verification of smoking cessation.
2 secondary outcomes
Device Loss
Time frame: 13 weeks post-enrollment
Completion of Ecological Momentary Assessment
Time frame: 5 weeks post-enrollment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2024.
- Results publication: PubMed 32293568Kendzor DE, Businelle MS, Waring JJC, Mathews AJ, Geller DW, Barton JM, Alexander AC, Hebert ET, Ra CK, Vidrine DJ. Automated Mobile Delivery of Financial Incentives for Smoking Cessation Among Socioeconomically Disadvantaged Adults: Feasibility Study. JMIR Mhealth Uhealth. 2020 Apr 15;8(4):e15960. doi: 10.2196/15960.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Darla E. Kendzor, PhD principal investigator
The University of Oklahoma Health Sciences Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mobile Contingency Management in people with Smoking Cessation, run by University of Oklahoma 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 7 inclusion and 5 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 29 Mar 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Biochemically-verified smoking cessation (time frame: 12 weeks post-quit date). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03517397, which also lists 1 linked publication.
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 29 Mar 2024; AzTrials last refreshed its copy on 6 Nov 2026.