Smoking CessationNCT01817842
Study of Mobile Phone Support for the DC Tobacco Quitline
A study testing Mobile EX cessation support and DC Quitline Support in people with Smoking Cessation, run by Truth Initiative at 1 site in United States.
Trial summary
This is a study of the effectiveness of mobile phone support for the D.C. Tobacco Quitline. The project will test the efficacy of a web-based system that uses mobile phones to improve quit rates at 3-month intervals, relative to standard quitline services. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Smoking Cessation
- What is being tested?
- Mobile EX cessation support and DC Quitline Support
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 803 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2010to Feb 2012
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Active tobacco smoker of at least 5 cigarettes / day
- Read, speak and write English
- Access to a telephone at either home or work
- Contacts DC Tobacco Quitline and makes an attempt to quit smoking
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
United States1 site
United Medical Center
Washington D.C., District of Columbia, 20036
About this study
Official title: Comparative Effectiveness of Web-based Mobile Support for the DC Tobacco Quitline
This is a study of the effectiveness of mobile phone support for the D.C. Tobacco Quitline. The project will test the efficacy of a web-based system that uses mobile phones to improve quit rates at 3-month intervals, relative to standard quitline services. Under the standard model, relatively infrequent, periodic support is provided to smokers who want to quit and seek out the services. The new system will complement that effort by increasing the quality, frequency and accessibility of quit smoking support - when and where the smoker needs it most. It is hypothesized that successful abstinence rates will improve to the degree that participants utilize the support system and engage with the quitline.
Read the detailed description
This study aims to bolster the effectiveness of the Washington D.C. Quitline (DCQL) program with the addition of a web-based mobile EX (mEX) cessation support system. This mEX system is designed to fill the gaps between quitline calls with ready access to a menu of evidenced-based treatment components, while also providing DCQL counselors with detailed information about their clients' ongoing progress with cessation - two developments that constitute a major advance over standard quitline programming. With the addition of mEX, DCQL counselors will be able to tailor their advice from the outset of each call and even identify counterproductive patterns that would have otherwise gone unnoticed. This innovative extension of our previous work leverages our expertise with ecological assessment methodology and behavioral informatics for the purpose of dynamic relapse prevention support within the context of an underserved community QL.
The project is an additive two-group randomized controlled trial to test whether the addition of mEX improves abstinence rates at 1-, 3-, 6-, and 9-months relative to standard care provided by DCQL. Participants will be 700 smokers who contact the DCQL and are randomized to receive either standard DCQL programming (N=300) or DCQL plus MQE (N=400). Participants assigned to standard DCQL programming will receive 6 proactive QL counseling sessions and free nicotine replacement therapy (NRT). Participants assigned to DCQL plus MQE will also receive mobile access to the MQE system via a web-enabled cellular telephone provided by the study. Relative to usual care, we expect that MQE will improve outcomes by improving delivery, utilization and thereby effectiveness of DCQL resources.
Specific Aim 1. Examine abstinence rates in DCQL participants receiving usual-care relative to those also receiving mobile quitline enhancement. Relative to usual-care controls, mobile quitline enhancement is expected to improve 7-day point prevalence abstinence rates at 1-, 3-, 6-, and 9-months.
Specific Aim 2. Examine treatment utilization in DCQL participants receiving usual-care relative to those also receiving mobile quitline enhancement. Relative to usual-care controls, mobile quitline enhancement is expected to improve utilization of available DCQL programming resources.
Specific Aim 3. Examine whether utilization of DCQL or mobile support services moderates their impact on outcomes. Treatment effects are expected to vary with the degree that they are utilized, such that greater utilization will predict improved abstinence rates at all time points.
- Conditions
- Smoking Cessation
- Being tested
- Mobile EX cessation support, DC Quitline Support, Device Control
- Keywords
- mHealth, EMA, Ecological Momentary Assessment, Personal Informatics, Tobacco Quitline
- 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 EX cessation supportBehavioural
Also called mEX
Mobile EX cessation support is designed to enhance the Washington D.C. Quitline (DCQL) by giving participants the ability track their cessation attempt on a phone-based app and thus create a profile documenting their progress and set-backs over the days or weeks in between QL contacts. Participants receive summary information and graphics that help them understand what is working best for them. Participants also receive 24-hr, momentary access to a set of interactive cessation tools on their phone.
DC Quitline SupportBehavioural
Participants assigned to standard DC Quitline programming receive 6 proactive QL counseling sessions and optional, free nicotine replacement therapy (NRT).
Device ControlBehavioural
Mobile phone for use during cessation attempt but with no mEX support components
| Study group | Role | What they receive |
|---|---|---|
| mEX support | Experimental | Participants in this arm receive both standard DC Quitline Support and Mobile EX cessation support. Mobile EX cessation support is designed to enhance the Washington D.C. Quitline (DCQL) by giving participants the ability track their cessation attempt on a phone-based app and thus create a profile documenting their progress and set-backs over the days or weeks in between QL contacts. Participants receive summary information and graphics that help them understand what is working best for them. Participants also receive 24-hr, momentary access to a set of interactive cessation tools on their phone. Receives: Behavioral: Mobile EX cessation support; Behavioral: DC Quitline Support |
| Device Control | Active comparator | Participants randomized to this arm receive standard DC Quitline Support plus the device control. Device control includes an identical device (i.e., mobile phone) to that provided to the intervention group, but participants do not receive any of the phone-based mEX support features. Those in the device control group receive their device at the 1-month time point - a design feature that allows a direct comparison of the mEX intervention to standard quitline services over the first month. Receives: Behavioral: DC Quitline Support; Behavioral: Device Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Smoking Abstinence
Point-prevalent abstinence from smoking cigarettes over the past 7-days. Verified with expired carbon monoxide at 1-month. Reported by participants at 3-, 6- and 9-months.
Measured: 9-months
Secondary outcomes (2)
Daily Lapse Status
Daily abstinence versus any smoking (i.e., lapse) status among those who are actively trying to abstain (i.e., not those who have completely relapsed).
Measured: Month 1
Quitline utilization
Participant receipt and initiation of support calls from DC Quitline staff.
Measured: Month 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2013 (estimated)
- Study startJul 2010
- Primary completionFeb 2012
- Study completionFeb 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Smoking CessationStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 803 participants (actual)
Sponsor and investigators
- Lead sponsor
- Truth Initiative
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Thomas Kirchner, Truth Initiative
- Investigators
- Thomas R Kirchner, PhD, Principal investigator, Truth Initiative
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01817842
- Sponsor's protocol ID
- RC1DA028710
- Status last verified
- Mar 2013
- First submitted
- 20 Mar 2013
- Last updated
- 26 Mar 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effectiveness of Web-based Mobile Support for the DC Tobacco Quitline
- ClinicalTrials.gov ID
- NCT01817842
- Acronym / sponsor ID
- RC1DA028710
- Conditions
- Smoking Cessation
- Keywords
- mHealth, EMA, Ecological Momentary Assessment, Personal Informatics, Tobacco Quitline
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 803 participants (actual)
- Lead sponsor
- Truth InitiativeUniversity, hospital or other
- Study start
- Jul 2010
- Primary completion
- Feb 2012 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 26 Mar 2013 (estimated)
- 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.
This is a study of the effectiveness of mobile phone support for the D.C. Tobacco Quitline. The project will test the efficacy of a web-based system that uses mobile phones to improve quit rates at 3-month intervals, relative to standard quitline services. Under the standard model, relatively infrequent, periodic support is provided to smokers who want to quit and seek out the services. The new system will complement that effort by increasing the quality, frequency and accessibility of quit smoking support - when and where the smoker needs it most. It is hypothesized that successful abstinence rates will improve to the degree that participants utilize the support system and engage with the quitline.
Detailed description
This study aims to bolster the effectiveness of the Washington D.C. Quitline (DCQL) program with the addition of a web-based mobile EX (mEX) cessation support system. This mEX system is designed to fill the gaps between quitline calls with ready access to a menu of evidenced-based treatment components, while also providing DCQL counselors with detailed information about their clients' ongoing progress with cessation - two developments that constitute a major advance over standard quitline programming. With the addition of mEX, DCQL counselors will be able to tailor their advice from the outset of each call and even identify counterproductive patterns that would have otherwise gone unnoticed. This innovative extension of our previous work leverages our expertise with ecological assessment methodology and behavioral informatics for the purpose of dynamic relapse prevention support within the context of an underserved community QL.
The project is an additive two-group randomized controlled trial to test whether the addition of mEX improves abstinence rates at 1-, 3-, 6-, and 9-months relative to standard care provided by DCQL. Participants will be 700 smokers who contact the DCQL and are randomized to receive either standard DCQL programming (N=300) or DCQL plus MQE (N=400). Participants assigned to standard DCQL programming will receive 6 proactive QL counseling sessions and free nicotine replacement therapy (NRT). Participants assigned to DCQL plus MQE will also receive mobile access to the MQE system via a web-enabled cellular telephone provided by the study. Relative to usual care, we expect that MQE will improve outcomes by improving delivery, utilization and thereby effectiveness of DCQL resources.
Specific Aim 1. Examine abstinence rates in DCQL participants receiving usual-care relative to those also receiving mobile quitline enhancement. Relative to usual-care controls, mobile quitline enhancement is expected to improve 7-day point prevalence abstinence rates at 1-, 3-, 6-, and 9-months.
Specific Aim 2. Examine treatment utilization in DCQL participants receiving usual-care relative to those also receiving mobile quitline enhancement. Relative to usual-care controls, mobile quitline enhancement is expected to improve utilization of available DCQL programming resources.
Specific Aim 3. Examine whether utilization of DCQL or mobile support services moderates their impact on outcomes. Treatment effects are expected to vary with the degree that they are utilized, such that greater utilization will predict improved abstinence rates at all time points.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| mEX support | Experimental | Behavioral: Mobile EX cessation support, Behavioral: DC Quitline SupportParticipants in this arm receive both standard DC Quitline Support and Mobile EX cessation support. Mobile EX cessation support is designed to enhance the Washington D.C. Quitline (DCQL) by giving participants the ability track their cessation attempt on a phone-based app and thus create a profile documenting their progress and set-backs over the days or weeks in between QL contacts. Participants receive summary information and graphics that help them understand what is working best for them. Participants also receive 24-hr, momentary access to a set of interactive cessation tools on their phone. |
| Device Control | Active comparator | Behavioral: DC Quitline Support, Behavioral: Device ControlParticipants randomized to this arm receive standard DC Quitline Support plus the device control. Device control includes an identical device (i.e., mobile phone) to that provided to the intervention group, but participants do not receive any of the phone-based mEX support features. Those in the device control group receive their device at the 1-month time point - a design feature that allows a direct comparison of the mEX intervention to standard quitline services over the first month. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Active tobacco smoker of at least 5 cigarettes / day
- Read, speak and write English
- Access to a telephone at either home or work
- Contacts DC Tobacco Quitline and makes an attempt to quit smoking
Key exclusion criteria (1 listed)
- -
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 EX cessation supportAlso: mEXMobile EX cessation support is designed to enhance the Washington D.C. Quitline (DCQL) by giving participants the ability track their cessation attempt on a phone-based app and thus create a profile documenting their progress and set-backs over the days or weeks in between QL contacts. Participants receive summary information and graphics that help them understand what is working best for them. Participants also receive 24-hr, momentary access to a set of interactive cessation tools on their phone. | Behavioural | mEX support |
| DC Quitline SupportParticipants assigned to standard DC Quitline programming receive 6 proactive QL counseling sessions and optional, free nicotine replacement therapy (NRT). | Behavioural | Device Control, mEX support |
| Device ControlMobile phone for use during cessation attempt but with no mEX support components | Behavioural | Device Control |
Primary outcome
Smoking Abstinence
Time frame: 9-months
Point-prevalent abstinence from smoking cigarettes over the past 7-days. Verified with expired carbon monoxide at 1-month. Reported by participants at 3-, 6- and 9-months.
2 secondary outcomes
Daily Lapse Status
Time frame: Month 1
Quitline utilization
Time frame: Month 1
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 26 Mar 2013.
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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.
Thomas R Kirchner, PhD principal investigator
Truth Initiative
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 EX cessation support and DC Quitline Support in people with Smoking Cessation, run by Truth Initiative 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 4 inclusion and 1 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 26 Mar 2013. 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?
Smoking Abstinence (time frame: 9-months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Mar 2013.