Smoking CessationMyMAPNCT02136498

My Mobile Advice Program: A Randomized Pilot Feasibility Study

A study testing Varenicline, Cognitive-behavioral self-help and MyMAP (My Mobile Advice Program) in people with Smoking Cessation and Medication Adherence, run by Kaiser Permanente at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this pilot study is to evaluate the acceptability and feasibility of the proposed smoking cessation intervention (called MyMAP or My Mobile Advice Program). Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Smoking Cessation, Medication Adherence
What is being tested?: Varenicline, Cognitive-behavioral self-help and MyMAP (My Mobile Advice Program)
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 66 participants
Where: 1 siteUnited States
Study dates: Oct 2014to Feb 2016
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

An invited member of Group Health, a health care system in the Pacific Northwest
Plan to remain enrolled in Group Health for the next 6 months
aged 18 - 65
Eligible for smoking cessation treatment through Group Health insurance coverage
smoke >= 10 cigs a day
speak and read in English

Show all 13Show fewer

willing to use varenicline and no contraindications for this medication
ready to quit smoking
have a smart phone with internet access
willing to receive study texts and emails
receive care at a Group Health clinic and have electronic medical records in this system
fill prescriptions through the Group Health pharmacy
agree to use birth control while taking study medication, if there is a risk of pregnancy

Who cannot join

lifetime history of dementia
psychosis or bipolar disorder based on self-report or medical record review
hearing, comprehension or visual limitations that preclude full study participation
current use of other forms of tobacco
any medical contraindication for varenicline use
documented history of suicidal ideation/intent

Trial locations and contacts

1 site in 1 country.

United States1 site

Group Health Research Institute
Seattle, Washington, 98101

Other trials in United States

About this study

Official title: Internet-based Medication Adherence Program for Nicotine Dependence Treatment

The purpose of this pilot study is to evaluate the acceptability and feasibility of the proposed smoking cessation intervention (called MyMAP or My Mobile Advice Program).

Read the detailed description

Investigators will develop and pilot test a prototype of the MyMAP intervention.The intervention is designed to help smokers better manage issues known to reduce treatment adherence (withdrawal symptoms, medication side-effects, low motivation, and inadequate behavioral skills for medication adherence) and to facilitate greater communication between patients and providers so clinicians can provide appropriate oversight of medication use, intervene when medically necessary, and address patient concerns that may otherwise lead to non-adherence or early treatment termination.

Conditions: Smoking Cessation, Medication Adherence
Being tested: Varenicline, Cognitive-behavioral self-help, MyMAP (My Mobile Advice Program)
Keywords: smoking cessation, varenicline, adherence
Medical subject headings: Smoking Cessation, Medication Adherence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

VareniclineDrug
Also called Chantix
Standard 12 week course of varenicline, provided in both arms
Cognitive-behavioral self-helpBehavioural
Standard self-help education for smoking cessation, delivered via mobile-optimized website accessible via smartphone.
MyMAP (My Mobile Advice Program)Behavioural
Same standard self-help intervention as in control arm + automatically-tailored support and advice for managing nicotine withdrawal symptoms + secure messaging with cessation counselor

Study groups in NCT02136498
Study group	Role	What they receive
mHealth self-help + varenicline	Active comparator	Participants in this control arm received standard cognitive-behavioral self-help materials delivered via a mobile health (mHealth) program + a standard course of varenicline. Receives: Drug: Varenicline; Behavioral: Cognitive-behavioral self-help
mHealth MyMAP program + varenicline	Experimental	Participants in the experimental arm received standard cognitive-behavioral self-help materials delivered via a mHealth program + additional personalized support features (automated, tailored advice managing nicotine withdrawal symptoms and medication side-effects \& secure messaging with a cessation counselor; i.e., MyMAP program) + a standard course of varenicline. Receives: Drug: Varenicline; Behavioral: Cognitive-behavioral self-help; Behavioral: MyMAP (My Mobile Advice Program)

What is being measured

The primary outcome is the main question the study is designed to answer.

Point Prevalence Abstinence
Self-report of no-smoking, even a puff during the last 7 days.
Measured: 5 month follow-up

Secondary outcomes (1)

Number of Days of Varenicline Use
Number of days varenicline was used
Measured: 5 mo follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 2014Feb 2016

First posted13 May 2014 (estimated)
Study startOct 2014
Primary completionFeb 2016
Study completionFeb 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
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: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Outcomes assessor
Enrolment: 66 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02136498
Sponsor's protocol ID: 1R34DA034612
Acronym: MyMAP
Status last verified: Oct 2017
First submitted: 9 May 2014
Last updated: 13 Nov 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No

Publications

McClure JB, Anderson ML, Bradley K, An LC, Catz SL. Evaluating an Adaptive and Interactive mHealth Smoking Cessation and Medication Adherence Program: A Randomized Pilot Feasibility Study. JMIR Mhealth Uhealth. 2016 Aug 3;4(3):e94. doi: 10.2196/mhealth.6002.
PubMed 27489247

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Smoking Cessation trials

Study at a glance

From the registry record, last updated by the sponsor on 13 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Internet-based Medication Adherence Program for Nicotine Dependence Treatment
ClinicalTrials.gov ID: NCT02136498
Acronym / sponsor ID: MyMAP / 1R34DA034612
Conditions: Smoking Cessation, Medication Adherence
Keywords: smoking cessation, varenicline, adherence
Study type: Interventional
Recruitment status: Completed
Enrolment: 66 participants (actual)
Lead sponsor: Kaiser PermanenteUniversity, hospital or other
Collaborators: University of Michigan, University of California, Davis
Study start: Oct 2014
Primary completion: Feb 2016 (actual)
Study completion: Feb 2016 (actual)
First posted: 13 May 2014 (estimated)
Results: Posted 10 Oct 2016

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The purpose of this pilot study is to evaluate the acceptability and feasibility of the proposed smoking cessation intervention (called MyMAP or My Mobile Advice Program).

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
mHealth self-help + varenicline	Active comparator	Drug: Varenicline, Behavioral: Cognitive-behavioral self-helpParticipants in this control arm received standard cognitive-behavioral self-help materials delivered via a mobile health (mHealth) program + a standard course of varenicline.
mHealth MyMAP program + varenicline	Experimental	Drug: Varenicline, Behavioral: Cognitive-behavioral self-help, Behavioral: MyMAP (My Mobile Advice Program)Participants in the experimental arm received standard cognitive-behavioral self-help materials delivered via a mHealth program + additional personalized support features (automated, tailored advice managing nicotine withdrawal symptoms and medication side-effects \& secure messaging with a cessation counselor; i.e., MyMAP program) + a standard course of varenicline.

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (13 listed)

An invited member of Group Health, a health care system in the Pacific Northwest
Plan to remain enrolled in Group Health for the next 6 months
aged 18 - 65
Eligible for smoking cessation treatment through Group Health insurance coverage
smoke >= 10 cigs a day

Key exclusion criteria (6 listed)

lifetime history of dementia
psychosis or bipolar disorder based on self-report or medical record review
hearing, comprehension or visual limitations that preclude full study participation
current use of other forms of tobacco
any medical contraindication for varenicline use

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
VareniclineAlso: ChantixStandard 12 week course of varenicline, provided in both arms	Drug	mHealth MyMAP program + varenicline, mHealth self-help + varenicline
Cognitive-behavioral self-helpStandard self-help education for smoking cessation, delivered via mobile-optimized website accessible via smartphone.	Behavioural	mHealth MyMAP program + varenicline, mHealth self-help + varenicline
MyMAP (My Mobile Advice Program)Same standard self-help intervention as in control arm + automatically-tailored support and advice for managing nicotine withdrawal symptoms + secure messaging with cessation counselor	Behavioural	mHealth MyMAP program + varenicline

Primary outcome

Point Prevalence Abstinence
Time frame: 5 month follow-up
Self-report of no-smoking, even a puff during the last 7 days.

1 secondary outcome

Number of Days of Varenicline Use
Time frame: 5 mo follow-up

Results and safety

Results posted to the registry on 10 Oct 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
mHealth Self-help + Varenicline	33	33
mHealth MyMAP + Varenicline	33	33

Primary outcome: Point Prevalence Abstinence

Time frame: 5 month follow-up. Number. Unit: Percentage of people not smoking

Measure	mHealth Self-help + Varenicline n = 33	Augmented mHealth Self-help + Varenicline n = 33
Value	24	36

Population analysed: Intent to treat analyses with missing cases imputed as smokers.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Adverse events were monitored throughout the study period (~ 6 months).. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
mHealth Self-help + Varenicline	0 of 33 (0%)	30 of 33 (90.9%)	Not reported
mHealth MyMAP + Varenicline	1 of 33 (3%)	30 of 33 (90.9%)	Not reported

Limitations and caveats (from the sponsor): The primary limitation of this pilot study is the small sample size, which prevents definitive conclusions about the efficacy of the MyMAP intervention.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 27489247McClure JB, Anderson ML, Bradley K, An LC, Catz SL. Evaluating an Adaptive and Interactive mHealth Smoking Cessation and Medication Adherence Program: A Randomized Pilot Feasibility Study. JMIR Mhealth Uhealth. 2016 Aug 3;4(3):e94. doi: 10.2196/mhealth.6002.
Primary outcome paperLink provided by the sponsor.
Individual participant dataSharing planned: No

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Flavored Electronic Nicotine Delivery Systems to Lower Smoking and Exposure to Tobacco Toxicants Among Cigarette Smokers Interested in Quitting, REFLECT Trial
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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.

Jennifer McClure, PhD principal investigator

Group Health Research Institute

Sheryl Catz, PhD principal investigator

University of California, Davis

Larry An, MD principal investigator

University of Michigan

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 13 inclusion and 6 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 13 Nov 2017. 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?

Yes. Results are posted in the registry (first posted 10 Oct 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Point Prevalence Abstinence (time frame: 5 month follow-up). 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 NCT02136498, 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 13 Nov 2017.