Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| University of Michigan | OTHER |
| University of California, Davis | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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).
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Varenicline | Drug | Standard 12 week course of varenicline, provided in both arms |
|
| Measure | Description | Time Frame |
|---|---|---|
| Point Prevalence Abstinence | Self-report of no-smoking, even a puff during the last 7 days. | 5 month follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Days of Varenicline Use | Number of days varenicline was used | 5 mo follow-up |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Jennifer McClure, PhD | Group Health Research Institute | Principal Investigator |
| Sheryl Catz, PhD | University of California, Davis | Principal Investigator |
| Larry An, MD | University of Michigan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Group Health Research Institute | Seattle | Washington | 98101 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27489247 | Result | 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. |
| Label | URL |
|---|---|
| Primary outcome paper | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | mHealth Self-help + Varenicline | Participants in the control arm received standard self-help education delivered via an mHealth program (accessible via smart phone) and a prescription for a standard 12 week course of varenicline. Standard self-help included topics such as: how to make a quit plan, how to use varenicline, how to manage cravings to smoke, how tot manage nicotine withdrawal and medication side-effects, relapse prevention, etc. |
| FG001 | mHealth MyMAP + Varenicline | Participants in the experimental arm received a mHealth program (accessible via smartphone) and a prescription for a standard 12 week course of varenicline. The mHealth intervention included the same self-help content offered to controls + a) real-time, adaptively-tailored advice for managing nicotine withdrawal symptoms and medication side-effects and b) asynchronous secure messaging with a cessation counselor. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | mHealth Self-help + Varenicline | Participants in the control arm received standard self-help education delivered via an mHealth program (accessible via smart phone) and a prescription for a standard 12 week course of varenicline. Standard self-help included topics such as: how to make a quit plan, how to use varenicline, how to manage cravings to smoke, how tot manage nicotine withdrawal and medication side-effects, relapse prevention, etc. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Point Prevalence Abstinence | Self-report of no-smoking, even a puff during the last 7 days. | Intent to treat analyses with missing cases imputed as smokers. | Posted | Number | Percentage of people not smoking | 5 month follow-up |
|
Adverse events were monitored throughout the study period (~ 6 months).
Medication side-effects/nicotine withdrawal symptoms (adverse events) were assessed at each follow-up using a standard checklist of events, resulting in a high number of reports in both arms. Experimental participants were also asked to report ongoing side-effects and symptoms to receive tailored treatment advice, increasing reports in this arm.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | mHealth Self-help + Varenicline | Participants in the control arm received standard self-help education delivered via an mHealth program (accessible via smart phone) and a prescription for a standard 12 week course of varenicline. Standard self-help included topics such as: how to make a quit plan, how to use varenicline, how to manage cravings to smoke, how tot manage nicotine withdrawal and medication side-effects, relapse prevention, etc. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Passive suicidal ideation without intent | Psychiatric disorders | Systematic Assessment | Participant reported passive suicidal ideation (without intent) on his wedding anniversary from his estranged wife. Participant had a history of psychiatric issues and was not taking varenicline at the time. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anger or irritability | Psychiatric disorders | Systematic Assessment |
The primary limitation of this pilot study is the small sample size, which prevents definitive conclusions about the efficacy of the MyMAP intervention.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Principle Investigator | Group Health Research Institute | 206-287-2737 | mcclure.j@ghc.org |
Not provided
| ID | Term |
|---|---|
| D016540 | Smoking Cessation |
| D055118 | Medication Adherence |
| ID | Term |
|---|---|
| D015438 | Health Behavior |
| D001519 | Behavior |
| D010349 | Patient Compliance |
| D010342 | Patient Acceptance of Health Care |
Not provided
Not provided
| ID | Term |
|---|---|
| D000068580 | Varenicline |
| ID | Term |
|---|---|
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Cognitive-behavioral self-help | Behavioral | Standard self-help education for smoking cessation, delivered via mobile-optimized website accessible via smartphone. |
|
| MyMAP (My Mobile Advice Program) | Behavioral | Same standard self-help intervention as in control arm + automatically-tailored support and advice for managing nicotine withdrawal symptoms + secure messaging with cessation counselor |
|
| BG001 | mHealth MyMAP + Varenicline | Participants in the experimental arm received a mHealth program (accessible via smartphone) and a prescription for a standard 12 week course of varenicline. The mHealth intervention included the same self-help content offered to controls + a) real-time, adaptively-tailored advice for managing nicotine withdrawal symptoms and medication side-effects and b) asynchronous secure messaging with a cessation counselor. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| Cigarettes smoked per day | Mean | Standard Deviation | cigarettes |
|
| Prior use of varenicline | Number | participants |
|
Participants in the experimental arm received a mHealth program (accessible via smartphone) and a prescription for a standard 12 week course of varenicline. The mHealth intervention included the same self-help content offered to controls + a) real-time, adaptively-tailored advice for managing nicotine withdrawal symptoms and medication side-effects and b) asynchronous secure messaging with a cessation counselor. |
|
|
| Secondary | Number of Days of Varenicline Use | Number of days varenicline was used | Posted | Mean | Standard Deviation | Mean number of days | 5 mo follow-up |
|
|
|
| 0 |
| 33 |
| 30 |
| 33 |
| EG001 | mHealth MyMAP + Varenicline | Participants in the experimental arm received a mHealth program (accessible via smartphone) and a prescription for a standard 12 week course of varenicline. The mHealth intervention included the same self-help content offered to controls + a) real-time, adaptively-tailored advice for managing nicotine withdrawal symptoms and medication side-effects and b) asynchronous secure messaging with a cessation counselor. | 1 | 33 | 30 | 33 |
|
| Anxiety | Psychiatric disorders | Systematic Assessment |
|
| Change in appetite | Gastrointestinal disorders | Systematic Assessment |
|
| Confusion/difficulty concentrating | Psychiatric disorders | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Craving to smoke | Psychiatric disorders | Systematic Assessment |
|
| Depression | Psychiatric disorders | Systematic Assessment |
|
| Diarhhea | Gastrointestinal disorders | Systematic Assessment |
|
| vivid or unusual dreams | General disorders | Systematic Assessment |
|
| Drowsiness | General disorders | Systematic Assessment |
|
| Gas | Gastrointestinal disorders | Systematic Assessment |
|
| Headache | General disorders | Systematic Assessment |
|
| Insomnia or trouble sleeping | General disorders | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | Systematic Assessment |
|
| Rapid heart beat or chest pain | General disorders | Systematic Assessment |
|
| stomach pain or vomiting | Gastrointestinal disorders | Systematic Assessment |
|
| Memory problems | Psychiatric disorders | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
Not provided
Not provided
| D000074822 |
| Treatment Adherence and Compliance |
| D011810 | Quinoxalines |