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| ID | Type | Description | Link |
|---|---|---|---|
| 4R00DA037276-03 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
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Quitting smoking has important health benefits for people with serious mental illness, more than half of whom are smokers. Smoking reductions in this population, in turn, could contribute to saving billions of dollars in healthcare expenditures.
Finding ways to deliver more effective and wider reaching smoking cessation interventions to individuals with serious mental illness is a pressing priority. Smartphone apps are a wide reaching technology that could provide a viable platform to deliver smoking cessation interventions for individuals with serious mental illness.
However, do smoking cessation apps need to be tailored for people with serious mental illness to ensure their success? Or can providers simply use standard and freely available smoking cessation mobile health treatments designed for the general population? Furthermore, is it feasible to conduct mHealth trials in this population?
Therefore, this trial will test whether (1) a tailored smoking cessation app for people with serious mental illness results in higher levels of engagement with smoking cessation content as compared to an app designed for the general population and (2) smoking cessation mHealth trials can be feasibly conducted in this population.
Smoking tobacco shortens the lifespan of adults with serious mental illness by 25 years and contributes to $317 billion expenditures in healthcare, indirect loss of earnings and disability benefits. Determining whether it is possible to deliver more effective and wider reaching smoking cessation interventions to individuals with serious mental illness is a high priority. Smartphone apps are a wide reaching technology that could provide individuals with serious mental illness the necessary skills for quitting.
This feasibility trial will test whether a tailored smoking cessation app for people with serious mental illness, Learn to Quit, results in higher levels of engagement with smoking cessation content as compared to an app designed for the general population, NCI QuitGuide. The trial will also demonstrate whether it is possible to (a) feasibly recruit and retain individuals with serious mental illness in an mHealth clinical trial, and (b) successfully gather smoking cessation outcomes. Ninety individuals with serious mental illness will be randomly assigned to one of two conditions. In the experimental condition, participants will use the Learn to Quit app. In the comparator condition, participants will use the NCI QuitGuide app. Participants in both conditions will receive Nicotine Replacement Therapy (standard dosing of nicotine patch + 1-week course of 4mg nicotine lozenges) and technical coaching. Study duration will be 4 months, with four follow-up appointments at 1-month, 2-month, 3-month, and 4-months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Learn to Quit | Experimental | A smartphone app developed by the research team designed for people with serious mental illness, that provides Acceptance and Commitment Therapy skills to address (a) smoking cessation and (b) mental health symptoms. |
|
| NCI QuitGuide | Active Comparator | A smartphone app developed by the National Cancer Institute which uses smoking cessation recommendations contained in the US DHHS Clinical Practice Guidelines. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Learn to Quit App | Device | A smartphone app designed for individuals with serious mental illness. The main intervention components of the app are skills based on an intervention called Acceptance and Commitment Therapy that will (a) teach smoking cessation skills and (b) help cope with mental health symptoms. The app incorporates gaming features to keep users engaged, and a tracking component to record smoking habits and moods. |
| Measure | Description | Time Frame |
|---|---|---|
| Days of App Use | Frequency of app openings in each group | Daily throughout study duration, 4 months |
| Duration of App Use | Mean duration of app use in each group over the course of study participation (4 months) | Daily throughout study duration, 4 months |
| Feasibility as Measured by Study Accrual Relative to Recruitment Goal | Percent of subjects consented into study relative to study recruitment goal (N=90).92 subjects signed consent prior to eligibility determination and randomization. | Approximately 15 months |
| Feasibility as Measured by Study Attrition | Number and percentage of subjects who complete 4-month follow up assessment | 4-months |
| Recruitment Yield Effort | Percent of subjects responding to ads and clinician referrals | Approximately 15 months |
| Feasibility of Measurement Strategy | Percent completion of assessment measures. Assessment measures include surveys, questionnaires, and cognitive tasks. | Approximately 19 months |
| Usability of App Design as Measured by the System Usability Scale (SUS) | 10-item scale giving a global assessment of systems usability using a 5-point Likert Scale with a composite score ranging from 0-100. Higher scores indicate higher usability rating. |
| Measure | Description | Time Frame |
|---|---|---|
| Biochemically Confirmed 7-day Point Prevalence Abstinence | Percent of subjects in each group reporting biochemically confirmed 7-day point prevalence abstinence. Abstinence is determined by a self-report of not smoking for 7 days prior to the specified timepoint AND by a result of ≤ 5 ppm in carbon monoxide breath testing. If the participant does not meet both criteria, they are not considered abstinent. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Roger Vilardaga, PhD | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke University | Durham | North Carolina | 27705 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34347865 | Derived | Browne J, Halverson TF, Vilardaga R. Engagement with a digital therapeutic for smoking cessation designed for persons with psychiatric illness fully mediates smoking outcomes in a pilot randomized controlled trial. Transl Behav Med. 2021 Sep 15;11(9):1717-1725. doi: 10.1093/tbm/ibab100. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Learn to Quit | A smartphone app developed by the research team designed for people with serious mental illness, that provides Acceptance and Commitment Therapy skills to address (a) smoking cessation and (b) mental health symptoms. This app intervention is combined with an 8-week course of nicotine replacement therapy (NRT) patches and a 2-week course of NRT lozenges. Participants also receive technical smartphone coaching for the first 4 weeks of the study. |
| FG001 | NCI QuitGuide | A smartphone app developed by the National Cancer Institute which uses smoking cessation recommendations contained in the US DHHS Clinical Practice Guidelines. The app intervention is combined with an 8-week course of nicotine replacement therapy (NRT) patches and a 2-week course of NRT lozenges. Participants also receive technical smartphone coaching for the first 4 weeks of the study. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
One participant (Learn to Quit arm) was withdrawn by physician and therefore was not included in these analyses.
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| ID | Title | Description |
|---|---|---|
| BG000 | Learn to Quit | A smartphone app developed by the research team designed for people with serious mental illness, that provides Acceptance and Commitment Therapy skills to address (a) smoking cessation and (b) mental health symptoms. This app intervention is combined with an 8-week course of nicotine replacement therapy (NRT) patches and a 2-week course of NRT lozenges. Participants also receive technical smartphone coaching for the first 4 weeks of the study. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Days of App Use | Frequency of app openings in each group | Posted | Mean | Standard Deviation | days | Daily throughout study duration, 4 months |
|
16 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Learn to Quit | A smartphone app developed by the research team designed for people with serious mental illness, that provides Acceptance and Commitment Therapy skills to address (a) smoking cessation and (b) mental health symptoms. This app intervention is combined with an 8-week course of nicotine replacement therapy (NRT) patches and a 2-week course of NRT lozenges. Participants also receive technical smartphone coaching for the first 4 weeks of the study. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Second degree burns | Skin and subcutaneous tissue disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anxiety and stress | Psychiatric disorders | Systematic Assessment | Feeling anxious, stressed, or "on edge" |
NRT adherence measure relied on self-report. Participant stratification did not successfully balance presence of mood vs. psychotic disorders in each group. 26% of outcomes measures collected via phone or web survey due to transportation barriers.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Roger Vilardaga | Duke University Psychiatry & Behavioral Sciences | 9196813441 | roger.vilardaga@duke.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 5, 2018 | Dec 16, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D014029 | Tobacco Use Disorder |
| D012907 | Smoking |
| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D061485 | Tobacco Use Cessation Devices |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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Subjects will be assigned to one of two smoking cessation apps for the duration of the study: Learn to Quit or NCI QuitGuide. One app was designed to address the needs of people with serious mental illness (Learn to Quit) and the other was designed for the general population (NCI QuitGuide).
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|
| Nicotine patch | Drug | Participants enrolled in the study will be given an 8-week course of Nicotine patches. The 8-week course of trans-dermal nicotine patches starting at 21mg/24h for 4 weeks, then transitioning to 14mg/24h for 2 weeks, and finally to 7mg/24h for the last 2 weeks. This dosing will follow recommendations contained in the US DHHS Clinical Practice Guidelines. |
|
| Nicotine lozenge | Drug | Each participant will be given a 1-week course of 4mg Nicotine lozenges to be taken orally as nicotine cravings arise (about 10 lozenges per day). They will be directed to use them for the week following their quit date, using no more than once every 1-2 hours. This dosing will follow recommendations contained in the US DHHS Clinical Practice Guidelines. |
|
| Technical Coaching | Behavioral | Coaching to assist the user on the use of each assigned smartphone app. This coaching will be delivered by research staff following a coaching procedure. These in-person coaching meetings will be brief (~15 minutes), done on a weekly basis for 4 weeks, and will have a focus on providing technical assistance. |
|
| NCI QuitGuide App | Device | A smartphone app developed by the National Cancer Institute which uses recommendations contained in the US DHHS Clinical Practice Guidelines and smokefree.gov. NCI QuitGuide has the following intervention components: (a) psycho-education about the impact of smoking in health, (b) tracking of smoking habits, and (c) Tips for quitting (e.g., distraction strategies). |
|
| 1-month follow-up |
| Usability of App Design as Measured by the System Usability Scale (SUS) | 10-item scale giving a global assessment of systems usability using a 5-point Likert Scale with a composite score ranging from 0-100. Higher scores indicate higher usability rating. | 2-month follow-up |
| Usability of App Design as Measured by the System Usability Scale (SUS) | 10-item scale giving a global assessment of systems usability using a 5-point Likert Scale with a composite score ranging from 0-100. Higher scores indicate higher usability rating. | 3-month follow-up |
| Usability of App Design as Measured by the System Usability Scale (SUS) | 10-item scale giving a global assessment of systems usability using a 5-point Likert Scale with a composite score ranging from 0-100. Higher scores indicate higher usability rating. | 4-month follow-up |
| 1 month follow-up |
| Biochemically Confirmed 7-day Point Prevalence Abstinence | Percent of subjects in each group reporting biochemically confirmed 7-day point prevalence abstinence. Abstinence is determined by a self-report of not smoking for 7 days prior to the specified timepoint AND by a result of ≤ 5 ppm in carbon monoxide breath testing. If the participant does not meet both criteria, they are not considered abstinent. | 2 month follow-up |
| Biochemically Confirmed 7-day Point Prevalence Abstinence | Percent of subjects in each group reporting biochemically confirmed 7-day point prevalence abstinence. Abstinence is determined by a self-report of not smoking for 7 days prior to the specified timepoint AND by a result of ≤ 5 ppm in carbon monoxide breath testing. If the participant does not meet both criteria, they are not considered abstinent. | 3 month follow-up |
| Biochemically Confirmed 7-day Point Prevalence Abstinence | Percent of subjects in each group reporting biochemically confirmed 7-day point prevalence abstinence. Abstinence is determined by a self-report of not smoking for 7 days prior to the specified timepoint AND by a result of ≤ 5 ppm in carbon monoxide breath testing. If the participant does not meet both criteria, they are not considered abstinent. | 4 month follow-up |
| Biochemically Confirmed Prolonged Abstinence Rates | Total number of participants in each group reporting prolonged abstinence at the specified time point. Abstinence is determined by a self-report of not relapsing after their quit date (i.e., not smoking for 7 consecutive days, or not smoking at least once each week for 2 consecutive weeks) following a 2-week grace period, AND by a result of ≤ 6 ppm in carbon monoxide breath testing. If the participant does not meet both criteria, they are not considered abstinent | 1 month follow up |
| Biochemically Confirmed Prolonged Abstinence Rates | Total number of participants in each group reporting prolonged abstinence at the specified time point. Abstinence is determined by a self-report of not relapsing after their quit date (i.e., not smoking for 7 consecutive days, or not smoking at least once each week for 2 consecutive weeks) following a 2-week grace period, AND by a result of ≤ 6 ppm in carbon monoxide breath testing. If the participant does not meet both criteria, they are not considered abstinent | 2 month follow up |
| Biochemically Confirmed Prolonged Abstinence Rates | Total number of participants in each group reporting prolonged abstinence at the specified time point. Abstinence is determined by a self-report of not relapsing after their quit date (i.e., not smoking for 7 consecutive days, or not smoking at least once each week for 2 consecutive weeks) following a 2-week grace period, AND by a result of ≤ 6 ppm in carbon monoxide breath testing. If the participant does not meet both criteria, they are not considered abstinent. | 3 month follow up |
| Biochemically Confirmed Prolonged Abstinence Rates | Total number of participants in each group reporting prolonged abstinence at the specified time point. Abstinence is determined by a self-report of not relapsing after their quit date (i.e., not smoking for 7 consecutive days, or not smoking at least once each week for 2 consecutive weeks) following a 2-week grace period, AND by a result of ≤ 6 ppm in carbon monoxide breath testing. If the participant does not meet both criteria, they are not considered abstinent. | 4 month follow up |
| 30-day Point Prevalence Abstinence Rates | Participants who self-reported not smoking for 30 days prior to the specified timepoint. | 1 month follow up |
| 30-day Point Prevalence Abstinence Rates | Participants who self-reported not smoking for 30 days prior to the specified timepoint. | 2 month follow up |
| 30-day Prevalence Abstinence Rates | Participants who self-reported not smoking for 30 days prior to the specified timepoint. | 3 month follow up |
| 30-day Point Prevalence Abstinence Rates | Participants who self-reported not smoking for 30 days prior to the specified timepoint. | 4 month follow up |
| 7-day Point Prevalence Abstinence | Participants who self-reported not smoking for 7 days prior to the specified timepoint. | 1 month follow up |
| 7-day Point Prevalence Abstinence | Participants who self-reported not smoking for 7 days prior to the specified timepoint. | 2 month follow up |
| 7-day Point Prevalence Abstinence | Participants who self-reported not smoking for 7 days prior to the specified timepoint. | 3 month follow up |
| 7-day Point Prevalence Abstinence | Participants who self-reported not smoking for 7 days prior to the specified timepoint. | 4 month follow up |
| 24-hour Point Prevalence Abstinence | Participants who self-reported not smoking for 24 hours prior to the specified timepoint. | 1 month follow up |
| 24-hour Point Prevalence Abstinence | Participants who self-reported not smoking for 24 hours prior to the specified timepoint. | 2 month follow up |
| 24-hour Point Prevalence Abstinence | Participants who self-reported not smoking for 24 hours prior to the specified timepoint. | 3 month follow up |
| 24-hour Point Prevalence Abstinence | Participants who self-reported not smoking for 24 hours prior to the specified timepoint. | 4 month follow up |
| Average Number of Quit Attempts Per Arm | Average number of quit attempts per group defined as self-reported no smoking at all for 24 hours at the specified time point. | 1 month follow up |
| Average Number of Quit Attempts Per Arm | Average number of quit attempts per group defined as self-reported no smoking at all for 24 hours at the specified time point. | 2 month follow up |
| Average Number of Quit Attempts Per Arm | Average number of quit attempts per group defined as self-reported no smoking at all for 24 hours at the specified time point. | 3 month follow up |
| Average Number of Quit Attempts Per Arm | Average number of quit attempts per group defined as self-reported no smoking at all for 24 hours at the specified time point. | 4 month follow up |
| Change in Nicotine Dependence as Measured by the Fagerstrom Test of Nicotine Dependence | The Fagerstrom Test of Nicotine Dependence ranges from 0 to 10 with the lower score indicating "no dependence" and the highest score indicating "very dependent" | Baseline to 1, 2, 3 and 4 month follow up |
| Change in Average Number of Cigarettes Smoked Per Day | Change in average number of self-reported cigarettes smoked per day per arm from baseline to the specified time point. | Baseline to 1, 2, 3 and 4 month follow up |
| Nicotine Replacement Patch Utilization | Days of patch use over the last 30 days. | 1 month follow up |
| Nicotine Replacement Patch Utilization | Days of patch use over the last 30 days. | 2 month follow up |
| Nicotine Replacement Patch Utilization | Days of patch use over the last 30 days. | 3 month follow up |
| Nicotine Replacement Patch Utilization | Days of patch use over the last 30 days. | 4 month follow up |
| Nicotine Replacement Lozenge Utilization | Days of lozenge use over the last 30 days. | 1 month follow up |
| Nicotine Replacement Lozenge Utilization | Days of lozenge use over the last 30 days. | 2 month follow up |
| Nicotine Replacement Lozenge Utilization | Days of lozenge use over the last 30 days. | 3 month follow up |
| Nicotine Replacement Lozenge Utilization | Days of lozenge use over the last 30 days. | 4 month follow up |
| Affect Ratings - Learn to Quit | Average mood rating as self-reported through the Learn to Quit app. Ratings range from 1-10 with lower scores indicating poorer mood ratings. | Daily throughout study duration, 4 months |
| Affect Ratings - QuitGuide | Percent of reported positive, negative, and mixed affect. Negative affect was coded as '1' when the following types of mood were reported using the mood tracking feature within the app: frustrated, stressed, nervous, anxious, angry, sad. Positive affect was coded as '1' when the following types of mood were reported using the mood tracking feature within the app: happy, relaxed, excited. Mixed affect was coded as '1' when there were instances where participants reported both positive and negative affect at different times of the day. | Daily throughout study, 4 months |
| Smoking Cravings | Average daily smoking cravings as self-reported through each smartphone app. Cravings range from a score of 1 to 10 with higher scores indicating higher cravings to smoke. | Daily throughout study duration, 4 months |
| Psychotic Symptoms | Psychotic symptoms (positive and negative symptoms) at the specified time point as measured by the Positive and Negative Symptoms Scale. Scores range from 7 to 49 with higher scores indicating more psychopathology. | 1 month follow up |
| Psychotic Symptoms | Psychotic symptoms (positive and negative symptoms) at the specified time point as measured by the Positive and Negative Symptoms Scale. Scores range from 7 to 49 with higher scores indicating more psychopathology. | 2 month follow up |
| Psychotic Symptoms | Psychotic symptoms (positive and negative symptoms) at the specified time point as measured by the Positive and Negative Symptoms Scale. Scores range from 7 to 49 with higher scores indicating more psychopathology. | 3 month follow up |
| Psychotic Symptoms | Psychotic symptoms (positive and negative symptoms) at the specified time point as measured by the Positive and Negative Symptoms Scale. Scores range from 7 to 49 with higher scores indicating more psychopathology. | 4 month follow up |
| General Psychiatric Symptoms | General psychiatric symptoms at the specified time point as measured by the Global Severity Index of the Brief Symptom Inventory. Scores range from 0 to 4 with higher scores indicating more psychiatric symptoms. | 1 month follow up |
| General Psychiatric Symptoms | General psychiatric symptoms at the specified time point as measured by the Global Severity Index of the Brief Symptom Inventory. Scores range from 0 to 4 with higher scores indicating more psychiatric symptoms. | 2 month follow up |
| General Psychiatric Symptoms | General psychiatric symptoms at the specified time point as measured by the Global Severity Index of the Brief Symptom Inventory. Scores range from 0 to 4 with higher scores indicating more psychiatric symptoms. | 3 month follow up |
| General Psychiatric Symptoms | General psychiatric symptoms at the specified time point as measured by the Global Severity Index of the Brief Symptom Inventory. Scores range from 0 to 4 with higher scores indicating more psychiatric symptoms. | 4 month follow up |
| BG001 | NCI QuitGuide | A smartphone app developed by the National Cancer Institute which uses smoking cessation recommendations contained in the US DHHS Clinical Practice Guidelines. The app intervention is combined with an 8-week course of nicotine replacement therapy (NRT) patches and a 2-week course of NRT lozenges. Participants also receive technical smartphone coaching for the first 4 weeks of the study. |
| BG002 | Total | Total of all reporting groups |
| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| CPD at Baseline | Number of average cigarettes smoked per day at baseline. | Mean | Standard Deviation | cigarettes per day |
|
| MDD Diagnosis | Percentage of participant enrolled who had a diagnosis of recurrent major depressive disorder. | Count of Participants | Participants |
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| Bipolar Diagnosis | Percentage of participants enrolled who had diagnosis of bipolar I or II disorder. | Count of Participants | Participants |
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| Schizophrenia Spectrum Diagnosis | Percentage of participants enrolled who had a diagnosis of schizophrenia or schizoaffective disorder. | Count of Participants | Participants |
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| Education Levels | The highest level of education by participants completed across groups. | Count of Participants | Participants |
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| Disability Status | Number of participants who self-reported to be on employment disability across groups. | Count of Participants | Participants |
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| Years of Smoking | Self-reported years of everyday smoking across groups | Mean | Standard Deviation | years |
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| Nicotine Dependence | Nicotine dependence across groups as determined by the Fagerstrom Test for Nicotine Dependence. Scores range from 0 to 11 with higher scores indicating higher nicotine dependence. | Mean | Standard Deviation | units on a scale |
|
| Cognitive Functioning | Cognitive functioning as assessed by the Brief Assessment of Cognition. Means are represented as Z-scores (lower scores = lower cognitive functioning, higher scores = higher cognitive functioning). | Mean | Full Range | units on a scale |
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| Household Income | Self-reported combined yearly income for all members living in the participants' households, across groups. | Count of Participants | Participants |
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| Primary | Duration of App Use | Mean duration of app use in each group over the course of study participation (4 months) | Posted | Mean | Standard Deviation | hours | Daily throughout study duration, 4 months |
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| Primary | Feasibility as Measured by Study Accrual Relative to Recruitment Goal | Percent of subjects consented into study relative to study recruitment goal (N=90).92 subjects signed consent prior to eligibility determination and randomization. | The number of participants analyzed in this sample is larger than the number of participants who were ultimately randomized to the study as reflected in the participant flow section. This sample includes all participants who were consented into the study regardless of their final eligibility status prior to randomization. | Posted | Number | percentage of target accrual | Approximately 15 months |
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| Primary | Feasibility as Measured by Study Attrition | Number and percentage of subjects who complete 4-month follow up assessment | Posted | Count of Participants | Participants | 4-months |
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| Primary | Recruitment Yield Effort | Percent of subjects responding to ads and clinician referrals | Posted | Count of Participants | Participants | Approximately 15 months |
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| Primary | Feasibility of Measurement Strategy | Percent completion of assessment measures. Assessment measures include surveys, questionnaires, and cognitive tasks. | Number of total possible assessment measures that could have been completed in each group. | Posted | Count of Units | assessments | Approximately 19 months | assessments | assessments |
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| Primary | Usability of App Design as Measured by the System Usability Scale (SUS) | 10-item scale giving a global assessment of systems usability using a 5-point Likert Scale with a composite score ranging from 0-100. Higher scores indicate higher usability rating. | Posted | Mean | Standard Deviation | score on a scale | 1-month follow-up |
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| Primary | Usability of App Design as Measured by the System Usability Scale (SUS) | 10-item scale giving a global assessment of systems usability using a 5-point Likert Scale with a composite score ranging from 0-100. Higher scores indicate higher usability rating. | Posted | Mean | Standard Deviation | score on a scale | 2-month follow-up |
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| Primary | Usability of App Design as Measured by the System Usability Scale (SUS) | 10-item scale giving a global assessment of systems usability using a 5-point Likert Scale with a composite score ranging from 0-100. Higher scores indicate higher usability rating. | Posted | Mean | Standard Deviation | score on a scale | 3-month follow-up |
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| Primary | Usability of App Design as Measured by the System Usability Scale (SUS) | 10-item scale giving a global assessment of systems usability using a 5-point Likert Scale with a composite score ranging from 0-100. Higher scores indicate higher usability rating. | Posted | Mean | Standard Deviation | score on a scale | 4-month follow-up |
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| Secondary | Biochemically Confirmed 7-day Point Prevalence Abstinence | Percent of subjects in each group reporting biochemically confirmed 7-day point prevalence abstinence. Abstinence is determined by a self-report of not smoking for 7 days prior to the specified timepoint AND by a result of ≤ 5 ppm in carbon monoxide breath testing. If the participant does not meet both criteria, they are not considered abstinent. | Posted | Count of Participants | Participants | 1 month follow-up |
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| Secondary | Biochemically Confirmed 7-day Point Prevalence Abstinence | Percent of subjects in each group reporting biochemically confirmed 7-day point prevalence abstinence. Abstinence is determined by a self-report of not smoking for 7 days prior to the specified timepoint AND by a result of ≤ 5 ppm in carbon monoxide breath testing. If the participant does not meet both criteria, they are not considered abstinent. | Posted | Count of Participants | Participants | 2 month follow-up |
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| Secondary | Biochemically Confirmed 7-day Point Prevalence Abstinence | Percent of subjects in each group reporting biochemically confirmed 7-day point prevalence abstinence. Abstinence is determined by a self-report of not smoking for 7 days prior to the specified timepoint AND by a result of ≤ 5 ppm in carbon monoxide breath testing. If the participant does not meet both criteria, they are not considered abstinent. | Posted | Count of Participants | Participants | 3 month follow-up |
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| Secondary | Biochemically Confirmed 7-day Point Prevalence Abstinence | Percent of subjects in each group reporting biochemically confirmed 7-day point prevalence abstinence. Abstinence is determined by a self-report of not smoking for 7 days prior to the specified timepoint AND by a result of ≤ 5 ppm in carbon monoxide breath testing. If the participant does not meet both criteria, they are not considered abstinent. | Posted | Count of Participants | Participants | 4 month follow-up |
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| Secondary | Biochemically Confirmed Prolonged Abstinence Rates | Total number of participants in each group reporting prolonged abstinence at the specified time point. Abstinence is determined by a self-report of not relapsing after their quit date (i.e., not smoking for 7 consecutive days, or not smoking at least once each week for 2 consecutive weeks) following a 2-week grace period, AND by a result of ≤ 6 ppm in carbon monoxide breath testing. If the participant does not meet both criteria, they are not considered abstinent | A survey branching logic error led to incomplete data collection for this measure. Therefore, we could not collect data from all participants. | Posted | Count of Participants | Participants | 1 month follow up |
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| Secondary | Biochemically Confirmed Prolonged Abstinence Rates | Total number of participants in each group reporting prolonged abstinence at the specified time point. Abstinence is determined by a self-report of not relapsing after their quit date (i.e., not smoking for 7 consecutive days, or not smoking at least once each week for 2 consecutive weeks) following a 2-week grace period, AND by a result of ≤ 6 ppm in carbon monoxide breath testing. If the participant does not meet both criteria, they are not considered abstinent | A survey branching logic error led to incomplete data collection for this measure. Therefore, we could not collect data from all participants. | Posted | Count of Participants | Participants | 2 month follow up |
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| Secondary | Biochemically Confirmed Prolonged Abstinence Rates | Total number of participants in each group reporting prolonged abstinence at the specified time point. Abstinence is determined by a self-report of not relapsing after their quit date (i.e., not smoking for 7 consecutive days, or not smoking at least once each week for 2 consecutive weeks) following a 2-week grace period, AND by a result of ≤ 6 ppm in carbon monoxide breath testing. If the participant does not meet both criteria, they are not considered abstinent. | A survey branching logic error led to incomplete data collection for this measure. Therefore, we could not collect data from all participants. | Posted | Count of Participants | Participants | 3 month follow up |
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| Secondary | Biochemically Confirmed Prolonged Abstinence Rates | Total number of participants in each group reporting prolonged abstinence at the specified time point. Abstinence is determined by a self-report of not relapsing after their quit date (i.e., not smoking for 7 consecutive days, or not smoking at least once each week for 2 consecutive weeks) following a 2-week grace period, AND by a result of ≤ 6 ppm in carbon monoxide breath testing. If the participant does not meet both criteria, they are not considered abstinent. | A survey branching logic error led to incomplete data collection for this measure. Therefore, we could not collect data from all participants. | Posted | Count of Participants | Participants | 4 month follow up |
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| Secondary | 30-day Point Prevalence Abstinence Rates | Participants who self-reported not smoking for 30 days prior to the specified timepoint. | Posted | Count of Participants | Participants | 1 month follow up |
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| Secondary | 30-day Point Prevalence Abstinence Rates | Participants who self-reported not smoking for 30 days prior to the specified timepoint. | Posted | Count of Participants | Participants | 2 month follow up |
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| Secondary | 30-day Prevalence Abstinence Rates | Participants who self-reported not smoking for 30 days prior to the specified timepoint. | Posted | Count of Participants | Participants | 3 month follow up |
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| Secondary | 30-day Point Prevalence Abstinence Rates | Participants who self-reported not smoking for 30 days prior to the specified timepoint. | Posted | Count of Participants | Participants | 4 month follow up |
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| Secondary | 7-day Point Prevalence Abstinence | Participants who self-reported not smoking for 7 days prior to the specified timepoint. | Posted | Count of Participants | Participants | 1 month follow up |
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| Secondary | 7-day Point Prevalence Abstinence | Participants who self-reported not smoking for 7 days prior to the specified timepoint. | Posted | Count of Participants | Participants | 2 month follow up |
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| Secondary | 7-day Point Prevalence Abstinence | Participants who self-reported not smoking for 7 days prior to the specified timepoint. | Posted | Count of Participants | Participants | 3 month follow up |
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| Secondary | 7-day Point Prevalence Abstinence | Participants who self-reported not smoking for 7 days prior to the specified timepoint. | Posted | Count of Participants | Participants | 4 month follow up |
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| Secondary | 24-hour Point Prevalence Abstinence | Participants who self-reported not smoking for 24 hours prior to the specified timepoint. | Posted | Count of Participants | Participants | 1 month follow up |
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| Secondary | 24-hour Point Prevalence Abstinence | Participants who self-reported not smoking for 24 hours prior to the specified timepoint. | Posted | Count of Participants | Participants | 2 month follow up |
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| Secondary | 24-hour Point Prevalence Abstinence | Participants who self-reported not smoking for 24 hours prior to the specified timepoint. | Posted | Count of Participants | Participants | 3 month follow up |
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| Secondary | 24-hour Point Prevalence Abstinence | Participants who self-reported not smoking for 24 hours prior to the specified timepoint. | Posted | Count of Participants | Participants | 4 month follow up |
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| Secondary | Average Number of Quit Attempts Per Arm | Average number of quit attempts per group defined as self-reported no smoking at all for 24 hours at the specified time point. | Posted | Mean | Standard Deviation | quit attempts | 1 month follow up |
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| Secondary | Average Number of Quit Attempts Per Arm | Average number of quit attempts per group defined as self-reported no smoking at all for 24 hours at the specified time point. | Posted | Mean | Standard Deviation | quit attempts | 2 month follow up |
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| Secondary | Average Number of Quit Attempts Per Arm | Average number of quit attempts per group defined as self-reported no smoking at all for 24 hours at the specified time point. | Posted | Mean | Standard Deviation | quit attempts | 3 month follow up |
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| Secondary | Average Number of Quit Attempts Per Arm | Average number of quit attempts per group defined as self-reported no smoking at all for 24 hours at the specified time point. | Posted | Mean | Standard Deviation | quit attempts | 4 month follow up |
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| Secondary | Change in Nicotine Dependence as Measured by the Fagerstrom Test of Nicotine Dependence | The Fagerstrom Test of Nicotine Dependence ranges from 0 to 10 with the lower score indicating "no dependence" and the highest score indicating "very dependent" | Posted | Mean | Standard Deviation | units on a scale | Baseline to 1, 2, 3 and 4 month follow up |
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| Secondary | Change in Average Number of Cigarettes Smoked Per Day | Change in average number of self-reported cigarettes smoked per day per arm from baseline to the specified time point. | Posted | Mean | Standard Deviation | cigarettes per day | Baseline to 1, 2, 3 and 4 month follow up |
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| Secondary | Nicotine Replacement Patch Utilization | Days of patch use over the last 30 days. | Posted | Mean | Standard Deviation | days of patch use | 1 month follow up |
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| Secondary | Nicotine Replacement Patch Utilization | Days of patch use over the last 30 days. | Posted | Mean | Standard Deviation | days of patch use | 2 month follow up |
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| Secondary | Nicotine Replacement Patch Utilization | Days of patch use over the last 30 days. | Posted | Mean | Standard Deviation | days of patch use | 3 month follow up |
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| Secondary | Nicotine Replacement Patch Utilization | Days of patch use over the last 30 days. | Posted | Mean | Standard Deviation | days of patch use | 4 month follow up |
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| Secondary | Nicotine Replacement Lozenge Utilization | Days of lozenge use over the last 30 days. | Posted | Mean | Standard Deviation | days of lozenge use | 1 month follow up |
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| Secondary | Nicotine Replacement Lozenge Utilization | Days of lozenge use over the last 30 days. | Posted | Mean | Standard Deviation | days of lozenge use | 2 month follow up |
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| Secondary | Nicotine Replacement Lozenge Utilization | Days of lozenge use over the last 30 days. | Posted | Mean | Standard Deviation | days of lozenge use | 3 month follow up |
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| Secondary | Nicotine Replacement Lozenge Utilization | Days of lozenge use over the last 30 days. | Posted | Mean | Standard Deviation | days of lozenge use | 4 month follow up |
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| Secondary | Affect Ratings - Learn to Quit | Average mood rating as self-reported through the Learn to Quit app. Ratings range from 1-10 with lower scores indicating poorer mood ratings. | Participants in the Learn to Quit group. | Posted | Mean | Standard Deviation | score on a scale | Daily throughout study duration, 4 months |
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| Secondary | Affect Ratings - QuitGuide | Percent of reported positive, negative, and mixed affect. Negative affect was coded as '1' when the following types of mood were reported using the mood tracking feature within the app: frustrated, stressed, nervous, anxious, angry, sad. Positive affect was coded as '1' when the following types of mood were reported using the mood tracking feature within the app: happy, relaxed, excited. Mixed affect was coded as '1' when there were instances where participants reported both positive and negative affect at different times of the day. | Participants in the QuitGuide group. | Posted | Number | Percent of counts | Daily throughout study, 4 months |
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| Secondary | Smoking Cravings | Average daily smoking cravings as self-reported through each smartphone app. Cravings range from a score of 1 to 10 with higher scores indicating higher cravings to smoke. | Posted | Mean | Standard Deviation | units on a scale | Daily throughout study duration, 4 months |
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| Secondary | Psychotic Symptoms | Psychotic symptoms (positive and negative symptoms) at the specified time point as measured by the Positive and Negative Symptoms Scale. Scores range from 7 to 49 with higher scores indicating more psychopathology. | Posted | Mean | Standard Deviation | score on a scale | 1 month follow up |
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| Secondary | Psychotic Symptoms | Psychotic symptoms (positive and negative symptoms) at the specified time point as measured by the Positive and Negative Symptoms Scale. Scores range from 7 to 49 with higher scores indicating more psychopathology. | Posted | Mean | Standard Deviation | score on a scale | 2 month follow up |
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| Secondary | Psychotic Symptoms | Psychotic symptoms (positive and negative symptoms) at the specified time point as measured by the Positive and Negative Symptoms Scale. Scores range from 7 to 49 with higher scores indicating more psychopathology. | Posted | Mean | Standard Deviation | score on a scale | 3 month follow up |
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| Secondary | Psychotic Symptoms | Psychotic symptoms (positive and negative symptoms) at the specified time point as measured by the Positive and Negative Symptoms Scale. Scores range from 7 to 49 with higher scores indicating more psychopathology. | Posted | Mean | Standard Deviation | score on a scale | 4 month follow up |
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| Secondary | General Psychiatric Symptoms | General psychiatric symptoms at the specified time point as measured by the Global Severity Index of the Brief Symptom Inventory. Scores range from 0 to 4 with higher scores indicating more psychiatric symptoms. | Posted | Mean | Standard Deviation | score on a scale | 1 month follow up |
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| Secondary | General Psychiatric Symptoms | General psychiatric symptoms at the specified time point as measured by the Global Severity Index of the Brief Symptom Inventory. Scores range from 0 to 4 with higher scores indicating more psychiatric symptoms. | Posted | Mean | Standard Deviation | score on a scale | 2 month follow up |
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| Secondary | General Psychiatric Symptoms | General psychiatric symptoms at the specified time point as measured by the Global Severity Index of the Brief Symptom Inventory. Scores range from 0 to 4 with higher scores indicating more psychiatric symptoms. | Posted | Mean | Standard Deviation | score on a scale | 3 month follow up |
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| Secondary | General Psychiatric Symptoms | General psychiatric symptoms at the specified time point as measured by the Global Severity Index of the Brief Symptom Inventory. Scores range from 0 to 4 with higher scores indicating more psychiatric symptoms. | Posted | Mean | Standard Deviation | score on a scale | 4 month follow up |
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| 0 |
| 33 |
| 6 |
| 33 |
| 30 |
| 33 |
| EG001 | NCI QuitGuide | A smartphone app developed by the National Cancer Institute which uses smoking cessation recommendations contained in the US DHHS Clinical Practice Guidelines. The app intervention is combined with an 8-week course of nicotine replacement therapy (NRT) patches and a 2-week course of NRT lozenges. Participants also receive technical smartphone coaching for the first 4 weeks of the study. | 0 | 29 | 4 | 29 | 23 | 29 |
| Low blood pressure | Blood and lymphatic system disorders | Systematic Assessment |
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| Hospitalization from elevated blood sugar | Blood and lymphatic system disorders | Systematic Assessment |
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| Heroin overdose | Social circumstances | Systematic Assessment |
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| Withdrawal from methadone | Social circumstances | Systematic Assessment |
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| Knee surgery | Surgical and medical procedures | Systematic Assessment |
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| Hospitalized because of two broken arms | Surgical and medical procedures | Systematic Assessment |
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| Hospitalization due to suicidal ideation | Psychiatric disorders | Systematic Assessment |
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| Mini-stroke (TIA) | Nervous system disorders | Systematic Assessment |
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| Asthma attack | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Hernia repair surgery | Surgical and medical procedures | Systematic Assessment |
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| Dental procedures | Surgical and medical procedures | Systematic Assessment |
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| Body aches and pains | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Changes in blood pressure | Vascular disorders | Systematic Assessment |
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| Burning in mouth/throat/chest | Gastrointestinal disorders | Systematic Assessment |
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| Broken/sprained body parts | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Coughing | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Cold/flu | Infections and infestations | Systematic Assessment |
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| Acid reflux | Gastrointestinal disorders | Systematic Assessment |
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| Allergies/asthma | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | Systematic Assessment |
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| Itchy/irritated skin | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Skin breakouts | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Suicidal ideation | Psychiatric disorders | Systematic Assessment |
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| Nightmares/vivid dreams | Psychiatric disorders | Systematic Assessment |
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| Hiccups | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Sleep issues | Psychiatric disorders | Systematic Assessment |
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| Frustration due to phone/app issues | Psychiatric disorders | Systematic Assessment |
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| Infections | Infections and infestations | Systematic Assessment |
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| Tumor removal (procedure) | Surgical and medical procedures | Systematic Assessment |
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| Cyst/abcess removal | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
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| Accidents | Social circumstances | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | Systematic Assessment |
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| Lacerations | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Agoraphobia | Psychiatric disorders | Systematic Assessment |
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| Aversion to NRT taste | Product Issues | Systematic Assessment |
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| Headaches | General disorders | Systematic Assessment |
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| Eye procedure | Surgical and medical procedures | Systematic Assessment |
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| Reproductive problems | Reproductive system and breast disorders | Systematic Assessment |
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| Cancer | General disorders | Systematic Assessment |
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| Opioid withdrawal | Psychiatric disorders | Systematic Assessment |
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| Vision problems | Eye disorders | Systematic Assessment |
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| Congestion | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Dry mouth while using lozenges | Product Issues | Systematic Assessment |
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| Memory problems | Psychiatric disorders | Systematic Assessment |
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| Changes in blood sugar levels | Congenital, familial and genetic disorders | Systematic Assessment |
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| Thyroid problems | Metabolism and nutrition disorders | Systematic Assessment |
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| Sore throat | Infections and infestations | Systematic Assessment |
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| Increased heart rate | Cardiac disorders | Systematic Assessment |
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| Changes in mood | Psychiatric disorders | Systematic Assessment |
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| Tooth pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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Not provided
Not provided
| Week 12 |
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| Week 16 |
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| Week 12 |
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| Week 16 |
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| Title | Measurements |
|---|---|
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