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This study is evaluating the feasibility and short term smoking cessation outcomes of an automated smoking cessation intervention delivered via mobile phone text messaging as an adjunct to Varenicline in a primary care setting.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Motivational Text Messages | Experimental |
| |
| Control | Sham Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Motivational Text Messages | Behavioral | Usual care plus motivational text messages sent via Mobile Phone. All participants receive the active medication, Varenicline. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Point Prevalence of 7-day Tobacco Abstinence Biochemically Validated by Exhaled CO < 10ppm at Visit 3 (12 Weeks After Target Quit Day) | 12 weeks | |
| Sustained Abstinence at the 12-week Follow up | 12 weeks | |
| Number of Days of Varenicline Use | 12 weeks | |
| Number of Active Smoking Cessation Activities Used | Number of activities completed out of 6 | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Continuous Lapse-free Tobacco Abstinence From 4 Weeks to 12 Weeks, Biochemically Validated at Visit 2 and Visit 3. | 12 weeks | |
| Time (in Days) to Relapse After the Target Quit Day | 12 weeks | |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Penn State Milton S. Hershey Medical Center | Hershey | Pennsylvania | 17033 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29578832 | Derived | Yingst JM, Veldheer S, Hrabovsky S, Hammett E, Nicholson J, Berg A, Foulds J. Pilot Randomized Trial of an Automated Smoking Cessation Intervention via Mobile Phone Text Messages as an Adjunct to Varenicline in Primary Care. J Health Commun. 2018;23(4):370-378. doi: 10.1080/10810730.2018.1453890. Epub 2018 Mar 26. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Motivational Text Messages | Motivational Text Messages: Usual care plus motivational text messages sent via Mobile Phone. All participants receive the active medication, Varenicline. |
| FG001 | Control | Control: Usual Care. All participants receive the active medication, Varenicline. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Motivational Text Messages | Motivational Text Messages: Usual care plus motivational text messages sent via Mobile Phone. All participants receive the active medication, Varenicline. |
| BG001 | Control |
| 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 of 7-day Tobacco Abstinence Biochemically Validated by Exhaled CO < 10ppm at Visit 3 (12 Weeks After Target Quit Day) | Posted | Count of Participants | Participants | 12 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 | Motivational Text Messages | Motivational Text Messages: Usual care plus motivational text messages sent via Mobile Phone. All participants receive the active medication, Varenicline. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Development of Diabetes | Endocrine disorders |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Project Coordinator | Penn State College of Medicine | 7175310003 | 289511 | jyingst@phs.psu.edu |
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| ID | Term |
|---|---|
| D014029 | Tobacco Use Disorder |
| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| Control | Behavioral | Usual Care. All participants receive the active medication, Varenicline. |
|
| Total Score on the Positive Smoking Cessation Activities Measure |
Total score for 6 items (scored 0-3). Total score range 0-18. |
| 12 weeks |
Control: Usual Care. All participants receive the active medication, Varenicline.
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Counts |
|---|
| Participants |
|
|
| Primary | Sustained Abstinence at the 12-week Follow up | Posted | Count of Participants | Participants | 12 weeks |
|
|
|
| Primary | Number of Days of Varenicline Use | Posted | Mean | Standard Deviation | days | 12 weeks |
|
|
|
| Primary | Number of Active Smoking Cessation Activities Used | Number of activities completed out of 6 | This data is presented for only participants who showed to Visit 2. | Posted | Mean | Standard Deviation | activities | 12 weeks |
|
|
|
| Secondary | Continuous Lapse-free Tobacco Abstinence From 4 Weeks to 12 Weeks, Biochemically Validated at Visit 2 and Visit 3. | Posted | Count of Participants | Participants | 12 weeks |
|
|
|
| Secondary | Time (in Days) to Relapse After the Target Quit Day | Posted | Mean | Standard Deviation | days | 12 weeks |
|
|
|
| Secondary | Total Score on the Positive Smoking Cessation Activities Measure | Total score for 6 items (scored 0-3). Total score range 0-18. | This data is presented for only participants who showed to Visit 2. | Posted | Mean | Standard Deviation | activities | 12 weeks |
|
|
|
| 1 |
| 74 |
| 39 |
| 74 |
| EG001 | Control | Control: Usual Care. All participants receive the active medication, Varenicline. | 2 | 76 | 33 | 76 |
| Gallbladder Surgery | Hepatobiliary disorders |
|
| Abdominal Pain | Gastrointestinal disorders |
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| Vivid or Unusual Dreams | Psychiatric disorders |
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| Nicotine Withdrawal Symptoms | Psychiatric disorders |
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| Rash | Skin and subcutaneous tissue disorders |
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| Thoughts of death | Psychiatric disorders |
|
| Excessive Sweating | Endocrine disorders |
|
| Increased mucus production in eye | Eye disorders |
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| Migraines | Nervous system disorders |
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| Increased Salivation | Gastrointestinal disorders |
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| Atrial Fibrillation | Cardiac disorders |
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| Abdominal Pain | Musculoskeletal and connective tissue disorders |
|
| Ringing in ears | Ear and labyrinth disorders |
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| Vomitting | Gastrointestinal disorders |
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| Chest Pain | Cardiac disorders |
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| Skin Peeling | Skin and subcutaneous tissue disorders |
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| Increase in hot flashes | Reproductive system and breast disorders |
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| Coughing up blood | Gastrointestinal disorders |
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| Back Pain | Musculoskeletal and connective tissue disorders |
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| Diarrhea | Gastrointestinal disorders |
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| Stomach Pain | Gastrointestinal disorders |
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| Balance Problems | Ear and labyrinth disorders |
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| Drug/Alcohol Rehab | Social circumstances |
|
| Hysterectomy | Reproductive system and breast disorders |
|
| Pregnancy | Reproductive system and breast disorders |
|
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