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| Name | Class |
|---|---|
| University of Kansas | OTHER |
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This study is a preliminary research aimed to compare the feasibility and effectiveness of motivational interview (MI), Personalized text messages (TM) and usual care for outpatients, with focus on smoking cessation as the main outcome. Smokers patients have received brief interventions and nicotine replacement therapy during the hospitalization. After discharge smokers were allocated into a intervention or control arm. In the first and third months, after randomization, the patients were contact to smoke abstinence assessment.
Background: Research suggests that smokers who receive treatment inside the hospital and post-discharge follow up for at least a month are more likely to quit smoking than those who didn't receive any intervention. The current challenge is to know the best way to support post-discharge quit attempts in the Brazilian context. Objective: The aim of this study was to compare the feasibility and effectiveness of motivational interview (MI) plus Personalized text messages (TM) and usual care for support smoking cessation among post-discharge patients. Methods: All patients admitted to the University Hospital of Juiz de Fora (HU/UFJF), between 06/2015 to 01/2016, were asked about the cigarettes consumption in the last 30 days. Smokers patients received brief interventions and nicotine replacement therapy during the hospitalization. After hospitalization discharge smokers were allocated into a intervention or control arm. The intervention group received a singular MI session by phone and mobile phone TM twice a day during eight or fifteen days. The control group received only usual care available inside the hospital. Results: At the first and third months, after randomization, the patients were contacted for smoke abstinence assessment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Motivational Interview plus text message | Experimental | Inside the hospital: All participants have received the written materials. Patients with high tobacco dependence (Fagerstrom screening test score 5 or higher) have received also Nicotine Replacement Therapy (NRT). The written materials provided information on benefits of quitting and strategies for a successful quit plan, including information on relapse prevention. Post discharge extended treatment: Participants in this arm have received a telephone counseling session using a motivational interviewing approach and fifteen or eight days of text messages. The timing, duration, and content of the counseling session were consistent with guideline-based recommendations. |
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| Control Arm | No Intervention | Inside the hospital: All participants have receive the written materials. Patients with high tobacco dependence (Fagerstrom screening test score 5 or higher) have received also Nicotine Replacement Therapy (NRT). The written materials provided information on benefits of quitting and strategies for a successful quit plan, including information on relapse prevention. Post discharge extended care: None |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Motivational Interview plus text message | Behavioral | After discharge the experimental group has received extended care including a counseling session and text messages. The session provided basic information about smoking and successful quitting. The counselor has used motivational interview techniques to build coping skills with the goal of helping the participant build and implement a quit plan. The focus was to increase motivation to make quit attempt, including confidence building, medication use, and cessation planning. The session lasted approximately 30 minutes. Participants in the experimental arm were offered up to 30 text messages to help them to implement the quit plan discussed during the phone call. Patients motivated to quit in the next 30 days or those that had already quit have received 30 messages (2 per day) and patients unwilling to quit 16 (2 per day). The messages followed the self efficacy theory. |
| Measure | Description | Time Frame |
|---|---|---|
| Self Reported Smoking Abstinence | No smoking (even a puff) in the past 7 days at the first month follow up. | Smoking abstinence at the first month after randomization |
| Measure | Description | Time Frame |
|---|---|---|
| Daily Cigarettes Consumption at 3 Months Among Continuing Smokers | The experimental group self reported daily cigarettes consumption at the third month after randomization with be compared to the control group. | At the third month after randomization |
| Self Reported Seek for Specialized Tobacco Treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Erica Cruvinel, MD | Federal University of Juiz de Fora | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Federal Hospital of Juiz de Fora | Juiz de Fora | Minas Gerais | 36038-330 | Brazil |
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| ID | Title | Description |
|---|---|---|
| FG000 | Motivational Interview Plus Text Message | Inside the hospital: All participants will receive the written materials. Patients with high tobacco dependence (Fagerstrom screening test score 5 or higher) will receive also Nicotine replacement therapy. The written materials provide information on, benefits of quitting smoking, and strategies for a successful quit plan, including information on relapse prevention. Post discharge extended treatment: Participants in this arm will receive a telephone counseling session using a motivational interviewing approach and fifteen or eight days of text messages. The timing, duration, and content of the counseling session will be consistent with guideline-based recommendations. Motivational Interview plus text message: After discharge the experimental group will receive extended care including a counseling session and text messages. The session will provide basic information about smoking and successful quitting. The counselor will use motivational interview techniques to build coping |
| FG001 | Control Arm | Inside the hospital: All participants will receive the written materials. Patients with high tobacco dependence (Fagerstrom screening test score 5 or higher) will receive also Nicotine replacement therapy. The written materials provide information on, benefits of quitting smoking and strategies for a successful quit plan, including information on relapse prevention. Post discharge extended care: None |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
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| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Motivational Interview Plus Text Message | Inside the hospital: All participants will receive the written materials. Patients with high tobacco dependence (Fagerstrom screening test score 5 or higher) will receive also Nicotine replacement therapy. The written materials provide information on, benefits of quitting smoking, and strategies for a successful quit plan, including information on relapse prevention. Post discharge extended treatment: Participants in this arm will receive a telephone counseling session using a motivational interviewing approach and fifteen or eight days of text messages. The timing, duration, and content of the counseling session will be consistent with guideline-based recommendations. Motivational Interview plus text message: After discharge the experimental group will receive extended care including a counseling session and text messages. The session will provide basic information about smoking and successful quitting. The counselor will use motivational interview techniques to build coping. |
| Units | Counts |
|---|---|
| Participants |
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| 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 | Self Reported Smoking Abstinence | No smoking (even a puff) in the past 7 days at the first month follow up. | The primary analysis was intention-to-treat and involved all patients who were randomly assigned. The 7-day point prevalence abstinence rate was assessed as the first outcome (1-month assessment). | Posted | Count of Participants | Participants | Smoking abstinence at the first month after randomization |
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Participants received text message during 15 days. Adverse events were not collected during this period.
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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 Interview Plus Text Message | Inside the hospital: All participants will receive the written materials. Patients with high tobacco dependence (Fagerstrom screening test score 5 or higher) will receive also Nicotine replacement therapy. The written materials provide information on, benefits of quitting smoking, and strategies for a successful quit plan, including information on relapse prevention. Post discharge extended treatment: Participants in this arm will receive a telephone counseling session using a motivational interviewing approach and fifteen or eight days of text messages. The timing, duration, and content of the counseling session will be consistent with guideline-based recommendations.Motivational Interview plus text message: After discharge the experimental group will receive extended care including a counseling session and text messages. The session will provide basic information about smoking and successful quitting. The counselor will use motivational interview techniques to build coping |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Erica Cruvinel | Federal University of Juiz de Fora/Brazil | 55-32-99174-8855 | ericacruvinel@gmail.com |
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| ID | Term |
|---|---|
| D020340 | Tobacco Use Cessation |
| D014029 | Tobacco Use Disorder |
| D019966 | Substance-Related Disorders |
| D001519 | Behavior |
| D001523 | Mental Disorders |
| ID | Term |
|---|---|
| D015438 | Health Behavior |
| D064419 | Chemically-Induced Disorders |
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| ID | Term |
|---|---|
| D062405 | Motivational Interviewing |
| ID | Term |
|---|---|
| D037001 | Directive Counseling |
| D003376 | Counseling |
| D008605 | Mental Health Services |
| D004191 | Behavioral Disciplines and Activities |
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self reported seek for specialized tobacco treatment after hospitalization |
| at the third month after randomization |
| Self Reported Smoking Abstinence | No smoking (even a puff) in the past 7 days at the third month after randomization. | Smoking abstinence at the third month after randomization |
| Carbon Monoxide Verified Smoking Abstinence | Carbon Monoxide verified Smoking Abstinence at third-month follow up. Abstinence defined as Carbon Monoxide ≤ 6. | At third-month follow up |
| BG001 | Control Arm | Inside the hospital: All participants will receive the written materials. Patients with high tobacco dependence (Fagerstrom screening test score 5 or higher) will receive also Nicotine replacement therapy. The written materials provide information on, benefits of quitting smoking and strategies for a successful quit plan, including information on relapse prevention. Post discharge extended care: None |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| OG001 | Control Arm | Inside the hospital: All participants will receive the written materials. Patients with high tobacco dependence (Fagerstrom screening test score 5 or higher) will receive also Nicotine replacement therapy. The written materials provide information on, benefits of quitting smoking and strategies for a successful quit plan, including information on relapse prevention. Post discharge extended care: None |
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| Secondary | Daily Cigarettes Consumption at 3 Months Among Continuing Smokers | The experimental group self reported daily cigarettes consumption at the third month after randomization with be compared to the control group. | It was included only patients that were able to be contacted for follow up (per protocol analysis). | Posted | Mean | Standard Deviation | Number of cigarettes smoked per day | At the third month after randomization |
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| Secondary | Self Reported Seek for Specialized Tobacco Treatment | self reported seek for specialized tobacco treatment after hospitalization | It was included only patients that were able to be contacted for follow up (per protocol analysis). | Posted | Count of Participants | Participants | at the third month after randomization |
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| Secondary | Self Reported Smoking Abstinence | No smoking (even a puff) in the past 7 days at the third month after randomization. | The primary analysis was intention-to-treat and involved all patients who were randomly assigned. The 7-day point prevalence abstinence rate, at 3-month assessment, was assessed as a secondary outcome. | Posted | Count of Participants | Participants | Smoking abstinence at the third month after randomization |
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| Secondary | Carbon Monoxide Verified Smoking Abstinence | Carbon Monoxide verified Smoking Abstinence at third-month follow up. Abstinence defined as Carbon Monoxide ≤ 6. | Intention to Treat Analysis | Posted | Count of Participants | Participants | At third-month follow up |
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| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Control Arm | Inside the hospital: All participants will receive the written materials. Patients with high tobacco dependence (Fagerstrom screening test score 5 or higher) will receive also Nicotine replacement therapy. The written materials provide information on, benefits of quitting smoking and strategies for a successful quit plan, including information on relapse prevention. Post discharge extended care: None | 0 | 0 | 0 | 0 | 0 | 0 |
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| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |