Tobacco Use Cessation, Tobacco Use Disorder
Conditions
Keywords
Tobacco Use Disorder, Hospitalized patients, Text message, Motivational Interview, Substance-Related Disorders, Behaviors and Mental Disorders
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALMotivational Interview plus text message
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.
Sponsors
University of Kansas
Federal University of Juiz de Fora
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Aged 18 years or older * Smoked cigarettes in the last 30 days (even a puff) * Have own mobile phone * Have received at least one text message in the last year * Have no problem with the mobile phone signal
Exclusion criteria
* Don't have a mobile phone * Unstable cognitive or physical condition * Physical or breath contact restrictions * Intensive care units
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Self Reported Smoking Abstinence | Smoking abstinence at the first month after randomization | No smoking (even a puff) in the past 7 days at the first month follow up. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Daily Cigarettes Consumption at 3 Months Among Continuing Smokers | At the third month after randomization | The experimental group self reported daily cigarettes consumption at the third month after randomization with be compared to the control group. |
| Self Reported Seek for Specialized Tobacco Treatment | at the third month after randomization | self reported seek for specialized tobacco treatment after hospitalization |
| Self Reported Smoking Abstinence | Smoking abstinence at the third month after randomization | No smoking (even a puff) in the past 7 days at the third month after randomization. |
| Carbon Monoxide Verified Smoking Abstinence | At third-month follow up | Carbon Monoxide verified Smoking Abstinence at third-month follow up. Abstinence defined as Carbon Monoxide ≤ 6. |
Countries
Brazil
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 44 |
| 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 | 22 |
| Total | 66 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 1 |
| Overall Study | Unable to reach out post discharge | 3 | 0 |
Baseline characteristics
| Characteristic | Control Arm | Total | Motivational Interview Plus Text Message |
|---|---|---|---|
| Age, Continuous | 48.2 years STANDARD_DEVIATION 8.9 | 47.7 years STANDARD_DEVIATION 11.5 | 47.5 years STANDARD_DEVIATION 12.7 |
| Race (NIH/OMB) Race American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Race Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Race Black or African American | 2 Participants | 8 Participants | 6 Participants |
| Race (NIH/OMB) Race More than one race | 3 Participants | 14 Participants | 11 Participants |
| Race (NIH/OMB) Race Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Race Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Race White | 17 Participants | 44 Participants | 27 Participants |
| Sex: Female, Male Female | 12 Participants | 32 Participants | 20 Participants |
| Sex: Female, Male Male | 10 Participants | 34 Participants | 24 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Primary
Self Reported Smoking Abstinence
No smoking (even a puff) in the past 7 days at the first month follow up.
Time frame: Smoking abstinence at the first month after randomization
Population: 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).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Motivational Interview Plus Text Message | Self Reported Smoking Abstinence | 11 Participants |
| Control Arm | Self Reported Smoking Abstinence | 2 Participants |
95% CI: [0.99, 1.85]
Secondary
Carbon Monoxide Verified Smoking Abstinence
Carbon Monoxide verified Smoking Abstinence at third-month follow up. Abstinence defined as Carbon Monoxide ≤ 6.
Time frame: At third-month follow up
Population: Intention to Treat Analysis
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Motivational Interview Plus Text Message | Carbon Monoxide Verified Smoking Abstinence | 9 Participants |
| Control Arm | Carbon Monoxide Verified Smoking Abstinence | 1 Participants |
95% CI: [1.07, 1.92]
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.
Time frame: At the third month after randomization
Population: It was included only patients that were able to be contacted for follow up (per protocol analysis).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Motivational Interview Plus Text Message | Daily Cigarettes Consumption at 3 Months Among Continuing Smokers | 12.9 Number of cigarettes smoked per day | Standard Deviation 5.2 |
| Control Arm | Daily Cigarettes Consumption at 3 Months Among Continuing Smokers | 14.6 Number of cigarettes smoked per day | Standard Deviation 5.5 |
p-value: 0.28t-test, 2 sided
Secondary
Self Reported Seek for Specialized Tobacco Treatment
self reported seek for specialized tobacco treatment after hospitalization
Time frame: at the third month after randomization
Population: It was included only patients that were able to be contacted for follow up (per protocol analysis).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Motivational Interview Plus Text Message | Self Reported Seek for Specialized Tobacco Treatment | 0 Participants |
| Control Arm | Self Reported Seek for Specialized Tobacco Treatment | 1 Participants |
p-value: 0.42Fisher Exact
Secondary
Self Reported Smoking Abstinence
No smoking (even a puff) in the past 7 days at the third month after randomization.
Time frame: Smoking abstinence at the third month after randomization
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Motivational Interview Plus Text Message | Self Reported Smoking Abstinence | 14 Participants |
| Control Arm | Self Reported Smoking Abstinence | 2 Participants |
95% CI: [1.08, 1.95]