Tobacco Use CessationNCT02571244
Text Messaging for Supporting Quit Attempts
A study testing Motivational Interview plus text message in people with Tobacco Use Cessation and Tobacco Use Disorder, run by Federal University of Juiz de Fora at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tobacco Use Cessation, Tobacco Use Disorder
- What is being tested?
- Motivational Interview plus text message
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteBrazil
- Study dates
- Jun 2015to 8 Mar 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Don't have a mobile phone
- Unstable cognitive or physical condition
- Physical or breath contact restrictions
- Intensive care units
Trial locations and contacts
1 site in 1 country.
Brazil1 site
University Federal Hospital of Juiz de Fora
Juiz de Fora, Minas Gerais, 36038-330
About this study
Official title: Telephone Counseling and Text Messaging for Supporting Post-discharge Quit Attempts Among Hospitalized Smokers in Brazil
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.
Read the 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.
- Conditions
- Tobacco Use Cessation, Tobacco Use Disorder
- Being tested
- Motivational Interview plus text message
- Keywords
- Tobacco Use Disorder, Hospitalized patients, Text message, Motivational Interview, Substance-Related Disorders, Behaviors and Mental Disorders
- Medical subject headings
- Tobacco Use Cessation, Tobacco Use Disorder, Substance-Related Disorders, Behavior, Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motivational Interview plus text messageBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Motivational Interview plus text message |
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self Reported Smoking Abstinence
No smoking (even a puff) in the past 7 days at the first month follow up.
Measured: Smoking abstinence at the first month after randomization
Secondary outcomes (4)
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.
Measured: At the third month after randomization
Self Reported Seek for Specialized Tobacco Treatment
self reported seek for specialized tobacco treatment after hospitalization
Measured: 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.
Measured: 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.
Measured: At third-month follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2015 (estimated)
- Study startJun 2015
- Primary completionJan 2016
- Study completion8 Mar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Tobacco Use CessationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of Juiz de Fora
- Sponsor type
- University, hospital or other
- Collaborators
- University of Kansas
- Responsible party
- Principal investigator, Erica Cruvinel, Federal University of Juiz de Fora
- Investigators
- Erica Cruvinel, MD, Principal investigator, Federal University of Juiz de Fora
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02571244
- Sponsor's protocol ID
- 0022.420.000-11
- Status last verified
- Oct 2017
- First submitted
- 24 Sep 2015
- Last updated
- 30 Jul 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Telephone Counseling and Text Messaging for Supporting Post-discharge Quit Attempts Among Hospitalized Smokers in Brazil
- ClinicalTrials.gov ID
- NCT02571244
- Acronym / sponsor ID
- 0022.420.000-11
- Conditions
- Tobacco Use Cessation, Tobacco Use Disorder
- Keywords
- Tobacco Use Disorder, Hospitalized patients, Text message, Motivational Interview, Substance-Related Disorders, Behaviors and Mental Disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Federal University of Juiz de ForaUniversity, hospital or other
- Collaborators
- University of Kansas
- Study start
- Jun 2015
- Primary completion
- Jan 2016 (actual)
- Study completion
- 8 Mar 2016 (actual)
- First posted
- 8 Oct 2015 (estimated)
- Results
- Posted 30 Jul 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Motivational Interview plus text message | Experimental | Behavioral: Motivational Interview plus text messageInside 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. |
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- Don't have a mobile phone
- Unstable cognitive or physical condition
- Physical or breath contact restrictions
- Intensive care units
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Motivational Interview plus text messageAfter 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. | Behavioural | Motivational Interview plus text message |
Primary outcome
Self Reported Smoking Abstinence
Time frame: Smoking abstinence at the first month after randomization
No smoking (even a puff) in the past 7 days at the first month follow up.
4 secondary outcomes
Daily Cigarettes Consumption at 3 Months Among Continuing Smokers
Time frame: At the third month after randomization
Self Reported Seek for Specialized Tobacco Treatment
Time frame: at the third month after randomization
Self Reported Smoking Abstinence
Time frame: Smoking abstinence at the third month after randomization
Carbon Monoxide Verified Smoking Abstinence
Time frame: At third-month follow up
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Erica Cruvinel, MD principal investigator
Federal University of Juiz de Fora
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Motivational Interview plus text message in people with Tobacco Use Cessation and Tobacco Use Disorder, run by Federal University of Juiz de Fora at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Jul 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self Reported Smoking Abstinence (time frame: Smoking abstinence at the first month after randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2018.