- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02571244
Text Messaging for Supporting Quit Attempts
October 26, 2017 updated by: Erica Cruvinel, Federal University of Juiz de Fora
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
66
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Minas Gerais
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Juiz de Fora, Minas Gerais, Brazil, 36038-330
- University Federal Hospital of Juiz de Fora
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Motivational Interview plus text message
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.
|
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.
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No Intervention: Control Arm
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
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Self Reported Smoking Abstinence
Time Frame: Smoking abstinence at the first month after randomization
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No smoking (even a puff) in the past 7 days at the first month follow up.
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Smoking abstinence at the first month after randomization
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Self Reported Smoking Abstinence
Time Frame: Smoking abstinence at the third month after randomization
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No smoking (even a puff) in the past 7 days at the third month after randomization.
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Smoking abstinence at the third month after randomization
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Daily Cigarettes Consumption at 3 Months Among Continuing Smokers
Time Frame: At the third month after randomization
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The experimental group self reported daily cigarettes consumption at the third month after randomization with be compared to the control group.
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At the third month after randomization
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Self Reported Seek for Specialized Tobacco Treatment
Time Frame: at the third month after randomization
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self reported seek for specialized tobacco treatment after hospitalization
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at the third month after randomization
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Carbon Monoxide Verified Smoking Abstinence
Time Frame: At third-month follow up
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Carbon Monoxide verified Smoking Abstinence at third-month follow up.
Abstinence defined as Carbon Monoxide ≤ 6.
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At third-month follow up
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Erica Cruvinel, MD, Federal University of Juiz de Fora
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2015
Primary Completion (Actual)
January 1, 2016
Study Completion (Actual)
March 8, 2016
Study Registration Dates
First Submitted
September 24, 2015
First Submitted That Met QC Criteria
October 6, 2015
First Posted (Estimate)
October 8, 2015
Study Record Updates
Last Update Posted (Actual)
July 30, 2018
Last Update Submitted That Met QC Criteria
October 26, 2017
Last Verified
October 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0022.420.000-11
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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