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Text Messaging for Supporting Quit Attempts

Primary Purpose

Tobacco Use Cessation, Tobacco Use Disorder

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Motivational Interview plus text message
Sponsored by
Federal University of Juiz de Fora
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Tobacco Use Cessation focused on measuring Tobacco Use Disorder, Hospitalized patients, Text message, Motivational Interview, Substance-Related Disorders, Behaviors and Mental Disorders

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Federal Hospital of Juiz de Fora

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Motivational Interview plus text message

Control Arm

Arm Description

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.

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

Outcomes

Primary Outcome Measures

Self Reported Smoking Abstinence
No smoking (even a puff) in the past 7 days at the first month follow up.

Secondary Outcome Measures

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.
Self Reported Seek for Specialized Tobacco Treatment
self reported seek for specialized tobacco treatment after hospitalization
Self Reported Smoking Abstinence
No smoking (even a puff) in the past 7 days 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.

Full Information

First Posted
September 24, 2015
Last Updated
October 26, 2017
Sponsor
Federal University of Juiz de Fora
Collaborators
University of Kansas
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1. Study Identification

Unique Protocol Identification Number
NCT02571244
Brief Title
Text Messaging for Supporting Quit Attempts
Official Title
Telephone Counseling and Text Messaging for Supporting Post-discharge Quit Attempts Among Hospitalized Smokers in Brazil
Study Type
Interventional

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
June 2015 (undefined)
Primary Completion Date
January 2016 (Actual)
Study Completion Date
March 8, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federal University of Juiz de Fora
Collaborators
University of Kansas

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tobacco Use Cessation, Tobacco Use Disorder
Keywords
Tobacco Use Disorder, Hospitalized patients, Text message, Motivational Interview, Substance-Related Disorders, Behaviors and Mental Disorders

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
66 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Motivational Interview plus text message
Arm Type
Experimental
Arm Description
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.
Arm Title
Control Arm
Arm Type
No Intervention
Arm Description
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
Intervention Type
Behavioral
Intervention Name(s)
Motivational Interview plus text message
Intervention Description
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.
Primary Outcome Measure Information:
Title
Self Reported Smoking Abstinence
Description
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
Secondary Outcome Measure Information:
Title
Daily Cigarettes Consumption at 3 Months Among Continuing Smokers
Description
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
Title
Self Reported Seek for Specialized Tobacco Treatment
Description
self reported seek for specialized tobacco treatment after hospitalization
Time Frame
at the third month after randomization
Title
Self Reported Smoking Abstinence
Description
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
Title
Carbon Monoxide Verified Smoking Abstinence
Description
Carbon Monoxide verified Smoking Abstinence at third-month follow up. Abstinence defined as Carbon Monoxide ≤ 6.
Time Frame
At third-month follow up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Erica Cruvinel, MD
Organizational Affiliation
Federal University of Juiz de Fora
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Federal Hospital of Juiz de Fora
City
Juiz de Fora
State/Province
Minas Gerais
ZIP/Postal Code
36038-330
Country
Brazil

12. IPD Sharing Statement

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Text Messaging for Supporting Quit Attempts

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