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Text Messaging and Telephone Counseling for Supporting Post-discharge Quit Attempts

Primary Purpose

Tobacco Use Cessation, Tobacco Use Disorder

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Phone counseling
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

Active Comparator

Experimental

Arm Label

Phone counseling

Text message

Arm Description

The patient will receive standard care inside the hospital. After discharge the active comparator group will receive four phone counseling sessions. The sessions will provide basic information about smoking and successful quitting. The counselor will use motivational interview techniques to build coping skills with the goal of helping the participant build and implement a quit plan. The counseling timing, duration, and content will be consistent with guideline-based recommendations.

The patient will receive standard care inside the hospital. After discharge the experimental group will receive extended care including text messages. Participants in this arm will be offered up to 30 text messages to help implement the quit plan discussed during the hospitalization. Patients motivated to quit in the next 30 days or that had already quit will receive 30 messages and patients unwilling to quit will receive 16 messages. The messages content follows the self efficacy theory.

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

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.
Reduction of Daily Cigarettes Consumption From Baseline
The self reported daily cigarettes consumption at the third month after randomization will be compared to the baseline.

Full Information

First Posted
July 31, 2017
Last Updated
June 30, 2020
Sponsor
Federal University of Juiz de Fora
Collaborators
University of Kansas Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT03237949
Brief Title
Text Messaging and Telephone Counseling for Supporting Post-discharge Quit Attempts
Official Title
Comparative Effectiveness of Text Messaging and Telephone Counseling for Supporting Post-discharge Quit Attempts Among Hospitalized Smokers in Brazil
Study Type
Interventional

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
May 30, 2017 (Actual)
Primary Completion Date
December 31, 2019 (Actual)
Study Completion Date
January 31, 2020 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This is an extension of a previous feasibility study (Clinical Trials Registry - NCT02571244). The actual study is a research aimed to compare the effectiveness of telephone counseling and personalized text messages (TM) for supporting post-discharge quit attempts among hospitalized smokers, with focus on smoking cessation as the main outcome. Smokers patients will receive brief interventions and nicotine replacement therapy during the hospitalization. After discharge smoker patients will be allocated into a intervention or control arm. In the first and third months, after randomization, the patients will be contact to smoke abstinence assessment.
Detailed Description
This is an extension of a previous feasibility study (Clinical Trials Registry - NCT02571244). Background: Research suggests that smokers who receive treatment inside the hospital and post-discharge follow up for at least a month is most 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 is compare the effectiveness of personalized text messages (TM) and telephone counseling to support smoking cessation between post discharge patients. Methods: All patients admitted to the University Hospital of Juiz de Fora (HU/UFJF), between 06/2017 to 11/2018, will be asked about the cigarettes consumption in the last 30 days. Smokers patients will receive brief interventions and nicotine replacement therapy during hospitalization. After discharge these patients will be allocated into an intervention or control arm. The intervention group will receive mobile phone TM twice a day up to fifteen days. The control group will receive usual care (four telephone counseling sessions using motivational interviewing approach). Results: At the first and third months, after randomization, the patients will be 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
400 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Phone counseling
Arm Type
Active Comparator
Arm Description
The patient will receive standard care inside the hospital. After discharge the active comparator group will receive four phone counseling sessions. The sessions will provide basic information about smoking and successful quitting. The counselor will use motivational interview techniques to build coping skills with the goal of helping the participant build and implement a quit plan. The counseling timing, duration, and content will be consistent with guideline-based recommendations.
Arm Title
Text message
Arm Type
Experimental
Arm Description
The patient will receive standard care inside the hospital. After discharge the experimental group will receive extended care including text messages. Participants in this arm will be offered up to 30 text messages to help implement the quit plan discussed during the hospitalization. Patients motivated to quit in the next 30 days or that had already quit will receive 30 messages and patients unwilling to quit will receive 16 messages. The messages content follows the self efficacy theory.
Intervention Type
Behavioral
Intervention Name(s)
Phone counseling
Intervention Description
Four telephone counseling sessions using a motivational interviewing approach
Intervention Type
Behavioral
Intervention Name(s)
Text message
Intervention Description
30 messages (2 per day) and patients unwilling to quit 16 (2 per day). The messages follows the self efficacy theory. The messages follows 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
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
Title
Reduction of Daily Cigarettes Consumption From Baseline
Description
The self reported daily cigarettes consumption at the third month after randomization will be compared to the baseline.
Time Frame
At the third month after randomization

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
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

Plan to Share IPD
No
Citations:
PubMed Identifier
35346351
Citation
do Amaral LM, Ronzani TM, Cruvinel E, Richter K, Oliveira Andrade R, Lanzieri IO, de Macedo ACDAD, Leite ICG. Text messaging interventions to support smoking cessation among hospitalized patients in Brazil: a randomized comparative effectiveness clinical trial. BMC Res Notes. 2022 Mar 26;15(1):119. doi: 10.1186/s13104-022-06002-6.
Results Reference
derived
Available IPD and Supporting Information:
Available IPD/Information Type
Study Protocol
Available IPD/Information URL
https://clinicaltrials.gov
Available IPD/Information Identifier
NCT02571244
Available IPD/Information Comments
This protocol is an extension of a previous research:Telephone Counseling and Text Messaging for Supporting Post-discharge Quit Attempts Among Hospitalized Smokers in Brazil, a feasibility study.

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Text Messaging and Telephone Counseling for Supporting Post-discharge Quit Attempts

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