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

Tobacco Use Disorder Clinical Trial

Official title:

Comparative Effectiveness of Text Messaging and Telephone Counseling for Supporting Post-discharge Quit Attempts Among Hospitalized Smokers in Brazil

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03237949
• Other study ID #: 1.939.046
• Status: Completed
• Phase: N/A
• Start date: May 30, 2017
• Est. completion date: January 31, 2020

Study information

• Verified date: June 2020
• Source: Federal University of Juiz de Fora
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: January 31, 2020
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Tobacco Use Cessation
• Tobacco Use Disorder

Intervention

Behavioral:
• Phone counseling
Four telephone counseling sessions using a motivational interviewing approach
• Text message
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.

Locations

Country	Name	City	State
Brazil	University Federal Hospital of Juiz de Fora	Juiz de Fora	Minas Gerais

Sponsors (2)

Lead Sponsor	Collaborator
Federal University of Juiz de Fora	University of Kansas Medical Center

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Self Reported Smoking Abstinence	No smoking (even a puff) in the past 7 days at the first month follow up.	Smoking abstinence at the first month after randomization
Secondary	Self Reported Smoking Abstinence	No smoking (even a puff) in the past 7 days at the third month after randomization.	Smoking abstinence at the third month after randomization
Secondary	Carbon monoxide verified Smoking Abstinence	Carbon monoxide verified Smoking Abstinence at third-month follow up. Abstinence defined as Carbon monoxide = 6.	At third-month follow up
Secondary	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.	At the third month after randomization