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

Not Applicable

Completed

• Conditions: Tobacco Use Cessation; Tobacco Use Disorder

• Registration Number: NCT03237949
• Lead Sponsor: Federal University of Juiz de Fora

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.

Study Timeline

• Study Start: 2017-05-30
• Study First Submitted: 2017-07-31
• Study First Submitted QC: 2017-07-31
• Study First Posted: 2017-08-03
• Primary Completion: 2019-12-31
• Study Completion: 2020-01-31
• Status Verified: 2020-06
• Last Update Submitted: 2020-06-30
• Last Update Posted: 2020-07-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 400

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Self Reported Smoking Abstinence	Smoking abstinence at the first month after randomization	No smoking (even a puff) in the past 7 days at the first month follow up.

Secondary Outcome Measures

Name	Time	Method
Self Reported Smoking Abstinence	Smoking abstinence at the third month after randomization	No smoking (even a puff) in the past 7 days at the third month after randomization.
Reduction of Daily Cigarettes Consumption From Baseline	At the third month after randomization	The self reported daily cigarettes consumption at the third month after randomization will be compared to the baseline.
Carbon monoxide verified Smoking Abstinence	At third-month follow up	Carbon monoxide verified Smoking Abstinence at third-month follow up. Abstinence defined as Carbon monoxide ≤ 6.

Trial Locations

Locations (1)

University Federal Hospital of Juiz de Fora; 🇧🇷 Juiz de Fora, Minas Gerais, Brazil