Text Messaging for Supporting Quit Attempts

Tobacco Use Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02571244
• Other study ID #: 0022.420.000-11
• Status: Completed
• Phase: N/A
• Start date: June 2015
• Est. completion date: March 8, 2016

Study information

• Verified date: October 2017
• Source: Federal University of Juiz de Fora
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: March 8, 2016
• Est. primary completion date: January 2016
• 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:
• Motivational Interview plus text message
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.

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

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	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.	At the third month after randomization
Secondary	Self Reported Seek for Specialized Tobacco Treatment	self reported seek for specialized tobacco treatment after hospitalization	at the third 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