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

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

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.

Study Overview

• Status: Completed
• Conditions: Tobacco Use Disorder; Tobacco Use Cessation
• Intervention / Treatment: Behavioral: Phone counseling; Behavioral: Text message

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 Type: Interventional
• Enrollment (Actual): 400
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • Minas Gerais
    • Juiz de Fora, Minas Gerais, Brazil, 36038-330
      • University Federal Hospital of Juiz de Fora

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Phone counseling; 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.	Behavioral: Phone counseling; Four telephone counseling sessions using a motivational interviewing approach
Experimental: Text message; 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.	Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: Federal University of Juiz de Fora
• Collaborators: University of Kansas Medical Center

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 30, 2017
• Primary Completion (Actual): December 31, 2019
• Study Completion (Actual): January 31, 2020

Study Registration Dates

• First Submitted: July 31, 2017
• First Submitted That Met QC Criteria: July 31, 2017
• First Posted (Actual): August 3, 2017

Study Record Updates

• Last Update Posted (Actual): July 2, 2020
• Last Update Submitted That Met QC Criteria: June 30, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Keywords: Motivational Interview; Substance-Related Disorders; Tobacco Use Disorder; Hospitalized patients; Text message; Behaviors and Mental Disorders
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; Tobacco Use Disorder
• Other Study ID Numbers: 1.939.046

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Study Data/Documents

1. Study Protocol
   Information identifier: NCT02571244
   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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No