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

NCT03237949 | Completed

• 1 other identifier: 1.939.046
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

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.

Conditions

Tobacco Use Cessation; Tobacco Use Disorder

Keywords

Tobacco Use Disorder; Hospitalized patients; Text message; Motivational Interview; Substance-Related Disorders; Behaviors and Mental Disorders

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Self Reported Smoking Abstinence

  Smoking abstinence at the third month after randomization

• Carbon monoxide verified Smoking Abstinence

  At third-month follow up

• Reduction of Daily Cigarettes Consumption From Baseline

  At the third month after randomization

Study Arms (2)

Phone counseling

ACTIVE COMPARATOR

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

Text message

EXPERIMENTAL

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

Interventions

Phone counseling BEHAVIORAL

Four telephone counseling sessions using a motivational interviewing approach

Phone counseling

Text message BEHAVIORAL

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.

Text message

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Don't have a mobile phone
• Unstable cognitive or physical condition
• Physical or breath contact restrictions
• Intensive care units

Sponsors & Collaborators

• Federal University of Juiz de Fora: lead
• University of Kansas Medical Center: collaborator

Study Sites (1)

University Federal Hospital of Juiz de Fora

Juiz de Fora, Minas Gerais, 36038-330, Brazil

Location

Related Publications (1)

• 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.

  PMID: 35346351 DERIVED

MeSH Terms

Conditions

Tobacco Use Cessation; Tobacco Use Disorder; Substance-Related Disorders; Behavior; Mental Disorders

Condition Hierarchy (Ancestors)

Health Behavior; Chemically-Induced Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 31, 2017
• First Posted: August 3, 2017
• Study Start: May 30, 2017
• Primary Completion: December 31, 2019
• Study Completion: January 31, 2020
• Last Updated: July 2, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)