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

NCT ID: NCT03237949

Last Updated: 2020-07-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 400 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-05-30
• Study Completion Date: 2020-01-31

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.

Conditions

Tobacco Use Cessation; Tobacco Use Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Phone counseling

Intervention Type: BEHAVIORAL

Four telephone counseling sessions using a motivational interviewing approach

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.

Group Type: EXPERIMENTAL

Text message

Intervention Type: 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.

Interventions

Phone counseling

Four telephone counseling sessions using a motivational interviewing approach

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Kansas Medical Center

OTHER

Sponsor Role: collaborator

Federal University of Juiz de Fora

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University Federal Hospital of Juiz de Fora

Juiz de Fora, Minas Gerais, Brazil

Countries

Brazil

References

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.

Reference Type: DERIVED

PMID: 35346351 (View on PubMed)

Study Documents

Document Type: Study Protocol

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.

View Document

Other Identifiers

1.939.046

Identifier Type: -

Identifier Source: org_study_id