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Completed

NCT Number: NCT03237949

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Federal Hospital of Juiz de Fora

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

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Phone counseling

Behavioral

Four telephone counseling sessions using a motivational interviewing approach

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.

Primary outcomes

  1. Self Reported Smoking Abstinence

    Time frame: 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 outcomes

  1. Self Reported Smoking Abstinence

    Time frame: Smoking abstinence at the third month after randomization

    No smoking (even a puff) in the past 7 days at the third month after randomization.

  2. Carbon monoxide verified Smoking Abstinence

    Time frame: At third-month follow up

    Carbon monoxide verified Smoking Abstinence at third-month follow up. Abstinence defined as Carbon monoxide ≤ 6.

  3. Reduction of Daily Cigarettes Consumption From Baseline

    Time frame: At the third month after randomization

    The self reported daily cigarettes consumption at the third month after randomization will be compared to the baseline.

Sponsors and collaborators

Lead sponsor

Federal University of Juiz de Fora

Other

Collaborators

  • University of Kansas Medical Center

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2019
Study completion
2020
First posted
Aug 3, 2017
Registry last updated
Jul 2, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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