Clinical trial NCT03237949: Text Messaging and Telephone Counseling for Supporting Post-discharge Quit Attempts
Official title: Comparative Effectiveness of Text Messaging and Telephone Counseling for Supporting Post-discharge Quit Attempts Among Hospitalized Smokers in Brazil
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tobacco Use Cessation
Tobacco Use Disorder
Keywords: Tobacco Use Disorder
Hospitalized patients
Text message
Motivational Interview
Substance-Related Disorders
Behaviors and Mental Disorders
Lead sponsor: Federal University of Juiz de Fora
Sponsor class: OTHER
Collaborators: name: University of Kansas Medical Center
First posted: 2017-08-03
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Self Reported Smoking Abstinence
timeFrame: Smoking abstinence at the first month after randomization
Secondary outcomes:
measure: Self Reported Smoking Abstinence
timeFrame: Smoking abstinence at the third month after randomization
measure: Carbon monoxide verified Smoking Abstinence
timeFrame: At third-month follow up
measure: Reduction of Daily Cigarettes Consumption From Baseline
timeFrame: At the third month after randomization
Other outcomes:
Locations:
city: Juiz de Fora
country: Brazil
facility: University Federal Hospital of Juiz de Fora
state: Minas Gerais
Study officials:
References:
citation: 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.