NCT02571244

Brief Summary

This study is a preliminary research aimed to compare the feasibility and effectiveness of motivational interview (MI), Personalized text messages (TM) and usual care for outpatients, with focus on smoking cessation as the main outcome. Smokers patients have received brief interventions and nicotine replacement therapy during the hospitalization. After discharge smokers were allocated into a intervention or control arm. In the first and third months, after randomization, the patients were contact to smoke abstinence assessment.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
66

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2015

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2015

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

September 24, 2015

Completed
14 days until next milestone

First Posted

Study publicly available on registry

October 8, 2015

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 8, 2016

Completed
2.4 years until next milestone

Results Posted

Study results publicly available

July 30, 2018

Completed
Last Updated

July 30, 2018

Status Verified

October 1, 2017

Enrollment Period

7 months

First QC Date

September 24, 2015

Results QC Date

March 28, 2017

Last Update Submit

October 26, 2017

Conditions

Keywords

Tobacco Use DisorderHospitalized patientsText messageMotivational InterviewSubstance-Related DisordersBehaviors 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 (4)

  • Daily Cigarettes Consumption at 3 Months Among Continuing Smokers

    At the third month after randomization

  • Self Reported Seek for Specialized Tobacco Treatment

    at the third month after randomization

  • Self Reported Smoking Abstinence

    Smoking abstinence at the third month after randomization

  • Carbon Monoxide Verified Smoking Abstinence

    At third-month follow up

Study Arms (2)

Motivational Interview plus text message

EXPERIMENTAL

Inside the hospital: All participants have received the written materials. Patients with high tobacco dependence (Fagerstrom screening test score 5 or higher) have received also Nicotine Replacement Therapy (NRT). The written materials provided information on benefits of quitting and strategies for a successful quit plan, including information on relapse prevention. Post discharge extended treatment: Participants in this arm have received a telephone counseling session using a motivational interviewing approach and fifteen or eight days of text messages. The timing, duration, and content of the counseling session were consistent with guideline-based recommendations.

Behavioral: Motivational Interview plus text message

Control Arm

NO INTERVENTION

Inside the hospital: All participants have receive the written materials. Patients with high tobacco dependence (Fagerstrom screening test score 5 or higher) have received also Nicotine Replacement Therapy (NRT). The written materials provided information on benefits of quitting and strategies for a successful quit plan, including information on relapse prevention. Post discharge extended care: None

Interventions

After discharge the experimental group has received extended care including a counseling session and text messages. The session provided basic information about smoking and successful quitting. The counselor has used motivational interview techniques to build coping skills with the goal of helping the participant build and implement a quit plan. The focus was to increase motivation to make quit attempt, including confidence building, medication use, and cessation planning. The session lasted approximately 30 minutes. Participants in the experimental arm were offered up to 30 text messages to help them to implement the quit plan discussed during the phone call. Patients motivated to quit in the next 30 days or those that had already quit have received 30 messages (2 per day) and patients unwilling to quit 16 (2 per day). The messages followed the self efficacy theory.

Motivational Interview plus text message

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Federal Hospital of Juiz de Fora

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

Location

MeSH Terms

Conditions

Tobacco Use CessationTobacco Use DisorderSubstance-Related DisordersBehaviorMental Disorders

Interventions

Motivational Interviewing

Condition Hierarchy (Ancestors)

Health BehaviorChemically-Induced Disorders

Intervention Hierarchy (Ancestors)

Directive CounselingCounselingMental Health ServicesBehavioral Disciplines and ActivitiesHealth ServicesHealth Care Facilities Workforce and Services

Results Point of Contact

Title
Dr. Erica Cruvinel
Organization
Federal University of Juiz de Fora/Brazil

Study Officials

  • Erica Cruvinel, MD

    Federal University of Juiz de Fora

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Master degree, PhD student

Study Record Dates

First Submitted

September 24, 2015

First Posted

October 8, 2015

Study Start

June 1, 2015

Primary Completion

January 1, 2016

Study Completion

March 8, 2016

Last Updated

July 30, 2018

Results First Posted

July 30, 2018

Record last verified: 2017-10

Locations