This study is currently recruiting participants.
Verified January 2014 by Basque Health Service
Information provided by (Responsible Party):
Raquel Cobos Campos, Basque Health Service
ClinicalTrials.gov Identifier:
First received: December 7, 2012
Last updated: January 7, 2014
Last verified: January 2014

Smoking remains a major risk factor for chronic diseases and is a real problem for health systems. The use of emerging technologies, such as mobile phone , may have a important role in smoking cessation programs through sending reinforcement messages when patients quits smoking.

Main objective: To evaluate the effectiveness of a combined 6 months smoking cessation program including health advice provided by a doctor and sending support messages to mobile phone of patients.

Methods: Study design: Randomized single blind clinical trial. Study population: Patients over 18 who are willing to start a smoking cessation program, who have mobile phone, who are able to receive and send messages, and who have a score greater than 5 or equal to 5 on the Richmond scale.

Sample size: 160 patients per arm to detect a difference in the percentage of smoking cessation than 10% (14.9% vs. 4.9%) between the two groups. Intervention: Experimental group: Health advice and support messages to mobile phone patients.

Control group: Health advice. Assessment of the primary endpoint: At 6 months (positive/negative coximetry test).

Statistical analysis: The analysis of the primary endpoint (positive / negative coximetry test) will be performed using logistic regression.

Condition Intervention
Behavioral: Quit smoking combined cessation programme

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Evaluation of a Reinforcement Program Using Text Messages Through Mobile Phone in Smoking Cessation Programs in Primary Care

Resource links provided by NLM:

Further study details as provided by Basque Health Service:

Primary Outcome Measures:
  • Coximetry test (positive/negative) [ Time Frame: at 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Continuous abstinence at 6 months: Yes / No [ Time Frame: At 6 months ] [ Designated as safety issue: No ]
    Continuous Abstinence is defined as smoking more than 5 cigarettes since the beginning of the follow-up period self-reported by the patient.

  • Abstinence point during the first 7 days self-reported by the patient: Yes / No. [ Time Frame: at first week ] [ Designated as safety issue: No ]
    Abstinence is defined as not smoking anything punctual during the last seven days.

  • -Prevalence abstinence at the 4th week self-reported by the patient: Yes / No. [ Time Frame: At 4th week ] [ Designated as safety issue: No ]
  • -Prevalence abstinence at 12th week self-reported by the patient: Yes / No. [ Time Frame: At 12th week ] [ Designated as safety issue: No ]
  • -Outcome of coxymetry test at 12 months of start: Positive / Negative. [ Time Frame: at 12 months ] [ Designated as safety issue: No ]
    Only in patients with a negative result in the 6 months test

  • Number of messages requested by the patient anxiety. [ Time Frame: at 12 months ] [ Designated as safety issue: No ]
  • slip: Yes / No. [ Time Frame: at 12 months ] [ Designated as safety issue: No ]
    Treated as the first use (consumption point) after a period of abstinence

  • - Relapse: Yes / No. [ Time Frame: At 12 months ] [ Designated as safety issue: No ]
    Relapse is defined to return dependent behavior that had tried to change, recovering or not the baseline levels before treatment.

  • Number of messages relapse-slip timely requested by the patient. [ Time Frame: At 12 months ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • other variables [ Time Frame: at baseline ] [ Designated as safety issue: No ]
    Sex (male / female), age (years), number of cigarettes per day before starting program, age of start smoking (years), smoke related pathology (Yes/No), score on the anxiety scale Goldberg, previous attempts to quit smoking (Yes / No if yes, specify number of attempts and reasons for relapse), ), smoking dependence fagerström test score), type of smoker (occasional / daily).

Estimated Enrollment: 320
Study Start Date: February 2013
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: health advice
Experimental: Quit smoking combined cessation programme
Health advice and support sms messages to patient's mobile phone
Behavioral: Quit smoking combined cessation programme
Support sms messages to patient's mobile phone and health advice


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Over 18 years.
  • Current smoker (25): Current smoker is defined as the person who at the time of the study beginning declares that smoked daily or occasionally.
  • Possessing mobile phone.
  • Able to receive and send messages through mobile phone.
  • Score greater than 5 or equal to 5 on the Richmond scale

Exclusion criteria:

  • People with a history of mental and behavioral disorders.
  • Patients with a diagnosis of depression using the depression subscale of Goldberg (two or more positive responses).
  • Patients who with pharmacological therapy for smoking cessation or who require it throughout the study.
  • Pregnant women.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01746069

Health centre Lakuabizkarra Recruiting
Vitoria-Gasteiz, Alava, Spain, 01009
Contact: Raquel Cobos    945007413    raquel.coboscampos@osakidetza.net   
Sub-Investigator: Antxon Apiñaniz         
Sponsors and Collaborators
Basque Health Service
  More Information

No publications provided

Responsible Party: Raquel Cobos Campos, pharmaceutical, Basque Health Service
ClinicalTrials.gov Identifier: NCT01746069     History of Changes
Other Study ID Numbers: TAB-01
Study First Received: December 7, 2012
Last Updated: January 7, 2014
Health Authority: Spain: Ethics Committee

Keywords provided by Basque Health Service:
smoke cessation
quit smoke

Additional relevant MeSH terms:

ClinicalTrials.gov processed this record on April 17, 2014