EFFECTIVENESS OF MESSAGES TO MOBILE PHONE IN SMOKE CESSATION

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by Basque Health Service
Sponsor:
Information provided by (Responsible Party):
Raquel Cobos Campos, Basque Health Service
ClinicalTrials.gov Identifier:
NCT01746069
First received: December 7, 2012
Last updated: January 7, 2014
Last verified: January 2014
  Purpose

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
Smoking
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

  Eligibility

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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01746069

Locations
Spain
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:
smoking
smoke cessation
sms
quit smoke

ClinicalTrials.gov processed this record on August 28, 2014