EFFECTIVENESS OF MESSAGES TO MOBILE PHONE IN SMOKE CESSATION
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 salivary cotinine test. Statistical analysis: The analysis of the primary endpoint (positive / negative salivary cotinine test) will be performed using logistic regression.
|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|
- Test result salivary cotinine (positive/negative) [ Time Frame: at six months ] [ Designated as safety issue: No ]
- 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 salivary cotinine 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 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).
|Study Start Date:||February 2013|
|Estimated Study Completion Date:||June 2014|
|Estimated Primary Completion Date:||August 2013 (Final data collection date for primary outcome measure)|
|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
|Health centre Lakuabizkarra||Recruiting|
|Vitoria-Gasteiz, Alava, Spain, 01009|
|Contact: Raquel Cobos 945007413 firstname.lastname@example.org|
|Sub-Investigator: Antxon Apiñaniz|