Effectiveness of Messages to Mobile Phone in Smoke Cessation
- Conditions
- Smoking
- Interventions
- Behavioral: health adviceBehavioral: Quit smoking combined cessation programme
- Registration Number
- NCT01746069
- Lead Sponsor
- Basque Health Service
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 320
- 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.
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description health advice health advice clinical practice routine Quit smoking combined cessation programme Quit smoking combined cessation programme Health advice and support sms messages to patient's mobile phone + clinical routine practice
- Primary Outcome Measures
Name Time Method Coximetry test (positive/negative) at 6 months
- Secondary Outcome Measures
Name Time Method Number of messages requested by the patient anxiety. at 12 months -Prevalence abstinence at the 4th week self-reported by the patient: Yes / No. At 4th week Number of messages relapse-slip timely requested by the patient. At 12 months slip: Yes / No. at 12 months Treated as the first use (consumption point) after a period of abstinence
-Outcome of coxymetry test at 12 months of start: Positive / Negative. at 12 months Only in patients with a negative result in the 6 months test
- Relapse: Yes / No. At 12 months Relapse is defined to return dependent behavior that had tried to change, recovering or not the baseline levels before treatment.
Continuous abstinence at 6 months: Yes / No At 6 months 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. at first week Abstinence is defined as not smoking anything punctual during the last seven days.
-Prevalence abstinence at 12th week self-reported by the patient: Yes / No. At 12th week
Trial Locations
- Locations (1)
Health centre Lakuabizkarra
🇪🇸Vitoria-Gasteiz, Alava, Spain