Effectiveness of Messages to Mobile Phone in Smoke Cessation

Basque Health Service

Status: Completed

Conditions: Smoking

Treatments: Behavioral: health advice; Behavioral: Quit smoking combined cessation programme

Study type: Interventional

Funder types: Other

Identifiers

NCT01746069

TAB-01

Details and patient eligibility

About

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.

Enrollment: 320 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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320 participants in 2 patient groups, including a placebo group

health advice

Placebo Comparator group

Description:

clinical practice routine

Treatment:

Behavioral: health advice

Quit smoking combined cessation programme

Experimental group

Description:

Health advice and support sms messages to patient's mobile phone + clinical routine practice

Treatment:

Behavioral: Quit smoking combined cessation programme