Effectiveness of Messages to Mobile Phone in Smoke Cessation

NCT ID: NCT01746069

Last Updated: 2015-10-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 320 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-03-31
• Study Completion Date: 2015-10-31

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.

Conditions

Smoking

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

health advice

clinical practice routine

Group Type: PLACEBO_COMPARATOR

health advice

Intervention Type: BEHAVIORAL

routine clinical practice

Quit smoking combined cessation programme

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

Group Type: EXPERIMENTAL

Quit smoking combined cessation programme

Intervention Type: BEHAVIORAL

Support sms messages to patient's mobile phone and health advice

Interventions

Quit smoking combined cessation programme

Support sms messages to patient's mobile phone and health advice

Intervention Type: BEHAVIORAL

health advice

routine clinical practice

Intervention Type: BEHAVIORAL

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Basque Health Service

OTHER_GOV

Sponsor Role: lead

Responsible Party

Raquel Cobos Campos

pharmaceutical

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Health centre Lakuabizkarra

Vitoria-Gasteiz, Alava, Spain

Countries

Spain

Other Identifiers

TAB-01

Identifier Type: -

Identifier Source: org_study_id