Effectiveness of Messages to Mobile Phone in Smoke Cessation

Evaluation of a Reinforcement Program Using Text Messages Through Mobile Phone in Smoking Cessation Programs in Primary Care

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.

Study Overview

• Status: Completed
• Conditions: Smoking
• Intervention / Treatment: Behavioral: health advice; Behavioral: Quit smoking combined cessation programme

• Study Type: Interventional
• Enrollment (Actual): 320
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Alava
    • Vitoria-Gasteiz, Alava, Spain, 01009
      • Health centre Lakuabizkarra

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: health advice; clinical practice routine	Behavioral: health advice; routine clinical practice
Experimental: Quit smoking combined cessation programme; Health advice and support sms messages to patient's mobile phone + clinical routine practice	Behavioral: Quit smoking combined cessation programme; Support sms messages to patient's mobile phone and health advice

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Coximetry test (positive/negative)	at 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Continuous abstinence at 6 months: Yes / No	Continuous Abstinence is defined as smoking more than 5 cigarettes since the beginning of the follow-up period self-reported by the patient.	At 6 months
Abstinence point during the first 7 days self-reported by the patient: Yes / No.	Abstinence is defined as not smoking anything punctual during the last seven days.	at first week
-Prevalence abstinence at the 4th week self-reported by the patient: Yes / No.		At 4th week
-Prevalence abstinence at 12th week self-reported by the patient: Yes / No.		At 12th week
-Outcome of coxymetry test at 12 months of start: Positive / Negative.	Only in patients with a negative result in the 6 months test	at 12 months
Number of messages requested by the patient anxiety.		at 12 months
slip: Yes / No.	Treated as the first use (consumption point) after a period of abstinence	at 12 months
- Relapse: Yes / No.	Relapse is defined to return dependent behavior that had tried to change, recovering or not the baseline levels before treatment.	At 12 months
Number of messages relapse-slip timely requested by the patient.		At 12 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
other variables	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).	at baseline

Collaborators and Investigators

• Sponsor: Basque Health Service

Study record dates

Study Major Dates

• Study Start: March 1, 2013
• Primary Completion (Actual): March 1, 2015
• Study Completion (Actual): October 1, 2015

Study Registration Dates

• First Submitted: December 7, 2012
• First Submitted That Met QC Criteria: December 7, 2012
• First Posted (Estimate): December 10, 2012

Study Record Updates

• Last Update Posted (Estimate): October 21, 2015
• Last Update Submitted That Met QC Criteria: October 20, 2015
• Last Verified: October 1, 2015

More Information

Terms related to this study

• Keywords: smoking; smoke cessation; sms; quit smoke
• Other Study ID Numbers: TAB-01