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OpenTrials
Completed

NCT Number: NCT01746069

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 (positive/negative coximetry test).

Statistical analysis: The analysis of the primary endpoint (positive / negative coximetry test) will be performed using logistic regression.

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Key information

Conditions

Smoking Abnormalities, Multiple Behavior Chromosome Disorders Chronobiology Disorders Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Health Behavior Nervous System Diseases Smith-Magenis Syndrome Smoking Cessation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Health centre Lakuabizkarra

Vitoria-Gasteiz, Alava, 01009, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Quit smoking combined cessation programme

Behavioral

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

health advice

Behavioral

routine clinical practice

Primary outcomes

  1. Coximetry test (positive/negative)

    Time frame: at 6 months

Secondary outcomes

  1. Continuous abstinence at 6 months: Yes / No

    Time frame: 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.

  2. Abstinence point during the first 7 days self-reported by the patient: Yes / No.

    Time frame: at first week

    Abstinence is defined as not smoking anything punctual during the last seven days.

  3. -Prevalence abstinence at the 4th week self-reported by the patient: Yes / No.

    Time frame: At 4th week

  4. -Prevalence abstinence at 12th week self-reported by the patient: Yes / No.

    Time frame: At 12th week

  5. -Outcome of coxymetry test at 12 months of start: Positive / Negative.

    Time frame: at 12 months

    Only in patients with a negative result in the 6 months test

  6. Number of messages requested by the patient anxiety.

    Time frame: at 12 months

  7. slip: Yes / No.

    Time frame: at 12 months

    Treated as the first use (consumption point) after a period of abstinence

  8. - Relapse: Yes / No.

    Time frame: At 12 months

    Relapse is defined to return dependent behavior that had tried to change, recovering or not the baseline levels before treatment.

  9. Number of messages relapse-slip timely requested by the patient.

    Time frame: At 12 months

Other outcomes

  1. other variables

    Time frame: at baseline

    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).

Sponsors and collaborators

Lead sponsor

Basque Health Service

Other Gov

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Dec 10, 2012
Registry last updated
Oct 21, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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