SmokingNCT01746069
Effectiveness of Messages to Mobile Phone in Smoke Cessation
A study testing Quit smoking combined cessation programme and health advice in people with Smoking, run by Basque Health Service at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Smoking
- What is being tested?
- Quit smoking combined cessation programme and health advice
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 320 participants
- Where
- 1 siteSpain
- Study dates
- Mar 2013to Oct 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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
- Being tested
- Quit smoking combined cessation programme, health advice
- Keywords
- smoking, smoke cessation, sms, quit smoke
- Medical subject headings
- Smoking, Smoking Cessation, Smith-Magenis Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quit smoking combined cessation programmeBehavioural
Support sms messages to patient's mobile phone and health advice
health adviceBehavioural
routine clinical practice
| Study group | Role | What they receive |
|---|---|---|
| health advice | Placebo comparator | clinical practice routine Receives: Behavioral: health advice |
| Quit smoking combined cessation programme | Experimental | Health advice and support sms messages to patient's mobile phone + clinical routine practice Receives: Behavioral: Quit smoking combined cessation programme |
What is being measured
The primary outcome is the main question the study is designed to answer.
Coximetry test (positive/negative)
Measured: at 6 months
Secondary outcomes (9)
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.
Measured: 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.
Measured: at first week
-Prevalence abstinence at the 4th week self-reported by the patient: Yes / No.
Measured: At 4th week
-Prevalence abstinence at 12th week self-reported by the patient: Yes / No.
Measured: 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
Measured: at 12 months
Number of messages requested by the patient anxiety.
Measured: at 12 months
slip: Yes / No.
Treated as the first use (consumption point) after a period of abstinence
Measured: 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.
Measured: At 12 months
Number of messages relapse-slip timely requested by the patient.
Measured: At 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2012 (estimated)
- Study startMar 2013
- Primary completionMar 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SmokingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 320 participants (actual)
Sponsor and investigators
- Lead sponsor
- Basque Health Service
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Raquel Cobos Campos, Basque Health Service
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01746069
- Sponsor's protocol ID
- TAB-01
- Status last verified
- Oct 2015
- First submitted
- 7 Dec 2012
- Last updated
- 21 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Reinforcement Program Using Text Messages Through Mobile Phone in Smoking Cessation Programs in Primary Care
- ClinicalTrials.gov ID
- NCT01746069
- Acronym / sponsor ID
- TAB-01
- Conditions
- Smoking
- Keywords
- smoking, smoke cessation, sms, quit smoke
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 320 participants (actual)
- Lead sponsor
- Basque Health ServiceOther government
- Study start
- Mar 2013
- Primary completion
- Mar 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 10 Dec 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| health advice | Placebo comparator | Behavioral: health adviceclinical practice routine |
| Quit smoking combined cessation programme | Experimental | Behavioral: Quit smoking combined cessation programmeHealth advice and support sms messages to patient's mobile phone + clinical routine practice |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Quit smoking combined cessation programmeSupport sms messages to patient's mobile phone and health advice | Behavioural | Quit smoking combined cessation programme |
| health adviceroutine clinical practice | Behavioural | health advice |
Primary outcome
Coximetry test (positive/negative)
Time frame: at 6 months
9 secondary outcomes
Continuous abstinence at 6 months: Yes / No
Time frame: At 6 months
Abstinence point during the first 7 days self-reported by the patient: Yes / No.
Time frame: at first week
-Prevalence abstinence at the 4th week self-reported by the patient: Yes / No.
Time frame: At 4th week
-Prevalence abstinence at 12th week self-reported by the patient: Yes / No.
Time frame: At 12th week
-Outcome of coxymetry test at 12 months of start: Positive / Negative.
Time frame: at 12 months
Number of messages requested by the patient anxiety.
Time frame: at 12 months
slip: Yes / No.
Time frame: at 12 months
- Relapse: Yes / No.
Time frame: At 12 months
Number of messages relapse-slip timely requested by the patient.
Time frame: At 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Quit smoking combined cessation programme and health advice in people with Smoking, run by Basque Health Service at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Coximetry test (positive/negative) (time frame: at 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2015.