Tobacco SmokingNCT02028962
Computer Tailored Program for Smoking Cessation Among Romanian Adults
A study testing Lifestyle counseling in people with Tobacco Smoking, run by Iuliu Hatieganu University of Medicine and Pharmacy at 1 site in Romania.
Trial summary
The research aim is the development, implementation and evaluation of the first computer tailored smoking cessation progam for Romanian adult smokers. It will be implemented among smokers from Romania aged 20-60 years. Read more about this study
- Who is it for?
- Ages 20 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Tobacco Smoking
- What is being tested?
- Lifestyle counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 640 participants
- Where
- 1 siteRomania
- Study dates
- Oct 2013to Nov 2014
- 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 20 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- smokers (smoked in the last 7 days)who intend to quit smoking in the next 6 months
Who cannot join
- non-smokers
- smokers who do not intend to quit smoking in the next 6 months
Trial locations and contacts
1 site in 1 country.
Romania1 site, 1 recruiting
- Recruiting
Iuliu Hatieganu University of Medicine and Pharmacy
Cluj-Napoca, Cluj, 400340
Lucia M Lotrean, MD, PhD, 0040724367460, llotrean@umfcluj.ro
Lucia M Lotrean, MD, PhD
About this study
Official title: Development, Implementation and Evaluation of a Computer Tailored Program for Smoking Cessation Among Romanian Adults
The research aim is the development, implementation and evaluation of the first computer tailored smoking cessation progam for Romanian adult smokers. It will be implemented among smokers from Romania aged 20-60 years. The participants will beneficiate of tailored information received in letters generated by using sophisticated computer algorithms, allowing the creation of highly individualized messages that address each individual's unique needs, motivations and beliefs related to smoking .
Program implementation will comprise of :
Read more
- ''diagnosis'' by means of questionnaires at the individual level of characteristics that are relevant for a person's smoking behavior
- development of the ''message library'' that contains all education messages that may be needed
- development of an ''algorithm'', a set of decision rules that evaluates the diagnosis, selects and generates messages tailored to the specific needs of the individual user
- generating of personalized letters for each participant
- sending of theses personalized letters to the participants. The participants will receive three personalized letters during a period of six months after registration into the program.
The effects of the program will be evaluated with a randomized controlled trial which will assess the changes in smoking behaviour as well as smoking related attitudes, self-efficacy and quiting attempts at 6 months after the enrolment into the program.
A process evaluation will assess participants' opinion about the program.
- Conditions
- Tobacco Smoking
- Being tested
- Lifestyle counseling
- Keywords
- Smoking cessation, Romanian adults
- Medical subject headings
- Tobacco Smoking, Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lifestyle counselingBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Lifestyle counseling | Experimental | The experimental group will receive three letters with advices for smoking cessation-the first letter after the enrolment in the study, the second one one month after the first letter, the third one three months after the first letter Receives: Behavioral: Lifestyle counseling |
| Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
abstinence from smoking in the last 7 days
Measured: baseline and 6 months after
Secondary outcomes (3)
quiting attempts in the last 6 months
Measured: baseline and 6 months after
smoking related attitudes
Measured: baseline and six months after
self-eficacy in quiting smoking
Measured: baseline and 6 months after
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2014 (estimated)
- Study startOct 2013
- Primary completionAug 2014 (estimated)
- Study completionNov 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tobacco 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 640 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Iuliu Hatieganu University of Medicine and Pharmacy
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lucia Maria Lotrean, Iuliu Hatieganu University of Medicine and Pharmacy
- Investigators
- Lucia M Lotrean, MD, PhD, Principal investigator, Iuliu Hatieganu University of Medicine and Pharmacy, Cluj-Napoca, Romania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02028962
- Sponsor's protocol ID
- Renuntlafumat
- Status last verified
- Jan 2014
- First submitted
- 6 Jan 2014
- Last updated
- 7 Jan 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development, Implementation and Evaluation of a Computer Tailored Program for Smoking Cessation Among Romanian Adults
- ClinicalTrials.gov ID
- NCT02028962
- Acronym / sponsor ID
- Renuntlafumat
- Conditions
- Tobacco Smoking
- Keywords
- Smoking cessation, Romanian adults
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 640 participants (estimated)
- Lead sponsor
- Iuliu Hatieganu University of Medicine and PharmacyUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- Aug 2014 (estimated)
- Study completion
- Nov 2014 (estimated)
- First posted
- 7 Jan 2014 (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.
The research aim is the development, implementation and evaluation of the first computer tailored smoking cessation progam for Romanian adult smokers. It will be implemented among smokers from Romania aged 20-60 years. The participants will beneficiate of tailored information received in letters generated by using sophisticated computer algorithms, allowing the creation of highly individualized messages that address each individual's unique needs, motivations and beliefs related to smoking .
Program implementation will comprise of :
- ''diagnosis'' by means of questionnaires at the individual level of characteristics that are relevant for a person's smoking behavior
- development of the ''message library'' that contains all education messages that may be needed
- development of an ''algorithm'', a set of decision rules that evaluates the diagnosis, selects and generates messages tailored to the specific needs of the individual user
- generating of personalized letters for each participant
- sending of theses personalized letters to the participants. The participants will receive three personalized letters during a period of six months after registration into the program.
The effects of the program will be evaluated with a randomized controlled trial which will assess the changes in smoking behaviour as well as smoking related attitudes, self-efficacy and quiting attempts at 6 months after the enrolment into the program.
A process evaluation will assess participants' opinion about the program.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lifestyle counseling | Experimental | Behavioral: Lifestyle counselingThe experimental group will receive three letters with advices for smoking cessation-the first letter after the enrolment in the study, the second one one month after the first letter, the third one three months after the first letter |
| Control | No intervention | – |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- smokers (smoked in the last 7 days)who intend to quit smoking in the next 6 months
Key exclusion criteria (2 listed)
- non-smokers
- smokers who do not intend to quit smoking in the next 6 months
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 |
|---|---|---|
| Lifestyle counseling | Behavioural | Lifestyle counseling |
Primary outcome
abstinence from smoking in the last 7 days
Time frame: baseline and 6 months after
3 secondary outcomes
quiting attempts in the last 6 months
Time frame: baseline and 6 months after
smoking related attitudes
Time frame: baseline and six months after
self-eficacy in quiting smoking
Time frame: baseline and 6 months after
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2014.
- Related InfoLink provided by the sponsor.
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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.
Lucia M Lotrean, MD, PhD principal investigator
Iuliu Hatieganu University of Medicine and Pharmacy, Cluj-Napoca, Romania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lifestyle counseling in people with Tobacco Smoking, run by Iuliu Hatieganu University of Medicine and Pharmacy at 1 site in Romania.
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 1 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 7 Jan 2014. 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 Romania. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lucia M Lotrean, MD, PhD (0040724367460, llotrean@umfcluj.ro), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
abstinence from smoking in the last 7 days (time frame: baseline and 6 months after). 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 7 Jan 2014.