Computer Tailored Program for Smoking Cessation Among Romanian Adults

NCT ID: NCT02028962

Last Updated: 2014-01-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

640 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-10-31

Study Completion Date

2014-11-30

Brief Summary

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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 :

1. ''diagnosis'' by means of questionnaires at the individual level of characteristics that are relevant for a person's smoking behavior
2. development of the ''message library'' that contains all education messages that may be needed
3. 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
4. generating of personalized letters for each participant
5. 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.

Detailed Description

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Conditions

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Tobacco Smoking

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Lifestyle counseling

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

Group Type EXPERIMENTAL

Lifestyle counseling

Intervention Type BEHAVIORAL

Control

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Lifestyle counseling

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* smokers (smoked in the last 7 days)who intend to quit smoking in the next 6 months

Exclusion Criteria

* non-smokers
* smokers who do not intend to quit smoking in the next 6 months
Minimum Eligible Age

20 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Iuliu Hatieganu University of Medicine and Pharmacy

OTHER

Sponsor Role lead

Responsible Party

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Lucia Maria Lotrean

MD, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Lucia M Lotrean, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Iuliu Hatieganu University of Medicine and Pharmacy, Cluj-Napoca, Romania

Locations

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Iuliu Hatieganu University of Medicine and Pharmacy

Cluj-Napoca, Cluj, Romania

Site Status RECRUITING

Countries

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Romania

Central Contacts

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Lucia M Lotrean, MD, PhD

Role: CONTACT

0040724367460

Facility Contacts

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Lucia M Lotrean, MD, PhD

Role: primary

0040724367460

Related Links

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Other Identifiers

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Renuntlafumat

Identifier Type: -

Identifier Source: org_study_id

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