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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02028962
Other study ID # Renuntlafumat
Secondary ID
Status Recruiting
Phase N/A
First received January 6, 2014
Last updated January 6, 2014
Start date October 2013
Est. completion date November 2014

Study information

Verified date January 2014
Source Iuliu Hatieganu University of Medicine and Pharmacy
Contact Lucia M Lotrean, MD, PhD
Phone 0040724367460
Email llotrean@umfcluj.ro
Is FDA regulated No
Health authority Romania: National Authority for Scientific Research
Study type Interventional

Clinical 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. 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 640
Est. completion date November 2014
Est. primary completion date August 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 20 Years to 60 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Behavioral:
Lifestyle counseling


Locations

Country Name City State
Romania Iuliu Hatieganu University of Medicine and Pharmacy Cluj-Napoca Cluj

Sponsors (1)

Lead Sponsor Collaborator
Iuliu Hatieganu University of Medicine and Pharmacy

Country where clinical trial is conducted

Romania, 

Outcome

Type Measure Description Time frame Safety issue
Primary abstinence from smoking in the last 7 days baseline and 6 months after No
Secondary quiting attempts in the last 6 months baseline and 6 months after No
Secondary smoking related attitudes baseline and six months after No
Secondary self-eficacy in quiting smoking baseline and 6 months after No
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