- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02028962
Computer Tailored Program for Smoking Cessation Among Romanian Adults
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 :
- ''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.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Forventet)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
-
-
Cluj
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Cluj-Napoca, Cluj, Rumænien, 400340
- Rekruttering
- Iuliu Hatieganu University of Medicine and Pharmacy
-
Kontakt:
- Lucia M Lotrean, MD, PhD
- Telefonnummer: 0040724367460
- E-mail: llotrean@umfcluj.ro
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Ledende efterforsker:
- Lucia M Lotrean, MD, PhD
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Ingen indgriben: Styring
|
|
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Eksperimentel: 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
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
abstinence from smoking in the last 7 days
Tidsramme: baseline and 6 months after
|
baseline and 6 months after
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
quiting attempts in the last 6 months
Tidsramme: baseline and 6 months after
|
baseline and 6 months after
|
|
smoking related attitudes
Tidsramme: baseline and six months after
|
baseline and six months after
|
|
self-eficacy in quiting smoking
Tidsramme: baseline and 6 months after
|
baseline and 6 months after
|
Samarbejdspartnere og efterforskere
Efterforskere
- Ledende efterforsker: Lucia M Lotrean, MD, PhD, Iuliu Hatieganu University of Medicine and Pharmacy, Cluj-Napoca, Romania
Publikationer og nyttige links
Hjælpsomme links
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Forventet)
Studieafslutning (Forventet)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Andre undersøgelses-id-numre
- Renuntlafumat
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