- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving 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.
Studieoversikt
Studietype
Registrering (Forventet)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
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Cluj
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Cluj-Napoca, Cluj, Romania, 400340
- Rekruttering
- Iuliu Hatieganu University of Medicine and Pharmacy
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Ta kontakt med:
- Lucia M Lotrean, MD, PhD
- Telefonnummer: 0040724367460
- E-post: llotrean@umfcluj.ro
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Hovedetterforsker:
- Lucia M Lotrean, MD, PhD
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
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 studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Ingen inngripen: Styre
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Eksperimentell: 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
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
abstinence from smoking in the last 7 days
Tidsramme: baseline and 6 months after
|
baseline and 6 months after
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Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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quiting attempts in the last 6 months
Tidsramme: baseline and 6 months after
|
baseline and 6 months after
|
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smoking related attitudes
Tidsramme: baseline and six months after
|
baseline and six months after
|
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self-eficacy in quiting smoking
Tidsramme: baseline and 6 months after
|
baseline and 6 months after
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Samarbeidspartnere og etterforskere
Etterforskere
- Hovedetterforsker: Lucia M Lotrean, MD, PhD, Iuliu Hatieganu University of Medicine and Pharmacy, Cluj-Napoca, Romania
Publikasjoner og nyttige lenker
Hjelpsomme linker
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Forventet)
Studiet fullført (Forventet)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Andre studie-ID-numre
- Renuntlafumat
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