- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01383278
Evaluation of a Computer-Delivered 5 A's Intervention for Smoking
This is a 2-group RCT in 380 tobacco-using medical patients that will compare a single session, computer-directed 5 A's intervention for smoking (experimental condition) to screening and resource provision (control condition). Follow-up visits will occur at 1 and 3 months post study enrollment. Measures will focus on tobacco use and related psychosocial outcomes (e.g. mood, stress). We will compare resources used and economic costs needed to implement each intervention.
The Investigators hypothesize that patients receiving the computer-directed intervention will have significantly higher tobacco abstinence rates at 3 months post study enrollment compared to the control group. If indeed the computerized intervention increases tobacco abstinence rates compared to the control group, this intervention could be used to increase access to treatment for the millions of US smokers, ultimately reducing tobacco mortality and morbidity rates in this country.
Studieoversigt
Status
Betingelser
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
-
-
Virginia
-
Richmond, Virginia, Forenede Stater, 23298
- Virginia Commonwealth University
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- 18 - 65 years
- Primary care patient
- Smoked at least one cigarette per day for the past seven days or at least 10 cigarettes total during the past week
- Smoked at least 100 cigarettes (lifetime)
- Had no recent (past 90 days) use of other forms of tobacco (pipes, cigars, NRT)
- Able to speak English
Exclusion Criteria:
- Pregnant
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Enkelt gruppeopgave
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: Computer-directed 5 A's intervention for smoking
|
Computer-directed 5 A's intervention for smoking
|
Aktiv komparator: Screening and resource provision
|
Screening and resource provision
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Tobacco use
Tidsramme: 3 months post-randomization
|
The primary outcome variable for this study will be smoking cessation at 3 month follow-up as measured by self-report, salivary cotinine and carbon monoxide levels.
|
3 months post-randomization
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Mood and stress
Tidsramme: 3 months post-randomization
|
By using the K-10 Instrument
|
3 months post-randomization
|
Resource utilization and economic costs
Tidsramme: 3 months post-randomization
|
3 months post-randomization
|
Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
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
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .