- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT00843505
Utvärdera ett telemedicinskt rökavvänjningsprogram i primärvård på landsbygden
Telemedicin för rökavvänjning inom primärvården på landsbygden
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
Människor som bor på landsbygden är mer benägna att röka cigaretter än människor som bor i stads- och förortsområden. Men många resurser och program för att sluta röka kanske inte är tillgängliga för invånare på landsbygden. Avgiftsfria tobakstelefoner har visat sig hjälpa människor att sluta röka och är tillgängliga för nästan alla som bor i USA, men bara 1% till 5% av rökarna använder dem faktiskt. Ett annat alternativ för att hjälpa människor att sluta röka kan innebära att läkare tillhandahåller program för att sluta röka på sina kontor eller kliniker; de flesta läkarmottagningar har dock inte resurserna att tillhandahålla denna typ av tjänster. Telemedicin tillhandahåller medicinsk information via telefon eller via Internet genom att använda olika tekniker, inklusive webbkameror eller videokonferensutrustning. Det har använts framgångsrikt för att tillhandahålla psykiatrisk vård och beroenderådgivning, men det har inte gjorts några studier som har undersökt effektiviteten av ett telemedicinskt rökavvänjningsprogram. Syftet med denna studie är att jämföra effektiviteten av ett telemedicinskt rökavvänjningsprogram som äger rum på en läkarmottagning mot effektiviteten av ett traditionellt program för rökavvänjning via telefon bland rökare på landsbygden.
Studien kommer att genomföras på 25 landsbygdsläkarmottagningar i Kansas. Deltagarna kommer att slumpmässigt tilldelas att delta i ett telefon quitline-program eller ett telemedicinprogram. Deltagare i telefon-quitline-programmet kommer att få fyra sessioner med telefon-quitline-rådgivning från rökavvänjningsrådgivare under en 8-veckorsperiod. Deltagare i telemedicinprogrammet kommer att få fyra sessioner med telemedicinsk rådgivning från rökavvänjningsrådgivare under en 8-veckorsperiod, som kommer att levereras genom tvåvägswebbkameror vid datorer på läkarmottagningarna. Alla deltagare kommer att få utbildningsmaterial och individuellt skräddarsydda planer för att sluta sluta, inklusive information om mediciner för att sluta röka. Vid baslinjen och månaderna 3, 6 och 12 kommer alla deltagare att delta i telefonintervjuer med studieforskare för att bedöma rökvanor. Vid baslinjen och månad 12 kommer deltagarna att skicka ett salivprov till forskare i syfte att bestämma nivån av nikotin i kroppen.
Studietyp
Inskrivning (Faktisk)
Fas
- Fas 3
Kontakter och platser
Studieorter
-
-
Kansas
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Kansas City, Kansas, Förenta staterna, 66160
- University of Kansas Medical Center
-
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inklusionskriterier:
- Röker cigaretter varje dag
- Röker fem eller fler cigaretter per dag
- Har rökt cigaretter i minst 1 år innan studiestart
- Har hemadress och telefonnummer
- Vill gärna delta i telefonbedömningar
- Vill gärna bli anställd på något av de två utbildningarna
Exklusions kriterier:
- Gravid eller ammar
- Ytterligare en hushållsmedlem är inskriven i studien
- Flyttning från bostadsområdet inom 14 månader efter studieinträde
- Primärvårdsgivaren deltar inte i studien
- Användning av andra former av tobaksprodukter (t.ex. cigarrer, spott, snus) förutom cigaretter
- Användning av ett rökavvänjningsmedicin
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Experimentell: 1
Deltagarna kommer att delta i ett telemedicinskt program för rökavvänjning.
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Deltagarna kommer att få fyra sessioner med telemedicinsk rådgivning om rökavvänjning under en 8-veckorsperiod.
Telemedicinsessionerna kommer att levereras av tvåvägswebbkameror monterade på stationära datorer på läkarmottagningarna.
|
Aktiv komparator: 2
Deltagarna kommer att delta i ett telefonprogram för att sluta röka.
|
Deltagarna kommer att få fyra sessioner med rökavvänjningsrådgivning levererade per telefon i sina hem under en 8-veckorsperiod.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
---|---|
7-dagars punktprevalensabstinens
Tidsram: Uppmätt vid 3, 6 och 12 månader
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Uppmätt vid 3, 6 och 12 månader
|
Sekundära resultatmått
Resultatmått |
Tidsram |
---|---|
Långvarig abstinens
Tidsram: Uppmätt vid 3, 6 och 12 månader
|
Uppmätt vid 3, 6 och 12 månader
|
Samarbetspartners och utredare
Sponsor
Samarbetspartners
Utredare
- Huvudutredare: Kimber P. Richter, PhD, MPH, MA, University of Kansas
Publikationer och användbara länkar
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