Valutazione di un programma di cessazione del fumo di telemedicina nelle pratiche di assistenza primaria rurale
4 ottobre 2012 aggiornato da: Kimber Richter, PhD, MPH, MA
Telemedicina per smettere di fumare nelle cure primarie rurali
Le persone che fumano sigarette e vivono nelle zone rurali potrebbero non avere accesso a un'ampia varietà di risorse per aiutarle a smettere di fumare.
Questo studio valuterà due programmi per smettere di fumare, un programma di telemedicina basato su Internet e un programma di quitline basato sul telefono, tra i residenti rurali.
Panoramica dello studio
Stato
Completato
Condizioni
Descrizione dettagliata
Le persone che vivono nelle aree rurali hanno maggiori probabilità di fumare sigarette rispetto alle persone che vivono nelle aree urbane e suburbane. Tuttavia, molte risorse e programmi per smettere di fumare potrebbero non essere disponibili per i residenti delle aree rurali. È dimostrato che le quitline telefoniche gratuite per il tabacco aiutano le persone a smettere di fumare e sono disponibili per quasi tutti coloro che vivono negli Stati Uniti, ma solo dall'1% al 5% dei fumatori le utilizza effettivamente. Un'altra opzione per aiutare le persone a smettere di fumare può comportare che i medici forniscano programmi per smettere di fumare nei loro uffici o cliniche; tuttavia, la maggior parte degli studi medici non dispone delle risorse per fornire questo tipo di servizio. La telemedicina fornisce informazioni mediche per telefono o tramite Internet utilizzando varie tecnologie, tra cui webcam o apparecchiature di videoconferenza. È stato utilizzato con successo per fornire assistenza psichiatrica e consulenza sulle dipendenze, ma non sono stati condotti studi che abbiano esaminato l'efficacia di un programma di telemedicina per smettere di fumare. Lo scopo di questo studio è confrontare l'efficacia di un programma di cessazione del fumo di telemedicina che si svolge in uno studio medico rispetto all'efficacia di un tradizionale programma di cessazione del fumo telefonico tra i fumatori rurali.
Lo studio sarà condotto presso gli uffici di 25 medici rurali in Kansas. I partecipanti verranno assegnati in modo casuale a partecipare a un programma di quitline telefonico o a un programma di telemedicina. I partecipanti al programma telefonico per smettere di fumare riceveranno quattro sessioni di consulenza telefonica per smettere di fumare da consulenti per smettere di fumare per un periodo di 8 settimane. I partecipanti al programma di telemedicina riceveranno quattro sessioni di consulenza telemedicina da consulenti per la cessazione del fumo per un periodo di 8 settimane, che saranno erogate tramite webcam bidirezionali presso i computer negli studi medici. Tutti i partecipanti riceveranno dispense educative e piani personalizzati per smettere, comprese informazioni sui farmaci per smettere di fumare. Al basale e ai mesi 3, 6 e 12, tutti i partecipanti parteciperanno a interviste telefoniche con i ricercatori dello studio per valutare le abitudini al fumo. Al basale e al mese 12, i partecipanti invieranno un campione di saliva ai ricercatori allo scopo di determinare il livello di nicotina nel corpo.
Tipo di studio
Interventistico
Iscrizione (Effettivo)
566
Fase
- Fase 3
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
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Kansas
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Kansas City, Kansas, Stati Uniti, 66160
- University of Kansas Medical Center
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
18 anni e precedenti (Adulto, Adulto più anziano)
Accetta volontari sani
No
Sessi ammissibili allo studio
Tutto
Descrizione
Criterio di inclusione:
- Fuma sigarette tutti i giorni
- Fuma cinque o più sigarette al giorno
- Ha fumato sigarette per almeno 1 anno prima dell'ingresso nello studio
- Ha un indirizzo di casa e un numero di telefono
- Disponibilità a partecipare a valutazioni telefoniche
- Disponibilità ad essere assegnata ad uno dei due corsi di studio
Criteri di esclusione:
- Incinta o allattamento
- Un altro membro della famiglia è iscritto allo studio
- Spostamento fuori dalla zona di residenza nei 14 mesi successivi all'ingresso per studio
- Il fornitore di cure primarie non partecipa allo studio
- Uso di altre forme di prodotti del tabacco (ad es. sigari, spiedi, tabacco da fiuto) oltre alle sigarette
- Uso di un farmaco per smettere di fumare
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Sperimentale: 1
I partecipanti prenderanno parte a un programma di telemedicina per smettere di fumare.
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I partecipanti riceveranno quattro sessioni di consulenza per smettere di fumare in telemedicina per un periodo di 8 settimane.
Le sessioni di telemedicina saranno erogate da webcam bidirezionali montate su computer desktop negli studi medici.
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Comparatore attivo: 2
I partecipanti prenderanno parte a un programma telefonico per smettere di fumare.
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I partecipanti riceveranno quattro sessioni di consulenza per smettere di fumare fornite per telefono nelle loro case per un periodo di 8 settimane.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
|---|---|
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Astinenza con prevalenza puntuale di 7 giorni
Lasso di tempo: Misurato ai mesi 3, 6 e 12
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Misurato ai mesi 3, 6 e 12
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Misure di risultato secondarie
Misura del risultato |
Lasso di tempo |
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Astinenza prolungata
Lasso di tempo: Misurato ai mesi 3, 6 e 12
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Misurato ai mesi 3, 6 e 12
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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Collaboratori
Investigatori
- Investigatore principale: Kimber P. Richter, PhD, MPH, MA, University of Kansas
Pubblicazioni e link utili
La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.
Pubblicazioni generali
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Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio
1 giugno 2009
Completamento primario (Effettivo)
1 aprile 2012
Completamento dello studio (Effettivo)
1 aprile 2012
Date di iscrizione allo studio
Primo inviato
12 febbraio 2009
Primo inviato che soddisfa i criteri di controllo qualità
12 febbraio 2009
Primo Inserito (Stima)
13 febbraio 2009
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
5 ottobre 2012
Ultimo aggiornamento inviato che soddisfa i criteri QC
4 ottobre 2012
Ultimo verificato
1 ottobre 2012
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Altri numeri di identificazione dello studio
- 625
- R01HL087643-01A2 (Sovvenzione/contratto NIH degli Stati Uniti)
- HL087643-01A2
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .