Evaluatie van een programma voor stoppen met roken op telegeneeskunde in huisartspraktijken op het platteland
4 oktober 2012 bijgewerkt door: Kimber Richter, PhD, MPH, MA
Telegeneeskunde voor stoppen met roken in de eerstelijnszorg op het platteland
Mensen die sigaretten roken en op het platteland wonen, hebben mogelijk geen toegang tot een breed scala aan middelen om hen te helpen stoppen met roken.
Deze studie zal twee programma's om te stoppen met roken evalueren - een op internet gebaseerd telegeneeskundeprogramma en een op de telefoon gebaseerd stoplijnprogramma - onder plattelandsbewoners.
Studie Overzicht
Toestand
Voltooid
Conditie
Gedetailleerde beschrijving
Mensen die op het platteland wonen, roken vaker sigaretten dan mensen die in stedelijke en voorstedelijke gebieden wonen. Veel middelen en programma's om te stoppen met roken zijn echter mogelijk niet beschikbaar voor inwoners van plattelandsgebieden. Het is bewezen dat gratis tabakstelefoonstoplijnen mensen helpen stoppen met roken en zijn beschikbaar voor bijna iedereen die in de Verenigde Staten woont, maar slechts 1% tot 5% van de rokers maakt er daadwerkelijk gebruik van. Een andere mogelijkheid om mensen te helpen stoppen met roken, is dat artsen programma's voor stoppen met roken aanbieden in hun kantoren of klinieken; de meeste dokterspraktijken hebben echter niet de middelen om dit soort diensten te verlenen. Telegeneeskunde verstrekt medische informatie via de telefoon of via internet met behulp van verschillende technologieën, waaronder webcams of apparatuur voor videoconferenties. Het is met succes gebruikt om psychiatrische zorg en verslavingszorg te bieden, maar er zijn geen studies die de effectiviteit hebben onderzocht van een programma voor stoppen met roken op afstand. Het doel van deze studie is om de effectiviteit te vergelijken van een telegeneeskundeprogramma voor stoppen met roken dat plaatsvindt in een dokterspraktijk versus de effectiviteit van een traditioneel telefonisch stoppen met rokenprogramma bij rokers op het platteland.
De studie zal worden uitgevoerd in 25 landelijke dokterspraktijken in Kansas. Deelnemers worden willekeurig toegewezen om deel te nemen aan een telefonisch quitline-programma of een telegeneeskundeprogramma. Deelnemers aan het telefonische quitline-programma krijgen vier sessies telefonische quitline-counseling van rookstopadviseurs gedurende een periode van 8 weken. Deelnemers aan het programma voor telegeneeskunde krijgen gedurende een periode van 8 weken vier sessies telegeneeskunde-counseling van adviseurs voor stoppen met roken, die worden afgeleverd via tweerichtingswebcams op computers in de artsenpraktijken. Alle deelnemers ontvangen educatieve hand-outs en individueel op maat gemaakte stopplannen, inclusief informatie over stoppen met roken-medicatie. Bij baseline en maanden 3, 6 en 12 zullen alle deelnemers deelnemen aan telefonische interviews met onderzoeksonderzoekers om rookgewoonten te beoordelen. Bij baseline en maand 12 sturen de deelnemers een speekselmonster naar onderzoekers om het nicotinegehalte in het lichaam te bepalen.
Studietype
Ingrijpend
Inschrijving (Werkelijk)
566
Fase
- Fase 3
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
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Kansas
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Kansas City, Kansas, Verenigde Staten, 66160
- University of Kansas Medical Center
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
18 jaar en ouder (Volwassen, Oudere volwassene)
Accepteert gezonde vrijwilligers
Nee
Geslachten die in aanmerking komen voor studie
Allemaal
Beschrijving
Inclusiecriteria:
- Rookt elke dag sigaretten
- Rookt vijf of meer sigaretten per dag
- Heeft minstens 1 jaar sigaretten gerookt voordat hij aan de studie begon
- Heeft een huisadres en telefoonnummer
- Bereid om deel te nemen aan telefonische assessments
- Bereid om te worden toegewezen aan een van de twee opleidingen
Uitsluitingscriteria:
- Zwanger of borstvoeding
- Een ander lid van het huishouden neemt deel aan het onderzoek
- Verhuizen uit het woongebied in de 14 maanden na toelating tot de studie
- De huisarts doet niet mee aan het onderzoek
- Gebruik van andere vormen van tabaksproducten (bijv. sigaren, spuug, snuiftabak) naast sigaretten
- Gebruik van een middel om te stoppen met roken
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
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Experimenteel: 1
Deelnemers zullen deelnemen aan een telegeneeskunde stoppen met roken programma.
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Deelnemers krijgen gedurende een periode van 8 weken vier sessies telegeneeskunde om te stoppen met roken.
De telegeneeskundesessies worden geleverd door tweerichtingswebcams die op desktopcomputers in de dokterspraktijken zijn gemonteerd.
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Actieve vergelijker: 2
Deelnemers zullen deelnemen aan een telefonisch stoppen met roken-programma.
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Deelnemers krijgen gedurende een periode van 8 weken vier telefonische begeleiding bij het stoppen met roken bij hen thuis.
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
|---|---|
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7-daagse puntprevalentie onthouding
Tijdsspanne: Gemeten op maand 3, 6 en 12
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Gemeten op maand 3, 6 en 12
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Secundaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
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Langdurige onthouding
Tijdsspanne: Gemeten op maand 3, 6 en 12
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Gemeten op maand 3, 6 en 12
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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Onderzoekers
- Hoofdonderzoeker: Kimber P. Richter, PhD, MPH, MA, University of Kansas
Publicaties en nuttige links
De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.
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Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start
1 juni 2009
Primaire voltooiing (Werkelijk)
1 april 2012
Studie voltooiing (Werkelijk)
1 april 2012
Studieregistratiedata
Eerst ingediend
12 februari 2009
Eerst ingediend dat voldeed aan de QC-criteria
12 februari 2009
Eerst geplaatst (Schatting)
13 februari 2009
Updates van studierecords
Laatste update geplaatst (Schatting)
5 oktober 2012
Laatste update ingediend die voldeed aan QC-criteria
4 oktober 2012
Laatst geverifieerd
1 oktober 2012
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Andere studie-ID-nummers
- 625
- R01HL087643-01A2 (Subsidie/contract van de Amerikaanse NIH)
- HL087643-01A2
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