Bewertung eines telemedizinischen Programms zur Raucherentwöhnung in ländlichen Grundversorgungspraxen
4. Oktober 2012 aktualisiert von: Kimber Richter, PhD, MPH, MA
Telemedizin zur Raucherentwöhnung in der ländlichen Grundversorgung
Menschen, die Zigaretten rauchen und in ländlichen Gebieten leben, haben möglicherweise keinen Zugang zu einer Vielzahl von Ressourcen, die ihnen helfen, mit dem Rauchen aufzuhören.
Diese Studie wird zwei Raucherentwöhnungsprogramme – ein internetbasiertes Telemedizinprogramm und ein telefonbasiertes Quitline-Programm – unter Landbewohnern bewerten.
Studienübersicht
Status
Abgeschlossen
Bedingungen
Detaillierte Beschreibung
Menschen, die in ländlichen Gebieten leben, rauchen häufiger Zigaretten als Menschen, die in städtischen und vorstädtischen Gebieten leben. Viele Ressourcen und Programme zur Raucherentwöhnung stehen Bewohnern ländlicher Gebiete jedoch möglicherweise nicht zur Verfügung. Gebührenfreie Tabaktelefon-Quitlines helfen nachweislich Menschen, mit dem Rauchen aufzuhören, und stehen fast allen Einwohnern der Vereinigten Staaten zur Verfügung, aber nur 1 % bis 5 % der Raucher nutzen sie tatsächlich. Eine weitere Möglichkeit, Menschen dabei zu helfen, mit dem Rauchen aufzuhören, kann darin bestehen, dass Ärzte Raucherentwöhnungsprogramme in ihren Praxen oder Kliniken anbieten; Die meisten Arztpraxen verfügen jedoch nicht über die Ressourcen, um diese Art von Dienstleistung anzubieten. Die Telemedizin stellt medizinische Informationen über das Telefon oder das Internet bereit, indem verschiedene Technologien verwendet werden, darunter Webcams oder Videokonferenzgeräte. Es wurde erfolgreich zur psychiatrischen Versorgung und Suchtberatung eingesetzt, aber es gibt keine Studien, die die Wirksamkeit eines telemedizinischen Programms zur Raucherentwöhnung untersucht haben. Der Zweck dieser Studie ist es, die Wirksamkeit eines telemedizinischen Raucherentwöhnungsprogramms, das in einer Arztpraxis stattfindet, mit der Wirksamkeit eines traditionellen Telefon-Quittline-Raucherentwöhnungsprogramms unter ländlichen Rauchern zu vergleichen.
Die Studie wird in 25 ländlichen Arztpraxen in Kansas durchgeführt. Die Teilnehmer werden nach dem Zufallsprinzip der Teilnahme an einem telefonischen Quitline-Programm oder einem Telemedizinprogramm zugeteilt. Teilnehmer des Telefon-Quitline-Programms erhalten über einen Zeitraum von 8 Wochen vier Sitzungen telefonischer Quitline-Beratung durch Raucherentwöhnungsberater. Die Teilnehmer des Telemedizinprogramms erhalten über einen Zeitraum von 8 Wochen vier telemedizinische Beratungssitzungen von Raucherentwöhnungsberatern, die über bidirektionale Webcams an Computern in den Arztpraxen durchgeführt werden. Alle Teilnehmer erhalten Schulungsunterlagen und individuell zugeschnittene Entwöhnungspläne, einschließlich Informationen zu Medikamenten zur Raucherentwöhnung. Zu Studienbeginn und in den Monaten 3, 6 und 12 nehmen alle Teilnehmer an Telefoninterviews mit Studienforschern teil, um ihre Rauchgewohnheiten zu beurteilen. Zu Beginn und in Monat 12 schicken die Teilnehmer eine Speichelprobe an die Forscher, um den Nikotinspiegel im Körper zu bestimmen.
Studientyp
Interventionell
Einschreibung (Tatsächlich)
566
Phase
- Phase 3
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienorte
-
-
Kansas
-
Kansas City, Kansas, Vereinigte Staaten, 66160
- University of Kansas Medical Center
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Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
18 Jahre und älter (Erwachsene, Älterer Erwachsener)
Akzeptiert gesunde Freiwillige
Nein
Studienberechtigte Geschlechter
Alle
Beschreibung
Einschlusskriterien:
- Raucht jeden Tag Zigaretten
- Raucht fünf oder mehr Zigaretten pro Tag
- Hat vor Studieneintritt mindestens 1 Jahr lang Zigaretten geraucht
- Hat eine Privatadresse und eine Telefonnummer
- Bereitschaft zur Teilnahme an telefonischen Assessments
- Bereitschaft, einem der beiden Studiengänge zugeordnet zu werden
Ausschlusskriterien:
- Schwanger oder stillend
- Ein weiteres Haushaltsmitglied wird in die Studie aufgenommen
- Wegzug aus dem Wohngebiet in den 14 Monaten nach Studienaufnahme
- Der Hausarzt nimmt nicht an der Studie teil
- Verwendung anderer Formen von Tabakprodukten (z. B. Zigarren, Spucke, Schnupftabak) zusätzlich zu Zigaretten
- Verwendung eines Medikaments zur Raucherentwöhnung
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
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Experimental: 1
Die Teilnehmer nehmen an einem telemedizinischen Programm zur Raucherentwöhnung teil.
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Die Teilnehmer erhalten über einen Zeitraum von 8 Wochen vier Sitzungen telemedizinischer Raucherentwöhnungsberatung.
Die telemedizinischen Sitzungen werden von Zwei-Wege-Webcams bereitgestellt, die auf Desktop-Computern in den Arztpraxen montiert sind.
|
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Aktiver Komparator: 2
Die Teilnehmer nehmen an einem telefonischen Quitline-Programm zur Raucherentwöhnung teil.
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Die Teilnehmer erhalten über einen Zeitraum von 8 Wochen vier telefonische Beratungssitzungen zur Raucherentwöhnung bei sich zu Hause.
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
|---|---|
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7-Tage-Punktprävalenz Abstinenz
Zeitfenster: Gemessen in den Monaten 3, 6 und 12
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Gemessen in den Monaten 3, 6 und 12
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
|---|---|
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Längere Abstinenz
Zeitfenster: Gemessen in den Monaten 3, 6 und 12
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Gemessen in den Monaten 3, 6 und 12
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Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Sponsor
Ermittler
- Hauptermittler: Kimber P. Richter, PhD, MPH, MA, University of Kansas
Publikationen und hilfreiche Links
Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.
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Studienaufzeichnungsdaten
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Haupttermine studieren
Studienbeginn
1. Juni 2009
Primärer Abschluss (Tatsächlich)
1. April 2012
Studienabschluss (Tatsächlich)
1. April 2012
Studienanmeldedaten
Zuerst eingereicht
12. Februar 2009
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
12. Februar 2009
Zuerst gepostet (Schätzen)
13. Februar 2009
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
5. Oktober 2012
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
4. Oktober 2012
Zuletzt verifiziert
1. Oktober 2012
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Andere Studien-ID-Nummern
- 625
- R01HL087643-01A2 (US NIH Stipendium/Vertrag)
- HL087643-01A2
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