- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT03978455
A Pilot Study of the Learn, Connect, and Quit Mobile Application
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Detailní popis
The overarching goal of this study is to develop a novel, effective mobile application for patients to use while waiting in the clinic exam room to see their provider and to access on-line after their visit. The Learn, Connect, and Quit (LCQ) application will present patients with a variety of videos designed to increase their understanding of, and engagement in, evidence-based smoking cessation treatment (e.g., videos that address barriers to cessation and explain treatment options). The LCQ app will also be coordinated within the clinical care system to allow patients to self-refer for smoking treatment and will serve as a prompt to begin a conversation with the provider thereby connecting smokers to evidence-based treatment with minimal staff burden, thus, increasing the feasibility and sustainability of this intervention. This research will pursue the following specific aims:
Specific Aim 1: Develop the Learn, Connect, and Quit mobile application to: 1) present educational and motivational content in an easily accessible manner (i.e., via videos); and 2) provide avenues for smokers to connect to evidence-based treatment (e.g., request a referral to the Wisconsin Tobacco Quitline via the app, initiate a discussion with their provider).
Specific Aim 2: Identify optimal implementation procedures and clinical workflows to facilitate the use of the LCQ app within the clinical setting.
Specific Aim 3: Establish the feasibility, acceptability, and preliminary effects of the Learn, Connect, and Quit app among smokers in a primary care clinic to support an NIH R01 application.
This research will create an innovative, patient-driven intervention that can be integrated into healthcare systems and leverage the patient wait times in traditional clinical settings to provide motivational content and treatment information to increase: motivation, smoking treatment engagement, and connections with evidence-based treatment resources. This innovative product will then be tested in larger implementation trials with external funding.
Typ studie
Zápis (Aktuální)
Kontakty a umístění
Studijní místa
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Wisconsin
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Madison, Wisconsin, Spojené státy, 53711
- University of Wisconsin Center for Tobacco Research and Intervention
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Metoda odběru vzorků
Studijní populace
The Smoker Participant Group will consist of adult English-speaking smokers attending a clinic visit at their primary care clinic.
The Clinic Staff Group will consist of adult staff (rooming staff and clinical providers) at the primary care clinic where Smoker Participant Group participants will be recruited.
Popis
Inclusion Criteria for Smoker Participant Group:
- participant be age 18 or older, speak and understand English, smoke cigarettes, and complete the referral form agreeing to be contacted for an assessment
Exclusion Criteria:
- none
Inclusion Criteria for Clinic Staff Group:
- must be either rooming staff or clinical provider (e.g., physician, nurse practitioner, etc.)
Exclusion Criteria:
- none
Studijní plán
Jak je studie koncipována?
Detaily designu
Kohorty a intervence
Skupina / kohorta |
Intervence / Léčba |
|---|---|
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Patients Who Smoke
This group will consist of up to 100 English-speaking adult smokers recruited from their primary care clinic who are willing to complete a brief phone-based interview about their experience in using the "Learn, Connect, and Quit" (LCQ) tablet-based mobile application.
The LCQ app presents smoking and cessation-related educational and motivational content in an easily accessible manner (i.e., via videos) and provides avenues for smokers to connect to evidence-based treatment.
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The Learn, Connect, and Quit (LCQ) Mobile Application is an application for electronic tablets that can: assess smokers' interest in quitting; answer smokers' questions about smoking, quitting, and available treatments; provide information about treatment options; communicate information about patients' smoking status, concerns, and treatment interest to their provider; and connect patients with treatment options including the Wisconsin Tobacco Quitline (WTQL), and other smoking intervention resources provided by their healthcare system.
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Clinic Staff
Rooming staff and physicians from the primary care clinic (where "Patients Who Smoke" group participants are recruited) will be asked to participate in interviews about the feasibility of implementing the LCQ app including implementation burden, impact on clinical workload, and clinical utility of the app (i.e., Did patients ask more questions about smoking treatment?
How challenging was it to try to give all smokers the app to explore?).
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The Learn, Connect, and Quit (LCQ) Mobile Application is an application for electronic tablets that can: assess smokers' interest in quitting; answer smokers' questions about smoking, quitting, and available treatments; provide information about treatment options; communicate information about patients' smoking status, concerns, and treatment interest to their provider; and connect patients with treatment options including the Wisconsin Tobacco Quitline (WTQL), and other smoking intervention resources provided by their healthcare system.
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Total time spent watching videos
Časové okno: One day
|
Total minutes spent watching videos presented on the Learn, Connect, and Quit Mobile Application
|
One day
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Clinical Utility of the Learn, Connect, and Quit Mobile Application
Časové okno: One day
|
Clinic staff rating of whether they would like to see use of the LCQ app continue (yes/no)
|
One day
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Spolupracovníci a vyšetřovatelé
Sponzor
Spolupracovníci
Vyšetřovatelé
- Vrchní vyšetřovatel: Megan E Piper, PhD, University of Wisconsin Center for Tobacco Research and Intervention, School of Medicine and Public Health
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další identifikační čísla studie
- 2019-0274
- A534253 (Jiný identifikátor: UW- Madison)
- SMPH/MEDICINE/GEN INT MD (Jiný identifikátor: UW Madison)
- R35CA197573 (Grant/smlouva NIH USA)
- Protocol Version 1/22/2019 (Jiný identifikátor: UW Madison)
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
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