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Lo studio clinico NCT07459621 (GEMS) per Comportamenti legati al fumo è non ancora in arruolamento. Consulti la vista a schede del Radar degli Studi Clinici e gli strumenti di scoperta IA per tutti i dettagli. Oppure, ponga pure una domanda qui. | ||
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Evaluation of a Novel mHealth Intervention for People Who Are Ambivalent About Quitting Smoking: A Randomized Controlled Trial (GEMS) 800 Randomizzato Innovativo
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La sperimentazione clinica NCT07459621 (GEMS) è uno studio interventistico per Comportamenti legati al fumo, attualmente non ancora in arruolamento. L'arruolamento dovrebbe iniziare il 1 marzo 2026, con l'obiettivo di raggiungere 800 partecipanti. Sotto la guida di Kaiser Permanente, dovrebbe concludersi entro il 1 dicembre 2028. I dati più recenti da ClinicalTrials.gov sono stati aggiornati l'ultima volta il 10 marzo 2026.
Sommario breve
The goal of this study is to compare the effectiveness of two smoking cessation programs to determine which better helps people change their smoking behavior, the control or the experimental intervention? Both interventions include access to a mHealth app and other publicly available stop-smoking resources. The two app versions each include best practice advice and guidance for quitting smoking, but one includes addi...Mostra di più
Titolo ufficiale
Evaluation of a Novel mHealth Intervention for People Who Are Ambivalent About Quitting Smoking: A Randomized Controlled Trial
Patologie
Comportamenti legati al fumoAltri ID dello studio
Numero NCT
Data di inizio (effettiva)
2026-03
Ultimo aggiornamento pubblicato
2026-03-10
Data di completamento (stimata)
2028-12
Arruolamento (previsto)
800
Tipo di studio
Interventistico
FASE
N.D.
Stato
Non ancora in arruolamento
Parole chiave
Smoking
mHealth
motivation
ambivalent smokers
mHealth
motivation
ambivalent smokers
Scopo principale
Trattamento
Allocazione
Randomizzato
Modello di intervento
In parallelo
Mascheramento
Triplo
Bracci / Interventi
| Gruppo/Braccio di partecipanti | Intervento/Trattamento |
|---|---|
Comparatore attivoControl Intervention Control participants receive a study-branded mHealth app and access to other publicly-available, evidence-based smoking cessation interventions. | Intervento di Controllo GEMS mHealth app including standard, best-practice information and advice to support quitting smoking, in-app motivational support, and access to publicly-available, evidence-based stop smoking resources and treatment. App can be used ad-lib during the study duration. |
SperimentaleExperimental Experimental participants receive a study-branded mHealth app and access to other publicly-available, evidence-based smoking cessation interventions. | Intervento sperimentale GEMS mHealth app including same standard care, best-practice information and advice for quitting smoking and in-app motivational support as in the control arm, plus additional content designed to help users clarify their values, build motivation for change, and learn skills necessary to quit smoking. App can be used ad-lib during the study duration. |
Esito primario
Esito secondario
| Misure di esito | Descrizione della misura | Arco temporale |
|---|---|---|
Evidence-based treatment request | Composite indicator of (1) Earning the ability to request free nicotine replacement therapy (NRT) through sufficient app participation and requesting NRT and/or (2) accessing free quitline services through the app. | 6-months post-randomization |
7-day Point Prevalence Abstinence (PPA) [Self-report] | Self-report of no smoking, even a puff, in the past 7 days. | 6-months post-randomization |
| Misure di esito | Descrizione della misura | Arco temporale |
|---|---|---|
7-day Point Prevalence Abstinence (PPA) [Self-report] | Self-report of no smoking, even a puff, in the past 7 days. (Co-primary outcome assessed at earlier time point) | 3-months post-randomization |
30-day Point Prevalence Abstinence (PPA) [Self-report] | Self-report of no smoking, even a puff, in the past 30 days. | 3- and 6-months post-randomization |
7-day Point Prevalence Abstinence (PPA) [Confirmed] | Biochemically confirmed self-report of no smoking, even a puff, in the past 7 days. | 6-months post-randomization |
Evidence-based treatment request | Composite indicator of (1) Earning the ability to request free nicotine replacement therapy (NRT) through sufficient app participation and requesting NRT and/or (2) accessing free quitline services through the app. (Co-primary outcome assessed at earlier time point). | 3-months post-randomization |
Use of any cessation treatment | Self-reported use of any evidence-based smoking cessation treatment (FDA-approved medication or behavioral interventions) since enrollment, whether provided by study or not. | 3- and 6-months post-randomization |
Successful 24-hour quit attempt | Self-reported presence of an intentional quit attempt lasting at least 24 hrs (Y/N) since randomization. | By 3-months and 6-months post-randomization |
Any quit attempt | Self-reported presence of any intentional quit attempt, regardless of duration (Y/N) since study enrollment. | By 3-months and 6-months post-randomization |
Change in cigarettes per day | Change from baseline in number of cigarettes smoked per day at follow-up, calculated both as a continuous measure and as a dichotomous measure (Y/N \>=50% reduction from baseline). | Baseline to each of 3-months and 6-months post-randomization |
Tobacco and nicotine abstinence | Self-report of abstinence from all non-therapeutic nicotine and tobacco products. | 3- and 6-months post-randomization |
Assistente alla partecipazione
Criteri di eleggibilità
Età idonea
Adulto, Adulto anziano
Età minima
18 Years
Sessi idonei
Tutti
- 18 years of age and older
- Current cigarette smoker who is ambivalent about smoking
- Not actively using any treatment to quit smoking
- Own and regularly use a smartphone
- State willingness to install and use their assigned app
- Willingness to receive study communications
- Smoke at least half a pack a day
- Meet geolocation requirements
- A lifetime history of dementia or psychosis
- Visual impairments that prevent viewing phone content and they lack adaptive devices
- Report medical contra-indications for over-the-counter NRT use
- Due to the potential for bias introduced by fraudulent participants, other exclusions will be applied to deter fraudulent enrollment.
Kaiser PermanenteContatti principali dello studio
Contatto: Jennifer B McClure, PhD, 503-335-2400, [email protected]
Contatto: Anna C Edelmann, MScN, 866-459-2816, [email protected]
1 Centri dello studio in 1 paesi
Oregon
Kaiser Permanente Center for Health Research, Portland, Oregon, 97227, United States
Anna C Edelmann, MScN, Contatto, 866-459-2816, [email protected]
Jennifer B McClure, PhD, Investigatore principale