- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT02666482
Using Technology to Help Low-income and Latino Smokers Quit
The Institute for International Internet Interventions for Health (i4Health) at Palo Alto University proposes to develop digital tools specifically designed to help low income English-speaking and Spanish-speaking smokers to quit. The investigators aim to test whether a mobile-based digital intervention designed with systematic input from low-income English- and Spanish-speaking smokers from a public sector health care system can significantly improve its acceptability, utilization, and effectiveness. Using human-centered development methods, the project will involve low-income patients of the San Francisco Health Network in the design of a web app/text messaging tool. The investigators will also use participants input to improve the recruitment and dissemination strategies. i4Health will join forces with the Center for Behavioral Intervention Technologies (CBITs) at Northwestern University to iteratively develop successive versions of the digital interventions informed by our human-centered approach.
The full study involves 4 successive outcome studies testing the effectiveness of the Stop Smoking San Francisco web app.
The first three are single-group non-randomized pre-post studies with 1, 2, and 3-month follow-ups. These will test gradually improved versions of the app.
The fourth study will involve a randomized trial comparing the initial version (the baseline version) of the web app to the final version of the web app, to determine if the final version is significantly better than the baseline version in terms of increased utilization and abstinence rates.
To join this study, go to: https://stopsmokingsf.org
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
The project involves three specific aims:
Specific Aim #1: Human-centered development of an English/Spanish smoking cessation web app. The investigators will develop iterative versions of a digital smoking cessation tool (a web app with text messaging components) that is highly responsive to the needs and preferences of low-income English- and Spanish-speaking smokers. Development will take place with systematic input from patients who are part of the San Francisco Health Network (SFHN). The SFHN serves 70,000 members, most of whom are low-income individuals.
Specific Aim #2: Improvement of dissemination strategies. Input from SFHN patients will identify effective ways of reaching and encouraging low-income English- and Spanish-speaking smokers to use the digital smoking cessation interventions to be developed. This information will support ongoing dissemination and implementation efforts beyond the grant period.
Specific Aim #3: Evaluation of resulting smoking cessation web app. Researchers will evaluate the effectiveness of the successive versions of the resulting stop smoking web app by recruiting smokers at two levels: a) within the SFHN, and b) throughout the state of California, culminating with an online randomized controlled trial. Increased effectiveness will be defined as 1) increased utilization of the web app and 2) higher abstinence rates than those obtained by a baseline "usual care" web app.
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
California
-
Palo Alto, California, Förenta staterna, 94304
- Palo Alto University
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inclusion Criteria:
- English speaking (ES) and Spanish speaking (SS)
Exclusion Criteria:
- Not a smoker
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Experimentell: Stop Smoking SF Web App - baseline
Online Study 1 will test the data gathering aspects of the proposed web app using a baseline, "usual care" intervention consisting of a static smoking cessation guide, the Guía para Dejar de Fumar, tested in printed form in the Muñoz et al. (1997) study.
The print version of the guide yielded an 11% quit rate at 3 months.
The investigators will utilize the content of the guide as the main element of the baseline app, so it will serve to estimate baseline utilization and quit rates when this already tested intervention is provided in a web app format.
Participants can join the study online by going to: https://stopsmokingsf.org
|
Smoking cessation web app in Spanish and English.
Accessible online at no charge.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
---|---|
7-day Quit rate
Tidsram: 1 Month
|
1 Month
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Utilization of web app: Number of times web app screens are accessed and data entered
Tidsram: 1 month
|
Number of times web app screens are accessed and data entered
|
1 month
|
Samarbetspartners och utredare
Sponsor
Utredare
- Huvudutredare: Ricardo F. Munoz, Ph.D., Director, i4Health, Palo Alto University
Publikationer och användbara länkar
Allmänna publikationer
- Munoz RF, Marin BV, Posner SF, Perez-Stable EJ. Mood management mail intervention increases abstinence rates for Spanish-speaking Latino smokers. Am J Community Psychol. 1997 Jun;25(3):325-43. doi: 10.1023/a:1024676626955.
- Muñoz, R. F., Bunge, E. L., Chen, K., Schueller, S. M., Bravin, J. I., Shaughnessy, E. A., & Pérez-Stable, E. J. (2015). Massive Open Online Interventions: A novel model for delivering behavioral-health services worldwide. Clinical Psychological Science. Advance online publication. doi: 10.1177/2167702615583840
- Munoz RF, Bunge EL, Barrera AZ, Wickham RE, Lee J. Using Behavioral Intervention Technologies to Help Low-Income and Latino Smokers Quit: Protocol of a Randomized Controlled Trial. JMIR Res Protoc. 2016 Jun 14;5(2):e127. doi: 10.2196/resprot.5355. Erratum In: JMIR Res Protoc. 2016 Sep 23;5(3):e189.
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Andra studie-ID-nummer
- 24RT-0027
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
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