- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT02613689
Addressing Tobacco Use Disparities Through an Innovative Mobile Phone Intervention
Addressing Tobacco Use Disparities Through an Innovative Mobile Phone Intervention: The Text to Forgo Smokeless Tobacco
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
Participants will be randomized to either the Scheduled Gradual Reduction (SGR) group or the control group. All participants in both groups will complete surveys at the baseline, end of program, and 6 month time points. All participants in both groups will also receive supportive counseling text messages at various times during the day over a period of 4 weeks.
Participants assigned to the SGR intervention group will receive their intervention, in addition to the supportive counseling messages received by the control group, via text message over a period of four weeks. Participants will initially report their smokeless tobacco use according to their usual habit, and over the course of the intervention be directed via text message precise times to start and stop each instance of smokeless tobacco use, gradually reducing the occurrences of use.
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
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North Carolina
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Durham, North Carolina, Stati Uniti, 27710
- Duke University School of Nursing
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
- Over 18 years of age
- Have used smokeless tobacco for the last year, currently (past 30 days) uses smokeless tobacco daily, and use of at least one or more tins/cans per week
- Have an address in a rural census tract defined by a RUCA code of 4-10.
- Interested in participating in a cessation program
- Have access to a cell phone with unlimited texting ability and have knowledge of text messaging
Exclusion Criteria:
- Non-English speaking
- Have smoked cigarettes or used any other tobacco product in the past 30 days (i.e., dual user)
- Currently participating in a smokeless tobacco cessation study
- Family member participating in a smokeless tobacco cessation study
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
---|---|
Sperimentale: Scheduled Gradual Reduction (SGR)
Subjects will receive the Scheduled Gradual Reduction (SGR) intervention, as well as SMS support text messages.
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Participants in this group will group will receive the Scheduled Gradual Reduction (SGR) smokeless tobacco cessation reduction intervention via text message over a period of four weeks.
Participants will initially report their smokeless tobacco use according to their usual habit, and over the course of the intervention be directed via text message precise times to start and stop each instance of smokeless tobacco use, gradually reducing the occurrences of use.
In addition, this group will also receive the support messages that are sent to the control group.
Participants in this group will receive text messages about smokeless tobacco cessation in the form of counseling messages at various times throughout the day over a period of four weeks.
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Comparatore attivo: Control Group
Subjects will receive SMS support text messages
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Participants in this group will receive text messages about smokeless tobacco cessation in the form of counseling messages at various times throughout the day over a period of four weeks.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Proportion of Return Text Messages sent in Response to SGR Intervention
Lasso di tempo: 1 month
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Assessed via text history
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1 month
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Proportion of Support Messages Read by Participants
Lasso di tempo: 1 month
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Self-report
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1 month
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Ratings of Usefulness of the Intervention Received
Lasso di tempo: 1 month
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Ratings will be assessed via patient questionnaire.
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1 month
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Quit Rate at 1 month
Lasso di tempo: 1 month
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Quit rate will be assessed by participant self report via questionnaires.
Participants will also be asked to provide a saliva sample to check for nicotine if they report that they have quit using smokeless tobacco.
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1 month
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Quit Rate at 6 Months
Lasso di tempo: 6 months
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Quit rate will be assessed by participant self report via questionnaires.
Participants will also be asked to provide a saliva sample to check for nicotine if they report that they have quit using smokeless tobacco.
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6 months
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Collaboratori e investigatori
Sponsor
Collaboratori
Investigatori
- Investigatore principale: Devon Noonan, PhD, Duke University School of Nursing
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Altri numeri di identificazione dello studio
- Pro00063791
- 1R15CA198841-01 (Sovvenzione/contratto NIH degli Stati Uniti)
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .