- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving 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
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
-
-
North Carolina
-
Durham, North Carolina, Forente stater, 27710
- Duke University School of Nursing
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Eksperimentell: Scheduled Gradual Reduction (SGR)
Subjects will receive the Scheduled Gradual Reduction (SGR) intervention, as well as SMS support text messages.
|
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.
|
Aktiv komparator: Control Group
Subjects will receive SMS support text messages
|
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.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Proportion of Return Text Messages sent in Response to SGR Intervention
Tidsramme: 1 month
|
Assessed via text history
|
1 month
|
Proportion of Support Messages Read by Participants
Tidsramme: 1 month
|
Self-report
|
1 month
|
Ratings of Usefulness of the Intervention Received
Tidsramme: 1 month
|
Ratings will be assessed via patient questionnaire.
|
1 month
|
Quit Rate at 1 month
Tidsramme: 1 month
|
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.
|
1 month
|
Quit Rate at 6 Months
Tidsramme: 6 months
|
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.
|
6 months
|
Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Devon Noonan, PhD, Duke University School of Nursing
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Andre studie-ID-numre
- Pro00063791
- 1R15CA198841-01 (U.S. NIH-stipend/kontrakt)
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .