- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT03064724
Practice-based Intervention for Vietnamese and Korean Patients
22 februari 2017 uppdaterad av: Thu Quach, Asian Health Services
This pilot project examined the feasibility of an multilingual interactive video education intervention "an interactive Mobile Doctor intervention (iMD)" to promote patient-provider discussion on tobacco use for Korean- and Vietnamese-speaking male patients at primary care settings.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Detaljerad beskrivning
While California has made significant strides in tobacco control and is leading the nation in reducing smoking use, the decline is not observed in all groups.
Select groups still have much higher smoking rates and thus bear an unequal burden of tobacco-related illnesses and deaths.
Of important note, Asian American men as a combined group have a higher smoking rate than non-Hispanic Whites (22% vs. 18%, respectively); in particular, the highest smoking prevalence has been observed in Vietnamese (31%) and Korean (30%) men among major Asian subgroups.
Research also shows that smoking rates are higher for Asian American men with low acculturation (e.g., immigrant status, low English proficiency) than for those who are more acculturated; yet the reverse trend is observed in Asian American women.
These findings underscore the need for more targeted tobacco control efforts.
The scientific literature suggests that provider advice to quit smoking can influence a smoker's decision to quit.
However, research has shown that Asian Americans are less likely to receive such provider advice.
Providers often have very limited face-time with patients during the short clinic visit, which presents a challenge as to whether they can incorporate smoking cessation messages during the visit.
Overall, little research has focused on smoking cessation in the clinic setting, particularly research that focuses on Asian Americans.
The purpose of the pilot study was to develop a more streamlined smoking cessation intervention that can be integrated into the clinic visit, especially to maximize the time when patients are waiting to see their providers.
The research question was whether providing culturally appropriate video education that includes provider advice and was tailored to a patient's readiness for quitting smoking will increase whether a patient receives smoking cessation education according to the recommended Clinical Practice Guideline and whether this results in a decrease in tobacco use in low-income Vietnamese and Korean patients.
Using a community-based participatory research approach, the investigators created the iMD that delivers tailored in-language video messages via a mobile tablet to Korean and Vietnamese male smokers right before their clinic visit with a provider.
iMD delivers the "5 A's" and generates a bilingual tailored printout.
Participants were Korean- and Vietnamese-speaking patients who self-identify as daily smokers and receive primary care at a federally-qualified health center.
This study evaluated the feasibility and acceptability of iMD from the patients' perspectives.
This study examined patient-provider discussion on tobacco use from patients' self-report and electronic health record (EHR), and self-reported quit attempts and smoking abstinence at 3 months post iMD visit.
Studietyp
Interventionell
Inskrivning (Faktisk)
47
Fas
- Inte tillämpbar
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år till 75 år (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Manlig
Beskrivning
Inclusion Criteria:
- current smokers identified on electronic health records (EHR)
- have a scheduled primary care visit during the recruitment period
Exclusion Criteria:
- already quit smoking or not smoking daily in the past 7 days
- had already quit smoking or not smoking daily in the past 7 days
- had canceled or rescheduled their primary care visit outside of the study period
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
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: Smoking Cessation Group
Patients received the interactive mobile doctor (iMD) intervention.
|
iMD delivers tailored interactive video education via a mobile tablet to smoking patients right before their clinic visit with a provider.
iMD delivers the "5 A's" (ask, advise, assess, assist, and arrange) and generates a bilingual tailored printout, which aims to increase patient-provider discussion on tobacco use and to promote smoking cessation.
This version of iMD delivers the intervention in Korean or Vietnamese languages as preferred by the patient.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Participation Rate
Tidsram: Baseline
|
proportion of eligible participants consent to participate
|
Baseline
|
|
Acceptability
Tidsram: through study completion, an average of 1 year
|
proportion of participants who rated the intervention as moderately to extremely satisfied
|
through study completion, an average of 1 year
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Patient-provider discussion
Tidsram: "through study completion, an average of 1 year
|
self-reported by patient whether discussion on tobacco use took place at the indexed clinical encounter
|
"through study completion, an average of 1 year
|
|
Physician delivery of 5As
Tidsram: "through study completion, an average of 1 year
|
EHR-documented physician's delivery of assess, advice, assist, or arrange at the indexed clinical encounter
|
"through study completion, an average of 1 year
|
|
Quit attempt
Tidsram: 3-month
|
self-reported at least one or more 24 hour quit attempts
|
3-month
|
|
Abstinence
Tidsram: 3-month
|
self-reported 7-day point prevalent smoking abstinence
|
3-month
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Samarbetspartners
Utredare
- Huvudutredare: Thu Quach, PhD, MPH, Asian Health Services
- Huvudutredare: Janice Tsoh, University of California, San Francisco
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 augusti 2012
Primärt slutförande (Faktisk)
1 juli 2015
Avslutad studie (Faktisk)
1 juli 2015
Studieregistreringsdatum
Först inskickad
20 februari 2017
Först inskickad som uppfyllde QC-kriterierna
22 februari 2017
Första postat (Faktisk)
27 februari 2017
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
27 februari 2017
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
22 februari 2017
Senast verifierad
1 februari 2017
Mer information
Termer relaterade till denna studie
Andra studie-ID-nummer
- 21BT-0056
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .