- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT01228916
Community-Partnered Dominican Republic Tobacco Control
19 april 2016 uppdaterad av: Deborah Ossip, University of Rochester
Community-Partnered Tobacco Control in Underserved Dominican Republic Communities
Tobacco use and tobacco-caused illnesses and death are increasing in developing countries globally, so it is critical to study these countries in order to effectively address the tobacco epidemic.
The proposed project will test the effectiveness of community-based interventions for secondhand smoke and quitting smoking in eight underserved communities in the Dominican Republic.
The project will also partner with communities and national and international groups to determine whether the methods and interventions from this study in the Dominican Republic can also be used to help other countries in the region and underserved groups in the United States.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Detaljerad beskrivning
The globalization of the tobacco epidemic poses significant morbidity and mortality burdens, with the brunt of impact increasingly borne by low-middle income countries.
Research partnerships between investigators from high-income countries with well developed tobacco control research programs and their counterparts in low-middle income countries are needed to effectively address this global public health crisis.
The Dominican Republic (DR) is a key site that mirrors the trends in Latin America: it is a low-middle income tobacco growing country with significant tobacco use and high levels of secondhand smoke exposure, and it is at a very early stage of tobacco control.
The proposed project will assess baseline knowledge, attitudes, exposures, and behaviors regarding tobacco use and secondhand smoke, provide a randomized controlled trial of community-partnered interventions around secondhand smoke and tobacco cessation, and develop and implement a dissemination plan for national and regional impact and translation of methods and results to other underserved groups as appropriate.
A multimethod assessment approach will be used, to include qualitative community assessments (RAPs), a series of quantitative surveys (household surveillances, community and smoker cohort surveys, and health care provider surveys), and a biomarker assessment of secondhand smoke exposure.
Eight economically disadvantaged communities will be randomized to intervention or control conditions in a lagged treatment design; interventions will be developed and implemented based on the evidence base from other countries and from a current DR trial, and on input from national and local DR workgroups using a community partnered approach.
The intervention is hypothesized to decrease tobacco use rates, increase the number of smokefree homes, denormalize smoking, increase awareness of and change attitudes regarding tobacco use and secondhand smoke risks, decrease exposure to secondhand smoke, and increase health care provider intervention in intervention- relative to control communities, with differences by geographic and demographic characteristics to be examined.
The project will also engage international, national, and local DR workgroups to maintain communication of findings to key partners, host a national DR tobacco control conference with regional representation, and develop other action steps for local and regional dissemination of findings and evidence based interventions, resources, and infrastructures.
Finally, the project will coordinate with the University of Rochester Clinical and Translational Sciences Institute for translation of current evidence based approaches and methodologies for implementation in the DR, and to explore whether any methodologies or interventions from the proposed trial in the DR can be translated to underserved groups in the United States.
Effectively engaging early stage low-middle income countries in tobacco control research will be critical to reducing tobacco use and the burden of tobacco-caused illnesses globally.
Studietyp
Interventionell
Inskrivning (Faktisk)
3273
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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Santiago, Dominikanska republiken
- Centro de Atencion Primaria Juan XXIII
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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
4 månader till 97 år (Barn, Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
Inclusion Criteria: For main study: adults (age 18 and older), speak and understand Spanish. For biomarker sub-study (hair samples): children 10 years or younger.
Exclusion Criteria: Non-Spanish speaker, younger than 18 years (except for biomarker sub-study), anyone with questionable capacity or clear decisional impairment.
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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: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Experimentell: Tobacco Cessation and Secondhand Smoke Reduction
Community based interventions to raise awareness regarding secondhand smoke exposure, clean indoor air laws, smokefree homes, risks of tobacco use and benefits of cessation; include talks, healthcare provider training, radio public service announcements and talk shows, tleevision interviews, cessation classes and individual sessions, health fairs, community marches for smokefree spaces, materials and resources for assisting in tobacco use cessation, estsablishing smokefree homes, adhering to smokefree laws
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Awareness raising and resources for cessation and secondhand smoke reduction
Andra namn:
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Inget ingripande: Delayed Intervention Control
Assessment only during comparison period (no interventions will be provided over and above any secular trends in communities); delayed intervention will be provided at end of 1 year comparison period
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Self-Reported Tobacco Use
Tidsram: Yrs 5
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Self report of current use of any tobacco product
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Yrs 5
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Self Reported Exposure to Secondhand Smoke
Tidsram: Yrs 5
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Home smoking policies, implementation of clean indoor air laws, frequency of being close enough to breathe someone else's smoke
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Yrs 5
|
Self-Reported Tobacco Use
Tidsram: Year 4
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Self-reported use of any tobacco products after one year intervention-control period and prior to replication of intervention in control communities.
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Year 4
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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Samarbetspartners
Utredare
- Huvudutredare: Deborah J Ossip, PhD, University of Rochester
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 juni 2010
Primärt slutförande (Faktisk)
1 november 2013
Avslutad studie (Faktisk)
1 november 2013
Studieregistreringsdatum
Först inskickad
25 oktober 2010
Först inskickad som uppfyllde QC-kriterierna
25 oktober 2010
Första postat (Uppskatta)
27 oktober 2010
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
21 april 2016
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
19 april 2016
Senast verifierad
1 april 2016
Mer information
Termer relaterade till denna studie
Nyckelord
Andra studie-ID-nummer
- 1R01CA132950-01A2 (U.S.S. NIH-anslag/kontrakt)
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 .
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