Implementing a Scalable Smoke-free Home Intervention in Armenia and Georgia (SFHAMGE)
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Detailed Description
Study Type
Study Type
Enrollment (Estimated)
Enrollment
Phase
Phase
- Not Applicable
Contacts and Locations
Study Contact
Study Contact
- Name: Carla Berg
- Phone Number: 4045585395
- Email: carlaberg@gwu.edu
Study Locations
-
-
District of Columbia
-
Washington D.C., District of Columbia, United States, 20052
- Recruiting
- George Washington University
-
Contact:
- Carla J Berg, PhD
- Phone Number: 202-994-0168
- Email: carlaberg@gwu.edu
-
Contact:
- Darcey McCready, MS
- Phone Number: 202-994-2474
- Email: bergresearch@gwu.edu
-
-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- be greater than or equal to 18 years old
- smoke in the home and have a child and-or nonsmoker in the home, or be a non-smoker and live with someone who smokes in the home
- speak Armenian or Georgian
- live in a selected community
Exclusion Criteria:
N/A
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
No Intervention: Control
Assessment-only control
|
|
|
Experimental: Intervention
Theory-based intervention involving 3 mailed sets of educational materials and a brief coaching call using motivational interviewing, delivered over a 6-week period
|
Theory-based intervention involving 3 mailed sets of educational materials and a brief coaching call using motivational interviewing, delivered over a 6-week period.
|
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Complete smoke-free home rule
Time Frame: Current status; assessed at 6-months post baseline
|
"Which statement best describes the rules about smoking inside your home: smoking is not allowed anywhere inside my home; smoking is allowed in some places or at some times; smoking is allowed anywhere inside my home; or there are no rules about smoking inside my home."
Participant indicates no smoking allowed in the home (in any place or at any time).
|
Current status; assessed at 6-months post baseline
|
Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Secondhand smoke exposure in the home
Time Frame: Past 7 days; assessed at 6 months post baseline
|
Number of days smoking occurred in the home in the past 7 days
|
Past 7 days; assessed at 6 months post baseline
|
|
Secondhand smoke exposure in the home
Time Frame: Past 7 days; assessed at 3 months post baseline
|
Number of days smoking occurred in the home in the past 7 days
|
Past 7 days; assessed at 3 months post baseline
|
|
Complete smoke-free vehicle rule
Time Frame: Current status; assessed at 6 months post baseline
|
"Which statement best describes the rules about smoking in your household vehicles (cars or trucks)?
allowed in all vehicles; sometimes allowed in some vehicles; never allowed in any vehicle; no rules about smoking in the vehicles; don't own a vehicle."
Participant indicates no smoking allowed in the household vehicles (at any time).
|
Current status; assessed at 6 months post baseline
|
|
Complete smoke-free vehicle rule
Time Frame: Current status; assessed at 3 months post baseline
|
"Which statement best describes the rules about smoking in your household vehicles (cars or trucks)?
allowed in all vehicles; sometimes allowed in some vehicles; never allowed in any vehicle; no rules about smoking in the vehicles; don't own a vehicle."
Participant indicates no smoking allowed in the household vehicles (at any time).
|
Current status; assessed at 3 months post baseline
|
|
Among Smokers: Cigarette consumption
Time Frame: Past 7 days; assessed at 6 months post baseline
|
Cigarettes smoked per day; days smoked
|
Past 7 days; assessed at 6 months post baseline
|
|
Among Smokers: Cigarette consumption
Time Frame: Past 7 days; assessed at 3 months post baseline
|
Cigarettes smoked per day; days smoked
|
Past 7 days; assessed at 3 months post baseline
|
|
Among Smokers: Cigarette consumption
Time Frame: Past 30 days; assessed at 6 months post baseline
|
Cigarettes smoked per day; days smoked
|
Past 30 days; assessed at 6 months post baseline
|
|
Among Smokers: Cigarette consumption
Time Frame: Past 30 days; assessed at 3 months post baseline
|
Cigarettes smoked per day; days smoked
|
Past 30 days; assessed at 3 months post baseline
|
|
Among Smokers: Cessation attempts
Time Frame: Past 3 months; assessed at 6 months post baseline
|
Number of quit attempts in the past 3 months
|
Past 3 months; assessed at 6 months post baseline
|
|
Among Smokers: Cessation attempts
Time Frame: Past 3 months; assessed at 3 months post baseline
|
Number of quit attempts in the past 3 months
|
Past 3 months; assessed at 3 months post baseline
|
|
Complete smoke-free home rule
Time Frame: Current status; assessed at 3 months post baseline
|
"Which statement best describes the rules about smoking inside your home: smoking is not allowed anywhere inside my home; smoking is allowed in some places or at some times; smoking is allowed anywhere inside my home; or there are no rules about smoking inside my home."
Participant indicates no smoking allowed in the home (in any place or at any time).
|
Current status; assessed at 3 months post baseline
|
Collaborators and Investigators
Sponsor
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Estimated)
Primary Completion
Study Completion (Estimated)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
Other Study ID Numbers
- GW13528
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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