- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03380910
An Interprofessional Intervention to Reduce Smoking Rates
February 12, 2021 updated by: Virginia Commonwealth University
An Interprofessional Intervention With Behavioral Health and Pharmacy Trainees to Reduce Smoking Rates at a Free Health Clinic in Richmond
The purpose of this study is to test the effectiveness of an experimental process to aid Spanish-speaking patients in quitting smoking with the help of pharmacists and behavioral health psychologist trainees and clinicians.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
25
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Virginia
-
Henrico, Virginia, United States, 23229
- CrossOver Healthcare Ministry
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 89 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Spanish-speaking
- Uninsured
- Current cigarette smoker
Exclusion Criteria:
- Pregnant or breastfeeding
- Heart attack or stroke in the last 3 months
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Ready to Quit
Current patients who speak Spanish, smoke cigarettes, and are ready to quit will be included.
The intervention includes an interdisciplinary team approach using pharmacy and behavioral health trainees to provide smoking cessation services.
|
An interdisciplinary approach using medications through pharmacy support and counseling through behavioral health team members will be used to improve smoking cessation rates.
|
|
Other: Not Ready to Quit
Current patients who speak Spanish, smoke cigarettes, and are not ready to quit will be included.
The intervention includes an interdisciplinary team approach using pharmacy and behavioral health trainees to provide smoking cessation services.
|
Patients not ready to quit will be offered motivational interviewing to increase readiness to quit.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in smoking abstinence
Time Frame: Baseline to 6 months
|
Smoking abstinence will be measured by breath carbon monoxide level
|
Baseline to 6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Readiness to Quit Smoking
Time Frame: Baseline to 6 months
|
Improvement in readiness to quit will be measured by the quit ladder
|
Baseline to 6 months
|
|
Change in Nicotine Dependence
Time Frame: Baseline to 6 months
|
Nicotine dependence will be measured by the Fagerstrom scale
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Baseline to 6 months
|
|
Change in Number of Cigarettes Smoked
Time Frame: Baseline to 6 months
|
Change in the number of cigarettes smoked will be measured by patient reported values
|
Baseline to 6 months
|
|
Change Carbon Monoxide Levels
Time Frame: Baseline to 6 months
|
Measured by Carbon Monoxide Meter
|
Baseline to 6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 26, 2018
Primary Completion (Actual)
January 20, 2020
Study Completion (Actual)
January 20, 2020
Study Registration Dates
First Submitted
December 15, 2017
First Submitted That Met QC Criteria
December 15, 2017
First Posted (Actual)
December 21, 2017
Study Record Updates
Last Update Posted (Actual)
February 15, 2021
Last Update Submitted That Met QC Criteria
February 12, 2021
Last Verified
February 1, 2021
More Information
Terms related to this study
Other Study ID Numbers
- HM20010390
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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