Smoking, CigaretteNCT03380910
An Interprofessional Intervention to Reduce Smoking Rates
A study testing Pharmacy and Behavioral Health Team and Motivational Interviewing in people with Smoking, Cigarette, run by Virginia Commonwealth University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Smoking, Cigarette
- What is being tested?
- Pharmacy and Behavioral Health Team and Motivational Interviewing
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Jan 2018to 20 Jan 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Spanish-speaking
- Uninsured
- Current cigarette smoker
Who cannot join
- Pregnant or breastfeeding
- Heart attack or stroke in the last 3 months
Trial locations and contacts
1 site in 1 country.
United States1 site
CrossOver Healthcare Ministry
Henrico, Virginia, 23229
About this study
Official title: 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.
- Conditions
- Smoking, Cigarette
- Being tested
- Pharmacy and Behavioral Health Team, Motivational Interviewing
- Medical subject headings
- Cigarette Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pharmacy and Behavioral Health TeamBehavioural
An interdisciplinary approach using medications through pharmacy support and counseling through behavioral health team members will be used to improve smoking cessation rates.
Motivational InterviewingBehavioural
Patients not ready to quit will be offered motivational interviewing to increase readiness to quit.
| Study group | Role | What they receive |
|---|---|---|
| Ready to Quit | Experimental | 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. Receives: Behavioral: Pharmacy and Behavioral Health Team |
| Not Ready to Quit | Other | 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. Receives: Behavioral: Motivational Interviewing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in smoking abstinence
Smoking abstinence will be measured by breath carbon monoxide level
Measured: Baseline to 6 months
Secondary outcomes (4)
Change in Readiness to Quit Smoking
Improvement in readiness to quit will be measured by the quit ladder
Measured: Baseline to 6 months
Change in Nicotine Dependence
Nicotine dependence will be measured by the Fagerstrom scale
Measured: Baseline to 6 months
Change in Number of Cigarettes Smoked
Change in the number of cigarettes smoked will be measured by patient reported values
Measured: Baseline to 6 months
Change Carbon Monoxide Levels
Measured by Carbon Monoxide Meter
Measured: Baseline to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2017
- Study start26 Jan 2018
- Primary completion20 Jan 2020
- Study completion20 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Smoking, CigaretteStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Virginia Commonwealth University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03380910
- Sponsor's protocol ID
- HM20010390
- Status last verified
- Feb 2021
- First submitted
- 15 Dec 2017
- Last updated
- 15 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Interprofessional Intervention With Behavioral Health and Pharmacy Trainees to Reduce Smoking Rates at a Free Health Clinic in Richmond
- ClinicalTrials.gov ID
- NCT03380910
- Acronym / sponsor ID
- HM20010390
- Conditions
- Smoking, Cigarette
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Virginia Commonwealth UniversityUniversity, hospital or other
- Study start
- 26 Jan 2018 (actual)
- Primary completion
- 20 Jan 2020 (actual)
- Study completion
- 20 Jan 2020 (actual)
- First posted
- 21 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ready to Quit | Experimental | Behavioral: Pharmacy and Behavioral Health TeamCurrent 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. |
| Not Ready to Quit | Other | Behavioral: Motivational InterviewingCurrent 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. |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Spanish-speaking
- Uninsured
- Current cigarette smoker
Key exclusion criteria (2 listed)
- Pregnant or breastfeeding
- Heart attack or stroke in the last 3 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pharmacy and Behavioral Health TeamAn interdisciplinary approach using medications through pharmacy support and counseling through behavioral health team members will be used to improve smoking cessation rates. | Behavioural | Ready to Quit |
| Motivational InterviewingPatients not ready to quit will be offered motivational interviewing to increase readiness to quit. | Behavioural | Not Ready to Quit |
Primary outcome
Change in smoking abstinence
Time frame: Baseline to 6 months
Smoking abstinence will be measured by breath carbon monoxide level
4 secondary outcomes
Change in Readiness to Quit Smoking
Time frame: Baseline to 6 months
Change in Nicotine Dependence
Time frame: Baseline to 6 months
Change in Number of Cigarettes Smoked
Time frame: Baseline to 6 months
Change Carbon Monoxide Levels
Time frame: Baseline to 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pharmacy and Behavioral Health Team and Motivational Interviewing in people with Smoking, Cigarette, run by Virginia Commonwealth University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in smoking abstinence (time frame: Baseline to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2021.