StayQuit InterventionNCT03367520
Helping Veterans With SMI "StayQuit" From Smoking After Inpatient Hospitalization
A study testing StayQuit in people with StayQuit Intervention, run by University of Maryland, Baltimore at 1 site in United States.
Trial summary
Given the high prevalence and great cost of smoking for individuals with serious mental illness, an effective smoking cessation intervention for this group of smokers that begins in the hospital and continues following discharge is needed. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- StayQuit Intervention
- What is being tested?
- StayQuit
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Jun 2017to 31 Dec 2018
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Currently receiving inpatient care at the Baltimore VAMC inpatient psychiatric unit
- 18 years of age or older
- Self-reported smoking of 5+ cigarettes a day prior to hospitalization
Who cannot join
- Documented history of severe neurological disorder
- Intellectual developmental disorder indicated by chart review
Trial locations and contacts
1 site in 1 country.
United States1 site
Baltimore VA Medical Center
Baltimore, Maryland, 21201
About this study
Given the high prevalence and great cost of smoking for individuals with serious mental illness, an effective smoking cessation intervention for this group of smokers that begins in the hospital and continues following discharge is needed. The investigators will develop and pilot test StayQuit, a multifaceted smoking cessation intervention for smokers with serious mental illness that begins in the hospital and continues for three months after discharge. StayQuit will provide a personalized and tailored experience for smokers with serious mental illness at different levels of motivation to remain abstinent. In the hospital, StayQuit will include a brief motivational intervention that will help smokers relate sustained smoking cessation to their values and preferences, shore up motivation to stay quit, and gain experience using nicotine replacement therapy. This will be followed by cessation-focused discharge planning to engage Veterans in continued smoking cessation services with StayQuit staff. After discharge, StayQuit will offer 13 weeks (spread out over 3 months) of smoking cessation telephone counseling. The investigators will examine the feasibility of StayQuit by collecting both quantitative data on attendance and qualitative data on participants' experiences.
- Conditions
- StayQuit Intervention
- Being tested
- StayQuit
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
StayQuitBehavioural
StayQuit offers 3 meetings during hospitalization and up 13 telephone calls. StayQuit begins in the hospital with an assessment of motivation to remain quit after discharge and a brief intervention to develop discrepancy between values and behaviors and generate change talk. Participants are also encouraged to try nicotine replacement therapy during the hospitalization and after discharge. Telephone counseling is brief and focused on managing withdrawal from nicotine, coping with cravings, and supporting use of NRT. The investigators will work with hospital staff as needed to ensure that nicotine replacement therapy is offered to participants during the inpatient stay and prescribed at discharge.
| Study group | Role | What they receive |
|---|---|---|
| StayQuit | Experimental | StayQuit offers 3 meetings during hospitalization and up 13 telephone calls. StayQuit begins in the hospital with an assessment of motivation to remain quit after discharge and a brief intervention to develop discrepancy between values and behaviors and generate change talk. Participants are also encouraged to try nicotine replacement therapy during the hospitalization and after discharge. Telephone counseling is brief and focused on managing withdrawal from nicotine, coping with cravings, and supporting use of NRT. The investigators will work with hospital staff as needed to ensure that nicotine replacement therapy is offered to participants during the inpatient stay and prescribed at discharge. Receives: Behavioral: StayQuit |
What is being measured
The primary outcome is the main question the study is designed to answer.
Attendance at in-person StayQuit sessions
Number of in-person StayQuit sessions a participant completes
Measured: 4 weeks
Attendance at telephone StayQuit sessions
Number of telephone StayQuit sessions a participant completes
Measured: 13 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2017
- Study start7 Jun 2017
- Primary completion31 Dec 2018
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StayQuit InterventionStudies of the same condition, open and under way.
- More trials run by University of Maryland, BaltimoreThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Model description
- This project has two phases. Phase 1: Develop StayQuit materials and train the study interventionist. Phase 2: Implement StayQuit with 10-20 Veterans who are hospitalized on the inpatient psychiatric unit at the Baltimore VA Medical Center.
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Maryland, Baltimore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Melanie Bennett, University of Maryland, Baltimore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03367520
- Sponsor's protocol ID
- HP-00071331
- Status last verified
- Apr 2020
- First submitted
- 4 Dec 2017
- Last updated
- 6 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Helping Veterans With SMI "StayQuit" From Smoking After Inpatient Hospitalization
- ClinicalTrials.gov ID
- NCT03367520
- Acronym / sponsor ID
- HP-00071331
- Conditions
- StayQuit Intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- University of Maryland, BaltimoreUniversity, hospital or other
- Study start
- 7 Jun 2017 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 8 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.
Given the high prevalence and great cost of smoking for individuals with serious mental illness, an effective smoking cessation intervention for this group of smokers that begins in the hospital and continues following discharge is needed. The investigators will develop and pilot test StayQuit, a multifaceted smoking cessation intervention for smokers with serious mental illness that begins in the hospital and continues for three months after discharge. StayQuit will provide a personalized and tailored experience for smokers with serious mental illness at different levels of motivation to remain abstinent. In the hospital, StayQuit will include a brief motivational intervention that will help smokers relate sustained smoking cessation to their values and preferences, shore up motivation to stay quit, and gain experience using nicotine replacement therapy. This will be followed by cessation-focused discharge planning to engage Veterans in continued smoking cessation services with StayQuit staff. After discharge, StayQuit will offer 13 weeks (spread out over 3 months) of smoking cessation telephone counseling. The investigators will examine the feasibility of StayQuit by collecting both quantitative data on attendance and qualitative data on participants' experiences.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This project has two phases. Phase 1: Develop StayQuit materials and train the study interventionist. Phase 2: Implement StayQuit with 10-20 Veterans who are hospitalized on the inpatient psychiatric unit at the Baltimore VA Medical Center.
| Arm | Type | Receives |
|---|---|---|
| StayQuit | Experimental | Behavioral: StayQuitStayQuit offers 3 meetings during hospitalization and up 13 telephone calls. StayQuit begins in the hospital with an assessment of motivation to remain quit after discharge and a brief intervention to develop discrepancy between values and behaviors and generate change talk. Participants are also encouraged to try nicotine replacement therapy during the hospitalization and after discharge. Telephone counseling is brief and focused on managing withdrawal from nicotine, coping with cravings, and supporting use of NRT. The investigators will work with hospital staff as needed to ensure that nicotine replacement therapy is offered to participants during the inpatient stay and prescribed at discharge. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Currently receiving inpatient care at the Baltimore VAMC inpatient psychiatric unit
- 18 years of age or older
- Self-reported smoking of 5+ cigarettes a day prior to hospitalization
Key exclusion criteria (2 listed)
- Documented history of severe neurological disorder
- Intellectual developmental disorder indicated by chart review
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 |
|---|---|---|
| StayQuitStayQuit offers 3 meetings during hospitalization and up 13 telephone calls. StayQuit begins in the hospital with an assessment of motivation to remain quit after discharge and a brief intervention to develop discrepancy between values and behaviors and generate change talk. Participants are also encouraged to try nicotine replacement therapy during the hospitalization and after discharge. Telephone counseling is brief and focused on managing withdrawal from nicotine, coping with cravings, and supporting use of NRT. The investigators will work with hospital staff as needed to ensure that nicotine replacement therapy is offered to participants during the inpatient stay and prescribed at discharge. | Behavioural | StayQuit |
Primary outcome
Attendance at in-person StayQuit sessions
Time frame: 4 weeks
Number of in-person StayQuit sessions a participant completes
Attendance at telephone StayQuit sessions
Time frame: 13 weeks
Number of telephone StayQuit sessions a participant completes
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 6 Apr 2020.
- Individual participant dataSharing planned: No
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 StayQuit in people with StayQuit Intervention, run by University of Maryland, Baltimore 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 6 Apr 2020. 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?
Attendance at in-person StayQuit sessions (time frame: 4 weeks). The study lists 2 primary outcomes in all. 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 6 Apr 2020.