Nicotine Dependence, CigarettesNCT02986711
Penn State TXT2STAYQUIT Study- a Texting Study to Help Hospitalized Smokers Stay Quit
A study testing Motivational Text Messages in people with Nicotine Dependence, Cigarettes, run by Milton S. Hershey Medical Center at 1 site in United States.
Trial summary
This study aims to pilot a method of collecting the post-discharge follow-up data required by the Joint Commission Tobacco Measure Set, using text messages sent to and received from patients' cellular-telephones. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Nicotine Dependence, Cigarettes
- What is being tested?
- Motivational Text Messages
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 158 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2013to Apr 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Total length of hospital stay at least 24 hours
- Free of cognitive impairment
- Read and speak English
- Smoked at least 20 cigarettes in 30 days prior to entering the hospital
- Willing to give up all forms of tobacco
- Has a cell phone capable of receiving text messages (cell phone is powered on and charged)
Who cannot join
- Patient has been admitted for a transplant
- Patient has Intensive Care status
Trial locations and contacts
1 site in 1 country.
United States1 site
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033
About this study
Official title: Pilot Randomized Trial of Brief Automated Smoking Cessation Intervention and Evaluation for Smokers Discharged From Hospital
This study aims to pilot a method of collecting the post-discharge follow-up data required by the Joint Commission Tobacco Measure Set, using text messages sent to and received from patients' cellular-telephones. It also aims to assess whether specially designed relapse prevention text messages designed to encourage abstinence from smoking, can increase the proportion of smokers who remain abstinent during the first month after discharge from hospital.
Read the detailed description
Participants will be those who are hospitalized at Hershey Medical Center and are interested in help to stay quit when they leave the hospital.
- Conditions
- Nicotine Dependence, Cigarettes
- Being tested
- Motivational Text Messages, Control
- Medical subject headings
- Tobacco Use Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motivational Text MessagesBehavioural
Motivational text messages in addition to survey questions about smoking status
ControlBehavioural
Only survey questions about smoking status
| Study group | Role | What they receive |
|---|---|---|
| Motivational Text Messages | Experimental | Motivational text messages to help participants stay quit when they leave the hospital. Receives: Behavioral: Motivational Text Messages |
| Control | Sham comparator | Text messages to ask about current smoking status. Receives: Behavioral: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete Self-reported Tobacco Abstinence During the Prior 7 Days, as Reported on Telephone Interview, 28 Days After Discharge From Hospital (With Biochemical Verification in a Sub-sample, Exhaled Carbon-monoxide < 10 Parts Per Million).
Abstinence rate at 28 days
Measured: 28 days
Secondary outcomes (1)
Proportion of Participants Providing Smoking Cessation Status Via Text Message
proportion of participants providing data about smoking status via text message at 28 days
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2016 (estimated)
- Study startDec 2013
- Primary completionApr 2015
- Study completionApr 2015
Why it stopped: Funding exhausted
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Nicotine Dependence, CigarettesStudies of the same condition, open and under way.
- More trials run by Milton S. Hershey Medical CenterThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 158 participants (actual)
Sponsor and investigators
- Lead sponsor
- Milton S. Hershey Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jonathan Foulds, Milton S. Hershey Medical Center
- Investigators
- Jonathan Foulds, PhD, Principal investigator, Penn State College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02986711
- Sponsor's protocol ID
- 40683
- Status last verified
- Dec 2018
- First submitted
- 8 Oct 2015
- Last updated
- 19 Dec 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Randomized Trial of Brief Automated Smoking Cessation Intervention and Evaluation for Smokers Discharged From Hospital
- ClinicalTrials.gov ID
- NCT02986711
- Acronym / sponsor ID
- 40683
- Conditions
- Nicotine Dependence, Cigarettes
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Funding exhausted
- Enrolment
- 158 participants (actual)
- Lead sponsor
- Milton S. Hershey Medical CenterUniversity, hospital or other
- Study start
- Dec 2013
- Primary completion
- Apr 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 8 Dec 2016 (estimated)
- Results
- Posted 21 Sep 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to pilot a method of collecting the post-discharge follow-up data required by the Joint Commission Tobacco Measure Set, using text messages sent to and received from patients' cellular-telephones. It also aims to assess whether specially designed relapse prevention text messages designed to encourage abstinence from smoking, can increase the proportion of smokers who remain abstinent during the first month after discharge from hospital.
Detailed description
Participants will be those who are hospitalized at Hershey Medical Center and are interested in help to stay quit when they leave the hospital.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Motivational Text Messages | Experimental | Behavioral: Motivational Text MessagesMotivational text messages to help participants stay quit when they leave the hospital. |
| Control | Sham comparator | Behavioral: ControlText messages to ask about current smoking status. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Total length of hospital stay at least 24 hours
- Free of cognitive impairment
- Read and speak English
- Smoked at least 20 cigarettes in 30 days prior to entering the hospital
- Willing to give up all forms of tobacco
Key exclusion criteria (2 listed)
- Patient has been admitted for a transplant
- Patient has Intensive Care status
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 |
|---|---|---|
| Motivational Text MessagesMotivational text messages in addition to survey questions about smoking status | Behavioural | Motivational Text Messages |
| ControlOnly survey questions about smoking status | Behavioural | Control |
Primary outcome
Complete Self-reported Tobacco Abstinence During the Prior 7 Days, as Reported on Telephone Interview, 28 Days After Discharge From Hospital (With Biochemical Verification in a Sub-sample, Exhaled Carbon-monoxide < 10 Parts Per Million).
Time frame: 28 days
Abstinence rate at 28 days
1 secondary outcome
Proportion of Participants Providing Smoking Cessation Status Via Text Message
Time frame: 28 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Jonathan Foulds, PhD principal investigator
Penn State College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Motivational Text Messages in people with Nicotine Dependence, Cigarettes, run by Milton S. Hershey Medical Center 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 6 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: stopped early, as of the sponsor's last update on 19 Dec 2018. 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. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 21 Sep 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Complete Self-reported Tobacco Abstinence During the Prior 7 Days, as Reported on Telephone Interview, 28 Days After Discharge From Hospital (With Biochemical Verification in a Sub-sample, Exhaled Carbon-monoxide < 10 Parts Per Million). (time frame: 28 days). 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 19 Dec 2018.