- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02986711
Penn State TXT2STAYQUIT Study- a Texting Study to Help Hospitalized Smokers Stay Quit
December 17, 2018 updated by: Jonathan Foulds, Milton S. Hershey Medical Center
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.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
158
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
-
-
Pennsylvania
-
Hershey, Pennsylvania, United States, 17033
- Penn State Milton S. Hershey Medical Center
-
-
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
16 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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)
Exclusion Criteria:
- Patient has been admitted for a transplant
- Patient has Intensive Care status
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: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Motivational Text Messages
Motivational text messages to help participants stay quit when they leave the hospital.
|
Motivational text messages in addition to survey questions about smoking status
|
Sham Comparator: Control
Text messages to ask about current smoking status.
|
Only survey questions about smoking status
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
28 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Proportion of Participants Providing Smoking Cessation Status Via Text Message
Time Frame: 28 days
|
proportion of participants providing data about smoking status via text message at 28 days
|
28 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Jonathan Foulds, PhD, Penn State College of Medicine
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
December 1, 2013
Primary Completion (Actual)
April 1, 2015
Study Completion (Actual)
April 1, 2015
Study Registration Dates
First Submitted
October 8, 2015
First Submitted That Met QC Criteria
December 5, 2016
First Posted (Estimate)
December 8, 2016
Study Record Updates
Last Update Posted (Actual)
December 19, 2018
Last Update Submitted That Met QC Criteria
December 17, 2018
Last Verified
December 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 40683
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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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