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Trial record 22 of 663 for:    SMS

Short Messaging Service Program to Help Quit Smoking During Perioperative Period. (SMS2QUIT)

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ClinicalTrials.gov Identifier: NCT03839043
Recruitment Status : Recruiting
First Posted : February 15, 2019
Last Update Posted : March 25, 2019
Sponsor:
Information provided by (Responsible Party):
David Warner, Mayo Clinic

Brief Summary:
Smoking can increase the risk of complications around the time of surgery. Researchers are trying to see if a text messaging program can help smokers stay off cigarettes around the time of surgery.

Condition or disease Intervention/treatment Phase
Tobacco Use Cessation Perioperative/Postoperative Complications Tobacco Smoking Behavioral: Brief behavioral intervention Other: SMS Program Not Applicable

Detailed Description:
The long-term goal of the project is to increase the reach and effectiveness of tobacco use interventions in healthcare settings. The main objective of this project is to determine whether an innovative tobacco use intervention targeting abstinence from the morning of surgery until one week after surgery ("quit for a bit") can increase sustained engagement of surgical patients in treatment compared with a standard tobacco use intervention that specifically targets long-term abstinence ("quit for good").

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Two hypotheses will be tested using a randomized controlled trial of 200 cigarette smokers scheduled for elective surgery that are willing to maintain temporary abstinence from cigarettes. Using a validated decision aid, subjects stratify according to intended duration of abstinence and randomize within each stratum to receive either a "quit for a bit" or a "quit for good" intervention. Both stratums employ a Short Message Service (SMS or "text") to deliver extended follow-up and assess engagement, e.g. subject response to text requests (ex. # of cigarettes smoked). The "quit for a bit" intervention targets abstinence in the first 7 days after surgery, and has an option of receiving continued messages. Both interventions can continue messages beyond day 30. We will assess treatment engagement outcomes and the continuation rate. We will also obtain biochemically-confirmed abstinence data on the morning of surgery and 30 days post-surgery, as well as self-reported abstinence.
Masking: Single (Participant)
Masking Description: A randomization schedule for each strata will be generated by the biostatistician using variable length blocks of size 2 or 4 to ensure that the number of subjects assigned to each of the 2 intervention groups remains balanced within each strata. Using these randomization schedules, a computer application program will be used that allows the study personnel to enroll a patient into the trial and obtain the appropriate treatment assignment. The computer application will assign this patient the next sequential treatment assignment for the admission status, and update the randomization dataset accordingly.Once treatment assignment is determined, study personnel will deliver the assigned intervention. The patient will be blinded to treatment assignment to the extent of not knowing the goal of the intervention a priori.
Primary Purpose: Health Services Research
Official Title: Perioperative Smoking Cessation in Surgical Patients Using Short Messaging Service Program.
Actual Study Start Date : March 18, 2019
Estimated Primary Completion Date : December 18, 2020
Estimated Study Completion Date : March 18, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Smoking

Arm Intervention/treatment
Experimental: "Quit for a bit"
Brief behavioral intervention (~5 min) that focus on quitting smoking from the morning of surgery until one week after surgery + "Quit for a bit" SMS program.
Behavioral: Brief behavioral intervention
"Quit for a bit"- *advice to quit from the am. of surgery until one week post-surgery, a special emphasis on morning abstinence* risks of smoking to perioperative outcomes, includes wound infections, breathing problems, and heart problems*reduction of these risks if able to quit for a bit*the fact that most smokers don't experience cravings or increased stress around the time of surgery. Subjects will receive written summarizing instructions and a brief abstinence brochure. "Quit for good"- 3 out of the 5A's smoking cessation intervention, including Asking, Advising and Assistance will be provided. The advice endorses immediate, sustained quitting (quit for good), accent on the health and economic benefits of long-term abstinence. Assistance includes a method of setting the date of surgery as the quit date, enlisting social support, anticipation of withdrawal symptoms, and the need for complete abstinence. Subjects will receive written summarizing instructions and a 5As brochure.

Other: SMS Program
"Quit for a bit"- Subjects will get SMS messages focused on maintaining abstinence from the morning of surgery until one week after surgery. SMS content focus on the benefits of abstinence to surgical recovery rather than sustained benefits to overall health. Around day 7 postoperatively, messages will encourage subjects to consider extending their abstinence beyond 7 days."Quit for good"- Subjects will get SMS messages focused on general advice for maintaining abstinence, focusing on the long-term health benefits rather immediate benefits to recovery from surgery. SMS content focus on the the surgical date as the quit date, general advice and support for quitting based on the standard Truth Initiative (UbiQUITxt) message library and there will be no references to effects of short-term abstinence on surgical outcomes.

Active Comparator: "Quit for good"
Brief behavioral intervention (~5 min) that focus on quitting smoking permanently for as long as possible +" Quit for good" SMS program.
Behavioral: Brief behavioral intervention
"Quit for a bit"- *advice to quit from the am. of surgery until one week post-surgery, a special emphasis on morning abstinence* risks of smoking to perioperative outcomes, includes wound infections, breathing problems, and heart problems*reduction of these risks if able to quit for a bit*the fact that most smokers don't experience cravings or increased stress around the time of surgery. Subjects will receive written summarizing instructions and a brief abstinence brochure. "Quit for good"- 3 out of the 5A's smoking cessation intervention, including Asking, Advising and Assistance will be provided. The advice endorses immediate, sustained quitting (quit for good), accent on the health and economic benefits of long-term abstinence. Assistance includes a method of setting the date of surgery as the quit date, enlisting social support, anticipation of withdrawal symptoms, and the need for complete abstinence. Subjects will receive written summarizing instructions and a 5As brochure.

Other: SMS Program
"Quit for a bit"- Subjects will get SMS messages focused on maintaining abstinence from the morning of surgery until one week after surgery. SMS content focus on the benefits of abstinence to surgical recovery rather than sustained benefits to overall health. Around day 7 postoperatively, messages will encourage subjects to consider extending their abstinence beyond 7 days."Quit for good"- Subjects will get SMS messages focused on general advice for maintaining abstinence, focusing on the long-term health benefits rather immediate benefits to recovery from surgery. SMS content focus on the the surgical date as the quit date, general advice and support for quitting based on the standard Truth Initiative (UbiQUITxt) message library and there will be no references to effects of short-term abstinence on surgical outcomes.




Primary Outcome Measures :
  1. Proportion of subjects who elect to continue participating in the SMS service after postoperative day 30 [ Time Frame: 30 days Post Op ]
    Provides one measure of subject engagement in treatment - how many are willing to continue using the text messaging service after 30 days.

  2. The rate at which subjects respond to any requests for subject response delivered via SMS and/or use of "keywords" sent via SMS by the subjects [ Time Frame: Cumulative from Day 1 to Day 30 Post Op ]
    Another measure of treatment engagement, describing willingness of the subjects to interact with the SMS service



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Age 18 years or older
  • Greater than 100 cigarettes lifetime consumption and history of smoking cigarettes every day or most days within the week prior to enrollment
  • Willingness to either "quit for a bit" or "quit for good" in the perioperative period, and;
  • Owning a device with access to SMS with an unlimited text plan

Exclusion Criteria:

  • Surgery on the day of POE evaluation
  • Any active psychiatric condition

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03839043


Contacts
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Contact: Thulasee Jose, MD 5074220703 jose.thulasee@mayo.edu
Contact: Linda S Weise, RRT 5072932535 weise.linda@mayo.edu

Locations
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United States, Minnesota
Mayo Recruiting
Rochester, Minnesota, United States, 55905
Contact: Thulasee Jose, MD    507-422-0703    jose.thulasee@mayo.edu   
Principal Investigator: David Warner, MD         
Sponsors and Collaborators
Mayo Clinic
Investigators
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Principal Investigator: David O Warner, MD Mayo Clinic

Additional Information:
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Responsible Party: David Warner, Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier: NCT03839043     History of Changes
Other Study ID Numbers: 18-010950
First Posted: February 15, 2019    Key Record Dates
Last Update Posted: March 25, 2019
Last Verified: March 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by David Warner, Mayo Clinic:
Tobacco
Cigarettes
Surgery
Text Message
SMS
Additional relevant MeSH terms:
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Postoperative Complications
Pathologic Processes