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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03839043
Other study ID # 18-010950
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 18, 2019
Est. completion date June 11, 2021

Study information

Verified date July 2021
Source Mayo Clinic
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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").


Recruitment information / eligibility

Status Completed
Enrollment 100
Est. completion date June 11, 2021
Est. primary completion date June 11, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
United States Mayo Rochester Minnesota

Sponsors (1)

Lead Sponsor Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Proportion of subjects who elect to continue participating in the SMS service after postoperative day 30 Provides one measure of subject engagement in treatment - how many are willing to continue using the text messaging service after 30 days. 30 days Post Op
Primary 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 Another measure of treatment engagement, describing willingness of the subjects to interact with the SMS service Cumulative from Day 1 to Day 30 Post Op
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