Onsite Tobacco Cessation Treatment for Patients With PAD

Peripheral Artery Disease Clinical Trial

— PAD  

Official title:

Onsite Tobacco Cessation Treatment for Patients With Peripheral Artery Disease (PAD): A Feasibility Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05469698
• Other study ID #: 12774
• Status: Active, not recruiting
• Phase: N/A
• Start date: August 16, 2022
• Est. completion date: July 31, 2024

Study information

• Verified date: February 2024
• Source: University of Oklahoma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Tobacco cessation treatment is needed for individuals with peripheral artery disease (PAD) to improve symptoms, lower cardiovascular risk, and prevent amputation. While such treatment is effective, many PAD patients do not receive cessation therapy. Participants will receive nicotine replacement therapy, counseling, and and complete questionnaires. We hypothesize that integrating tobacco cessation services into a dedicated PAD clinic (OU CVI Limb Preservation Clinic) can improve tobacco cessation rates and improve PAD-related health outcomes in this at risk population.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 15
• Est. completion date: July 31, 2024
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

Inclusion Criteria:

• Have diagnosed peripheral artery disease
• Tobacco user
• 18 years of age or older
• Willing/able to attend all study visits
• Be able to read, speak, and understand English

Exclusion Criteria:

• Do not meet the specified inclusion criteria above

Related Conditions & MeSH terms

• Peripheral Arterial Disease
• Peripheral Artery Disease
• Tobacco Cessation

Intervention

Behavioral:
• Tobacco Treatment Research Program Standard Care
Participants interested in quitting tobacco will be offered standard tobacco cessation care including nicotine replacement therapy and counseling.

Locations

Country	Name	City	State
United States	TSET Health Promotion Research Center	Oklahoma City	Oklahoma

Sponsors (1)

Lead Sponsor	Collaborator
University of Oklahoma

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Improvements in PAD	We will evaluate improvements among participants based on their responses in surveys.	Baseline to 13 weeks post enrollment
Primary	Biochemically confirmed abstinence	We will measure the biochemically-confirmed self-reported smoking cessation rate at 13 weeks post-enrollment (a cessation rate of = 15-20% will be a sign of feasibility).	13 weeks post enrollment
Secondary	Rate of enrollment	We will measure the rate of enrollment over those approached to be in the study (= 25% enrolled will indicate feasibility).	Duration of the study (approximately 6 months)