Onsite Tobacco Cessation Treatment for Patients With PAD

Not Applicable

Active, not recruiting

• Conditions: Tobacco Cessation; Peripheral Artery Disease
• Interventions: Behavioral: Tobacco Treatment Research Program Standard Care

• Registration Number: NCT05469698
• Lead Sponsor: University of Oklahoma

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-07-13
• Study First Submitted QC: 2022-07-20
• Study First Posted: 2022-07-22
• Study Start: 2022-08-16
• Primary Completion: 2023-06-30
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-13
• Last Update Posted: 2024-02-15
• Study Completion: 2024-07-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 15

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Standard Care	Tobacco Treatment Research Program Standard Care	All participants will receive standard care by the Tobacco Treatment Research Program. This includes nicotine replacement therapy such as patches, gum, or lozenges, counseling by a Tobacco Treatment Specialist, and complete questionnaires.

Primary Outcome Measures

Name	Time	Method
Biochemically confirmed abstinence	13 weeks post enrollment	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).

Secondary Outcome Measures

Name	Time	Method
Rate of enrollment	Duration of the study (approximately 6 months)	We will measure the rate of enrollment over those approached to be in the study (≥ 25% enrolled will indicate feasibility).

Trial Locations

Locations (1)

TSET Health Promotion Research Center; 🇺🇸 Oklahoma City, Oklahoma, United States