Peripheral Artery Disease Clinical Trial
— PADOfficial title:
Onsite Tobacco Cessation Treatment for Patients With Peripheral Artery Disease (PAD): A Feasibility Study
Verified date | February 2024 |
Source | University of Oklahoma |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
United States | TSET Health Promotion Research Center | Oklahoma City | Oklahoma |
Lead Sponsor | Collaborator |
---|---|
University of Oklahoma |
United States,
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) |
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