Peripheral Artery Disease, Tobacco Cessation
Conditions
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.
Interventions
BEHAVIORALTobacco Treatment Research Program Standard Care
Participants interested in quitting tobacco will be offered standard tobacco cessation care including nicotine replacement therapy and counseling.
Sponsors
University of Oklahoma
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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). |
Other
| Measure | Time frame | Description |
|---|---|---|
| Improvements in PAD | Baseline to 13 weeks post enrollment | We will evaluate improvements among participants based on their responses in surveys. |
Countries
United States
Outcome results
None listed