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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard Care | Other | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tobacco Treatment Research Program Standard Care | Behavioral | Participants interested in quitting tobacco will be offered standard tobacco cessation care including nicotine replacement therapy and counseling. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Improvements in PAD | We will evaluate improvements among participants based on their responses in surveys. | Baseline to 13 weeks post enrollment |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Darla E Kendzor, PhD | University of Oklahoma | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| TSET Health Promotion Research Center | Oklahoma City | Oklahoma | 73104 | United States |
: Yes De-identified data will be made available to investigators upon request, after publication of the primary study findings, and with a data-sharing agreement that specifies the investigator(s) will 1) use the data only for research purposes and not to identify any individual participant, 2) store the data on a secure device (e.g., encrypted, password-protected), and 3) destroy or return the data after completion of the analyses.
De-identified data will be made available to investigators upon request after publication of the primary study findings.
Data sharing agreement
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| ID | Term |
|---|---|
| D020340 | Tobacco Use Cessation |
| D058729 | Peripheral Arterial Disease |
| ID | Term |
|---|---|
| D015438 | Health Behavior |
| D001519 | Behavior |
| D050197 | Atherosclerosis |
| D001161 | Arteriosclerosis |
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| D001157 |
| Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D016491 | Peripheral Vascular Diseases |