Onsite Tobacco Cessation Treatment for Patients With PAD (PAD)

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Tobacco Cessation; Peripheral Artery Disease
• Intervention / Treatment: Behavioral: Tobacco Treatment Research Program Standard Care

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73104
      • TSET Health Promotion Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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)

Other Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: University of Oklahoma
• Investigators: Principal Investigator: Darla E Kendzor, PhD, University of Oklahoma

Study record dates

Study Major Dates

• Study Start (Actual): August 16, 2022
• Primary Completion (Actual): June 30, 2023
• Study Completion (Estimated): July 31, 2024

Study Registration Dates

• First Submitted: July 13, 2022
• First Submitted That Met QC Criteria: July 20, 2022
• First Posted (Actual): July 22, 2022

Study Record Updates

• Last Update Posted (Actual): February 15, 2024
• Last Update Submitted That Met QC Criteria: February 13, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Atherosclerosis; Peripheral Vascular Diseases; Peripheral Arterial Disease
• Other Study ID Numbers: 12774

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: : 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.
• IPD Sharing Time Frame: De-identified data will be made available to investigators upon request after publication of the primary study findings.
• IPD Sharing Access Criteria: Data sharing agreement
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No