Onsite Tobacco Cessation Treatment for Patients With PAD

Sponsor
University of Oklahoma (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05469698
Collaborator
(none)
40
1
1
12.6
3.2

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Tobacco Treatment Research Program Standard Care
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Onsite Tobacco Cessation Treatment for Patients With Peripheral Artery Disease (PAD): A Feasibility Study
Anticipated Study Start Date :
Aug 12, 2022
Anticipated Primary Completion Date :
Mar 1, 2023
Anticipated Study Completion Date :
Aug 30, 2023

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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 Outcome Measures

  1. Improvements in PAD [Baseline to 13 weeks post enrollment]

    We will evaluate improvements among participants based on their responses in surveys.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 100 Years
Sexes Eligible for Study:
All
Accepts 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 TSET Health Promotion Research Center Oklahoma City Oklahoma United States 73104

Sponsors and Collaborators

  • University of Oklahoma

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University of Oklahoma
ClinicalTrials.gov Identifier:
NCT05469698
Other Study ID Numbers:
  • 12774
First Posted:
Jul 22, 2022
Last Update Posted:
Aug 3, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
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
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 3, 2022