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Onsite Tobacco Cessation Treatment for Patients With PAD (PAD)

Primary Purpose

Tobacco Cessation, Peripheral Artery Disease

Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Tobacco Treatment Research Program Standard Care
Sponsored by
University of Oklahoma
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tobacco Cessation

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • TSET Health Promotion Research Center

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Standard Care

Arm Description

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.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Rate of enrollment
We will measure the rate of enrollment over those approached to be in the study (≥ 25% enrolled will indicate feasibility).

Full Information

First Posted
July 13, 2022
Last Updated
January 9, 2023
Sponsor
University of Oklahoma
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1. Study Identification

Unique Protocol Identification Number
NCT05469698
Brief Title
Onsite Tobacco Cessation Treatment for Patients With PAD
Acronym
PAD
Official Title
Onsite Tobacco Cessation Treatment for Patients With Peripheral Artery Disease (PAD): A Feasibility Study
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
August 16, 2022 (Actual)
Primary Completion Date
June 1, 2023 (Anticipated)
Study Completion Date
August 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Oklahoma

4. Oversight

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

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tobacco Cessation, Peripheral Artery Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Standard Care
Arm Type
Other
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Tobacco Treatment Research Program Standard Care
Intervention Description
Participants interested in quitting tobacco will be offered standard tobacco cessation care including nicotine replacement therapy and counseling.
Primary Outcome Measure Information:
Title
Biochemically confirmed abstinence
Description
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).
Time Frame
13 weeks post enrollment
Secondary Outcome Measure Information:
Title
Rate of enrollment
Description
We will measure the rate of enrollment over those approached to be in the study (≥ 25% enrolled will indicate feasibility).
Time Frame
Duration of the study (approximately 6 months)
Other Pre-specified Outcome Measures:
Title
Improvements in PAD
Description
We will evaluate improvements among participants based on their responses in surveys.
Time Frame
Baseline to 13 weeks post enrollment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Darla E Kendzor, PhD
Organizational Affiliation
University of Oklahoma
Official's Role
Principal Investigator
Facility Information:
Facility Name
TSET Health Promotion Research Center
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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

Learn more about this trial

Onsite Tobacco Cessation Treatment for Patients With PAD

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