Onsite Tobacco Cessation Treatment for Patients With PAD

NCT ID: NCT05469698

Last Updated: 2024-02-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-08-16

Study Completion Date

2024-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Tobacco Cessation Peripheral Artery Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type OTHER

Tobacco Treatment Research Program Standard Care

Intervention Type BEHAVIORAL

Participants interested in quitting tobacco will be offered standard tobacco cessation care including nicotine replacement therapy and counseling.

Interventions

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Tobacco Treatment Research Program Standard Care

Participants interested in quitting tobacco will be offered standard tobacco cessation care including nicotine replacement therapy and counseling.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Oklahoma

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Darla E Kendzor, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Oklahoma

Locations

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TSET Health Promotion Research Center

Oklahoma City, Oklahoma, United States

Site Status

Countries

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United States

Other Identifiers

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12774

Identifier Type: -

Identifier Source: org_study_id

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