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NCT04928781 Clinical Trial

Smoking Cessation Study

Smoking Cessation Clinical Trial

Official title:
Smoking Cessation Intervention for Hospitalized Heart & Vascular Center (HVC) Patients at a Dartmouth-Hitchcock Medical Center Serving a Rural Population

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT04928781
Other study ID # STUDY02000943
Secondary ID
Status Withdrawn
Phase N/A
First received
Last updated
Start date June 28, 2022
Est. completion date June 1, 2023

Study information
Verified date February 2023
Source Dartmouth-Hitchcock Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This is a pilot study to determine the feasibility and success of offering smoking cessation counseling for ambulatory patients who present for scheduled cardiac catheterization.

Description:

This is a prospective randomized pilot study of feasibility and success of smoking cessation counselling for ambulatory patients who present for scheduled cardiac catheterization. Patients who meet inclusion and exclusion criteria will be eligible for enrollment and receive smoking cessation counseling. Patients will be followed for 6 months post intervention. A Usual care arm will be created using retrospective chart review.

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date June 1, 2023
Est. primary completion date February 1, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Presents to Dartmouth-Hitchcock Medical Center in Lebanon, NH as an ambulatory patient with a scheduled cardiac Catheterization - smoke one or more cigarettes per day for the past 12 months OR use of electronic-cigarettes containing tobacco at least once during the past 30 days. - proficient in English Exclusion Criteria: - N/A

Study Design

Related Conditions & MeSH terms

Intervention

Behavioral:
• Smoking Cessation Counseling
Smoking cessation counseling will be provided following standards set by the institution patients are receiving care at (Dartmouth-Hitchcock Medical Center).

Locations
Country Name City State
United States Dartmouth Health Lebanon New Hampshire

Sponsors (1)
Lead Sponsor Collaborator
Dartmouth-Hitchcock Medical Center

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Percentage of participants that self-report sustained smoking cessation Percentage of participants that self report sustained smoking cessation at 1 month. 1 month post index procedure
Primary Percentage of participants that self-report sustained smoking cessation Percentage of participants that self report sustained smoking cessation at 3 months. 3 months post index procedure
Primary Percentage of participants that self-report sustained smoking cessation Percentage of participants that self report sustained smoking cessation at 6 months. 6 months post index procedure
Secondary Percentage of participants that have had at least one subsequent cardiovascular hospital admission. Percentage of participants that have had at least one subsequent cardiovascular hospital admission at 1 month post index procedure. 1 month post index procedure
Secondary Percentage of participants that have had at least one subsequent cardiovascular hospital admission. Percentage of participants that have had at least one subsequent cardiovascular hospital admission at 3 months post index procedure. 3 months post index procedure
Secondary Percentage of participants that have had at least one subsequent cardiovascular hospital admission. Percentage of participants that have had at least one subsequent cardiovascular hospital admission at 6 months post index procedure. 6 months post index procedure
Secondary Percentage of participants that have had at least one emergency department presentation Percentage of participants that have had at least one emergency department presentation following discharge for their index procedure 1 month post index procedure 1 month post index procedure
Secondary Percentage of participants that have had at least one emergency department presentation Percentage of participants that have had at least one emergency department presentation following discharge for their index procedure 3 months post index procedure 3 months post index procedure
Secondary Percentage of participants that have had at least one emergency department presentation Percentage of participants that have had at least one emergency department presentation following discharge for their index procedure 6 months post index procedure 6 months post index procedure
Secondary Frequency of Cardiac Events following discharge from index procedure Frequency of cardiac events following discharge from hospitals, 1 month after index procedure. 1 month post index procedure
Secondary Frequency of Cardiac Events following discharge from index procedure Frequency of cardiac events following discharge from hospitals, 3 months after index procedure. 3 months post index procedure
Secondary Frequency of Cardiac Events following discharge from index procedure Frequency of cardiac events following discharge from hospitals, 6 months after index procedure. 6 months post index procedure
Secondary Percentage of participants that need subsequent coronary intervention following index procedure Percentage of participants that need subsequent coronary intervention following index procedure at 1 month post index procedure 1 month post index procedure
Secondary Percentage of participants that need subsequent coronary intervention following index procedure Percentage of participants that need subsequent coronary intervention following index procedure at 3 months post index procedure 3 moths post index procedure
Secondary Percentage of participants that need subsequent coronary intervention following index procedure Percentage of participants that need subsequent coronary intervention following index procedure at 6 months post index procedure 6 months post index procedure
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