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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06195007
Other study ID # IRB202201687
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date February 1, 2024
Est. completion date July 2025

Study information

Verified date January 2024
Source University of Florida
Contact Julie Segura
Phone (352) 733-2412
Email Julie.segura@neurology.ufl.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Motivational interviewing (MI) is a style of communication designed to elicit a person's own reasons for change to drive commitment toward a goal. The goal of this study is to assess the effect of trainee-led MI on patients diagnosed with acute stroke or TIA attributable to modifiable risk factors in comparison to conventional post-stroke counseling, based on patient outcomes, and meaning of work and sense of fulfillment for trainees.


Recruitment information / eligibility

Status Recruiting
Enrollment 86
Est. completion date July 2025
Est. primary completion date July 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years to 99 Years
Eligibility Inclusion Criteria: - Patient presentation consistent with a stroke or TIA - Patient is a current tobacco user and tobacco use contributed to the stroke - Resident enrolled in study assigned to Vascular Neurology service during patient admission. Exclusion Criteria: - Patient unable or unwilling to follow up in the outpatient stroke clinic after discharge - Patient has cognitive impairment or aphasia that would preclude meaningful participation in motivational interview (defined as a score of 0 on the National Institute of Health Stroke Scale [NIHSS] questions 1 and 9)

Study Design


Intervention

Behavioral:
Motivational Interview
The motivational interview (MI) is a 10-15 minute patient-centered conversation which will focus on tobacco use. Multiple communication strategies can be employed during the MI, including open-ended questions, affirmative statements, reflective listening, use of a 'confidence ruler', and summarizing. The 'confidence ruler' technique in this patient population involves asking the patient "On a scale of zero to ten, how confident are you that you can stop using tobacco?", and then requesting further information about why they selected a certain number. These communication strategies and techniques are designed to uncover and foster a patient's own internal motivations to change the target behavior.

Locations

Country Name City State
United States University of Florida Gainesville Florida

Sponsors (2)

Lead Sponsor Collaborator
University of Florida Accreditation Council for Graduate Medical Education

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Smoking cessation at 90-day post-discharge follow up Yes or no 90 days post-discharge
Primary Patient rating of ability to improve their health Patient answers question "I am confident that I can work together with my care team to improve my health" with a rating from 1 (do not agree at all) to 10 (completely agree) 90 days post-discharge
Primary Recurrence of stroke / TIA symptoms Yes or no 90 days post-discharge
Secondary Patient ability to take stroke prevention medications as prescribed Yes or no 90 days post-discharge
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