- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06195007
Motivational Interviewing for Stroke
August 19, 2024 updated by: University of Florida
Motivational Interviewing to Improve Outcomes After Stroke or Transient Ischemic Attack Attributable to Tobacco Use
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.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
1
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Florida
-
Gainesville, Florida, United States, 32608
- University of Florida
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Motivational Interview
Patients included in the study who are being treated by a resident in the MI intervention group will have a motivational interview during their initial hospitalization.
|
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.
|
|
No Intervention: Control
Patients included in the study who are being treated by a resident in the Control group will not have a motivational interview during their hospitalization.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Smoking cessation at 90-day post-discharge follow up
Time Frame: 90 days post-discharge
|
Yes or no
|
90 days post-discharge
|
|
Patient rating of ability to improve their health
Time Frame: 90 days post-discharge
|
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
|
|
Recurrence of stroke / TIA symptoms
Time Frame: 90 days post-discharge
|
Yes or no
|
90 days post-discharge
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Patient ability to take stroke prevention medications as prescribed
Time Frame: 90 days post-discharge
|
Yes or no
|
90 days post-discharge
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Christina Wilson, MD PhD, University of Florida
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 20, 2023
Primary Completion (Actual)
December 20, 2023
Study Completion (Actual)
January 1, 2024
Study Registration Dates
First Submitted
December 21, 2023
First Submitted That Met QC Criteria
January 5, 2024
First Posted (Actual)
January 8, 2024
Study Record Updates
Last Update Posted (Actual)
August 21, 2024
Last Update Submitted That Met QC Criteria
August 19, 2024
Last Verified
August 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB202201687
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Transient Ischemic Attack
-
Lawson Health Research InstituteHeart and Stroke Foundation of OntarioCompleted
-
University of Alabama at BirminghamRecruitingStroke | Transient Ischemic Attack (TIA)United States
-
University of California, San DiegoWithdrawnStroke | Transient Ischemic Attack (TIA)United States
-
Capital Medical UniversityRecruitingIschemic Stroke | Transient Ischemic AttackChina
-
Beijing Tiantan HospitalBeijing Tsinghua Chang Gung Hospital; The First Hospital of Jilin University; First People's Hospital of Foshan and other collaboratorsRecruitingIschemic Stroke | Transient Ischemic Attack (TIA)China
-
Versailles HospitalCompletedCryptogenic Transient Ischemic Attack and Minor StrokeFrance
-
Medtronic Cardiac Rhythm and Heart FailureMedtronic Bakken Research CenterCompletedCryptogenic Symptomatic Transient Ischemic Attack | Cryptogenic Ischemic StrokeNetherlands, United States, France, Belgium, Germany, Sweden, Italy, Austria, Canada, Denmark, Finland, Greece, Slovakia, Spain
-
Hamad Medical CorporationUnknownStroke | Transient Ischemic Attack (TIA)Qatar
-
Hend MansoorNational Institute on Minority Health and Health Disparities (NIMHD)CompletedStroke (CVA) or Transient Ischemic AttackUnited States
-
University of NottinghamNottingham University Hospitals NHS Trust; The Stroke Association, United KingdomCompletedStroke | Transient Ischaemic AttackUnited Kingdom
Clinical Trials on Motivational Interview
-
Ohio UniversityNew York Blood CenterCompleted
-
Centro Hospitalar Lisboa NorteUniversity of Lisbon; Faculdade de Psicologia e de Ciências de Educação da...Unknown
-
Kahramanmaras Sutcu Imam UniversityEnrolling by invitation
-
T.C. ORDU ÜNİVERSİTESİCompleted
-
Abdullah GerçekCompletedHemodialysis Complication | Motivation | Patient ComplianceTurkey
-
Istanbul University-CerrahpasaCompleted
-
Odense University HospitalCompletedPolycystic Ovary Syndrome | Overweight and Obesity | Motivation
-
Afyonkarahisar Health Sciences UniversityNot yet recruiting
-
Sultan Ayaz AlkayaCompleted