Acute StrokeNCT06195007
Motivational Interviewing for Stroke
A study testing Motivational Interview in people with Acute Stroke and Transient Ischemic Attack, run by University of Florida at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Acute Stroke, Transient Ischemic Attack
- What is being tested?
- Motivational Interview
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Dec 2023to 1 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Acute Stroke, Transient Ischemic Attack
- Being tested
- Motivational Interview
- Medical subject headings
- Stroke, Ischemic Attack, Transient
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motivational InterviewBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Motivational Interview | Experimental | 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. Receives: Behavioral: Motivational Interview |
| Control | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
Smoking cessation at 90-day post-discharge follow up
Yes or no
Measured: 90 days post-discharge
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)
Measured: 90 days post-discharge
Recurrence of stroke / TIA symptoms
Yes or no
Measured: 90 days post-discharge
Secondary outcomes (1)
Patient ability to take stroke prevention medications as prescribed
Yes or no
Measured: 90 days post-discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2024
- Study start20 Dec 2023
- Primary completion20 Dec 2023
- Study completion1 Jan 2024
Why it stopped: no research team to conduct study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute StrokeStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Collaborators
- Accreditation Council for Graduate Medical Education
- Responsible party
- Sponsor
- Investigators
- Christina Wilson, MD PhD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06195007
- Sponsor's protocol ID
- IRB202201687
- Status last verified
- Aug 2024
- First submitted
- 21 Dec 2023
- Last updated
- 21 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Motivational Interviewing to Improve Outcomes After Stroke or Transient Ischemic Attack Attributable to Tobacco Use
- ClinicalTrials.gov ID
- NCT06195007
- Acronym / sponsor ID
- IRB202201687
- Conditions
- Acute Stroke, Transient Ischemic Attack
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: no research team to conduct study
- Enrolment
- 1 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Collaborators
- Accreditation Council for Graduate Medical Education
- Study start
- 20 Dec 2023 (actual)
- Primary completion
- 20 Dec 2023 (actual)
- Study completion
- 1 Jan 2024 (actual)
- First posted
- 8 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Motivational Interview | Experimental | Behavioral: Motivational InterviewPatients 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. |
| Control | No intervention | –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. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Motivational InterviewThe 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. | Behavioural | Motivational Interview |
Primary outcome
Smoking cessation at 90-day post-discharge follow up
Time frame: 90 days post-discharge
Yes or no
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)
Recurrence of stroke / TIA symptoms
Time frame: 90 days post-discharge
Yes or no
1 secondary outcome
Patient ability to take stroke prevention medications as prescribed
Time frame: 90 days post-discharge
Results and safety
The study was stopped early (reason given: no research team to conduct study). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christina Wilson, MD PhD principal investigator
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Motivational Interview in people with Acute Stroke and Transient Ischemic Attack, run by University of Florida at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 21 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: no research team to conduct study). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Smoking cessation at 90-day post-discharge follow up (time frame: 90 days post-discharge). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2024.