NICE: NeuroImaging in Cessation Education

August 10, 2020 updated by: Yale University

Effect of Showing Stroke Neuroimaging to Patients in Setting of Smoking Cessation Education on Smoking Cessation Rates in Patients With New Stroke.

The investigators aim to examine the effect on smoking cessation rate by showing stroke patients who are active smokers images of their strokes.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The investigators hypothesize that showing actual images of a patient's stroke to the participant on either brain CT or MRI will be a similarly easy to understand quantification of damage done to the participant's body. Given the link between smoking and stroke risk, the investigators believe that providing this imaging in addition to standard smoking cessation education may improve rates of smoking cessation after stroke. If this proves true, addition of a patient's neuroimaging to standard post-stroke smoking cessation education would be an easy method to improve smoking cessation rates in stroke patients, at minimal cost.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
20

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age ≥18
  • Active smoker, as defined: at least 100 cigarettes in their entire life, must have smoked cigarette at least once in 4 days prior to onset of stroke
  • Primary ischemic or hemorrhagic stroke identified on neuroimaging (MRI DWI/ADC or CT of brain)
  • Onset of stroke symptoms within 30 days to time of recruitment
  • Capacity to comprehend counseling data: Each participant will be given a cognitive screening test to assess the ability to comprehend and accurately answer the medical history questionnaire (MMSE). If the participant fails this test (score < 23), they will be excluded.
  • Patients discharged home or short term rehab with expectation of returning home within the study period

Exclusion Criteria:

  • Patients whose stroke deficits clinically prevent them from reasonably being physically able to continue to smoke, such as bilateral upper extremity paresis, tracheostomy, GCS ≥9
  • Patients with sensory aphasia that impairs comprehension
  • Subarachnoid hemorrhage
  • Transient ischemic attack
  • Other cause of cerebral ischemia or hemorrhage not defined as primary ischemic or hemorrhagic stroke (i.e. hemorrhagic metastases)
  • Patients whose stroke symptoms started >30 days from time of enrollment
  • Patients discharged to acute rehab, long term acute care hospital or hospice who are unlikely to have access to cigarettes
  • Patients unable to complete cognitive screening test for whom an appropriate proxy does not exist
  • Patients who do not speak fluent English (given that the study largely revolves around oral education on smoking cessation, clear communication between participant and coordinator must be possible)

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Standardized smoking cessation counseling
Standardized smoking cessation counseling will be provided at the participant's initial interview. Participants will be provided pamphlets from the National Stroke Association and the American Heart Association regarding risk factor reduction. Packets will include general information on risks associated with smoking along with the benefits of cessation, and methods to quit. Pamphlets will include Life's Simple 7 (American Heart Association, 2014) and Be Smoke Free: Facts about Smoking and Stroke Risk (National Stroke Association, 2009). Counseling will be scripted and standardized to ensure similar language with all participants.
Behavioral: standardized smoking cessation counseling
Standardized smoking cessation counseling will be provided at their initial interview. They will be provided pamphlets from the National Stroke Association and the American Heart Association regarding risk factor reduction. Packets will include general information on risks associated with smoking along with the benefits of cessation, and methods to quit. Pamphlets will include Life's Simple 7 (American Heart Association, 2014) and Be Smoke Free: Facts about Smoking and Stroke Risk (National Stroke Association, 2009). Counseling will be scripted and standardized to ensure similar language with all participants.
Experimental: Neuroimages of stroke
Participants in the intervention group will undergo standardized smoking cessation counseling (as offered to the active comparator group) and will also be shown computer images of head CT or brain MRI (DWI/FLAIR series) of their strokes. Basic orientation to neuroimaging (laterality, positioning, parts of the brain) will be provided first, and then the image of the stroke itself will be reviewed. Participants will be provided with a paper copy of the slice demonstrating the largest volume of stroke to keep. In comparison, participants will also be shown images of a normal healthy, and images of a patient with recurrent strokes due to smoking. Participants will be told that smoking cessation would help to prevent additional stroke, but that it would not repair the damage already done, as visualized on the neuroimaging.
Behavioral: Neuroimages of stroke
Participants in the intervention group will be shown computer images of head CT or brain MRI (DWI/FLAIR series) of their strokes. Basic orientation to neuroimaging (laterality, positioning, parts of the brain) will be provided first, and then the image of the stroke itself will be reviewed. Participants will be provided with a paper copy of the slice demonstrating the largest volume of stroke to keep. In comparison, patients will also be shown images of a normal healthy, and images of a patient with recurrent strokes due to smoking. Patients will be told that smoking cessation would help to prevent additional stroke, but that it would not repair the damage already done, as visualized on the neuroimaging.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
cessation of smoking measured by self-report collected during follow-up phone interviews.
Time Frame: 30 day follow-up visit
30 day and 90 day post-stroke phone interviews will be by a blinded APRN. During these interviews, patients will be asked their smoking status. If they are still smoking, they will be asked how much they are still smoking,
30 day follow-up visit
cessation of smoking measured by self-report collected during follow-up phone interviews.
Time Frame: 90 day follow-up visit
30 day and 90 day post-stroke phone interviews will be by a blinded APRN. During these interviews, patients will be asked their smoking status. If they are still smoking, they will be asked how much they are still smoking,
90 day follow-up visit

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
number of cigarettes smoked per day measured by self-report collected during follow-up phone interviews.
Time Frame: 30 day follow-up visit
30 day and 90 day post-stroke phone interviews will be by a blinded APRN. During these interviews, patients will be asked their smoking status. If they are still smoking, they will be asked how much they are still smoking,
30 day follow-up visit
number of cigarettes smoked per day measured by self-report collected during follow-up phone interviews.
Time Frame: 90 day follow-up visit
30 day and 90 day post-stroke phone interviews will be by a blinded APRN. During these interviews, patients will be asked their smoking status. If they are still smoking, they will be asked how much they are still smoking.
90 day follow-up visit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Yale University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Hardik Amin, MD, Yale University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 10, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 10, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 12, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 12, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 10, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 1606017908

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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.

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