NICE: NeuroImaging in Cessation Education
2020年8月10日 更新者：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.
研究概览
详细说明
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.
研究类型
介入性
注册 (实际的)
20
阶段
- 不适用
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
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)
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：预防
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：三倍
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
有源比较器：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.
|
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.
|
|
实验性的：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.
|
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.
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
cessation of smoking measured by self-report collected during follow-up phone interviews.
大体时间：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.
大体时间：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
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
number of cigarettes smoked per day measured by self-report collected during follow-up phone interviews.
大体时间：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.
大体时间：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
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Hardik Amin, MD、Yale University
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2017年1月1日
初级完成 (实际的)
2020年7月1日
研究完成 (实际的)
2020年7月1日
研究注册日期
首次提交
2016年5月10日
首先提交符合 QC 标准的
2016年5月10日
首次发布 (估计)
2016年5月12日
研究记录更新
最后更新发布 (实际的)
2020年8月12日
上次提交的符合 QC 标准的更新
2020年8月10日
最后验证
2019年6月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.