LifeSkills Video Training in Patients About to Receive an Automatic Implantable Cardioverter-Defibrillator (AICD) (AICD)
2012年9月17日 更新者:Virginia P. Williams, Ph.D.、Williams LifeSkills
LifeSkills Video Training in Patients About to Receive an Automatic Implantable Cardioverter-Defibrillator
The purpose of this trial was to develop the initial sections of a video/DVD cassette that provided guidance about mastering stressful situations for patients who had been informed that they need an implantable cardioverter-defibrillator (AICD).
We adapted the existing LifeSkills video (which was already been shown effective in patients with heart diseases) to the specific needs of patients with AICD's.
Before its development, we held separate focus groups with healthcare providers of AICD patients, pre-implantation patients, and post-implantation patients.
After the video/accompanying workbook was produced, we held an additional focus group with patients who had received the video/workbook before receiving their AICD.
研究概览
地位
完全的
详细说明
Patients who had received the video/workbook told the focus group leader that they wanted more information about their AICD and a clearer presentation about how stress management was related to living with their AICD.
研究类型
介入性
注册 (实际的)
37
阶段
- 阶段1
联系人和位置
本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。
学习地点
-
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North Carolina
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Durham、North Carolina、美国、27710
- Duke University Medical Center
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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
21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:
- Adult patients (age> 21 years old)
- For one of the initial focus groups and for the focus group of patients who had watched the produced modules: Patients who have received a recommendation for an AICD and have agreed to have it in the pre-implantation stage (do not already have the implant)
- For the other initial focus group: patients who already have an AICD.
Exclusion Criteria:
- Patients who are medically unstable [New York Heart Association class IV heart failure, recent (within 30 days) myocardial infarction or admission for unstable angina or worsening heart failure, in-patients, or patients who were admitted less than 1 month before potential enrollment will be excluded].
- Patients who are suffering from other medical illnesses: only the following categories will be exclusionary: Diseases that cause severe cognitive impairment that may lead to inability to understand or follow study procedures (i.e., severe dementia, identified by the patients' inability to repeat the study procedures and by a mini-mental status exam that will be done if dementia is suspected); Diseases that cause severe psychotic symptoms leading to disorientation (i.e., hepatic encephalopathy).
- Patients who are actively suicidal (suspected from the suicide question on the depression questionnaire
- Patients who cannot understand the study procedures due to cognitive or language barriers (provided an effort was made to offer translation).
- The process for dealing with individuals who indicate that they may be suicidal, depressed or anxious will be as follows: Immediately upon receipt of the completed questionnaires at the coordinating office, the Beck Depression Inventory and the Impact of Event Scale will be evaluated. If the responses indicate suicidal ideation the subject will be called and asked to contact his/her primary care provider for an immediate appointment. The primary care provider will be contacted that day to inform him/her of the finding. If the responses to the Impact of Event Scale or the BDI indicate stress or depression, a letter will be sent to the subject recommending that he/she contact the primary care provider. A copy of the letter will be forwarded to the PCP.
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:治疗
- 分配:非随机化
- 介入模型:单组作业
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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其他:D.
The focus is evaluation of LifeSkills Video/Workbook for patients about to receive an AICD.
Patients who now have received their AICD were given a video/workbook pre-implantation as an intervention to reduce their concerns/distress.
After implantation, they will be asked what was and was not helpful about the materials they received.
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will view the 3 completed sections of the video/workbook
This exploratory intervention first met in a focus group with healthcare professionals and another focus group with patients who already had received an automatic implantable cardiac defibrillator to learn more about what video and accompanying workbook material it would be helpful for patients to receive pre-inplantation.
Another focus group was held with post-implantation patients asking them what additional knowledge would have been helpful.
Three sections of the video with accompanying workbook were then produced and given to pre-inplantation patients.
A focus group was then held with these patients after their procedure to ask them what had and had not proved helpful.
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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 |
|---|---|---|
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Whether patients understood the contents of the produced sections of the video/workbook and whether these contents were helpful. This will be determined by their comments during a focus group which will be held after they have watched the video.
大体时间:After AICD patients who watched the video/workbook before implantation have been implanted.
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AICD patients who watched the first three sections of the proposed video with accompanying workbook will be asked in a focus group if they found the information comprehensible and if the information was helpful.
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After AICD patients who watched the video/workbook before implantation have been implanted.
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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。
合作者
调查人员
- 首席研究员:Joseph Gordon Rogers, MD、Duke University, Eed Director, Cardiac Transplant and Mechanical Circulatory Support Program
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
2007年12月1日
初级完成 (实际的)
2009年8月1日
研究完成 (实际的)
2009年8月1日
研究注册日期
首次提交
2012年6月27日
首先提交符合 QC 标准的
2012年9月17日
首次发布 (估计)
2012年9月18日
研究记录更新
最后更新发布 (估计)
2012年9月18日
上次提交的符合 QC 标准的更新
2012年9月17日
最后验证
2012年9月1日
更多信息
与本研究相关的术语
关键字
其他研究编号
- 2924526
- 1R41HL083635-01A2 (美国 NIH 拨款/合同)
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.