Effectiveness of the HF-ACP Website Study
2018年5月28日 更新者：Jane MacIver、University Health Network, Toronto
Randomized Controlled Trial of an Interactive Website for Heart Failure Advance Care Planning
This study evaluates the effectiveness of an interactive website on advance care planning for patients living with heart failure (HF-ACP website).
The investigators will randomize patients to either the HF-ACP website or usual care to determine if the participants who use the HF-ACP website have higher advance care planning completion rates than participants assigned to usual care.
研究概览
详细说明
Advance care planning is a process that supports adults at any age or stage of health to understand and share their personal values, life goals and preferences in order to prepare for future decisions regarding medical care.
Public awareness campaigns to promote ACP have been taking place for about 10 years without significant improvements in ACP completion rates.
Content intended for use by the general public may be too vague for those living with a chronic illness.
Framing ACP within the context of a specific disease may provide the impetus for a person to engage in ACP.
The investigators believe the HF-ACP website will improve patient understanding of the life-limiting nature of HF, the ACP process and the need to plan ahead to help ensure the care they receive matches their treatment preferences.
研究类型
介入性
注册 (预期的)
20
阶段
- 不适用
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。
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:
- over the age of 18,
- a regular patient in our clinic,
- able to read and write English,
- familiar with the use and have access to a personal computer, email and the internet.
Exclusion Criteria:
- ineligible for participation in the trial if they do not meet the inclusion criteria described above.
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：支持治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：HF-ACP Website
The HF-ACP website leads participants through 4 e-learning modules.
Each module contains 3 core elements: (1) educational content which provides information and support to help patients complete the module (2) interactive tools for documenting their thoughts and progress and (3) motivational video clips that encourage behavior change by validating participants ambivalence, suggesting strategies to help participants complete the task and to encourage and reassure participants that they can do this.
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Each module is broken down into weekly topics and each module takes 3-6 weeks to complete.
Participants can access and review the material as often as needed as well as revisiting the information from modules they have completed.
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无干预：Usual Care
The standard of care for advance care planning at our institution is the "Speak Up" booklet and the Power of Attorney workbook from the Attorney General's Office - Ontario.
Patients randomized to the Control arm will be asked to register on a separate research portal where participants will have electronic access to both of the booklets and a link to the Speak Up online Interactive workbook.
There is no specific information on HF or HF treatments.
Participants in the control arm will be asked to complete the ACP using the interactive workbook.
Participants in the control arm will not receive any additional communication from the research team about their progress.
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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 |
|---|---|---|
|
Advance care planning completion rates
大体时间：6 months
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proportion of participants who complete the advance care planning process
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6 months
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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advance care planning knowledge
大体时间：6 months
|
% improvement in knowledge of advance care planning
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6 months
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The 5-level European Quality of Life scale
大体时间：6 months
|
The EQ-5D-5L is a generic quality of life measure that consists of a 5-item health state assessment and a visual analog scale.
The dimensions represented in the 5-item assessment include: mobility, self-care, usual activities, pain/discomfort and anxiety/depression.
Responses to the questions can be converted to a time tradeoff utility score from 0 (represents worst possible health) to 1.0 (represents perfect health).
The visual analog scale ranges from 0-100 with higher scores representing better quality of life.
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6 months
|
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Generalized Anxiety Disorder Scale (GAD-7)
大体时间：6 months
|
The GAD-7 is a 7 item self-administered screening tool for anxiety.
Scores range from 0-21 with cutoffs at 5, 10, and 15 representing mild, moderate and severe anxiety, respectively.
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6 months
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The Readiness to Change Scale (RCS)
大体时间：6 months
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The RCS is a study-specific tool based on Prochaska's algorithm for change.
It categorizes participants into one of the 5 categories of readiness.
The RCS will be used to measure change for the 3 discreet behaviors: (1) identifying a SDM, (2) developing the advance care plan and (3) communicating wishes to their SDM.
The RCS will be used to determine if readiness is associated with ACP completion
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6 months
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The Patient Health Questionnaire (PHQ-9)
大体时间：6 months
|
The PHQ -9 is a 9 item self-administered scale screening tool for depression.
Scores range from 0-27 with cutoffs at 5, 10, 15 and 20 representing mild, moderate, moderately severe and severe depression
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6 months
|
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The Perceived Stress Scale
大体时间：6 months
|
The PSS is a 10 item self-administered scale to measure perceived stress.
The scores range form 0-40 with higher scores representing greater stress.
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6 months
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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。
调查人员
- 首席研究员：Jane Maciver, RN PhD、UHN Toronto
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 (预期的)
2018年5月1日
初级完成 (预期的)
2018年12月1日
研究完成 (预期的)
2019年4月1日
研究注册日期
首次提交
2017年7月4日
首先提交符合 QC 标准的
2018年5月16日
首次发布 (实际的)
2018年5月29日
研究记录更新
最后更新发布 (实际的)
2018年5月30日
上次提交的符合 QC 标准的更新
2018年5月28日
最后验证
2018年5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.