The Benchmark Clinic: An Interdisciplinary Comprehensive Care Model for People With Parkinson Disease
2022年4月14日 更新者：Duke University
The purpose of this study is to determine if an interdisciplinary clinic can help people with Parkinson's disease care for themselves, improve their ability to follow recommended treatments, and have fewer problems like falls or visits to the emergency room.
Participants will be randomly assigned to receive either care from the interdisciplinary clinic or standard neurological specialist care.
This study involves questionnaires both before and 3 months after participation in a one time interdisciplinary care clinic or standard care depending on which type of care the participant is randomized to. Participants will be in the study for up to 6 months. The study will end upon completion of questionnaires about 3 months after treatment with the interdisciplinary care clinic or standard care.
研究概览
研究类型
介入性
注册 (实际的)
56
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。
学习地点
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North Carolina
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Durham、North Carolina、美国、27710
- Duke University
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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
30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:
- Patients with Parkinson's Disease over the age of 30,
- Caregiver willing to also participate.
- Must be able to provide consent.
Exclusion Criteria:
-Atypical Parkinsonism
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：随机化
- 介入模型：并行分配
- 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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实验性的：Interdisciplinary Care
If assigned to the interdisciplinary group, participants will see social work, physical therapy, occupational therapy, speech therapy, and pharmacy in a scheduled rotation for about 45 minutes each.
After these evaluations, the team meets with the participant's doctor for a discussion of treatment.
After this meeting, the participants doctor will meet to discuss a treatment plan and make recommendations.
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If assigned to the interdisciplinary group, participants will see social work, physical therapy, occupational therapy, speech therapy, and pharmacy in a scheduled rotation for about 45 minutes each.
After these evaluations, the team meets with the participants doctor for a discussion of treatment.
After this meeting, the participants doctor will meet to discuss a treatment plan and make recommendations.
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无干预：Standard of Care
If assigned to standard of care, group participants will have a normally scheduled visit with neurologist.
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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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Change in composite score on self-efficacy scale
大体时间：Baseline, 3 months after interdisciplinary or standard clinic visit
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Title of scale: Self-efficacy Scale for Chronic Diseases.
This is a validated scale.
Minimum score is 1, Maximum score is 10.
Higher score is a better outcome.
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Baseline, 3 months after interdisciplinary or standard clinic visit
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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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Change in total weekly minutes exercised as measured by patient engagement survey.
大体时间：Baseline, 3 months after interdisciplinary or standard care visit
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Investigator developed patient engagement survey
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Baseline, 3 months after interdisciplinary or standard care visit
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Change in caregiver burden score on Zarit Burden Interview scale
大体时间：Baseline, 3 months after interdisciplinary or standard care visit
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Title of scale: Zarit Burden Interview.
This is validated scale.
Minimum score is 0. Maximum score is 88.
Higher score is a worse outcome.
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Baseline, 3 months after interdisciplinary or standard care visit
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Number of skilled therapy visits as reported by participant
大体时间：Baseline, 3 months after interdisciplinary or standard care visit
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Number of skilled therapy visits as reported by participant
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Baseline, 3 months after interdisciplinary or standard care visit
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Number of hospitalizations as reported by participant and medical record review
大体时间：Baseline, 3-6 months after interdisciplinary or standard care visit
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Number of hospitalizations as reported by participant and medical record review
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Baseline, 3-6 months after interdisciplinary or standard care visit
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Number of ER visits as reported by participant and medical record review
大体时间：Baseline, 3-6 months after interdisciplinary or standard care visit
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Number of ER visits as reported by participant and medical record review
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Baseline, 3-6 months after interdisciplinary or standard care visit
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Number of falls as reported by participant
大体时间：Baseline, 3 months after interdisciplinary or standard care visit
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Number of falls as reported by participant
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Baseline, 3 months after interdisciplinary or standard care visit
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Number of contraindicated medication combinations as determined by medical record review
大体时间：Baseline, 3-6 months after interdisciplinary or standard care visit
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Number of contraindicated medication combinations as determined by medical record review
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Baseline, 3-6 months after interdisciplinary or standard care visit
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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：Kyle Mitchell, MD、Duke University
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)
2021年2月3日
初级完成 (实际的)
2021年9月28日
研究完成 (实际的)
2021年11月1日
研究注册日期
首次提交
2020年9月14日
首先提交符合 QC 标准的
2020年9月14日
首次发布 (实际的)
2020年9月21日
研究记录更新
最后更新发布 (实际的)
2022年4月22日
上次提交的符合 QC 标准的更新
2022年4月14日
最后验证
2022年4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.
Interdisciplinary Visit的临床试验
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Geisinger ClinicPatient-Centered Outcomes Research Institute; Penn State University; University of Nebraska; Iowa...主动，不招人
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Sarah CockayneUniversity of Nottingham; James Cook University, Queensland, Australia; Queensland Health; Humberside... 和其他合作者终止
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University of UtahUniversity of Chicago; University of Michigan完全的