Integrating Supportive Care in Cystic Fibrosis
2020年2月17日 更新者：Dio Kavalieratos, PhD、University of Pittsburgh
Integrating Supportive Care in Cystic Fibrosis: A Pilot Study
Individuals living with cystic fibrosis (CF) commonly report high symptom burden, poor quality of life, and additional psychosocial stressors; these burdens are particularly heightened in advanced stages of the disease.
Although supportive care (aka palliative care) has been shown to improve many of these outcomes among patients with illnesses such as cancer, no clinical trials to date have tested the impact of supportive care for patients with CF.
The purpose of this pilot randomized clinical trial study is to evaluate the feasibility, acceptability, and perceived effectiveness of an embedded supportive care intervention, whereby a supportive care specialist will be integrated within the usual care experience of patients with advanced CF.
The investigators will enroll 50 patients with advanced CF, who will be equally randomized to receive this embedded supportive care intervention or usual care.
Secondary measures include: patient quality of life, mood, coping style, satisfaction with care, and symptom burden.
This study will provide preliminary data to support the development of a larger, definitive, Phase III randomized clinical trial.
研究概览
详细说明
As described above.
研究类型
介入性
注册 (实际的)
50
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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Pennsylvania
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Pittsburgh、Pennsylvania、美国、15213
- University of Pittsburgh
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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
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:
- Ability to comprehend English
- Advanced CF
(Any of the following criteria will be indicative of "Advanced CF")
- Baseline supplemental oxygen requirement
- FEV1 ≤ 50%
- Baseline non-invasive mechanical ventilation requirement
- ≥ 2 hospitalizations in the past 12 months for respiratory complications related to CF
Exclusion Criteria:
- Prisoners
- Females who are pregnant
- Prior receipt of specialist SC services
- Cognitive impairments
- Patients younger than 18 years of age
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：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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无干预：Usual Care
Patients randomized to the control arm of this study will continue to receive the standard of high-quality CF care provided to all patients at the UPMC CF Center.
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实验性的：Supportive Care Intervention
Patients randomized to the intervention arm will receive a protocolized supportive care intervention from a palliative care nurse practitioner.
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Patients in the intervention arm of the study will see a SC specialist during regularly-scheduled CF clinic visits; per usual care, these visits should occur on a quarterly basis.
Using a structured intervention manual, these visits will span 30-60 minutes each.
Each visit will have a specific focus, such as: 1) comprehensive palliative care assessment; 2) symptom assessment and self-management; 3) advance care planning; and, 4) coping and resilience.
Patients requiring follow up with SC before the next CF appointment will receive telephone follow up or an extra SC visit at the discretion of the SC provider.
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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 |
|---|---|---|
|
Feasibility of intervention
大体时间：Up to 9 months (+/- 4 weeks)
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Measured by: eligibility rate, approach-to-consent rate, approach-to-enroll rate, rate of missed intervention sessions, rate of missing data on patient-reported outcomes.
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Up to 9 months (+/- 4 weeks)
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Acceptability of intervention
大体时间：Up to 9 months (+/- 4 weeks)
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Measured by: proportion of participants who endorse the intervention as acceptable.
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Up to 9 months (+/- 4 weeks)
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Perceived effectiveness of intervention
大体时间：Up to 9 months (+/- 4 weeks)
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Measured by: proportion of participants who endorse that they believe the intervention to have been beneficial.
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Up to 9 months (+/- 4 weeks)
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Intervention fidelity
大体时间：Up to 9 months (+/- 4 weeks)
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Evaluate the fidelity of intervention delivery using structured visit checklists to be completed by the interventionist and research staff.
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Up to 9 months (+/- 4 weeks)
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Patient quality of life: Cystic Fibrosis Questionnaire-Revised (CFQ-R)
大体时间：Up to 9 months (+/- 4 weeks)
|
Change in QOL from baseline as measured by the Cystic Fibrosis Questionnaire-Revised (CFQ-R) at 9 months.
Due to the pilot nature of this trial, this measure will not be used to assess the efficacy of the intervention.
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Up to 9 months (+/- 4 weeks)
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Patient mood
大体时间：Up to 9 months (+/- 4 weeks)
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Change in mood from baseline using the Hospital Anxiety and Depression Scale (HADS), reported at 0, 3, 6, 9 months.
Due to the pilot nature of this trial, this measure will not be used to assess the efficacy of the intervention.
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Up to 9 months (+/- 4 weeks)
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Coping style
大体时间：Up to 9 months (+/- 4 weeks)
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Change in coping style from baseline using the Brief COPE, reported at 0, 3, 6, 9 months.
Due to the pilot nature of this trial, this measure will not be used to assess the efficacy of the intervention.
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Up to 9 months (+/- 4 weeks)
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Satisfaction with care
大体时间：Up to 9 months (+/- 4 weeks)
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Change in satisfaction with care from baseline using the FAMCARE-P13, reported at 0, 3, 6, 9 months.
Due to the pilot nature of this trial, this measure will not be used to assess the efficacy of the intervention.
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Up to 9 months (+/- 4 weeks)
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Symptom burden
大体时间：Up to 9 months (+/- 4 weeks)
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Change in symptom burden from baseline using the Edmonton Symptom Assessment Scale (ESAS), reported at 0, 3, 6, 9 months.
Due to the pilot nature of this trial, this measure will not be used to assess the efficacy of the intervention.
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Up to 9 months (+/- 4 weeks)
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其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Healthcare utilization
大体时间：Up to 12 months
|
The investigators will evaluate various measures of healthcare utilization, such as: ED visits, unplanned hospitalizations, and healthcare expenditures.
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Up to 12 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：Dio Kavalieratos, PhD、Section of Palliative Care and Medical Ethics; Division of General Internal Medicine, University of Pittsburgh
- 首席研究员：Joseph Pilewski, MD、Pulmonary, Allergy, and Critical Care Medicine Division; University of Pittsburgh
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)
2016年3月2日
初级完成 (实际的)
2018年11月29日
研究完成 (实际的)
2019年10月7日
研究注册日期
首次提交
2016年1月14日
首先提交符合 QC 标准的
2016年1月26日
首次发布 (估计)
2016年1月29日
研究记录更新
最后更新发布 (实际的)
2020年2月18日
上次提交的符合 QC 标准的更新
2020年2月17日
最后验证
2020年2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
- IRB#: PRO14110168
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
是的
IPD 计划说明
It is possible that the investigators may use the information obtained from this study in other research studies examining the treatment of Cystic Fibrosis.
This information may also be shared with other researchers here and at other research centers, but those researchers will never be provided with any personal identifiers that would allow them to learn participant's identity.
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.