Hospice Problem Solving Intervention
2017年11月17日 更新者:George Demiris、University of Washington
A Problem Solving Intervention for Hospice Caregivers
In recent years, the demand for home hospice care has grown rapidly.
Family members and friends who act as informal caregivers are essential to the provision of palliative care services; however, this role is not without adverse effects on the caregivers themselves.
It is well documented that emotional needs of individuals caring for dying persons in their home are not well attended, and interventions aiming to provide support to informal hospice caregivers are notably lacking.
In this context, problem solving therapy (PST) provides an overall coping process that fosters adaptive situational coping and behavioral competence.
The investigators are conducting a randomized controlled trial to fully evaluate the PST intervention for informal hospice caregivers.
Additionally, the investigators aim to evaluate how the modality of the intervention (face to face vs video) impacts its effectiveness.
This investigator team is conducting a 4-year randomized trial study in which hospice caregivers will be randomly assigned to a group receiving standard hospice care with the addition of social support interactions (attention control group) or a group receiving standard hospice care with the addition of the problem solving intervention delivered face to face (intervention group 1) or a group receiving standard hospice care with the addition of the problem solving intervention delivered via video (intervention group 2).
The specific aims include an assessment of the impact of PST on caregiver quality of life, problem solving ability, and caregiver anxiety.
研究概览
研究类型
介入性
注册 (实际的)
514
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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Washington
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Seattle、Washington、美国、98195
- University of Washington
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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:
- enrolled as a family/informal caregiver of a hospice patient
- 18 years or older
- with access to a standard phone line or Internet and computer access at home
- without functional hearing loss or with a hearing aid that allows the participant to conduct telephone conversations as assessed by the research staff (by questioning and observing the caregiver)
- no or only mild cognitive impairment
- speak and read English, with at least a 6th-grade education
Exclusion Criteria:
- lack of phone or Internet access
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:Attention Control
This group receives standard care with the attention of social support/ "friendly interactions" and serves as an attention control group.
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实验性的:Intervention Group 1 (Face to Face)
This group receives Problem Solving Therapy in face to face visits.
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Problem-solving therapy (PST) focuses on behavioral change principles derived from this theoretical framework.
PST addresses four skills: 1) problem definition and formulation, which involves gathering data and information, articulating the issue in clear terms, identifying the challenge, and setting realistic goals; 2) generation of alternative strategies; 3) decision making; and 4) solution implementation.
The intervention is delivered in a series of interactions with the interventionist.
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实验性的:Intervention Group 2 (Video)
This group receives Problem Solving Therapy via video.
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Problem-solving therapy (PST) focuses on behavioral change principles derived from this theoretical framework.
PST addresses four skills: 1) problem definition and formulation, which involves gathering data and information, articulating the issue in clear terms, identifying the challenge, and setting realistic goals; 2) generation of alternative strategies; 3) decision making; and 4) solution implementation.
The intervention is delivered in a series of interactions with the interventionist.
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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 |
---|---|---|
Caregiver Anxiety: Change From Baseline to Post-Intervention Exit
大体时间:At Baseline and Exit (approximately 4 weeks after recruitment)
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Caregiver anxiety was measured with the 7-item Generalized Anxiety Disorder (GAD-7) Scale (Spitzer et al., 2006), which measures the frequency with which respondents experience symptoms of anxiety such as restlessness, difficulty relaxing, and uncontrollable worrying.
The GAD-7 total scores range from 0 to 21, with higher scores indicating more anxiety.
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At Baseline and Exit (approximately 4 weeks after recruitment)
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Caregiver Quality of Life - Physical: Change From Baseline to Post-Intervention Exit
大体时间:At Baseline and Exit (approximately 4 weeks after recruitment)
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An interview CQLI version was developed by using identical items from the paper-based CQLI and replacing the visual analogue response format with a 0-10 response scale.
Higher scores indicate better physical quality of life.
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At Baseline and Exit (approximately 4 weeks after recruitment)
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Caregiver Quality of Life - Social: Change From Baseline to Post-Intervention Exit
大体时间:At Baseline and Exit (approximately 4 weeks after recruitment)
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An interview CQLI version was developed by using identical items from the paper-based CQLI and replacing the visual analogue response format with a 0-10 response scale.
Higher scores indicate better social quality of life.
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At Baseline and Exit (approximately 4 weeks after recruitment)
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Caregiver Quality of Life - Emotional: Change From Baseline to Post-Intervention Exit
大体时间:At Baseline and Exit (approximately 4 weeks after recruitment)
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An interview CQLI version was developed by using identical items from the paper-based CQLI and replacing the visual analogue response format with a 0-10 response scale.
Higher scores indicate better emotional quality of life.
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At Baseline and Exit (approximately 4 weeks after recruitment)
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Caregiver Quality of Life - Financial: Change From Baseline to Post-Intervention Exit
大体时间:At Baseline and Exit (approximately 4 weeks after recruitment)
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An interview CQLI version was developed by using identical items from the paper-based CQLI and replacing the visual analogue response format with a 0-10 response scale.
Higher scores indicate better financial quality of life.
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At Baseline and Exit (approximately 4 weeks after recruitment)
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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:George Demiris, PhD、University of Washington
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。
一般刊物
- Starr LT, Bullock K, Washington K, Aryal S, Parker Oliver D, Demiris G. Anxiety, Depression, Quality of Life, Caregiver Burden, and Perceptions of Caregiver-Centered Communication among Black and White Hospice Family Caregivers. J Palliat Med. 2022 Apr;25(4):596-605. doi: 10.1089/jpm.2021.0302. Epub 2021 Nov 18.
- Demiris G, Oliver DP, Washington K, Pike K. A Problem-Solving Intervention for Hospice Family Caregivers: A Randomized Clinical Trial. J Am Geriatr Soc. 2019 Jul;67(7):1345-1352. doi: 10.1111/jgs.15894. Epub 2019 Apr 4.
- Benson JJ, Parker Oliver D, Demiris G, Washington K. Accounts of Family Conflict in Home Hospice Care: The Central Role of Autonomy for Informal Caregiver Resilience. J Fam Nurs. 2019 May;25(2):190-218. doi: 10.1177/1074840719828091. Epub 2019 Feb 17.
- Tarter R, Demiris G, Pike K, Washington K, Parker Oliver D. Pain in Hospice Patients With Dementia: The Informal Caregiver Experience. Am J Alzheimers Dis Other Demen. 2016 Sep;31(6):524-9. doi: 10.1177/1533317516653825. Epub 2016 Jun 14.
- Oliver DP, Demiris G, Washington KT, Clark C, Thomas-Jones D. Challenges and Strategies for Hospice Caregivers: A Qualitative Analysis. Gerontologist. 2017 Aug 1;57(4):648-656. doi: 10.1093/geront/gnw054.
- Washington KT, Pike KC, Demiris G, Parker Oliver D, Albright DL, Lewis AM. Gender Differences in Caregiving at End of Life: Implications for Hospice Teams. J Palliat Med. 2015 Dec;18(12):1048-53. doi: 10.1089/jpm.2015.0214. Epub 2015 Oct 20.
- Washington KT, Pike KC, Demiris G, Oliver DP. Unique characteristics of informal hospice cancer caregiving. Support Care Cancer. 2015 Jul;23(7):2121-8. doi: 10.1007/s00520-014-2570-z. Epub 2014 Dec 30.
- Washington KT, Wittenberg-Lyles E, Oliver DP, Baldwin PK, Tappana J, Wright JH, Demiris G. Rethinking family caregiving: tailoring cognitive-behavioral therapies to the hospice experience. Health Soc Work. 2014 Nov;39(4):244-50. doi: 10.1093/hsw/hlu031.
- Washington KT, Demiris G, Pike KC, Kruse RL, Oliver DP. Anxiety among informal hospice caregivers: an exploratory study. Palliat Support Care. 2015 Jun;13(3):567-73. doi: 10.1017/S1478951513001193. Epub 2014 Feb 13.
- Demiris G, Parker Oliver D, Capurro D, Wittenberg-Lyles E. Implementation science: implications for intervention research in hospice and palliative care. Gerontologist. 2014 Apr;54(2):163-71. doi: 10.1093/geront/gnt022. Epub 2013 Apr 4.
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
2011年10月1日
初级完成 (实际的)
2016年3月1日
研究完成 (实际的)
2016年3月1日
研究注册日期
首次提交
2011年9月28日
首先提交符合 QC 标准的
2011年9月29日
首次发布 (估计)
2011年9月30日
研究记录更新
最后更新发布 (实际的)
2017年12月13日
上次提交的符合 QC 标准的更新
2017年11月17日
最后验证
2017年11月1日
更多信息
与本研究相关的术语
其他研究编号
- 36909
- 1R01NR012213-01A1 (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.
Problem Solving Therapy的临床试验
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University of Applied Sciences and Arts of Southern...Vrije Universiteit Brussel; Universiteit Antwerpen; THIM - die internationale Hochschule für Physiotherapie完全的
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George Washington UniversityTranscultural Psychosocial Organization Nepal完全的
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Abbott Medical Devices完全的