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临床试验/NCT04037501
NCT04037501已完成不适用

"Care Management for Caregivers of People With Dementia: Effectiveness of a Care Management System to Reduce Unmet Needs of Informal Caregivers of People With Dementia"

German Center for Neurodegenerative Diseases (DZNE)2 个研究点 分布在 1 个国家目标入组 192 人开始时间: 2020年10月9日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
192
试验地点
2
主要终点
Change in number of Unmet Needs

研究概览

简要总结

The purpose of this study is to test the effectiveness of a computer assisted care management system to identify and reduce unmet needs for and to improve quality of life of informal caregivers of people with dementia.

详细描述

The identification of care needs of informal caregivers of people with dementia (PwD) at home is of particular importance to provide timely appropriate support and health care services to this vulnerable group. Family doctors and specialists have a key role in identifying the burden and care needs of informal caregivers. However, this often remains a challenge in everyday practice. In addition, the regionally available support and health care offers are often unknown. A computer-assisted care management system (CMS) can support the identification of unmet care needs and suggest individual, regional offers via a constantly updated database. On the basis of a standardized self-assessment, the VMS identifies personal, social, nursing and medical care needs of informal caregivers of PwD. The investigators apply the system in family and specialist practices as well as in memory clinics where it generates modularized recommendations for interventions based on predefined algorithms. The aim of the study is to test the effectiveness of a CMS to reduce the number of unmet care needs and to improve quality of life of informal caregivers of PwD. The study design is a cluster-randomized, controlled intervention study with two arms and two assessment times. The setting includes family and specialist practices for neurology and/ or psychiatry as well as memory clinics. The CMS will be used in the practices of the intervention group. Informal caregivers of PwD answer a self-administered questionnaire on a tablet PC. From the input, the system generates a list of unmet care needs based on predefined algorithms, and assigns these to individual intervention recommendations. The doctor evaluates each recommendation and forwards a validated list and possibly further intervention recommendations to a study assistant (Care Manager, CM). In a subsequent home visit, the care manager systematically collects additional information, specifies and concretizes the intervention recommendations and supports the informal caregivers of PwD in the implementation of the recommendations. In subsequent telephone contacts, the status of the implementation of the intervention recommendations will be discussed and the care manager coordinates the informal caregivers individual support. Patients of the control group will receive Care as Usual (CAU). After 6 months, a blinded, systematic, computer-based follow-up assessment will be conducted in both groups by hitherto uninvolved study assistants

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 18+ years
  • main caregiver of a PwD (Hauptversorgungsperson)
  • PwD lives at home
  • written informed consent of caregiver

排除标准

  • caregiver not living in the study region MV
  • not able to provide written consent
  • unable to fill out self-administered questionnaire an/or to be interviewed

结局指标

主要结局

Change in number of Unmet Needs

时间窗: Baseline values assessed at time of visit to the physician (T0), Outcome value assessed 6 months later at concluding home visit (T6)

A standardized assessment implemented as computer-assisted intervention management system (CMS) addresses caregiver burden, medical needs, home care needs, psychosocial needs (depression, sleep quality, pain, hearing, seeing, teeth problems, dementia related problems caused by PwD, medical aids). Based on predefined algorithms the CMS will generate a list of recommended intervention to address each of the unmet needs.

Change in Quality of Life

时间窗: Baseline values assessed at time of visit to the physician (T0), Outcome value assessed 6 months later at concluding home visit (T6)]

The questionnaire SF-12 (Short form of SF-36) will be used to assess quality of life. The SF-12 is a physical scale score that represents general health perception, physical functioning, physical role functioning, and pain. The mental health score represents emotional role functioning, mental well-being, negative affectivity, and social functioning. The mean score is set to 50. Scores higher than 50 indicate better physical or mental health than the mean while scores lower than 50 indicate worse physical mental health than the mean.

次要结局

  • Social Support(Baseline values assessed at time of visit to the physician (T0), Outcome value assessed 6 months later at concluding home visit (T6))
  • Use of medical and non-medical services(: Baseline values assessed at time of visit to the physician (T0), Outcome value assessed 6 months later at concluding home visit (T6)])
  • Change in Caregiver Burden(Baseline values assessed at time of visit to the physician (T0), Outcome value assessed 6 months later at concluding home visit (T6)])

研究者

发起方
German Center for Neurodegenerative Diseases (DZNE)
申办方类型
Other
责任方
Principal Investigator
主要研究者

Wolfgang Hoffmann

Site speaker

German Center for Neurodegenerative Diseases (DZNE)

研究点 (2)

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