Evaluating the Efficacy of a Detection and Prevention Program for Frail Community-dwelling Older Adults (D-SCOPE)
2019年4月24日 更新者：Liesbeth De Donder、Vrije Universiteit Brussel
Study Protocol of the D-SCOPE Project With a Randomized Controlled Trial, Evaluating the Efficacy of a Detection and Prevention Program for Frail Community-dwelling Older Adults
The evaluation of a detection and prevention program which aims to create a continuum of care and support for frail community-dwelling older people (from early detection, over intervention, to follow-up).
First, the program aims to develop methods to easily, accurately and timely detect and prevent a negative frailty-balance in older people.
Second, the study aims to improve the quality and efficacy of care and support given to frail community-dwelling older people.
研究概览
研究类型
介入性
注册 (实际的)
869
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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Gent、比利时、9000
- OCMW Gent
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Knokke-Heist、比利时、8300
- OCMW Knokke-Heist
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Tienen、比利时、3300
- OCMW Tienen
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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
60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:
Sample 1: 150 older people per municipality (total: 3 municipalities) (inclusion criteria: at least one selection criterion)
- Gender: 75 men - 75 women
- Age: 25 older people aged between 60 and 70 years old - 125 older people older than 70 years
- Marital status: 50 older people with partner - 100 older people without partner
- Living situation: 100 older people who have not moved last 10 years - 50 older people who have moved last 10 years
- Migration background: 100 older people born in Belgium - 50 older people born elsewhere
Sample 2: 150 older people per municipality (total: 3 municipalities) (inclusion criteria: all selection criteria at once)
- 75 men, older than 70 years, living together/widowed/divorced/never married, moved last 10 years
- 75 women, older than 70 years, widowed/divorced/never married, moved last 10 years
Exclusion Criteria:
- Current institutionalization
- Current hospitalization
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：预防
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：四人间
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Risk of being frail experimental group
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Offering tailored care and support whereby the competences, strengths and resources of the older person are taken into account.The intervention will be an enhancement of usual care and will depend on the availability of the municipality, and could be formal (i.e., home care) or informal (e.g.
activities of an older adult's association).
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无干预：Risk of being frail control group
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无干预：No/low risk of being frail
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无干预：Risk of being frail care avoiders
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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 from baseline Quality of Life at 6 months
大体时间：Assessed during baseline testing + 6 months after inclusion
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One question from the WHOQOL-BREF will be used to measure the quality of life of participants (1 item).
Older participants will also be asked to rate their quality of life on a scale from 0 to 10.
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Assessed during baseline testing + 6 months after inclusion
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Change from baseline Satisfaction with Life at 6 months
大体时间：Assessed during baseline testing + 6 months after inclusion
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The Satisfaction with Life Scale will be administered to explore the life satisfaction of the participants (5 items)
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Assessed during baseline testing + 6 months after inclusion
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Change from baseline sense of mastery at 6 months
大体时间：Assessed during baseline testing + 6 months after inclusion
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To assess the sense of mastery of older people, the current mastery questionnaire will be used and one self-constructed item will be added which will assess mastery in relation to others.
Older participants will also be asked to rate their mastery on a scale from 0 to 10.
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Assessed during baseline testing + 6 months after inclusion
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Change from baseline Meaning in Life at 6 months
大体时间：Assessed during baseline testing + 6 months after inclusion
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Meaning in life will be evaluated with 5 items from the Meaning in Life Questionnaire (MLQ).
Older participants will also be asked to rate their meaning in life on a scale from 0 to 10.
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Assessed during baseline testing + 6 months after inclusion
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Change from baseline Community Inclusion at 6 months
大体时间：Assessed during baseline testing + 6 months after inclusion
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Community inclusion will be measured using 1 item from the Community Integration Measure (CIM).
Older participants will also be asked to rate their community inclusion on a scale from 0 to 10.
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Assessed during baseline testing + 6 months after inclusion
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Change from baseline aging well in place at 6 months
大体时间：Assessed during baseline testing + 6 months after inclusion
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One self-constructed question (1 item) will assess if the older person lives at home in a qualitative manner
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Assessed during baseline testing + 6 months after inclusion
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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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Multidimensional frailty
大体时间：Assessed during baseline testing + 6 months after inclusion
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The Comprehensive Frailty Assessment Instrument (CFAI) will be used to measure multidimensional frailty: physical, cognitive, psychological, social and environmental frailty
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Assessed during baseline testing + 6 months after inclusion
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Physical phenotype of frailty
大体时间：Assessed during baseline testing + 6 months after inclusion
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The Fried's phenotype of frailty will be used to assess the physical phenotype of frailty as well as the questionnaire of Op het Veld
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Assessed during baseline testing + 6 months after inclusion
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Feeling frail
大体时间：Assessed during baseline testing + 6 months after inclusion
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The subjective feeling of frailty will be assessed using 1 self-constructed question and will assess to what extent an older person feels frail
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Assessed during baseline testing + 6 months after inclusion
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Resilience
大体时间：Assessed during baseline testing + 6 months after inclusion
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Resilience will be measured using the Connor-Davidson Resilience Scale (CD-RISC2), which is an abbreviated 2-item version of the original scale
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Assessed during baseline testing + 6 months after inclusion
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Coping
大体时间：Assessed during baseline testing + 6 months after inclusion
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Coping will be measured using 12 items from the BRIEF cope.
Two items from active coping, positive reframing, religion, use of emotional support and self-distraction and one item from acceptance and behavioral disengagement will be used
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Assessed during baseline testing + 6 months after inclusion
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Help needed for activities in daily life
大体时间：Assessed during baseline testing + 6 months after inclusion
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Older people will be asked if they need help with 8 activities of daily life, and to what extent the help they receive for these activities is sufficient.
These questions are adapted from the questionnaire of the Belgian Ageing Studies (BAS)
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Assessed during baseline testing + 6 months after inclusion
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Informal and formal care
大体时间：Assessed during baseline testing + 6 months after inclusion
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Older people will be asked if they receive care from 6 informal and 14 formal caregivers and if they are satisfied with the help they receive from these caregivers.
These questions are adapted from the BAS-questionnaire.
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Assessed during baseline testing + 6 months after inclusion
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Medical care
大体时间：Assessed during baseline testing + 6 months after inclusion
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The participants will be asked if they needed to go to the hospital, to a residential setting and a rehabilitation center over the past 6 months (day case/overnight stay).
These questions are adapted from the Health Interview Survey.
In addition, the participants will be asked when they visited the general practitioner for the last time over the last 6 months.
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Assessed during baseline testing + 6 months after inclusion
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Leisure time
大体时间：Assessed during baseline testing + 6 months after inclusion
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Leisure time will be measured by using an adapted question with 8 items derived from the BAS-questionnaire and will examine how often the participants perform the listed activities
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Assessed during baseline testing + 6 months after inclusion
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Neighborhood
大体时间：Assessed during baseline testing + 6 months after inclusion
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Different dimensions of neighborhood will be assessed.
First, the social environment will be administered by using 3 items from the social cohesion dimension of the Neighbourhood Scale.
Second, the physical environment will be explored by using 4 items from the BAS-questionnaire as well as from the Neighbourhood Environment Walkability Scale.
Finally, low-key participation will be examined by using 2 items from the questionnaire of Oswald & Konopik.
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Assessed during baseline testing + 6 months after inclusion
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Life-events
大体时间：Assessed during baseline testing + 6 months after inclusion
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A shortened version of the Geriatric Adverse Life Events Scale (GALES) will be adapted to assess to occurrence of life-events (11 items)
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Assessed during baseline testing + 6 months after inclusion
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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。
合作者
调查人员
- 首席研究员：Liesbeth De Donder, Prof. Dr.、Vrije Universiteit Brussel
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。
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)
2017年6月1日
初级完成 (实际的)
2018年4月30日
研究完成 (实际的)
2018年6月30日
研究注册日期
首次提交
2017年5月17日
首先提交符合 QC 标准的
2017年5月23日
首次发布 (实际的)
2017年5月30日
研究记录更新
最后更新发布 (实际的)
2019年4月25日
上次提交的符合 QC 标准的更新
2019年4月24日
最后验证
2019年4月1日
更多信息
与本研究相关的术语
其他研究编号
- D-SCOPE IWT 140027
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
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.
Tailored care and support的临床试验
-
Zealand University HospitalUniversity of Copenhagen; Steno Diabetes Center Copenhagen; Holbaek Sygehus招聘中