ABILITY - TelerehABILITation: TechnologY-enhanced Multi-domain at Home Continuum of Care Program
2017年1月16日 更新者：Fondazione Don Carlo Gnocchi Onlus
ABILITY - TelerehABILITation. TechnologY-enhanced Multi-domain at Home Continuum of Care Program for People With Cognitive Impairment.
The Ability research project, funded in Italy within the Smart Cities and Smart Communities funding program (MInistry of University and Research, Operational Regional Programme, Lombardy, Axis 1, Operational Regional Programme - European Funding for Regional Development 2007-2013), aims at developing and testing the efficacy and the impact of a Personal Smart Health Community able to provide innovative trajectories for people with cognitive impairment, putting them at the core of a continuous and intertwining treatment and support from both formal (e.g. physicians) and informal (e.g. near relatives) caregivers, with special focus on home-based care.
Within this framework of the Ability project the investigators test the efficacy of the home-based motor-cognitive rehabilitation program delivered with two different approaches: the Ability platform versus the usual care program
研究概览
研究类型
介入性
注册 (实际的)
30
阶段
- 不适用
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
65年 至 85年 (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:
- diagnosed as mild AD or MCI due to AD (Albert et al, 2011) according to DSM 5 diagnostic criteria (American Psychiatric Association, 2013);
- MMSE score >18
- school attendance (≥ 3 years).
Exclusion Criteria:
- dysmetria;
- serious deficits in visual acuity, acoustic perception, and in routine communication skills.
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：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Ability platform program
Multi-domain at home rehabilitation program delivered through the Ability platform.
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The Ability program is an at home participant-tailored and technology-enhanced platform a) delivering tablet-based intensive (five days/a week for six weeks) motor and cognitive activities; b) monitoring from remote vital and physical health parameters (i.e., weight, Heart Rate, O2 saturation, daily steps, sleep activity).
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有源比较器：Usual care program
Usual care at home program (paper and pencil cognitive activities; promotion of physical activity according to healthcare professional's advice)
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Usual care at home program (paper and pencil cognitive activities; promotion of physical activity according to healthcare professional's advice)
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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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activities of daily living
大体时间：change from baseline after 8 weeks (aMCI/AD subjects)
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Activities of Daily Living Inventory (ADCS/ADL)
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change from baseline after 8 weeks (aMCI/AD subjects)
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behavioral symptoms
大体时间：change from baseline after 8 weeks (aMCI/AD subjects)
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Neuropsychiatric Inventory (NPI) score
|
change from baseline after 8 weeks (aMCI/AD subjects)
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cognitive domain (long-term memory)
大体时间：change from baseline after 8 weeks (aMCI/AD subjects)
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Free and Cued Selective Recall Test (FCSRT) score
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change from baseline after 8 weeks (aMCI/AD subjects)
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cognitive domain (language)
大体时间：change from baseline after 8 weeks (aMCI/AD subjects)
|
Fluency score
|
change from baseline after 8 weeks (aMCI/AD subjects)
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cognitive domain (frontal-executive functions)
大体时间：change from baseline after 8 weeks (aMCI/AD subjects)
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Trail Making Test (TMT) score
|
change from baseline after 8 weeks (aMCI/AD subjects)
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quality of life
大体时间：change from baseline after 8 weeks (aMCI/AD subjects)
|
Dementia Quality of Life (D-QoL) Instrument
|
change from baseline after 8 weeks (aMCI/AD subjects)
|
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coping strategies
大体时间：change from baseline after 8 weeks (aMCI/AD subjects)
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Coping Orientation for Problems Experienced - Brief Version (Brief COPE)
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change from baseline after 8 weeks (aMCI/AD subjects)
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global cognitive level
大体时间：change from baseline after 12 months (aMCI/AD subjects)
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Montreal Cognitive Asssessment (MoCA) score
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change from baseline after 12 months (aMCI/AD subjects)
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
activities of daily living
大体时间：change from baseline after 12 months (aMCI/AD subjects)
|
Activities of Daily Living Inventory (ADCS/ADL)
|
change from baseline after 12 months (aMCI/AD subjects)
|
|
conversion rate MCI versus AD
大体时间：change from baseline after 12 months (aMCI subjects)
|
conversion rate score
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change from baseline after 12 months (aMCI subjects)
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cognitive domain - long term memory
大体时间：change from baseline after 12 months (aMCI/AD subjects)
|
Free and Cued Selective Recall Test (FCSRT) score
|
change from baseline after 12 months (aMCI/AD subjects)
|
|
cognitive domain - language
大体时间：change from baseline after 12 months (aMCI/AD subjects)
|
Fluency score
|
change from baseline after 12 months (aMCI/AD subjects)
|
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cognitive domain - frontal executive functions
大体时间：change from baseline after 12 months
|
Trail Making Test (TMT) score
|
change from baseline after 12 months
|
|
quality of life
大体时间：change from baseline after 12 months
|
Dementia Quality of Life (D-QoL) Instrument
|
change from baseline after 12 months
|
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coping strategies
大体时间：change from baseline after 12 months
|
Coping Orientation for Problems Experienced - Brief Version (Brief COPE)
|
change from baseline after 12 months
|
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caregiver quality of life
大体时间：change from baseline after 8 weeks and after 12 months
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Psychological Well-Being (PWB) scale
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change from baseline after 8 weeks and after 12 months
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caregiver coping strategies
大体时间：change from baseline after 8 weeks and after 12 months
|
Coping Orientation for Problems Experienced - Brief Version (Brief COPE)
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change from baseline after 8 weeks and after 12 months
|
|
caregiver burden
大体时间：change from baseline after 8 weeks and after 12 months
|
Caregiver Burden Inventory (CBI)
|
change from baseline after 8 weeks and after 12 months
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caregiver affect
大体时间：change from baseline after 8 weeks and after 12 months
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Positive and Negative Affect Schedule (PANAS)
|
change from baseline after 8 weeks and after 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。
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
- Albert MS, DeKosky ST, Dickson D, Dubois B, Feldman HH, Fox NC, Gamst A, Holtzman DM, Jagust WJ, Petersen RC, Snyder PJ, Carrillo MC, Thies B, Phelps CH. The diagnosis of mild cognitive impairment due to Alzheimer's disease: recommendations from the National Institute on Aging-Alzheimer's Association workgroups on diagnostic guidelines for Alzheimer's disease. Alzheimers Dement. 2011 May;7(3):270-9. doi: 10.1016/j.jalz.2011.03.008. Epub 2011 Apr 21.
- Realdon O, Rossetto F, Nalin M, Baroni I, Cabinio M, Fioravanti R, Saibene FL, Alberoni M, Mantovani F, Romano M, Nemni R, Baglio F. Technology-enhanced multi-domain at home continuum of care program with respect to usual care for people with cognitive impairment: the Ability-TelerehABILITation study protocol for a randomized controlled trial. BMC Psychiatry. 2016 Nov 25;16(1):425. doi: 10.1186/s12888-016-1132-y.
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
2015年4月1日
初级完成 (实际的)
2016年10月1日
研究完成 (实际的)
2016年10月1日
研究注册日期
首次提交
2016年4月12日
首先提交符合 QC 标准的
2016年4月20日
首次发布 (估计)
2016年4月21日
研究记录更新
最后更新发布 (估计)
2017年1月18日
上次提交的符合 QC 标准的更新
2017年1月16日
最后验证
2017年1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.