ABILITY - TelerehABILITation. TechnologY-enhanced Multi-domain at Home Continuum of Care Program for People With Cognitive Impairment.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 主要终点
- behavioral symptoms
研究概览
简要总结
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 85 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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).
排除标准
- •dysmetria;
- •serious deficits in visual acuity, acoustic perception, and in routine communication skills.
结局指标
主要结局
behavioral symptoms
时间窗: change from baseline after 8 weeks (aMCI/AD subjects)
Neuropsychiatric Inventory (NPI) score
cognitive domain (long-term memory)
时间窗: change from baseline after 8 weeks (aMCI/AD subjects)
Free and Cued Selective Recall Test (FCSRT) score
cognitive domain (language)
时间窗: change from baseline after 8 weeks (aMCI/AD subjects)
Fluency score
activities of daily living
时间窗: change from baseline after 8 weeks (aMCI/AD subjects)
Activities of Daily Living Inventory (ADCS/ADL)
cognitive domain (frontal-executive functions)
时间窗: change from baseline after 8 weeks (aMCI/AD subjects)
Trail Making Test (TMT) score
quality of life
时间窗: change from baseline after 8 weeks (aMCI/AD subjects)
Dementia Quality of Life (D-QoL) Instrument
coping strategies
时间窗: change from baseline after 8 weeks (aMCI/AD subjects)
Coping Orientation for Problems Experienced - Brief Version (Brief COPE)
global cognitive level
时间窗: change from baseline after 12 months (aMCI/AD subjects)
Montreal Cognitive Asssessment (MoCA) score
次要结局
- activities of daily living(change from baseline after 12 months (aMCI/AD subjects))
- conversion rate MCI versus AD(change from baseline after 12 months (aMCI subjects))
- cognitive domain - long term memory(change from baseline after 12 months (aMCI/AD subjects))
- cognitive domain - language(change from baseline after 12 months (aMCI/AD subjects))
- cognitive domain - frontal executive functions(change from baseline after 12 months)
- quality of life(change from baseline after 12 months)
- coping strategies(change from baseline after 12 months)
- caregiver quality of life(change from baseline after 8 weeks and after 12 months)
- caregiver coping strategies(change from baseline after 8 weeks and after 12 months)
- caregiver burden(change from baseline after 8 weeks and after 12 months)
- caregiver affect(change from baseline after 8 weeks and after 12 months)