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临床试验/DRKS00013638
DRKS00013638已完成2 期

Assistant to activate patients with dementia and their caregivers - MobiAssist

Ambulante Diakonische Dienste gGmbH0 个研究点目标入组 53 人开始时间: 2018年2月1日最近更新:
适应症

试验速览

阶段
2 期
状态
已完成
发起方
入组人数
53

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional
分配方式
Non-randomized controlled study
盲法
Open (masking not used)

入排标准

年龄范围
one 至 one(—)
性别
All

入选标准

  • 1) type of dementia: Alzheimer’s disease or vascular dementia; diagnosed by professionals in memory clinic (CERAD neuropsychological battery); alternative for Siegen: Clinical Dementia Rating (CDR; Morris, 1993) value > 0.5
  • 2) give consent
  • 3) participants are retired
  • 4) participants are mobile and able to stand up from a chair without support and walk 6m
  • 5) care dependency measured by barthel index (BI): criteria: BI< 60 points (Mahoney & Barthel, 1965)
  • 6) support by a professional caregiver or by an informal caregiver
  • 7) written informed consent from patient with dementia and the informal caregiver
  • 8) medical certification
  • 9) cognitive and social requirements (interested, motivated, no aggressive behavior, can imitate exercises, understand simple verbal information, control of emotional reactions)
  • 10) physical requirements (routine actions can be completed; also he/she can: see, hear, speak, sit and stand up, walk, grab and hold on a chair)
  • 11) conditions of the environments (TV with HDMI, wireless internet at home)

排除标准

  • 1) other types of dementia (frontotemporal dementia, dementia with Lewy bodies, alcohol-relates brain damage (Korsakoff´s syndrome), familial Alzheimer's disease)
  • 2) mental disorders like depression or generalized anxiety disorder who have not been satisfactorily medicated for at least six months; substance-related disorders in the last 2 years; schizophrenia and other psychological disorders
  • 3) neurodegenerative diseases of the Central Nervous System (CNS), Parkinson’s disease, multiple sclerosis, Amyotrophic Lateral Sclerosis (ALS)
  • 4) cardiovascular diseases: acute cardiac failure, acute cardiac insufficiency, angina pectoris, untreated cardiac arrhythmia or heart valve disease, pacemaker, untreated hypertension - systolic blood pressure >180 mm Hg or diastolic blood pressure > 110 mm Hg; untreated hypotension - < 90/60 mm Hg
  • 5) untreated cancer disease
  • 6) untreated hormone diseases
  • 7) badly controlled diabetes (blood glucose < 6 mmol/L or >15 mmol/L)
  • 8) epilepsy
  • 9) Chronic Obstructive Pulmonary Disease (COPD) grade 4
  • 10) acute infection or fever
  • 11) acute renal insufficiency
  • 12) osteoporosis
  • 13) surgical interventions in the last 6 months
  • 14) taking neuroleptics or benzodiazepine
  • 15) participation in another study for dementia

研究者

发起方
Ambulante Diakonische Dienste gGmbH

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