DRKS00013638CompletedPhase 2
Assistant to activate patients with dementia and their caregivers - MobiAssist
Ambulante Diakonische Dienste gGmbH0 sites53 target enrollmentStarted: February 1, 2018Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Enrollment
- 53
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
- Allocation
- Non-randomized controlled study
- Masking
- Open (masking not used)
Eligibility Criteria
- Ages
- one to one (—)
- Sex
- All
Inclusion Criteria
- •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)
Exclusion Criteria
- •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
Investigators
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