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This database contains 664 studies, archived under the term: "Randomised Controlled Trial"

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The Sydney Multisite Intervention of LaughterBosses and ElderClowns (SMILE) study: cluster randomised trial of humour therapy in nursing homes

OBJECTIVES: To determine whether humour therapy reduces depression (primary outcome), agitation and behavioural disturbances and improves social engagement and quality-of-life in nursing home residents. DESIGN: The Sydney Multisite Intervention of LaughterBosses and ElderClowns study was a single-blind cluster randomised controlled trial of humour therapy. SETTING: 35 Sydney nursing homes. PARTICIPANTS: All eligible residents within geographically […]

A phase II trial of tideglusib in Alzheimer’s disease

Background: The ARGO study was a phase II, double-blind, placebo controlled, four parallel arm trial of tideglusib in Alzheimer’s disease (AD). Objective: To prove the clinical efficacy of an inhibitor of glycogen synthase kinase-3 (GSK-3), in AD. Methods: Mild to moderate (Mini-Mental State Examination (MMSE) score, 14–26) AD patients on cholinesterase inhibitor and/or memantine treatment […]

Clinical effectiveness of a manual based coping strategy programme (START, STrAtegies for RelaTives) in promoting the mental health of carers of family members with dementia: pragmatic randomised controlled trial

Objective: To assess whether a manual based coping strategy compared with treatment as usual reduces depression and anxiety symptoms in carers of family members with dementia.; Design: Randomised, parallel group, superiority trial.; Setting: Three mental health community services and one neurological outpatient dementia service in London and Essex, UK.; Participants: 260 carers of family members […]

Effect of a high-intensity functional exercise program on functional balance: preplanned subgroup analyses of a randomized controlled trial in residential care facilities

Objectives: To evaluate whether age, sex, depression, dementia disorder, nutritional status, or level of functional balance capacity influences the effect of a high-intensity functional weight-bearing exercise program on functional balance.; Design: Preplanned subgroup analyses of a randomized controlled trial.; Setting: Nine residential care facilities.; Participants: One hundred ninety-one people aged 65 to 100 dependent in […]

Memantine improves goal attainment and reduces caregiver burden in Parkinson’s disease with dementia

Objective: Memantine, an uncompetitive antagonist of N‐methyl‐D‐aspartate receptors, may have a role in managing symptoms associated with dementia in Parkinson’s disease (PDD), although its role in improving patient‐reported outcomes (PROs) has not been extensively investigated. PROs may be more sensitive than standard psychometric measures for detecting change in complex conditions such as PDD. The aim […]

More insight into the concept of apathy: a multidisciplinary depression management program has different effects on depressive symptoms and apathy in nursing homes

Background: Apathy is common in nursing home (NH) residents and it overlaps with depression. This study examines the effects of a multidisciplinary depression program on apathy and depressive motivational and mood symptoms.; Methods: Secondary analyses of a stepped-wedge cluster-randomized controlled trial were conducted with six measurements. Sixteen dementia NH units and 17 somatic units were […]

A structural multidisciplinary approach to depression management in nursing-home residents: a multicentre, stepped-wedge cluster-randomised trial

Background: Depression in nursing-home residents is often under-recognised. We aimed to establish the effectiveness of a structural approach to its management.; Methods: Between May 15, 2009, and April 30, 2011, we undertook a multicentre, stepped-wedge cluster-randomised trial in four provinces of the Netherlands. A network of nursing homes was invited to enrol one dementia and […]

Management of apathy in nursing homes using a teaching program for care staff: the STIM-EHPAD study

Objective: This study aimed to evaluate the effectiveness of a nursing home (NH) staff education to manage apathy in older individuals with a diagnosis of dementia.; Methods: Sixteen NHs agreed to participate, and 230 demented apathetic residents were randomly assigned to the reference group (RG) or the intervention group (IG). IG received a month of […]

Evaluation of a computer-assisted errorless learning-based memory training program for patients with early Alzheimer’s disease in Hong Kong: a pilot study

Background: Improving the situation in older adults with cognitive decline and evidence of cognitive rehabilitation is considered crucial in long-term care of the elderly. The objective of this study was to implement a computerized errorless learning-based memory training program (CELP) for persons with early Alzheimer’s disease, and to compare the training outcomes of a CELP […]

A pilot study of yogic meditation for family dementia caregivers with depressive symptoms: effects on mental health, cognition, and telomerase activity

Background: This study examined the effects of brief daily yogic meditation on mental health, cognitive functioning, and immune cell telomerase activity in family dementia caregivers with mild depressive symptoms.; Methods: Thirty-nine family dementia caregivers (mean age 60.3 years old (SD = 10.2)) were randomized to practicing Kirtan Kriya or listening to relaxation music for 12 […]

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