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

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WHEDA study: effectiveness of occupational therapy at home for older people with dementia and their caregivers–the design of a pragmatic randomised controlled trial evaluating a Dutch programme in seven German centres

Background: A recent Dutch mono-centre randomised controlled trial has shown that occupational therapy improves daily functioning in dementia. The aim of this present study is to compare the effects of the Dutch community occupational therapy programme with a community occupational therapy consultation on daily functioning in older people with mild or moderate dementia and their […]

German adaptation of the Resources for Enhancing Alzheimer’s Caregiver Health II: study protocol of a single-centred, randomised controlled trial

Background: Caring for a family member with dementia is extremely stressful, and contributes to psychiatric and physical illness among caregivers. Therefore, a comprehensive programme called Resources for Enhancing Alzheimer’s Caregiver Health II (REACH II) was developed in the United States to enhance the health of Alzheimer’s caregivers. REACH II causes a clear reduction of the […]

Alzheimer’s disease–input of vitamin D with mEmantine assay (AD-IDEA trial): study protocol for a randomized controlled trial

Background: Current treatments for Alzheimer’s disease and related disorders (ADRD) are symptomatic and can only temporarily slow down ADRD. Future possibilities of care rely on multi-target drugs therapies that address simultaneously several pathophysiological processes leading to neurodegeneration. We hypothesized that the combination of memantine with vitamin D could be neuroprotective in ADRD, thereby limiting neuronal […]

Exercise rehabilitation on home-dwelling patients with Alzheimer’s disease–a randomized, controlled trial. Study protocol

Background: Besides cognitive decline, Alzheimer’s disease (AD) leads to physical disability, need for help and permanent institutional care. The trials investigating effects of exercise rehabilitation on physical functioning of home-dwelling older dementia patients are still scarce. The aim of this study is to investigate the effectiveness of intensive exercise rehabilitation lasting for one year on […]

Preserving cognition, quality of life, physical health and functional ability in Alzheimer’s disease: the effect of physical exercise (ADEX trial): rationale and design

Background: Exercise is hypothesized to improve cognition, physical performance, functional ability and quality of life, but evidence is scarce. Previous studies were of short duration, often underpowered and involving home-based light exercise programs in patients with undefined dementia. The aim of the ADEX (‘Preserving Cognition, Quality of Life, Physical Health and Functional Ability in Alzheimer’s […]

The Danish Alzheimer intervention study: rationale, study design and baseline characteristics of the cohort

Background: There is a lack of appropriately designed trials investigating the efficacy of psychosocial interventions for patients with mild dementia and their family caregivers. This paper reports the rationale and design of the Danish Alzheimer Disease Intervention Study and baseline characteristics of the cohort.; Methods: The study was a 1-year multicentre randomized controlled rater-blinded trial […]

A study protocol to investigate the management of depression and challenging behaviors associated with dementia in aged care settings

Background: The high occurrence and under-treatment of clinical depression and behavioral and psychological symptoms of dementia (BPSD) within aged care settings is concerning, yet training programs aimed at improving the detection and management of these problems have generally been ineffective. This article presents a study protocol to evaluate a training intervention for facility managers/registered nurses […]

Improving the health and well-being of community-dwelling caregivers of dementia sufferers: study protocol of a randomized controlled trial of structured meditation training

Background: Caring for a person with dementia can be an unrelenting and burdensome task, one that is often detrimental to the caregiver’s health, well-being, and functionality. The enduring stress and frustration of the caregiver role can also contribute to poorer outcomes for dementia sufferers. Building on growing clinical interest in the capacity for Transcendental Meditation(®) […]

Cognitive activity for the treatment of older adults with mild Alzheimer’s disease (AD)–PACE AD: study protocol for a randomised controlled trial

Background: Participation in cognitive stimulation therapy (CST) may reduce the rate of cognitive decline in people with Alzheimer’s disease (AD), however it is unclear if the training of carers to deliver activities is sufficient to improve the clinical outcome of patients. The Promoting Healthy Ageing with Cognitive Exercise for Alzheimer’s Disease (PACE-AD) study has been […]

Use of the Tailored Activities Program to reduce neuropsychiatric behaviors in dementia: an Australian protocol for a randomized trial to evaluate its effectiveness

Background: Behavioral and psychological symptoms of dementia (BPSD) are often considered to be the greatest challenge in dementia care, leading to increased healthcare costs, caregiver burden, and placement into care facilities. With potential for pharmacological intervention to exacerbate behaviors or even lead to mortality, the development and rigorous testing of non-pharmacological interventions is vital. A […]

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