Promoting Activity, Independence and Stability in Early Dementia and Mild Cognitive Impairment (PrAISED2)
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
Background and study aims People with memory problems can struggle with everyday activities and may stop doing things they want to do. They are more prone to accidents and have a higher risk of falling. Occupational therapists can advise how to do daily activities more easily and safely. Physiotherapists can teach exercises which increase activity and improve balance, and may help maintain memory. There is little research on how to make these interventions work for with people with memory problems. The aim of this study is to compare an activity and exercise programme developed for people with memory problems to standard falls prevention assessment and advice.
Who can participate? Patients aged 65 or over with early dementia or memory problems, recruited from memory clinics or the 'Join Dementia Research' register
What does the study involve? Participants are randomly allocated to either the control group or the intervention group. The control group receive standard brief falls assessment and advice, and up to two further visits if required. The intervention group receive an assessment, tailored strength and balance exercise programme, activity analysis and risk enablement advice, and assessment for environmental hazards. The intervention is delivered over 1 year in participants' own homes, and is tailored to individual interests, abilities and need for supervision. Participants are encouraged to exercise by themselves or with family members between visits, and once the programme ends. Researchers visit at the start of the study and after 12 months to measure ability in activities of daily living, activity, quality of life, memory and health service use. Participants complete monthly falls diaries over 15 months. The researchers conduct interviews and video record some therapy sessions to help understand how the programme works in practice.
What are the possible benefits and risks of participating? Some participants may benefit from taking part in the intervention, as exercise is generally known to be beneficial to health and well-being, including benefits to heart, blood pressure, diabetes, joints, mood and daily life. These participants may find that they are better able to do their daily activities. All participants and their relatives may enjoy having the researchers coming to visit them in their house. Some people appreciate having the opportunity to contribute to the well-being of others through research.
Tipo de estudo
Inscrição (Antecipado)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
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Derbyshire
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Derby, Derbyshire, Reino Unido, DE22 3LZ
- Recrutamento
- Derbyshire Healthcare NHS Foundation Trust
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Contato:
- Simon Thacker
- Número de telefone: 01332623683
- E-mail: Simon.thacker@derbyshcft.nhs.uk
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Contato:
- Gemma Harrison
- Número de telefone: 33474 01332623700
- E-mail: gemma.harrison3@nhs.net
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Lincolnshire
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Lincoln, Lincolnshire, Reino Unido, NG34 8GG
- Recrutamento
- Lincolnshire Partnership NHS Foundation Trust
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Contato:
- Carol Duff
- Número de telefone: 01522500690
- E-mail: Carol.Duff@LPFT.nhs.uk
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Contato:
- Tracy McCranor
- Número de telefone: 07795426736
- E-mail: Tracy.McCranor@lpft.nhs.uk
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Notts
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Nottingham, Notts, Reino Unido, NG3 6AA
- Recrutamento
- Nottinghamshire Healthcare NHS Foundation Trust
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Contato:
- Helen Smith
- Número de telefone: 01158837826
- E-mail: Helen.smith@nottshc.nhs.uk
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Contato:
- Kehinde Junaid
- Número de telefone: 01159560884
- E-mail: Kehinde.Junaid@nottshc.nhs.uk
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Somerset
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Bath, Somerset, Reino Unido, BA1 3NG
- Recrutamento
- RICE - Research Institute for the Care of Older People
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Contato:
- Vanessa Bishop
- Número de telefone: 01225 476420
- E-mail: V.Bishop@bath.ac.uk
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Contato:
- Lola Dali-Kemmery
- Número de telefone: 01225 476420
- E-mail: L.Dali-Kemmery@bath.ac.uk
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
- Age 65 or over (no maximum)
- Diagnosis of MCI or dementia (of any subtype, except Dementia with Lewy Bodies i.e. Parkinson's Disease Dementia)
- Have a carer or friend who knows the participant well (at least one hour a week contact over the phone, internet, or in person), and is willing and able to act as an informant
- Able to walk without human help
- Able to communicate in English
- Able to see, hear and have dexterity sufficiently to perform neuropsychological tests
- Have capacity to give consent to participate, and consenting to do so
Exclusion Criteria:
- Co-morbidity preventing participation (e.g. severe breathlessness, pain, psychosis, Parkinson's, Dementia with Lewy Bodies, or other severe neurological disease)
- Unavailable over the next year (e.g. plans to relocate or go on a long holiday, or has a life expectancy of less than a year)
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Sem intervenção: Control
The control group will receive standard brief falls assessment and advice.
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Comparador Ativo: Intervention
Therapy intervention.
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Assessment, tailored strength and balance exercise programme, activity analysis and risk enablement advice, and assessment for environmental hazards.
Tailored adherence support and supervision.
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Disability Assessment in Dementia (DAD)
Prazo: 12 months
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Primary outcomes will be disability in Activities of Daily Living (Disability Assessment in Dementia, DAD) measured 12 months after randomisation. This is as recommended in a recent NIHR systematic review [Webster 2017]. scale range is 0% to 100%. Where 0% = minimal functional ability and 100% maximal functional ability. Higher scores represent less disability in ADL and lower scores indicate more dysfunction. There are no subscales. "The total score is obtained by adding the rating for each question and converting this total score out of 100. The items rated as N/A are not considered for the total score. For example: A score of 33 on 40 (maximum score) converted out of 100 = 83% A score of 33 on 38 (max. score with 2 N/A) converted out of 100 = 87% This will result in a final score, a percentage which provides an appreciation of global function in ADL. Higher scores represent less disability in ADL while lower scores indicate more dysfunction." |
12 months
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Nottingham Extended ADL Scale
Prazo: 12 months
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Self-reported Activities of Daily Living (ADL) using the Nottingham Extended ADL Scale [Nouri and Lincoln 1980].
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12 months
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Falls Rate
Prazo: 12 months
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Falls rate in months four-15 from randomisation (defined as 'unintentionally coming to rest on the ground or at a lower level, however caused', and ascertained by monthly diary)
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12 months
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Quality of Life
Prazo: 12 months
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Quality of life (EQ5D3L and EQ5D5L proxy [EuroQol Group 1990]; DemQol and DemQol proxy, including Demqol-u weights [Smith 2005; Mulhern 2013])
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12 months
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Mood or 'Affect'
Prazo: 12 months
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Mood or 'Affect' - Hospital Anxiety and Depression Scale (HADS [Zigmond and Snaith 1983]; Apathy Evaluation Scale - AES [Marin, Biedrzycki and Firinciogullari 1991])
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12 months
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Physical activity
Prazo: 12 months
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Longitudinal Aging Study Amsterdam (LASA) physical activity questionnaire [Stel 2004], pedometers
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12 months
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Cognition
Prazo: 12 months
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three scales from CANTAB [Cambridge Cognition, 2015]; Montreal Cognitive Assessment - MoCA [Nasreddine 2005], verbal fluency (from MoCA)
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12 months
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Time to first fall
Prazo: 12 months
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Time to first fall (from diary)
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12 months
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Rate of fractures and injurious falls
Prazo: 12 months
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Rate of fractures and injurious falls (from diary)
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12 months
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Rate of hospital and care home admissions, and days spent in hospital
Prazo: 12 months
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Rate of hospital and care home admissions, and days spent in hospital (from diary, hospital administrative records)
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12 months
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Carer strain
Prazo: 12 months
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Carer strain (Carergiver Strain Index [Robinson 1983]).
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12 months
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Carer health-related quality of life
Prazo: 12 months
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Carer health-related quality of life (EQ5D-5L [EuroQol Group 1990])
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12 months
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Personality
Prazo: 12 months
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Personality (Big Five Personality Inventory- short [BFI-10, Rammstedt and John 2007])
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12 months
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Publicações e links úteis
Links úteis
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Antecipado)
Conclusão do estudo (Antecipado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 17HC006
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