Promoting Activity, Independence and Stability in Early Dementia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 主要终点
- Disability Assessment in Dementia (Gelinas and Gauthier, 1994)
研究概览
简要总结
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 people with memory problems. The investigators have developed two activity and exercise programmes suitable for people with memory problems. The investigators will study them in a feasibility trial. One programme involves high-intensity supervision (50 visits over one year), the other moderate-intensity supervision (11 visits over three months). The investigators will compare these with standard falls prevention assessment and advice (1-3 therapist visits). The investigators will encourage participants to exercise by themselves or with family members over the year, and once the programme ends.
People with early dementia or memory problems will be eligible for this study. If possible, the investigators will also recruit a family member. Participants will be recruited from memory clinics or the 'Join Dementia Research' register. The intervention will be delivered over a maximum of 1 year in their own homes. Researchers will visit to collect information at baseline and at 12 months. The investigators will measure ability in activities of daily living, activity, quality of life, memory and health service use. Participants will complete weekly falls diaries. Intervention persistence will be measured for 24 months.
The investigators will conduct interviews and discussion groups to help develop the programmes, and understand how they work in practice ('process evaluation'). The investigators will also do initial work on health economic modelling, dissemination and implementation.
Study findings will be used to refine the intervention, and inform a planned definitive randomised controlled trial.
详细描述
This is a feasibility randomised controlled trial which aims to answer practicability and feasibility questions required to ensure a large scale trial is successful. The specific questions are:
- Can the investigators develop and implement a successful and safe rehabilitation support worker (RSW) training programme?
- Can the investigators recruit participants at a sufficient rate across multiple sites? Will potential participants consent? Do randomisation systems work?
- Can the investigators deliver the intervention across sites? Can the investigators tailor the intervention? Do the components work together?
- Can the intervention be undertaken at home?
- Is the intervention acceptable, tolerated and adhered to? How many withdraw?
- What level of supervision intensity is required for the main trial that will enable engagement at a level likely to be effective at preventing falls? Or whether, in practice, level of supervision can be matched to individual participant characteristics.
- What proportion continue to adhere during 24 months follow-up?
- Are there unexpected or adverse consequences?
- Can the investigators collect trial health status and falls data at baseline and follow-up? Does blinding work? Is the assessment schedule too burdensome?
- Are our sample size assumptions correct? The feasibility trial will act as an external pilot trial. The investigators have chosen a randomised controlled trial design to minimise researcher bias during the allocation to groups and to enable differences at follow up to be attributed to the therapy rather than the characteristics of the participants involved. A control arm has been included of standard falls prevention, as requested by the NIHR.
Participants will either be recruited through Memory Clinics (the initial discussion about the study will be by the nurse or doctor in the clinic), or through the 'Join Dementia Research' dementia research volunteer register. If the patient is interested in taking part in the research, a researcher will visit them in their own home at a convenient time, assess their capacity to consent (The investigators will only recruit patients who have capacity to give informed consent), ensure they meet the eligibility criteria and then take informed consent. The investigators will collect information about participants in an interview conducted in their own home.
Baseline assessment
Those agreeing to take part will be screened for suitability and a baseline assessment undertaken at home or in a clinic setting. This will include:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age 65 or over (no maximum)
- •a diagnosis of dementia or an assessment of MCI (of any subtype), attendance at a memory assessment service, or on the Join Dementia Research register, with a cognitive score in the range defined, with no other apparent cause for cognitive impairment
- •Able to walk without human help
- •Able to communicate in English.
- •Able to see, hear and have dexterity sufficient to perform neuropsychological tests
- •Capacity to give consent to participate, and agreeing to do so
- •Montreal Cognitive Assessment (MoCA) 15-25 or standardised Mini-mental state examination (sMMSE) 18-26 or Addenbrookes Cognitive Examination (ACE-III) 60-94 .
- •Carer participants will be spouses, family members or others in a caring relationship who see the patient participant most weeks, or speaks by telephone most weeks, are willing to take part and can communicate in English.
排除标准
- •Co-morbidity preventing participation (e.g. severe breathlessness, pain, psychosis, Parkinson's or other severe neurological disease)
- •Life expectancy of less than 1 year
- •Likely to be unable to undertake the intervention regularly (e.g. planned elective surgery, planning to move away or commitments elsewhere).
- •Unable to communicate in English.
研究组 & 干预措施
Control
The control arm will comprise the offer of an assessment by a standard community falls prevention service.
High intensity supervision arm
high-intensity supervision
干预措施: High intensity supervision arm (Other)
Moderate intensity supervision arm
Moderate intensity supervision
干预措施: Moderate intensity supervision arm (Other)
结局指标
主要结局
Disability Assessment in Dementia (Gelinas and Gauthier, 1994)
时间窗: 1 Year
This is a feasibility study, so there are no primary outcome measures. However for the definitive trial, the primary outcome measure will be Activities of Daily Living (ADL) measured by the Disability Assessment in Dementia (DAD). The DAD measures functional disability based on the model of health proposed by the World Health Organisation. It consists of 40 questions which assess basic activities of daily living (dressing, hygiene, continence and eating), instrumental activities of daily living (meal preparation, telephoning, housework, taking care of finance, and correspondence, going on an outing, taking medications and ability to stay safely at home) and leisure activities. To understand the cognitive dimensions of disabilities in ADL, the activities are subdivided into initiation, planning and organisation and effective performance. The assessment is administered through an interview with the caregiver.
次要结局
- Falls (defined as 'unintentionally coming to rest on the ground or at a lower level, however caused')(4-12 Months from randomisation)