Promoting Activity, Independence and Stability in Early Dementia and Mild Cognitive Impairment
试验速览
- 阶段
- 不适用
- 入组人数
- 368
- 试验地点
- 8
- 主要终点
- Disability Assessment in Dementia (DAD)
研究概览
简要总结
A clinical trial to test the clinical and cost-effectiveness of a therapy intervention designed to promote activity and independence and reduce falls, amongst people with early dementia or mild cognitive impairment
详细描述
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.
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
- None
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)
- •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
排除标准
- •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)
结局指标
主要结局
Disability Assessment in Dementia (DAD)
时间窗: 12 months
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."
次要结局
- Time to first fall(12 months)
- Nottingham Extended ADL Scale(12 months)
- Personality(12 months)
- Rate of hospital and care home admissions, and days spent in hospital(12 months)
- Carer health-related quality of life(12 months)
- Quality of Life(12 months)
- Physical activity(12 months)
- Cognition(12 months)
- Rate of fractures and injurious falls(12 months)
- Falls Rate(12 months)
- Carer strain(12 months)
- Mood or 'Affect'(12 months)