A Feasibility Randomised Controlled Trial of a Digital Program to Prevent Falls and Improve Well-being in People Living With Dementia in the Community.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- The feasibility and acceptability of the intervention
研究概览
简要总结
"Keep on Keep up (KOKU)" is a tablet/iPad-based, digital strength and balance exercise programme specifically designed for older people at risk of falls. Research has shown that the exercises reduce falls by around a third in older people. People with Dementia are more reluctant and have greater challenges with using digital technologies. Evidence suggests that developing technologies in a Patient-Centered manner will be more acceptable in this population as People living with Dementia are more reluctant to using digital technologies. The existing version of the KOKU digital programme has been modified in collaboration with People living with Dementia and carers of People living with Dementia to suit their needs and make it Dementia-friendly, and accessible to People living with Dementia known as KOKU-LITE. The current project involves testing KOKU-LITE with People living with Dementia, their carers, and health and social care professionals. This project will have many possible benefits for People living with Dementia; It has the potential to improve quality of life (QoL), well-being, confidence, independence, and therefore has the potential to reduce general practice visits, hospital admissions, and health and social care costs.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 55 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participant inclusion criteria:
- •People living with dementia (PLwD) and carers of PLwD Participants will be selected purposively to derive a maximum variation sample including age, gender, diverse representation from different backgrounds and different levels of Dementia, early cognitive decline and different stages of disease progression thus, increase the external generalisability of the results.
- •PLwD and carers of PLwD aged ≥55 yrs
- •willing and able to give informed consent (assessed by the trained researchers and/or health and social care professionals (HSCPs)).
- •who lack capacity to consent themselves but can be supported by a carer or an advocate.
- •Carers of PLwD who lack capacity to consent themselves.
- •able to speak English.
- •able to see the tablet/iPad-based app and read instructions with or without glasses.
- •able to use tablet/iPad safely, as assessed by the trained research staff and/or HSCPs.
- •able to move indoors without help, and with or without a walking aid.
- •Professionals
- •HSCPs caring for PLwD
排除标准
- •Participants with:
- •Acute/chronic or uncontrolled medical condition (e.g. severe congestive cardiac failure, uncontrolled hypertension, acute systemic illness, neurological problems, poorly controlled diabetes).
- •recent fracture or surgery (within 6 months)
- •orthopaedic surgery (such as hip/knee surgery) in the past six months or on a waiting list to have the surgery.
- •heart problems such as myocardial infarction or stroke in the past six months
- •conditions requiring a specialist/exercise programme (e.g., uncontrolled epilepsy, or uses a wheelchair to mobilise indoors).
- •severe hearing/visual impairment.
- •any other medical condition likely to compromise the ability to use/access the app.
- •Participants currently in hospital or care home,
- •Participants who have limited understanding or ability to speak English, and .
- •Persons with Dementia who do not have a carer who can provide assent.
研究组 & 干预措施
Intervention: Keep-on-Keep-Up-LITE (KOKU-LITE) programme and dementia and falls prevention leaflet
Intervention arm: Keep-on-Keep-Up-LITE (KOKU-LITE) programme and dementia and falls prevention leaflet.
Participants will attend a KOKU-LITE training session lasting for 60 minutes. A carer may also accompany if the participant feels that their support would be beneficial. An iPad will be provided to participants for the duration of the project and the app instruction booklet will also be provided for reference purposes. For participants who do not wish to attend the group training, ad hoc one-to-one training will be offered. * Participants will be advised to use KOKU-LITE for 30 minutes, 3 times per week, for 6 weeks and also read the dementia and falls prevention leaflet
干预措施: Combined intervention: Keep-on-Keep-Up-LITE (KOKU-LITE) programme and dementia and falls prevention leaflet (Other)
Control arm (Dementia and Falls prevention leaflet)
If participants are allocated to the intervention group, they will use KOKU-LITE for 30 minutes 3 times a week for 6 weeks along with the dementia and falls prevention leaflet. If participants are allocated to the control group, they will receive Dementia and Falls prevention leaflet (https://www.dementiauk.org/wp-content/uploads/dementia-uk-falls.pdf)l (and not use KOKU-LITE).
干预措施: Combined intervention: Keep-on-Keep-Up-LITE (KOKU-LITE) programme and dementia and falls prevention leaflet (Other)
结局指标
主要结局
The feasibility and acceptability of the intervention
时间窗: 6 weeks
The feasibility and acceptability of the intervention will be evaluated in terms of recruitment, retention and adherence rates to the trial. This will be evaluated by calculating the percentage of people approached who participate in the trial (recruitment) and the percentage of participants who complete the trial (including using KOKU-LITE and dementia and falls prevention leaflet and completing the questionnaires) (retention and adherence).
次要结局
- Health-related Quality of life will be measured using EQ-5D-5L scale(6 weeks: Health-related Quality of life will measured at baseline and 6 weeks post follow-up)
- The Erlangen Test for Activities of Daily Living test(6 weeks: E-ADL-Test will be assessed at baseline and 6 weeks post-follow up)
- Short Physical Performance Battery(6 weeks: participants will be assessed at baseline and 6 weeks post-follow up using SPPB)
- Geriatric Depression Scale(6 weeks: The 5-item Geriatric Depression Scale screening tool will be measured at baseline and 6 weeks post follow-up)
- Falls risk will be measured with the use of the Assessment of falls risk tool.(6 weeks: FRAT tool will be measured at baseline and 6 weeks post follow-up)
- Short Falls Efficacy Scale-International(6 weeks: FES-1 scale will be measured at baseline and 6 weeks post-follow up)
- The User Experience Questionnaire(UEQ will only be measured at 6 weeks post-follow up in the intervention group only (to those who use KOKU-LITE)))
研究者
Jaheeda Gangannagaripalli
Dr
University of Manchester