A Digital Health App to Prevent Falls and Improve Well-being in People Living With Dementia (NCT06149702) | Clinical Trial Compass
CompletedNot Applicable
A Digital Health App to Prevent Falls and Improve Well-being in People Living With Dementia
United Kingdom60 participantsStarted 2024-06-30
Plain-language summary
"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.
Who can participate
Age range
55 Years – 90 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
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
Exclusion Criteria:
PLwD
* 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 my…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The feasibility and acceptability of the intervention