A Digital Health App to Prevent Falls and Improve Well-being in People Living With Dementia

NCT ID: NCT06149702

Last Updated: 2025-01-17

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-06-30
• Study Completion Date: 2025-09-30

Brief 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.

Conditions

Dementia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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

Group Type: OTHER

Combined intervention: Keep-on-Keep-Up-LITE (KOKU-LITE) programme and dementia and falls prevention leaflet

Intervention Type: OTHER

KOKU-LITE programme will be used by the participants for 6 weeks and outcome assessments will be performed at baseline and 6 weeks of use. Participants will also use dementia and falls prevention leaflet for 6 weeks.

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).

Group Type: OTHER

Combined intervention: Keep-on-Keep-Up-LITE (KOKU-LITE) programme and dementia and falls prevention leaflet

Intervention Type: OTHER

KOKU-LITE programme will be used by the participants for 6 weeks and outcome assessments will be performed at baseline and 6 weeks of use. Participants will also use dementia and falls prevention leaflet for 6 weeks.

Interventions

Combined intervention: Keep-on-Keep-Up-LITE (KOKU-LITE) programme and dementia and falls prevention leaflet

KOKU-LITE programme will be used by the participants for 6 weeks and outcome assessments will be performed at baseline and 6 weeks of use. Participants will also use dementia and falls prevention leaflet for 6 weeks.

Intervention Type: OTHER

Eligibility Criteria

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 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.

• Minimum Eligible Age: 55 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jaheeda Gangannagaripalli

OTHER

Sponsor Role: lead

Responsible Party

Jaheeda Gangannagaripalli

Dr

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Jaheeda Begum Gangannagaripalli, PhD

Role: PRINCIPAL_INVESTIGATOR

The University of Manchester

Locations

The University of Manchester

Manchester, , United Kingdom

Countries

United Kingdom

References

Gangannagaripalli J, Vardy E, Stanmore E. A digital programme to prevent falls and improve well-being in people living with dementia in the community: the KOKU-LITE feasibility randomised controlled trial protocol. BMJ Open. 2025 Aug 19;15(8):e091222. doi: 10.1136/bmjopen-2024-091222.

Reference Type: DERIVED

PMID: 40829848 (View on PubMed)

Other Identifiers

Version 3.1, 13.05.24

Identifier Type: -

Identifier Source: org_study_id