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

A Feasibility Randomised Controlled Trial of a Digital Program to Prevent Falls and Improve Well-being in People Living With Dementia in the Community.

"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.

Study Overview

• Status: Completed
• Conditions: Dementia
• Intervention / Treatment: Other: Combined intervention: Keep-on-Keep-Up-LITE (KOKU-LITE) programme and dementia and falls prevention leaflet

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Manchester, United Kingdom, M13 9PL
    • The University of Manchester

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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	Other: 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.
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).	Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The feasibility and acceptability of the intervention	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).	6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Health-related Quality of life will be measured using EQ-5D-5L scale	Health-related Quality of life as measured by The European Quality of Life 5 Dimensions (EQ-5D-5L) scale. EQ-5D-5L is a 5-dimension version of the original EQ-5D scale. It has two sections: the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). The 5 responses give a health state or profile represented by a 5-digit number (for example, 12231) corresponding to response categories reported by patients for successive dimensions: mobility, self care, usual activities, pain/discomfort, anxiety/depression. Current recommendations for scoring the EQ-5D-5L index will be followed. Index scores range from -0.59 to 1; 1 is the best possible health state. The EQ VAS records the patient's self-rated health on a vertical visual analogue scale where 0 indicates 'worst health you can imagine' and 100 indicates 'the best health you can imagine'.	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	The Erlangen Test for Activities of Daily Living test (E-ADL-Test) is a valid and reliable instrument for assessing the ADL capabilities of people with Dementia. It includes 4 domains: Pouring a drink, Cutting a piece of bread, Opening a little cupboard, Washing hands. The total score of the E-ADL ranges from 0-30, with a higher score representing better results.	6 weeks: E-ADL-Test will be assessed at baseline and 6 weeks post-follow up
Short Physical Performance Battery	The Short Physical Performance Battery (SPPB) is a validated and reliable instrument to assess functional mobility in people with cognitive impairment/dementia. SPPB is a validated and reliable instrument to assess functional mobility in people with cognitive impairment/dementia. The SPPB test includes three different domains: walking, sit-to-stand and balance. The scores range from 0 (worst performance) to 12 (best performance).	6 weeks: participants will be assessed at baseline and 6 weeks post-follow up using SPPB
Geriatric Depression Scale	The 5-item Geriatric Depression Scale screening tool for depression in older adults. The 5-item Geriatric Depression Scale screening tool for depression in older adults (validated to be as effective as the 15-item GDS for older adults in a wide range of settings). A score of 0 to 1 for the 5-item GDS suggests that the subject is not depressed, while 2 or higher indicates possible depression.	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.	Falls risk will be measured with the use of the Assessment of falls risk (FRAT) tool. (VI) Falls risk will be measured with the use of the Assessment of falls risk (FRAT) tool. This validated measure has 5 items which include; history of any fall in the previous year, four or more prescribed medications, diagnosis of stroke or Parkinson's disease, reported problems with balance and inability to rise from a chair without using arms. These are all strong indicators for risk of falling. If a person scores 3 or more they are at high risk of falling.	6 weeks: FRAT tool will be measured at baseline and 6 weeks post follow-up
Short Falls Efficacy Scale-International	The Short Falls Efficacy Scale-International (FES-I). The FES-I is a validated and reliable 7-item tool that measures confidence in performing a range of activities of daily living without falling. This scale has recently been modified to maximise its suitability for a range of different languages and cultures. Scoring: Minimum 7 (no concern about falling) to maximum 28 (severe concern about falling).	6 weeks: FES-1 scale will be measured at baseline and 6 weeks post-follow up
The User Experience Questionnaire	The User Experience Questionnaire (UEQ) is a standardized 26-item questionnaire that is used reliably to assess the quality and user experience of the interactive products. The standard interpretation of the scale means is that values between -0.8 and 0.8 represent a neural evaluation of the corresponding scale, values > 0,8 represent a positive evaluation and values < -0,8 represent a negative evaluation. The range of the scales is between -3 (horribly bad) and +3 (extremely good).	UEQ will only be measured at 6 weeks post-follow up in the intervention group only (to those who use KOKU-LITE))

Collaborators and Investigators

• Sponsor: Jaheeda Gangannagaripalli
• Investigators: Principal Investigator: Jaheeda Begum Gangannagaripalli, PhD, The University of Manchester

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 30, 2024
• Primary Completion (Actual): August 29, 2025
• Study Completion (Actual): September 24, 2025

Study Registration Dates

• First Submitted: November 20, 2023
• First Submitted That Met QC Criteria: November 20, 2023
• First Posted (Actual): November 29, 2023

Study Record Updates

• Last Update Posted (Actual): May 5, 2026
• Last Update Submitted That Met QC Criteria: May 4, 2026
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: Quality of life; Dementia; Well-being; Feasibility study; Technology; Falls prevention; strength and balance
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Mental Disorders; Neurocognitive Disorders; Dementia
• Other Study ID Numbers: Version 3.1, 13.05.24

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: At the end of the project, we will deposit a fully anonymised dataset [including de-identified interview transcripts] in an open data repository where it will be permanently stored. We will use Figshare at the University of Manchester Library. Researchers at other institutions and others can access the anonymised data directly from the repository and use it for further research or to check our analysis and results.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No