DementiaKOKU-DNCT06149702
A Digital Health App to Prevent Falls and Improve Well-being in People Living With Dementia
A study testing Combined intervention: Keep-on-Keep-Up-LITE (KOKU-LITE) programme and dementia and falls prevention leaflet in people with Dementia, run by Jaheeda Gangannagaripalli at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 55 to 90 years
- Conditions the study is for
- Dementia
- What is being tested?
- Combined intervention: Keep-on-Keep-Up-LITE (KOKU-LITE) programme and dementia and falls prevention leaflet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 30 Jun 2024to 24 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Dementia
- Being tested
- Combined intervention: Keep-on-Keep-Up-LITE (KOKU-LITE) programme and dementia and falls prevention leaflet
- Keywords
- Quality of life, Well-being, Dementia, Feasibility study, Technology, Falls prevention, strength and balance
- Medical subject headings
- Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combined intervention: Keep-on-Keep-Up-LITE (KOKU-LITE) programme and dementia and falls prevention leafletOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention: Keep-on-Keep-Up-LITE (KOKU-LITE) programme and dementia and falls prevention leaflet | Other | 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 Receives: Other: Combined intervention: Keep-on-Keep-Up-LITE (KOKU-LITE) programme and dementia and falls prevention leaflet |
| Control arm (Dementia and Falls prevention leaflet) | Other | 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). Receives: Other: Combined intervention: Keep-on-Keep-Up-LITE (KOKU-LITE) programme and dementia and falls prevention leaflet |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 6 weeks
Secondary outcomes (7)
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'.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: UEQ will only be measured at 6 weeks post-follow up in the intervention group only (to those who use KOKU-LITE))
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2023
- Study start30 Jun 2024
- Primary completion29 Aug 2025
- Study completion24 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DementiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This feasibility randomised controlled trial is a 6-week study comparing the intervention (KOKU-LITE programme + dementia and falls prevention leaflet) to control (dementia and falls prevention leaflet) in community dwelling people living with dementia and carers of people living with dementia. After assessing participants for eligibility, they will be allocated randomly to either intervention group or control group. Assessments will be performed at baseline and 6 weeks post follow up.
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jaheeda Gangannagaripalli
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jaheeda Gangannagaripalli, University of Manchester
- Investigators
- Jaheeda Begum Gangannagaripalli, PhD, Principal investigator, The University of Manchester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06149702
- Sponsor's protocol ID
- Version 3.1, 13.05.24
- Acronym
- KOKU-D
- Status last verified
- Jan 2025
- First submitted
- 20 Nov 2023
- Last updated
- 5 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
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.
PubMed 40829848
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Feasibility Randomised Controlled Trial of a Digital Program to Prevent Falls and Improve Well-being in People Living With Dementia in the Community.
- ClinicalTrials.gov ID
- NCT06149702
- Acronym / sponsor ID
- KOKU-D / Version 3.1, 13.05.24
- Conditions
- Dementia
- Keywords
- Quality of life, Well-being, Dementia, Feasibility study, Technology, Falls prevention, strength and balance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Jaheeda GangannagaripalliUniversity, hospital or other
- Study start
- 30 Jun 2024 (actual)
- Primary completion
- 29 Aug 2025 (actual)
- Study completion
- 24 Sep 2025 (actual)
- First posted
- 29 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
"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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This feasibility randomised controlled trial is a 6-week study comparing the intervention (KOKU-LITE programme + dementia and falls prevention leaflet) to control (dementia and falls prevention leaflet) in community dwelling people living with dementia and carers of people living with dementia. After assessing participants for eligibility, they will be allocated randomly to either intervention group or control group. Assessments will be performed at baseline and 6 weeks post follow up.
| Arm | Type | Receives |
|---|---|---|
| Intervention: Keep-on-Keep-Up-LITE (KOKU-LITE) programme and dementia and falls prevention leaflet | Other | Other: Combined intervention: Keep-on-Keep-Up-LITE (KOKU-LITE) programme and dementia and falls prevention leafletIntervention 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 |
| Control arm (Dementia and Falls prevention leaflet) | Other | Other: Combined intervention: Keep-on-Keep-Up-LITE (KOKU-LITE) programme and dementia and falls prevention leafletIf 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). |
Who may qualify
- Ages
- 55 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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.
Key exclusion criteria (12 listed)
- PLwD
- Participants with:
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Combined intervention: Keep-on-Keep-Up-LITE (KOKU-LITE) programme and dementia and falls prevention leafletKOKU-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), Intervention: Keep-on-Keep-Up-LITE (KOKU-LITE) programme and dementia and falls prevention leaflet |
Primary outcome
The feasibility and acceptability of the intervention
Time frame: 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).
7 secondary outcomes
Health-related Quality of life will be measured using EQ-5D-5L scale
Time frame: 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
Time frame: 6 weeks: E-ADL-Test will be assessed at baseline and 6 weeks post-follow up
Short Physical Performance Battery
Time frame: 6 weeks: participants will be assessed at baseline and 6 weeks post-follow up using SPPB
Geriatric Depression Scale
Time frame: 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.
Time frame: 6 weeks: FRAT tool will be measured at baseline and 6 weeks post follow-up
Short Falls Efficacy Scale-International
Time frame: 6 weeks: FES-1 scale will be measured at baseline and 6 weeks post-follow up
The User Experience Questionnaire
Time frame: UEQ will only be measured at 6 weeks post-follow up in the intervention group only (to those who use KOKU-LITE))
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2026.
- Derived from this study: PubMed 40829848Gangannagaripalli 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.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jaheeda Begum Gangannagaripalli, PhD principal investigator
The University of Manchester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Combined intervention: Keep-on-Keep-Up-LITE (KOKU-LITE) programme and dementia and falls prevention leaflet in people with Dementia, run by Jaheeda Gangannagaripalli at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The feasibility and acceptability of the intervention (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06149702, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2026.