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

Sponsor

Jaheeda Gangannagaripalli (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06149702

Collaborator

(none)

Enrollment

Arms

9.1

Anticipated Duration (Months)

Study Details

Study Description

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 with Dementia are more reluctant to using digital technologies. The existing version of the KOKU app has been modified in collaboration with People with Dementia and carers to suit their needs and make it Dementia-friendly and accessible to people with Dementia. The current project involves testing the modified new version of the KOKU app with people with Dementia, their carers, and health and social care professionals. This project will have many possible benefits for people 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.

Condition or Disease	Intervention/Treatment	Phase
Dementia	Other: Keep-on-Keep-Up	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

This feasibility randomised controlled trial is a 6-week study comparing the modified KOKU programme to usual care in community dwelling PwD and carers of PwD. 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 upThis feasibility randomised controlled trial is a 6-week study comparing the modified KOKU programme to usual care in community dwelling PwD and carers of PwD. 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)

Primary Purpose:

Other

Official Title:

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

Anticipated Study Start Date :

Nov 30, 2023

Anticipated Primary Completion Date :

Jun 1, 2024

Anticipated Study Completion Date :

Sep 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Other: Intervention Participants will attend a KOKU 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 the modified KOKU programme for 30 minutes, 3 times per week, for 6 weeks	Other: Keep-on-Keep-Up Keep-On-Keep-Up (KOKU) programme in the app will be used by the participants for 6 weeks and outcome assessments will be performed at baseline and 6 weeks of use
Other: Control arm Usual care	Other: Keep-on-Keep-Up Keep-On-Keep-Up (KOKU) programme in the app will be used by the participants for 6 weeks and outcome assessments will be performed at baseline and 6 weeks of use

Arm

Intervention/Treatment

Other: Intervention

Participants will attend a KOKU 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 the modified KOKU programme for 30 minutes, 3 times per week, for 6 weeks

Other: Keep-on-Keep-Up

Keep-On-Keep-Up (KOKU) programme in the app will be used by the participants for 6 weeks and outcome assessments will be performed at baseline and 6 weeks of use

Other: Control arm

Usual care

Other: Keep-on-Keep-Up

Keep-On-Keep-Up (KOKU) programme in the app will be used by the participants for 6 weeks and outcome assessments will be performed at baseline and 6 weeks of use

Outcome Measures

Primary Outcome Measures

The feasibility and acceptability of the intervention will be evaluated in terms of recruitment, retention and adherence rates to the trial. [6 weeks]

Secondary Outcome Measures

Quality of life (QoL) as measured by The European Quality of Life 5 Dimensions (EQ-5D-5L) scale. [6 weeks]
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. [6 weeks]
The Short Physical Performance Battery (SPPB) is a validated and reliable instrument to assess functional mobility in people with cognitive impairment/dementia [6 weeks]
The 5-item Geriatric Depression Scale screening tool for depression in older adults [6 weeks]
Falls risk will be measured with the use of the Assessment of falls risk (FRAT) tool. [6 weeks]
The Short Falls Efficacy Scale-International (FES-I) at the baseline assessment. [Baseline]
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 [6 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

55 Years to 90 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Participant inclusion criteria:

PwD and carers of PwD 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.

PwD and carers of PwD aged ≥55 yrs
willing and able to give informed consent (assessed by the trained researchers and/or HSCPs).
who lack capacity to consent themselves but can be supported by a carer or an advocate.
Carers of PwD 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 PwD

Exclusion Criteria:

PwD

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.