Clinical trial NCT06149702: A Digital Health App to Prevent Falls and Improve Well-being in People Living With Dementia
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.
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Dementia
Keywords: Quality of life
Well-being
Dementia
Feasibility study
Technology
Falls prevention
strength and balance
Lead sponsor: University of Manchester
Sponsor class: OTHER
First posted: 2023-11-29
Enrollment: 60
Sex: ALL
Minimum age (years): 55
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: PREVENTION

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.


Eligibility criteria: 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.

Primary outcomes:
measure: The feasibility and acceptability of the intervention
timeFrame: 6 weeks
Secondary outcomes:
measure: Health-related Quality of life will be measured using EQ-5D-5L scale
timeFrame: 6 weeks: Health-related Quality of life will measured at baseline and 6 weeks post follow-up
measure: The Erlangen Test for Activities of Daily Living test
timeFrame: 6 weeks: E-ADL-Test will be assessed at baseline and 6 weeks post-follow up
measure: Short Physical Performance Battery
timeFrame: 6 weeks: participants will be assessed at baseline and 6 weeks post-follow up using SPPB
measure: Geriatric Depression Scale
timeFrame: 6 weeks: The 5-item Geriatric Depression Scale screening tool will be measured at baseline and 6 weeks post follow-up
measure: Falls risk will be measured with the use of the Assessment of falls risk tool.
timeFrame: 6 weeks: FRAT tool will be measured at baseline and 6 weeks post follow-up
measure: Short Falls Efficacy Scale-International
timeFrame: 6 weeks: FES-1 scale will be measured at baseline and 6 weeks post-follow up
measure: The User Experience Questionnaire
timeFrame: UEQ will only be measured at 6 weeks post-follow up in the intervention group only (to those who use KOKU-LITE))
Other outcomes:
Locations:
city: Manchester
country: United Kingdom
facility: The University of Manchester
Study officials:
affiliation: The University of Manchester
name: Jaheeda Begum Gangannagaripalli, PhD
role: PRINCIPAL_INVESTIGATOR
References: