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

Dementia Clinical Trial

— KOKU-D  

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.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06149702
• Other study ID #: Version 3, 31.07.23
• Status: Not yet recruiting
• Phase: N/A
• Start date: November 30, 2023
• Est. completion date: September 2024

Study information

• Verified date: November 2023
• Source: University of Manchester
• Contact: Jaheeda Gangannagaripalli, PhD
• Phone: 07449345250
• Email: jaheeda.gangannagaripalli[@]manchester.ac.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: September 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dementia

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Jaheeda Gangannagaripalli

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The feasibility and acceptability of the intervention will be evaluated in terms of recruitment, retention and adherence rates to the trial.		6 weeks
Secondary	Quality of life (QoL) as measured by The European Quality of Life 5 Dimensions (EQ-5D-5L) scale.		6 weeks
Secondary	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
Secondary	The Short Physical Performance Battery (SPPB) is a validated and reliable instrument to assess functional mobility in people with cognitive impairment/dementia		6 weeks
Secondary	The 5-item Geriatric Depression Scale screening tool for depression in older adults		6 weeks
Secondary	Falls risk will be measured with the use of the Assessment of falls risk (FRAT) tool.		6 weeks
Secondary	The Short Falls Efficacy Scale-International (FES-I) at the baseline assessment.		Baseline
Secondary	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