Clinical trial NCT06687135: Keep-On-Keep-Up (KOKU)
Official title: The Effectiveness of a Digital Falls Prevention Programme (KOKU) Versus Usual Care to Improve Balance, Falls Risk and Function in Older Adults
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Balance
Falls Prevention
Functional Decline
Keywords: Balance
Falls Prevention
Functional Decline
Older People
Gerotechnology
Rehabilitation
Lead sponsor: University of Manchester
Sponsor class: OTHER
First posted: 2024-11-13
Enrollment: 196
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A two-arm randomised controlled trial.
Primary purpose: PREVENTION

Brief summary: Falls are the primary cause of fatal and non-fatal accidental injuries in older adults. Around a third of community-dwelling older adults fall per year with high associated personal and societal costs. The World Falls Prevention Guidelines recommend balance challenging, functional exercise programmes for falls prevention but there can be low uptake and adherence in community settings. A digital, NHS approved programme Keep-On-Keep-Up (KOKU) was co-developed with older adults and therapists, to provide progressive, evidence-based exercises and to raise awareness of home hazards and ways to improve bone health, nutrition and hydration. This trial aims to investigate the effectiveness of the KOKU digital strength and balance programme for improving balance, function and reducing falls risk in community dwelling older adults.

Objective:

The purpose of this study is to investigate the effectiveness and cost-effectiveness of an NHS (National Health Service) approved, digital falls prevention intervention; (Keep On Keep Up (KOKU) - see https://kokuhealth.com) for improving balance, maintaining function and reducing falls risk in community dwelling older adults.

Design:

A two-arm randomised controlled trial.

Participants and setting:

Community-dwelling older adults aged 65 years and older.

Interventions:

Digital 12-week strength and balance programme, plus standard care (falls prevention exercises advice and leaflet) against standard care only.

Main outcome measures:

The primary outcome measure is balance function at 12 weeks post-baseline, as assessed by the Berg Balance scale (BBS). Secondary outcomes include: healthcare utilisation and health-related quality of life, fear of falling, mobility, self-reported physical activity, falls risk, pain, mood, fatigue, and self-reported falls over a 3-month period. Randomisation will take place after participants are recruited and baseline data is collected.

Detailed description: * Eligible participants will be advised to use KOKU (a digital health wellbeing app) three times per week for 20-30 minutes
* The KOKU intervention will run for 12 weeks to test the effectiveness
* The control group will be given FaME/ OTAGO exercise and falls prevention information leaflets without KOKU
* Assessments will take place at baseline, 6 weeks, and at the end of the12-week period
* Outcome measures to be used include a series of standardised tests and questionnaires and each participant will be aided in completing these measures
* At the end of the 12 weeks, focus groups and interviews will be conducted to assess the care managers, carers and participant's perspectives regarding the effectiveness of the KOKU digital program and its usability

Eligibility criteria: Inclusion Criteria:

* Older adults (aged 60 years and older, inclusive of all genders and ethnicities)
* Are able and willing to provide informed consent (to participate in the study)
* Are able to understand and speak English (to communicate with researchers and understand what the research involves)
* Are able to see and safely use the tablet-based program and read instructions with or without glasses as assessed by the trained research staff (in order to access the intervention)

Exclusion Criteria:

* Inability to understand the study procedures
* Currently using other digital technologies to exercise (would not be a true experimental or control group participant)
* Medical contraindications to exercise e.g. acute illness, severe congestive cardiac failure, uncontrolled hypertension, recent fracture or surgery; myocardial infarction or stroke in past 6 months; severe cognitive impairment; orthopaedic surgery in last 6 months, or on waiting list to have orthopaedic surgery; wheelchair users; severe auditory or visual impairment; and peripheral neuropathy or other uncontrolled medical (conditions that are likely to compromise the ability to exercise)

Primary outcomes:
measure: Berg Balance Scale (BBS)
timeFrame: 0 Weeks (baseline), 6 weeks and 12 weeks (study completion)
Secondary outcomes:
measure: European Quality of Life 5 Dimensions (EQ5D-5L)
timeFrame: 0 Weeks (baseline), 6 weeks and 12 weeks (study completion)
measure: 5-item Geriatric Depression Scale (GDS)
timeFrame: 0 Weeks (baseline), 6 weeks and 12 weeks (study completion)
measure: Physical Activity Scale for the Elderly (PASE)
timeFrame: 0 Weeks (baseline), 6 weeks and 12 weeks (study completion)
measure: Short Falls Efficacy Scale-International (FES-I)
timeFrame: 0 Weeks (baseline), 6 weeks and 12 weeks (study completion)
measure: Five times Sit to Stand Test
timeFrame: Baseline, 6 weeks and 12 weeks
measure: Assessment of Falls Risk Tool (FRAT)
timeFrame: 0 Weeks (baseline), 6 weeks and 12 weeks (study completion)
measure: System Usability Scale (SUS)
timeFrame: 0 Weeks (baseline), 6 weeks and 12 weeks (study completion)
measure: Theoretical Framework for Acceptability (TFA)
timeFrame: 0 Weeks (baseline), 6 weeks and 12 weeks (study completion)
measure: 12 Item Short Scale for Measuring Technology Commitment
timeFrame: 0 Weeks (baseline), 6 weeks and 12 weeks (study completion)
measure: The Short Version of the User Experience Question
timeFrame: 0 Weeks (baseline), 6 weeks and 12 weeks (study completion)
Other outcomes:
Locations:
city: Manchester
country: United Kingdom
facility: The University of Manchester
state: Greater Manchester
city: Manchester
country: United Kingdom
facility: University of Manchester
state: Greater Manchester
Study officials:
affiliation: The University of Manchester
name: Emma Stanmore, PhD
role: PRINCIPAL_INVESTIGATOR
References: