Ignite Creation Date:
2025-12-24 @ 10:23 PM
Ignite Modification Date:
2025-12-30 @ 7:50 PM
Study NCT ID:
NCT06687135
Status:
RECRUITING
Last Update Posted:
2024-11-13
First Post:
2024-11-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Keep-On-Keep-Up (KOKU)
Sponsor:
University of Manchester
Organization:
Study Overview
Official Title:
The Effectiveness of a Digital Falls Prevention Programme (KOKU) Versus Usual Care to Improve Balance, Falls Risk and Function in Older Adults
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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
* 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
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: