The Effectiveness of a Digital Falls Prevention Programme (KOKU) Versus Usual Care to Improve Balance, Falls Risk and Function in Older Adults
概览
- 阶段
- 不适用
- 干预措施
- KOKU
- 疾病 / 适应症
- Balance
- 发起方
- University of Manchester
- 入组人数
- 202
- 试验地点
- 4
- 主要终点
- Berg Balance Scale (BBS)
- 状态
- 已完成
- 最后更新
- 4天前
概览
简要总结
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.
详细描述
* 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
研究者
Prof Emma Stanmore
Chief Investigator/ Principal Investigator
University of Manchester
入排标准
入选标准
- •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)
排除标准
- •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)
研究组 & 干预措施
KOKU
A maximum of 196 participants will be recruited to participate in the study, across sites in Greater Manchester and Lancashire, UK. Participants will be randomised into either; * the experimental group (n=98); who will receive the KOKU intervention or * the control group (n=98); who will receive the FaME/ OTAGO exercise and falls prevention information leaflets without KOKU.
干预措施: KOKU
FaME/OTAGO
A maximum of 196 participants will be recruited to participate in the study, across sites in Greater Manchester and Lancashire, UK. Participants will be randomised into either; * the experimental group (n=98); who will receive the KOKU intervention or * the control group (n=98); who will receive the FaME/ OTAGO exercise and falls prevention information leaflets without KOKU.
干预措施: FaME / OTAGO leaflet and AGE UK Stay Steady Leaflet
结局指标
主要结局
Berg Balance Scale (BBS)
时间窗: 0 Weeks (baseline), 6 weeks and 12 weeks (study completion)
The primary outcome measure is balance function as measured by the Berg Balance Scale (BBS). The BBS is a 14-item scale designed to measure balance of the older adult in a clinical setting. Each item consists of a five-point ordinal scale ranging from 0 to 4, with 0 indicating the lowest level of function and 4 the highest level of function and takes approximately 20 minutes to complete. The total score equals 56. Score of \< 45 indicates individuals may be at greater risk of falling (Berg et al., 1992).
次要结局
- European Quality of Life 5 Dimensions (EQ5D-5L)(0 Weeks (baseline), 6 weeks and 12 weeks (study completion))
- 5-item Geriatric Depression Scale (GDS)(0 Weeks (baseline), 6 weeks and 12 weeks (study completion))
- Physical Activity Scale for the Elderly (PASE)(0 Weeks (baseline), 6 weeks and 12 weeks (study completion))
- Short Falls Efficacy Scale-International (FES-I)(0 Weeks (baseline), 6 weeks and 12 weeks (study completion))
- Five times Sit to Stand Test(Baseline, 6 weeks and 12 weeks)
- Assessment of Falls Risk Tool (FRAT)(0 Weeks (baseline), 6 weeks and 12 weeks (study completion))
- System Usability Scale (SUS)(0 Weeks (baseline), 6 weeks and 12 weeks (study completion))
- Theoretical Framework for Acceptability (TFA)(0 Weeks (baseline), 6 weeks and 12 weeks (study completion))
- 12 Item Short Scale for Measuring Technology Commitment(0 Weeks (baseline), 6 weeks and 12 weeks (study completion))
- The Short Version of the User Experience Question(0 Weeks (baseline), 6 weeks and 12 weeks (study completion))