The impact of a mobile-based fall education application on fall risk factors in older adults
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 136
- 试验地点
- 1
- 主要终点
- Timed up and Go Test
研究概览
简要总结
The aim of the study is to develop a comprehensive and valid fall education program and a mobile-based application for older adults. The objectives are as follows:
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To develop a fall education program
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To develop a mobile-based fall education application
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To determine the impact of the mobile-based fall education application on fall risk factors in older adults
4. To understand older adults’perceptions and experiences of using wearables in a fall prevention program
Justification for study (whether of national significance with rationale) : The ageing population in India is increasing exponentially (United Nations, 2013). The prevalence of falls is 14-53% (Dsouza et al., 2014) and is expected to increase with the increasing prevalence of non-communicable diseases. Falls affect older adults and their families, especially financially, affect independent living and increase dependency. Falls commonly occur at home and are potentially preventable (World Health Organization (WHO), 2007; 2018). Fall prevention is a critical component of health aging initiatives. Fall education is an essential component of fall prevention. Currently, it is provided at busy out-patient departments by health professionals with brief dyadic sessions mostly for those with health-related risk factors and occasionally through webinars for older adults in the community. These vary in content and delivery. We did not find much evidence of effective fall education programs in India. The adoption of fall prevention strategies continues to be low. The brief one-to-one sessions or general webinars attended by many may not be adequate for older adults to remember all the details. For better adoption, the fall education needs to be contextually relevant, accessible, personalized and reinforced several times. The use of mobile phones by older adults in India is steadily increasing, especially with the ongoing Covid pandemic. A mobile-based application or mhealth would make fall education more accessible to them, provide reinforcement, increase awareness, promote adoption of strategies, reduce or prevent falls, and there by support healthy ageing. The use of mhealth for fall education and prevention in older adults is underexplored in India. The present study intends to address this gap and would support health aging initiatives in India and the attainment of its SDG goals.
Study description: The study will use a mixed-method approach and will involve three phases. In Phase I, the Fall education program and mobile-based application will be developed and tested. Phase II involves a quasi-experimental study with a two-arm cluster non-randomized controlled trial. Phase III involves a. focus group discussions with purposively selected participants of the experimental group/cluster for feedback regarding their experience with the mobile-based application and b. semi-structured interviews with purposively selected participants of both control and experimental groups to understand their experiences and perspectives on using wearables
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Open Label
入排标准
- 年龄范围
- 60.00 Year(s) 至 90.00 Year(s)（—）
- 性别
- All
入选标准
- •Older adults aged 60 years and above
- •English or Kannada speaking
- •Able to use internet-enabled Android smartphones (only experimental group)
- •High school education
- •Able to answer everyday questions at a normal conversation level from 5 feet distance
- •Able to read a headline and a sentence in the newspaper with their regular glasses
- •Interested to take part in a fall prevention program.
排除标准
- •Older adults with
- •Cognitive impairments (Mini-Mental Status Examination score of 24 and below)
- •High fall risk (based on World Fall guidelines (2022) this includes: •2 or more falls in the past year •inability to get up from the floor on falling •injuries severe enough to consult physicians •frailty (score of 4 or more on the Clinical Frailty Scale) •loss of consciousness or suspected syncope
- •Self-reported severely disabling physical (medical, neurological, orthopedic) and psychiatric conditions
- •Self-reported pain that precludes them from participating in exercises and activities
- •Having health conditions for which mild-intensity exercises and activities are contraindicated.
结局指标
主要结局
Timed up and Go Test
时间窗: pre-test and after 3 months
次要结局
- Falls Efficacy Scale International(pre-test and after 3 months)
- Home-related Fall Risk Assessment(pre-test and after 3 months)
- Exercise and Fall record(3 months after pre-test)
- Fall-related knowledge, attitudes and practices(pre-test, after 1 week of educational intervention and after 3 months)
- Timed up & Go test (Manual)(pre-test & after 3 months)
- Timed up & go test (Cognitive)(pre-test & after 3 months)
- 30 second Chair Stand Test(pre-test & after 3 months)
- General Self-Efficacy scale.(pre-test & after 3 months)