Interventions for prevention of falls among older persons - a randomized control trial in Kerala, India
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 300
- 试验地点
- 4
- 主要终点
- Reduction in the incidence of falls or risk for falls will be the primary outcome.
研究概览
简要总结
The main aim of the trial is to develop feasible interventions for the prevention of falls among older persons in Kerala.
The specific objectives include:
To examine whether a multifactorial fall prevention programme comprising education on falls, lifestyle advice, medication reviews, exercise intervention, and recommendations for environmental adaptation can reduce the incidence of falls and reduce the risk of falls among community-dwelling older persons when compared to conventional care, including education on falls and lifestyle advice.
The study will be conducted among community-dwelling older persons (60 years of age and older) attending outpatient departments in selected geriatric clinics.
All the participants will be assessed during the baseline, at six months, and at the end of one year. Information about the participant’s health and lifestyle (level of physical activity, alcohol use, smoking, and diet) will be ascertained. Body balance and gait will be assessed using a modified POMA scale and grip strength will be examined using a digital dynamometer. Activities of daily living and cognition will also be assessed using the ADL scale and the MoCA scale, respectively. Incident interviews will be conducted with participants who report falls or critical incidents during the study period. A sub-sample of the participants and service providers will be interviewed to explore their perspectives and experiences as part of the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 60.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •All willing ambulatory community-dwelling older adults (60 years and older) attending the NCD/geriatric clinics of selected secondary care units with moderate to high risk for falls (screened using a fall risk assessment tool) will be the participants of this study.
排除标准
- •Individuals who are hospitalised or ailing with acute injuries causing fractures or immobility at the time of data collection will be excluded.
结局指标
主要结局
Reduction in the incidence of falls or risk for falls will be the primary outcome.
时间窗: At baseline, 6 months and 12 months.
次要结局
- Changes in the body balance, muscle strength, Activities of Daily Living (ADL) and cognitive function will be considered as secondary outcomes.(Compared with the start of the trial to the six-month and 12-month data.)
研究者
Dr Rekha M Ravindran
Government District Hospital Nedumangaud