The Effect of Multifactorial Intervention on Frailty in Vulnerable Older Adults Living in Rural Communities: A Designed Delay Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 187
- 试验地点
- 4
- 主要终点
- Improve the score of Short Physical performance battery
研究概览
简要总结
Frailty is a highly prevalent, progressive condition in older adults that is characterized by multisystem physiologic impairments and vulnerability to stressful events, leading to increased risk of geriatric conditions, disability, falls, hospitalization, and mortality. An effective public health intervention to improve frailty in a rural aging population with limited resources remains unknown. The purpose of our study is to evaluate the effectiveness of multidimensional public health intervention to reduce frailty and related geriatric conditions in older adults in rural communities. Our hypotheses are that a multidimensional intervention consisting of group exercise, nutritional support, depression management, polypharmacy, and home safety intervention over a 6-month period will improve frailty and selected geriatric conditions in older adults who are in low socioeconomic status or living alone in a rural community. Our primary outcome is short physical performance battery at 6 month. Secondary outcomes include frailty status, nutritional status, depression, falls, sarcopenia, and health care utilization. The investigators will conduct a designed delay trial by implementing our intervention in one town for the first 6 months (intervention group), while measuring the outcomes without any intervention in another town (serving as a control group); in the following 6 months, the investigators will implement the 6-month intervention in the control town. The findings from our study will inform us to find effective public health interventions to promote healthy aging in resource-limited, rural populations.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 65 Years 至 —(Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Currently living in the PyeongChang county, GangWon province, South Korea
- •Aged 65 years or older
- •Living alone or receiving Medical aid services
- •Sign informed consent
排除标准
- •Unable to walk 100 meters, with or without assistive devices
- •Institutionalized for the past 6 months
- •Known metastatic cancer, end-stage heart disease, end-stage renal disease
- •Moderate to severe cognitive impairment (MMSE ≤ 18)
- •Plan to move out of the current residence in the next 6 months
结局指标
主要结局
Improve the score of Short Physical performance battery
时间窗: Change in every 6 months from baseline to end of the study
次要结局
- Frailty status by the K-FRAIL criteria(Change at 6 months from baseline)
- Sarcopenia measured by the consensus report of the Asian Working Group(Change in every 6 months from baseline to end of the study)
- Improve frailty index score calculated from the Cardiovascular Health Study criteria(Change at 6 months from baseline)
- Nutritional status by Mini-Nutritional Assessment Short Form(MNA-SF)(Change at 6 months from baseline)
- Occurrence of falls(Change at 6 months from baseline)
- Depressive symptoms by Center for Epidemiologic Studies Depression Scale(CES-D)(Change in every 6 months from baseline to end of the study)
- Health care utilization(emergency room visit and hospitalizations)(Change at 6 months from baseline)
研究者
Eunju Lee
Associate Professor
Asan Medical Center
