NCT02554994

Multifactorial Intervention on Frailty in Vulnerable Older Adults

The Effect of Multifactorial Intervention on Frailty in Vulnerable Older Adults Living in Rural Communities: A Designed Delay Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 187 (actual)
• Sponsor: Asan Medical Center · Academic / Other
• Sex: All
• Age: 65 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Frailty

Interventions

Type	Name	Description
OTHER	Multifactorial intervention	There are six components of intervention in this study. * For all participants: 1. Group exercise 2. Nutritional supplement(commercial liquid formula will be provided every day). * For selected participants: 1. Wellness visit in primary care setting, polypharmacy and multi-morbidity every month. 2. At risk of depression(the people identified as high risk of depression would meet psychiatrist every month). 3. Domestic safety(If there are possible hazards in participants' home, social worker provide amendments for getting rid of it).
OTHER	Usual care	Experienced nurses will visit all participants every month during 6 months of study period, and will conduct an interview and comprehensive geriatric assessments to collect information regarding physical, nutritional, mental, mood condition and health related quality of life. According to ASPRA cohort schedule, all participants will be assessed by the composite measurement method composed of K-FRAIL frailty scare, Mini-Nutritional Assessment Short Form(MNA-S), the Korean version of Mini-Mental State Examination(K-MMSE), Center for Epidemiological Studies depression(CES-D), EQ-5D 3 level version from EuroQol Research Foundation(EQ-5D 3 level), Short Physical Performance Battery(SPPB), and the Cardiovascular Health Study(CHS).

Timeline

• Start date: 2015-08-01
• Primary completion: 2017-01-01
• Completion: 2017-01-01
• First posted: 2015-09-21
• Last updated: 2017-02-23

Locations

2 sites across 1 country: South Korea