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Clinical Trials/NCT02554994
NCT02554994
Completed
N/A

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

Asan Medical Center2 sites in 1 country187 target enrollmentAugust 2015
ConditionsFrailty

Overview

Phase
N/A
Intervention
Not specified
Conditions
Frailty
Sponsor
Asan Medical Center
Enrollment
187
Locations
2
Primary Endpoint
Improve the score of Short Physical performance battery
Status
Completed
Last Updated
9 years ago

Overview

Brief 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.

Registry
clinicaltrials.gov
Start Date
August 2015
End Date
January 2017
Last Updated
9 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Eunju Lee

Associate Professor

Asan Medical Center

Eligibility Criteria

Inclusion Criteria

  • 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

Exclusion Criteria

  • 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

Outcomes

Primary Outcomes

Improve the score of Short Physical performance battery

Time Frame: Change in every 6 months from baseline to end of the study

Secondary Outcomes

  • 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)

Study Sites (2)

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