Multifactorial Intervention on Frailty in Vulnerable Older Adults

NCT02554994 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 187

Last updated 2017-02-23

No results posted yet for this study

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

Interventions

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).

Sponsors & Collaborators

  • PyeongChang Health Center & County Hospital

    collaborator UNKNOWN
  • Asan Medical Center

    lead OTHER

Principal Investigators

  • Eunju Lee · Division of Geriatric Medicine, Department of Internal Medicine, Asan Medical Center, University of Ulsan College of Medicine

Study Design

Allocation
NON_RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-08-31
Primary Completion
2017-01-31
Completion
2017-01-31

Countries

  • South Korea

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02554994 on ClinicalTrials.gov