Multifactorial Intervention on Frailty in Vulnerable Older Adults

Not Applicable

Completed

• Conditions: Frailty
• Interventions: Other: Multifactorial intervention; Other: Usual care

• Registration Number: NCT02554994
• Lead Sponsor: Asan Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-08
• Study First Submitted: 2015-09-17
• Study First Submitted QC: 2015-09-18
• Study First Posted: 2015-09-21
• Primary Completion: 2017-01
• Study Completion: 2017-01
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-20
• Last Update Posted: 2017-02-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 187

Inclusion Criteria

1. Currently living in the PyeongChang county, GangWon province, South Korea
2. Aged 65 years or older
3. Living alone or receiving Medical aid services
4. Sign informed consent

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Exclusion Criteria

1. Unable to walk 100 meters, with or without assistive devices
2. Institutionalized for the past 6 months
3. Known metastatic cancer, end-stage heart disease, end-stage renal disease
4. Moderate to severe cognitive impairment (MMSE ≤ 18)
5. Plan to move out of the current residence in the next 6 months

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	Multifactorial intervention	ASPRA (Aging Study of PyeongChang Rural Area) cohort is a population-based, prospective cohort study of older adults living in PyeongChang County of South Korea. This cohort study is supported by public health center, named PyeongChang Health Center and Country Hospital managed by government, to improve the quality of aged public health services. All participants will be recruited from ASPRA cohort. After 6 months of usual care period, eligible participants are screened by characteristics of ASPRA database, and are assigned to a multifactorial intervention arm.
Intervention	Usual care	ASPRA (Aging Study of PyeongChang Rural Area) cohort is a population-based, prospective cohort study of older adults living in PyeongChang County of South Korea. This cohort study is supported by public health center, named PyeongChang Health Center and Country Hospital managed by government, to improve the quality of aged public health services. All participants will be recruited from ASPRA cohort. After 6 months of usual care period, eligible participants are screened by characteristics of ASPRA database, and are assigned to a multifactorial intervention arm.
usual care	Usual care	The other participants enrolled to ASPRA cohort are acted as a control arm. The usual care according to ASPRA protocol will be maintained.

Primary Outcome Measures

Name	Time	Method
Improve the score of Short Physical performance battery	Change in every 6 months from baseline to end of the study

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (2)

Asan Medical Center; 🇰🇷 Seoul, Korea, Republic of

PyeongChang Health Center & County Hospital; 🇰🇷 Gangwon-Do, Korea, Republic of