Clinical trial NCT02554994: Multifactorial Intervention on Frailty in Vulnerable Older Adults
Official title: The Effect of Multifactorial Intervention on Frailty in Vulnerable Older Adults Living in Rural Communities: A Designed Delay Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Frailty
Keywords: ASPRA cohort
multifactorial intervention
Medicaid services
Geriatric disorder
Short Physical Performance Battery
Lead sponsor: Asan Medical Center
Sponsor class: OTHER
Collaborators: name: PyeongChang Health Center & County Hospital
First posted: 2015-09-21
Enrollment: 187
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


Eligibility criteria: 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

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

Primary outcomes:
measure: Improve the score of Short Physical performance battery
timeFrame: Change in every 6 months from baseline to end of the study
Secondary outcomes:
measure: Improve frailty index score calculated from the Cardiovascular Health Study criteria
timeFrame: Change at 6 months from baseline
measure: Frailty status by the K-FRAIL criteria
timeFrame: Change at 6 months from baseline
measure: Nutritional status by Mini-Nutritional Assessment Short Form(MNA-SF)
timeFrame: Change at 6 months from baseline
measure: Depressive symptoms by Center for Epidemiologic Studies Depression Scale(CES-D)
timeFrame: Change in every 6 months from baseline to end of the study
measure: Occurrence of falls
timeFrame: Change at 6 months from baseline
measure: Sarcopenia measured by the consensus report of the Asian Working Group
timeFrame: Change in every 6 months from baseline to end of the study
measure: Health care utilization(emergency room visit and hospitalizations)
timeFrame: Change at 6 months from baseline
Other outcomes:
Locations:
city: Gangwon-Do
country: Korea, Republic of
facility: PyeongChang Health Center & County Hospital
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
Study officials:
affiliation: Division of Geriatric Medicine, Department of Internal Medicine, Asan Medical Center, University of Ulsan College of Medicine
name: Eunju Lee
role: PRINCIPAL_INVESTIGATOR
References: