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Multifactorial Intervention on Frailty in Vulnerable Older Adults (ASPRA-IS)

Primary Purpose

Frailty

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Multifactorial intervention
Usual care
Sponsored by
Asan Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Frailty focused on measuring ASPRA cohort, multifactorial intervention, Medicaid services, Geriatric disorder, Short Physical Performance Battery

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • PyeongChang Health Center & County Hospital
  • Asan Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Intervention

usual care

Arm Description

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.

The other participants enrolled to ASPRA cohort are acted as a control arm. The usual care according to ASPRA protocol will be maintained.

Outcomes

Primary Outcome Measures

Improve the score of Short Physical performance battery

Secondary Outcome Measures

Improve frailty index score calculated from the Cardiovascular Health Study criteria
Frailty status by the K-FRAIL criteria
Nutritional status by Mini-Nutritional Assessment Short Form(MNA-SF)
Depressive symptoms by Center for Epidemiologic Studies Depression Scale(CES-D)
Occurrence of falls
Sarcopenia measured by the consensus report of the Asian Working Group
Health care utilization(emergency room visit and hospitalizations)

Full Information

First Posted
September 17, 2015
Last Updated
February 20, 2017
Sponsor
Asan Medical Center
Collaborators
PyeongChang Health Center & County Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02554994
Brief Title
Multifactorial Intervention on Frailty in Vulnerable Older Adults
Acronym
ASPRA-IS
Official Title
The Effect of Multifactorial Intervention on Frailty in Vulnerable Older Adults Living in Rural Communities: A Designed Delay Trial
Study Type
Interventional

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
August 2015 (Actual)
Primary Completion Date
January 2017 (Actual)
Study Completion Date
January 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Asan Medical Center
Collaborators
PyeongChang Health Center & County Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Frailty
Keywords
ASPRA cohort, multifactorial intervention, Medicaid services, Geriatric disorder, Short Physical Performance Battery

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
187 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Active Comparator
Arm Description
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.
Arm Title
usual care
Arm Type
Active Comparator
Arm Description
The other participants enrolled to ASPRA cohort are acted as a control arm. The usual care according to ASPRA protocol will be maintained.
Intervention Type
Other
Intervention Name(s)
Multifactorial intervention
Intervention Description
There are six components of intervention in this study. For all participants: Group exercise Nutritional supplement(commercial liquid formula will be provided every day). For selected participants: Wellness visit in primary care setting, polypharmacy and multi-morbidity every month. At risk of depression(the people identified as high risk of depression would meet psychiatrist every month). Domestic safety(If there are possible hazards in participants' home, social worker provide amendments for getting rid of it).
Intervention Type
Other
Intervention Name(s)
Usual care
Intervention Description
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).
Primary Outcome Measure Information:
Title
Improve the score of Short Physical performance battery
Time Frame
Change in every 6 months from baseline to end of the study
Secondary Outcome Measure Information:
Title
Improve frailty index score calculated from the Cardiovascular Health Study criteria
Time Frame
Change at 6 months from baseline
Title
Frailty status by the K-FRAIL criteria
Time Frame
Change at 6 months from baseline
Title
Nutritional status by Mini-Nutritional Assessment Short Form(MNA-SF)
Time Frame
Change at 6 months from baseline
Title
Depressive symptoms by Center for Epidemiologic Studies Depression Scale(CES-D)
Time Frame
Change in every 6 months from baseline to end of the study
Title
Occurrence of falls
Time Frame
Change at 6 months from baseline
Title
Sarcopenia measured by the consensus report of the Asian Working Group
Time Frame
Change in every 6 months from baseline to end of the study
Title
Health care utilization(emergency room visit and hospitalizations)
Time Frame
Change at 6 months from baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eunju Lee
Organizational Affiliation
Division of Geriatric Medicine, Department of Internal Medicine, Asan Medical Center, University of Ulsan College of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
PyeongChang Health Center & County Hospital
City
Gangwon-Do
ZIP/Postal Code
25377
Country
Korea, Republic of
Facility Name
Asan Medical Center
City
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of

12. IPD Sharing Statement

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Multifactorial Intervention on Frailty in Vulnerable Older Adults

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