Multifactorial Intervention on Frailty in Vulnerable Older Adults

Frailty Clinical Trial

— ASPRA-IS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02554994
• Other study ID #: 2015-0706
• Status: Completed
• Phase: N/A
• First received: September 17, 2015
• Last updated: February 20, 2017
• Start date: August 2015
• Est. completion date: January 2017

Study information

• Verified date: February 2017
• Source: Asan Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 187
• Est. completion date: January 2017
• Est. primary completion date: January 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Frailty

Intervention

Other:
• Multifactorial intervention
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).
• 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).

Locations

Country	Name	City	State
Korea, Republic of	PyeongChang Health Center & County Hospital	Gangwon-Do
Korea, Republic of	Asan Medical Center	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Asan Medical Center	PyeongChang Health Center & County Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improve the score of Short Physical performance battery		Change in every 6 months from baseline to end of the study
Secondary	Improve frailty index score calculated from the Cardiovascular Health Study criteria		Change at 6 months from baseline
Secondary	Frailty status by the K-FRAIL criteria		Change at 6 months from baseline
Secondary	Nutritional status by Mini-Nutritional Assessment Short Form(MNA-SF)		Change at 6 months from baseline
Secondary	Depressive symptoms by Center for Epidemiologic Studies Depression Scale(CES-D)		Change in every 6 months from baseline to end of the study
Secondary	Occurrence of falls		Change at 6 months from baseline
Secondary	Sarcopenia measured by the consensus report of the Asian Working Group		Change in every 6 months from baseline to end of the study
Secondary	Health care utilization(emergency room visit and hospitalizations)		Change at 6 months from baseline