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Completed

NCT Number: NCT02554994

Multifactorial Intervention on Frailty in Vulnerable Older Adults

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.

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Key information

Conditions

Frailty Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

PyeongChang Health Center & County Hospital, Gangwon-Do, South Korea

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

multifactorial intervention

Other

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

Other

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 outcomes

  1. Improve the score of Short Physical performance battery

    Time frame: Change in every 6 months from baseline to end of the study

Secondary outcomes

  1. Improve frailty index score calculated from the Cardiovascular Health Study criteria

    Time frame: Change at 6 months from baseline

  2. Frailty status by the K-FRAIL criteria

    Time frame: Change at 6 months from baseline

  3. Nutritional status by Mini-Nutritional Assessment Short Form(MNA-SF)

    Time frame: Change at 6 months from baseline

  4. 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

  5. Occurrence of falls

    Time frame: Change at 6 months from baseline

  6. 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

  7. Health care utilization(emergency room visit and hospitalizations)

    Time frame: Change at 6 months from baseline

Sponsors and collaborators

Lead sponsor

Asan Medical Center

Other

Collaborators

  • PyeongChang Health Center & County Hospital

Registry information

Official study title

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

Acronym: ASPRA-IS

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Sep 21, 2015
Registry last updated
Feb 23, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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