FrailtyASPRA-ISNCT02554994
Multifactorial Intervention on Frailty in Vulnerable Older Adults
A study testing Multifactorial intervention in people with Frailty, run by Asan Medical Center at 2 sites in South Korea.
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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Frailty
- What is being tested?
- Multifactorial intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 187 participants
- Where
- 2 sitesSouth Korea
- Study dates
- Aug 2015to Jan 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
South Korea2 sites
PyeongChang Health Center & County Hospital
Gangwon-Do, 25377
Asan Medical Center
Seoul, 05505
About this study
Official title: The Effect of Multifactorial Intervention on Frailty in Vulnerable Older Adults Living in Rural Communities: A Designed Delay Trial
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.
- Conditions
- Frailty
- Being tested
- Multifactorial intervention, Usual care
- Keywords
- ASPRA cohort, multifactorial intervention, Medicaid services, Geriatric disorder, Short Physical Performance Battery
- Medical subject headings
- Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multifactorial interventionOther
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 careOther
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).
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Active comparator | 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. Receives: Other: Multifactorial intervention; Other: Usual care |
| usual care | Active comparator | The other participants enrolled to ASPRA cohort are acted as a control arm. The usual care according to ASPRA protocol will be maintained. Receives: Other: Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improve the score of Short Physical performance battery
Measured: Change in every 6 months from baseline to end of the study
Secondary outcomes (7)
Improve frailty index score calculated from the Cardiovascular Health Study criteria
Measured: Change at 6 months from baseline
Frailty status by the K-FRAIL criteria
Measured: Change at 6 months from baseline
Nutritional status by Mini-Nutritional Assessment Short Form(MNA-SF)
Measured: Change at 6 months from baseline
Depressive symptoms by Center for Epidemiologic Studies Depression Scale(CES-D)
Measured: Change in every 6 months from baseline to end of the study
Occurrence of falls
Measured: Change at 6 months from baseline
Sarcopenia measured by the consensus report of the Asian Working Group
Measured: Change in every 6 months from baseline to end of the study
Health care utilization(emergency room visit and hospitalizations)
Measured: Change at 6 months from baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2015 (estimated)
- Study startAug 2015
- Primary completionJan 2017
- Study completionJan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FrailtyStudies of the same condition, open and under way.
- More trials run by Asan Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 187 participants (actual)
Sponsor and investigators
- Lead sponsor
- Asan Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- PyeongChang Health Center & County Hospital
- Responsible party
- Principal investigator, Eunju Lee, Asan Medical Center
- Investigators
- Eunju Lee, Principal investigator, Division of Geriatric Medicine, Department of Internal Medicine, Asan Medical Center, University of Ulsan College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02554994
- Sponsor's protocol ID
- 2015-0706
- Acronym
- ASPRA-IS
- Status last verified
- Feb 2017
- First submitted
- 17 Sep 2015
- Last updated
- 23 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Multifactorial Intervention on Frailty in Vulnerable Older Adults Living in Rural Communities: A Designed Delay Trial
- ClinicalTrials.gov ID
- NCT02554994
- Acronym / sponsor ID
- ASPRA-IS / 2015-0706
- Conditions
- Frailty
- Keywords
- ASPRA cohort, multifactorial intervention, Medicaid services, Geriatric disorder, Short Physical Performance Battery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 187 participants (actual)
- Lead sponsor
- Asan Medical CenterUniversity, hospital or other
- Collaborators
- PyeongChang Health Center & County Hospital
- Study start
- Aug 2015 (actual)
- Primary completion
- Jan 2017 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 21 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Active comparator | Other: Multifactorial intervention, Other: Usual careASPRA (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 | Active comparator | Other: Usual careThe other participants enrolled to ASPRA cohort are acted as a control arm. The usual care according to ASPRA protocol will be maintained. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multifactorial interventionThere are six components of intervention in this study. * For all participants: 1. Group exercise 2. Nutritional supplement(commercial liquid formula will be provided every day). * For selected participants: 1. Wellness visit in primary care setting, polypharmacy and multi-morbidity every month. 2. At risk of depression(the people identified as high risk of depression would meet psychiatrist every month). 3. Domestic safety(If there are possible hazards in participants' home, social worker provide amendments for getting rid of it). | Other | Intervention |
| Usual careExperienced 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). | Other | Intervention, usual care |
Primary outcome
Improve the score of Short Physical performance battery
Time frame: Change in every 6 months from baseline to end of the study
7 secondary outcomes
Improve frailty index score calculated from the Cardiovascular Health Study criteria
Time frame: Change at 6 months from baseline
Frailty status by the K-FRAIL criteria
Time frame: Change at 6 months from baseline
Nutritional status by Mini-Nutritional Assessment Short Form(MNA-SF)
Time frame: Change at 6 months from baseline
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
Occurrence of falls
Time frame: Change at 6 months from baseline
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
Health care utilization(emergency room visit and hospitalizations)
Time frame: Change at 6 months from baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eunju Lee principal investigator
Division of Geriatric Medicine, Department of Internal Medicine, Asan Medical Center, University of Ulsan College of Medicine
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multifactorial intervention in people with Frailty, run by Asan Medical Center at 2 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improve the score of Short Physical performance battery (time frame: Change in every 6 months from baseline to end of the study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2017.