Ignite Creation Date:
2025-12-25 @ 1:39 AM
Ignite Modification Date:
2026-03-06 @ 10:20 AM
Study NCT ID:
NCT02554994
Status:
COMPLETED
Last Update Posted:
2017-02-23
First Post:
2015-09-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Multifactorial Intervention on Frailty in Vulnerable Older Adults
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000073496', 'term': 'Frailty'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 187}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-02', 'completionDateStruct': {'date': '2017-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-02-20', 'studyFirstSubmitDate': '2015-09-17', 'studyFirstSubmitQcDate': '2015-09-18', 'lastUpdatePostDateStruct': {'date': '2017-02-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-09-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Improve the score of Short Physical performance battery', 'timeFrame': 'Change in every 6 months from baseline to end of the study'}], 'secondaryOutcomes': [{'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'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['ASPRA cohort', 'multifactorial intervention', 'Medicaid services', 'Geriatric disorder', 'Short Physical Performance Battery'], 'conditions': ['Frailty']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Currently living in the PyeongChang county, GangWon province, South Korea\n2. Aged 65 years or older\n3. Living alone or receiving Medical aid services\n4. Sign informed consent\n\nExclusion Criteria:\n\n1. Unable to walk 100 meters, with or without assistive devices\n2. Institutionalized for the past 6 months\n3. Known metastatic cancer, end-stage heart disease, end-stage renal disease\n4. Moderate to severe cognitive impairment (MMSE ≤ 18)\n5. Plan to move out of the current residence in the next 6 months'}, 'identificationModule': {'nctId': 'NCT02554994', 'acronym': 'ASPRA-IS', 'briefTitle': 'Multifactorial Intervention on Frailty in Vulnerable Older Adults', 'organization': {'class': 'OTHER', 'fullName': 'Asan Medical Center'}, 'officialTitle': 'The Effect of Multifactorial Intervention on Frailty in Vulnerable Older Adults Living in Rural Communities: A Designed Delay Trial', 'orgStudyIdInfo': {'id': '2015-0706'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Intervention', '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.\n\nAll 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.', 'interventionNames': ['Other: Multifactorial intervention', 'Other: Usual care']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'usual care', 'description': 'The other participants enrolled to ASPRA cohort are acted as a control arm. The usual care according to ASPRA protocol will be maintained.', 'interventionNames': ['Other: Usual care']}], 'interventions': [{'name': 'Multifactorial intervention', 'type': 'OTHER', 'description': "There are six components of intervention in this study.\n\n* For all participants:\n\n 1. Group exercise\n 2. Nutritional supplement(commercial liquid formula will be provided every day).\n* For selected participants:\n\n 1. Wellness visit in primary care setting, polypharmacy and multi-morbidity every month.\n 2. At risk of depression(the people identified as high risk of depression would meet psychiatrist every month).\n 3. Domestic safety(If there are possible hazards in participants' home, social worker provide amendments for getting rid of it).", 'armGroupLabels': ['Intervention']}, {'name': 'Usual care', 'type': 'OTHER', '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.\n\nAccording 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).', 'armGroupLabels': ['Intervention', 'usual care']}]}, 'contactsLocationsModule': {'locations': [{'zip': '25377', 'city': 'Gangwon-Do', 'country': 'South Korea', 'facility': 'PyeongChang Health Center & County Hospital'}, {'zip': '05505', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Asan Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Eunju Lee', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Division of Geriatric Medicine, Department of Internal Medicine, Asan Medical Center, University of Ulsan College of Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Asan Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'PyeongChang Health Center & County Hospital', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Eunju Lee', 'investigatorAffiliation': 'Asan Medical Center'}}}}