Ignite Creation Date:
2025-12-25 @ 3:09 AM
Ignite Modification Date:
2025-12-26 @ 1:48 AM
Study NCT ID:
NCT03528005
Status:
COMPLETED
Last Update Posted:
2020-04-21
First Post:
2018-04-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effectiveness of Integrated Care Network
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 398}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-06-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-04', 'completionDateStruct': {'date': '2020-03-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-04-20', 'studyFirstSubmitDate': '2018-04-24', 'studyFirstSubmitQcDate': '2018-05-05', 'lastUpdatePostDateStruct': {'date': '2020-04-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-05-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-03-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Changes from baseline high sensitive C-Reactive Protein in mg/dl at sixth and twelfth month', 'timeFrame': 'baseline, 6,12 month', 'description': 'Changes from baseline high sensitive C-Reactive Protein in mg/dl at sixth and twelfth month'}, {'measure': 'Changes from baseline total cholesterol in mg/dl at sixth and twelfth month', 'timeFrame': 'baseline, 6,12 month', 'description': 'Changes from baseline total cholesterol in mg/dl at sixth and twelfth month'}, {'measure': 'Changes from baseline triglycerides in mg/dl at sixth and twelfth month', 'timeFrame': 'baseline, 6,12 month', 'description': 'Changes from baseline triglycerides in mg/dl at sixth and twelfth month'}, {'measure': 'Changes from baseline HDL-C in mg/dl at sixth and twelfth month', 'timeFrame': 'baseline, 6,12 month', 'description': 'Changes from baseline High-density lipoproteins (HDL) in mg/dl at sixth and twelfth month'}, {'measure': 'Changes from baseline LDL-C in mg/dl at sixth and twelfth month', 'timeFrame': 'baseline, 6,12 month', 'description': 'Changes from baseline Low-density lipoproteins (LDL) in mg/dl at sixth and twelfth month'}, {'measure': 'Changes from baseline fasting glucose in mg/dl at sixth and twelfth month', 'timeFrame': 'baseline, 6,12 month', 'description': 'Changes from baseline fasting glucose in mg/dl at sixth and twelfth month'}, {'measure': 'Changes from baseline HbA1c in % at sixth and twelfth month', 'timeFrame': 'baseline, 6,12 month', 'description': 'Changes from baseline Hemoglobin A1c in % at sixth and twelfth month'}, {'measure': 'Changes from baseline insulin in mIU/L at sixth and twelfth month', 'timeFrame': 'baseline, 6,12 month', 'description': 'Changes from baseline insulin in mIU/L at sixth and twelfth month'}, {'measure': 'Changes from baseline uric acid in mg/dl at sixth and twelfth month', 'timeFrame': 'baseline, 6,12 month', 'description': 'Changes from baseline uric acid in mg/dl at sixth and twelfth month'}, {'measure': 'Changes from baseline body mass index in kg/m^2 at sixth and twelfth month', 'timeFrame': 'baseline, 6,12 month', 'description': 'Changes from baseline body mass index in kg/m\\^2 at sixth and twelfth month'}, {'measure': 'Changes from baseline albumin in g/dl at sixth and twelfth month', 'timeFrame': 'baseline, 6,12 month', 'description': 'Changes from baseline albumin in g/dl at sixth and twelfth month'}, {'measure': 'Changes from baseline Vitamin D in ng/ml at sixth and twelfth month', 'timeFrame': 'baseline, 6,12 month', 'description': 'Changes from baseline Vitamin D in ng/ml at sixth and twelfth month'}, {'measure': 'Changes from baseline Vitamin B12 in pg/ml at sixth and twelfth month', 'timeFrame': 'baseline, 6,12 month', 'description': 'Changes from baseline Vitamin B12 in pg/ml at sixth and twelfth month'}, {'measure': 'Changes from baseline homocysteine in micromol/l at sixth and twelfth month', 'timeFrame': 'baseline, 6,12 month', 'description': 'Changes from baseline homocysteine in micromol/l at sixth and twelfth month'}], 'primaryOutcomes': [{'measure': 'Changes from baseline life quality at 3, 6, 9, 12 month', 'timeFrame': 'baseline, 3, 6, 9, 12 month', 'description': 'measured by the 36-Item Short Form Health Survey (SF-36).'}], 'secondaryOutcomes': [{'measure': 'Changes from baseline standard set of health outcome measures for older persons at 3, 6, 9, 12 month', 'timeFrame': 'baseline, 3, 6, 9, 12 month', 'description': 'a standard health care set proposed by the International Consortium for Health Outcomes Measurement (ICHOM)'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Integrated Health Care Systems', 'Multimorbid', 'Multi-domain intervention', 'Clinical Trials, Randomized'], 'conditions': ['Fragility', 'Multimorbidity']}, 'referencesModule': {'references': [{'pmid': '37949432', 'type': 'DERIVED', 'citation': 'Lee WJ, Peng LN, Lin MH, Kim S, Hsiao FY, Chen LK. Enhancing Intrinsic Capacity and Related Biomarkers in Community-Dwelling Multimorbid Older Adults Through Integrated Multidomain Interventions: Ancillary Findings From the Taiwan Integrated Geriatric (TIGER) Trial. J Am Med Dir Assoc. 2024 May;25(5):757-763.e4. doi: 10.1016/j.jamda.2023.10.006. Epub 2023 Nov 7.'}, {'pmid': '36098028', 'type': 'DERIVED', 'citation': 'Lee WJ, Peng LN, Lin CH, Chen RC, Lin SZ, Loh CH, Kao SL, Hung TS, Chang CY, Huang CF, Tang TC, Huang ST, Wen YW, Hsiao FY, Chen LK; Taiwan Integrated Geriatric Care Study Group. Effects of incorporating multidomain interventions into integrated primary care on quality of life: a randomised controlled trial. Lancet Healthy Longev. 2021 Nov;2(11):e712-e723. doi: 10.1016/S2666-7568(21)00248-8. Epub 2021 Oct 22.'}]}, 'descriptionModule': {'briefSummary': 'This project aims to examine the effectiveness of the community-based integrated care service model , based on a multi-domain intervention program, among community-dwelling older adults. Moreover, the investigators use the value-based healthcare standard set as well as comprehensive geriatric assessment as outcome measures and to use the randomized controlled trial design to validate the clinical effectiveness.', 'detailedDescription': 'Population aging and the progress of medical technology are two main causes for the increase of healthcare expenditure. Effective management of medical expenditure and maintenance of health care quality have become the most important task for the public health and clinical care services. Both United Kingdom and the World Health Organization proposed introducing interdisciplinary team care to improve health of older people and to maximize their independence. Prof Michael Porter has addressed the current difficulty of healthcare system, and proposed that healthcare system should pursuit long-term outcome to promote the value of health care. This project aims to echo the international trends, using Taiwan healthcare system as the basis to establish the community-based integrated care service model, and to use the randomized controlled trial design to validate the clinical effectiveness.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age ≧ 65 years\n* three or more chronic conditions, defined by National Health Insurance list of chronic conditions\n* covered by National Health Insurance\n\nExclusion Criteria:\n\n* could not understanding protocol or communication with research nurses\n* malignant diseases under active treatments\n* life expectancy less than twelve months\n* admitted in the long term facility'}, 'identificationModule': {'nctId': 'NCT03528005', 'briefTitle': 'Effectiveness of Integrated Care Network', 'organization': {'class': 'OTHER', 'fullName': 'National Yang Ming Chiao Tung University'}, 'officialTitle': 'Effectiveness of Integrated Care Network for Community-living Older Adults: a Randomized-Controlled Trial', 'orgStudyIdInfo': {'id': 'YM107042F'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'A regular health education program was provided by case managers only.'}, {'type': 'EXPERIMENTAL', 'label': 'Intervention', 'description': 'Multi-domain intervention included exercise,cognitive training, diet education, and disease consultation was conducted for two hours twice per week in the first month, once per week in the second month, and once per month since third month.', 'interventionNames': ['Behavioral: Multi-domain intervention']}], 'interventions': [{'name': 'Multi-domain intervention', 'type': 'BEHAVIORAL', 'description': '60 minutes cognitive training, 45 minutes physical exercise, 15 diet nutrition and intermittent disease management consultation', 'armGroupLabels': ['Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '970', 'city': 'Hualien City', 'country': 'Taiwan', 'facility': 'Hualien Tzu Chi Hospital,Buddhist Tzu Chi Medical Foundation', 'geoPoint': {'lat': 23.97694, 'lon': 121.60444}}, {'zip': '238', 'city': 'New Taipei City', 'country': 'Taiwan', 'facility': 'Shulin Primary Care center', 'geoPoint': {'lat': 25.06199, 'lon': 121.45703}}, {'zip': '239', 'city': 'New Taipei City', 'country': 'Taiwan', 'facility': 'Yingge Primary Health Care center', 'geoPoint': {'lat': 25.06199, 'lon': 121.45703}}, {'zip': '241', 'city': 'New Taipei City', 'country': 'Taiwan', 'facility': "Cheng's primary care clinic", 'geoPoint': {'lat': 25.06199, 'lon': 121.45703}}, {'zip': '264', 'city': 'Yilan', 'country': 'Taiwan', 'facility': 'National Yang-Ming University Hospital', 'geoPoint': {'lat': 24.757, 'lon': 121.753}}, {'zip': '264', 'city': 'Yilan', 'country': 'Taiwan', 'facility': 'Taipei Veterans General Hospital Yuanshan Branch', 'geoPoint': {'lat': 24.757, 'lon': 121.753}}], 'overallOfficials': [{'name': 'Liang-Kung Chen, MD.PhD.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Aging and Health Research Center, National Yang Ming University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Yang Ming Chiao Tung University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Liang-Kung Chen', 'investigatorAffiliation': 'National Yang Ming Chiao Tung University'}}}}