Ignite Creation Date:
2025-12-25 @ 2:24 AM
Ignite Modification Date:
2025-12-28 @ 12:11 AM
Study NCT ID:
NCT05104034
Status:
RECRUITING
Last Update Posted:
2024-04-15
First Post:
2021-10-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comprehensive Risk Assessment and Prevention Plan of Osteoporosis and Sarcopenia for the Elderly Participating in Community-based Long-term Care Services
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010024', 'term': 'Osteoporosis'}, {'id': 'D055948', 'term': 'Sarcopenia'}, {'id': 'D000073496', 'term': 'Frailty'}], 'ancestors': [{'id': 'D001851', 'term': 'Bone Diseases, Metabolic'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D009133', 'term': 'Muscular Atrophy'}, {'id': 'D020879', 'term': 'Neuromuscular Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D001284', 'term': 'Atrophy'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D010335', 'term': 'Pathologic Processes'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D006301', 'term': 'Health Services Needs and Demand'}, {'id': 'D015444', 'term': 'Exercise'}, {'id': 'D009752', 'term': 'Nutritional Status'}, {'id': 'D010593', 'term': 'Pharmaceutical Services'}], 'ancestors': [{'id': 'D006302', 'term': 'Health Services Research'}, {'id': 'D006285', 'term': 'Health Planning'}, {'id': 'D004472', 'term': 'Health Care Economics and Organizations'}, {'id': 'D003695', 'term': 'Delivery of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}, {'id': 'D009747', 'term': 'Nutritional Physiological Phenomena'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D006304', 'term': 'Health Status'}, {'id': 'D003710', 'term': 'Demography'}, {'id': 'D011154', 'term': 'Population Characteristics'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 600}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-09-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-04-11', 'studyFirstSubmitDate': '2021-10-11', 'studyFirstSubmitQcDate': '2021-10-22', 'lastUpdatePostDateStruct': {'date': '2024-04-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-11-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Incidence of mortality', 'timeFrame': 'one year, two year, 3 year, four year', 'description': 'To define if the Incidence of mortality would be changed after intervention'}, {'measure': 'Changes of drug related problems', 'timeFrame': 'one year, two year, 3 year, four year', 'description': 'Under the assumption of the intervention of pharmaceutical care in the multi-component group can improve the DRPs of the elderly, we also measured the changes of drug number, anticholinergic burden and adherence (using the Adherence to Refills and Medications Scale).'}, {'measure': 'Phyiscal performance', 'timeFrame': 'one year, two years', 'description': 'Changes of muscle strength, body composition, physical performance, activites of daily living'}, {'measure': 'Sarcopenia related outcomes', 'timeFrame': 'one year, two years', 'description': 'We follow sarcopenia diagnosis rate, treatment rate, changes of muscle mass, fat, and muscle-fat index'}, {'measure': 'Osteoporosis related outcomes', 'timeFrame': 'one year, two years', 'description': 'We follow osteoporosis diagnosis rate, treatment rate, adherence to osteoporosis treatment, and changes of bone mineral density'}, {'measure': 'Mental health', 'timeFrame': 'one year, two years', 'description': 'We use Geriatric Depression Scale and Chinese Happiness Inventory to measure depression and happiness'}, {'measure': 'Nutrition related outcomes', 'timeFrame': 'one year, two years', 'description': 'Changes in protein intake, dietary/caloric intake, nutritional status'}, {'measure': 'Cognition', 'timeFrame': 'one year, two years', 'description': 'Changes in MMSE'}], 'primaryOutcomes': [{'measure': 'The changes of Quality of life and quality adjusted life year', 'timeFrame': 'one year, two year, 3 year, four year', 'description': 'Using EQ5D / WHOQOL Brief questionnaires to measure quality of life and evaluate the changes after intervention. In addition, to calculate quality adjusted life year by using utility index derived from qualify of life measurement.'}, {'measure': 'Intrinsic capacity', 'timeFrame': 'one year, two year, 3 year, four year', 'description': 'To define if the Intrinsic capacity would be changed after intervention'}, {'measure': 'Institutionalilzation rate', 'timeFrame': 'one year, two year, 3 year, four year', 'description': 'To define if the Institutionalilzation rate would be changed after intervention'}], 'secondaryOutcomes': [{'measure': 'Incidence of fall', 'timeFrame': 'one year, two year, 3 year, four year', 'description': 'To define if the fall frequency would be changed after intervention'}, {'measure': 'Incidence of fracture', 'timeFrame': 'one year, two year, 3 year, four year', 'description': 'To define if the incidence of fracture would be changed after intervention'}, {'measure': 'Incidence of unexpected hospitalization', 'timeFrame': 'one year, two year, 3 year, four year', 'description': 'To define if the unexpected hospitalization would be changed after intervention'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Osteoporosis', 'Sarcopenia', 'Quality of life', 'Intrinsic capacity', 'Frailty'], 'conditions': ['Osteoporosis', 'Sarcopenia', 'Frailty']}, 'referencesModule': {'references': [{'pmid': '39875677', 'type': 'DERIVED', 'citation': 'Fu SH, Lai WJ, Yen HK, Kukreti S, Li CY, Hung CC, Wang CY. Addressing healthcare disparities and improving osteoporosis management in rural communities: a cluster randomized control trial. Arch Osteoporos. 2025 Jan 28;20(1):15. doi: 10.1007/s11657-025-01498-4.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this project is:\n\n1. Provide the epidemiological data of the prevalence, incidence, and risk factors of osteoporosis and sarcopenia among the elderly in rural areas.\n2. Screen osteoporosis and sarcopenia among the elderly and provide with assistance for following care in order to improve the diagnosis and treatment rates of osteoporosis and sarcopenia\n3. Construct a pragmatic and integrated care service model for osteoporosis and sarcopenia in the elderly people from rural areas', 'detailedDescription': "Detailed Description:\n\nInvestigators plan to use a stepped-wedge cluster randomized trial that allocates participants into the following three groups:\n\n1. Screening group: Inform the elderly about the results of the screening and recommend those with moderate to high risk of fracture to receive active examination and treatment.\n2. Multi-disciplinary team intervention group: Introduce integrated services of health education, nutrition, rehabilitation, medication evaluation and other multi-specialties to assist study participants with health promotion.\n3. Control group (Delayed intervention): receive general care after collecting basic information, and provide health education related information such as osteoporosis sarcopenia. After two year's follow-up, multi-disciplinary team intervention service will be implemented."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Ageā„ 50 old and lived in the community\n\nExclusion Criteria:\n\n* Life expectancy less than two years'}, 'identificationModule': {'nctId': 'NCT05104034', 'briefTitle': 'Comprehensive Risk Assessment and Prevention Plan of Osteoporosis and Sarcopenia for the Elderly Participating in Community-based Long-term Care Services', 'organization': {'class': 'OTHER', 'fullName': 'National Taiwan University Hospital'}, 'officialTitle': 'Comprehensive Risk Assessment and Prevention Plan of Osteoporosis and Sarcopenia for the Elderly Participating in Community-based Long-term Care Services', 'orgStudyIdInfo': {'id': '202106076RIND'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Screening group', 'description': 'Inform the elderly about the results of the screening and recommend those with moderate to high risk of fracture to receive active examination and treatment.', 'interventionNames': ['Behavioral: Osteoporosis screening and treatment as needed']}, {'type': 'EXPERIMENTAL', 'label': 'Multi-component integrated intervention', 'description': 'Introduce integrated services of health education, nutrition, rehabilitation, pharmaceutical care, and other multi-specialties to assist study participants with health promotion', 'interventionNames': ['Behavioral: Osteoporosis screening and treatment as needed', 'Behavioral: Sarcopenia', 'Behavioral: Exercise', 'Dietary Supplement: Nutrition', 'Behavioral: Pharmaceutical care']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Delayed intervention', 'description': "receive general care after collecting basic information, and provide health education related information such as osteoporosis sarcopenia. After two year's follow-up, multi-disciplinary team intervention service will be implemented.", 'interventionNames': ['Behavioral: Osteoporosis screening and treatment as needed']}], 'interventions': [{'name': 'Osteoporosis screening and treatment as needed', 'type': 'BEHAVIORAL', 'description': 'All residents underwent screening using the Fracture Risk Assessment Tool (FRAX) and Mobile dual-energy X-ray absorptiometry (DXA) (Horizon Wi, Hologic Inc., Bedford, MA). Our study nurses actively assisted osteoporosis treatment if indicated.', 'armGroupLabels': ['Delayed intervention', 'Multi-component integrated intervention', 'Screening group']}, {'name': 'Sarcopenia', 'type': 'BEHAVIORAL', 'description': 'Sarcopenia assessment adhered to the 2019 Consensus Update on Sarcopenia Diagnosis and Treatment by the Asian Working Group for Sarcopenia guideline. Following screening, individuals identified with sarcopenia underwent tailored interventions involving exercise and nutrition as deemed necessary.', 'armGroupLabels': ['Multi-component integrated intervention']}, {'name': 'Exercise', 'type': 'BEHAVIORAL', 'description': 'TheraBand (resistance band) was utilized as the exercise tool within the community. T', 'armGroupLabels': ['Multi-component integrated intervention']}, {'name': 'Nutrition', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Nutrition Nutritional education programs aim to increase protein food serving and the choice of those with insufficient dietary intake. Protein supplement was added if indicated.', 'armGroupLabels': ['Multi-component integrated intervention']}, {'name': 'Pharmaceutical care', 'type': 'BEHAVIORAL', 'description': 'We collected drug information of the elderly. Detailed and real-time prescription drug information was retrieved from the National Health Insurance PharmaCloud System. A pharmaceutical care team performed patient-centered drug review and discussion every three to six months.', 'armGroupLabels': ['Multi-component integrated intervention']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Douliu', 'state': 'Yunlin County', 'status': 'RECRUITING', 'country': 'Taiwan', 'contacts': [{'name': 'Shau-Huai Fu, Doctor', 'role': 'CONTACT', 'email': 'b90401045@gmail.com', 'phone': '+886972655734'}, {'name': 'Chen-Yu Wang, Doctor', 'role': 'CONTACT', 'email': 'valinawang0220@gmail.com', 'phone': '+886952489782'}], 'facility': 'National Taiwan University Hospital, Yunlin branch', 'geoPoint': {'lat': 23.70944, 'lon': 120.54333}}], 'centralContacts': [{'name': 'Shau-Huai Fu, Doctor', 'role': 'CONTACT', 'email': 'b90401045@gmail.com', 'phone': '+886972655734'}, {'name': 'Chen-Yu Wang, Doctor', 'role': 'CONTACT', 'email': 'valinawang0220@gmail.com', 'phone': '+886952489782'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Taiwan University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Health Research Institutes, Taiwan', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}