Ignite Creation Date:
2025-12-24 @ 9:46 PM
Ignite Modification Date:
2025-12-25 @ 7:26 PM
Study NCT ID:
NCT00718432
Status:
COMPLETED
Last Update Posted:
2015-06-25
First Post:
2008-07-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
An Interventional Study of Geriatric Frailty, Osteoporosis, and Depression
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000073496', 'term': 'Frailty'}, {'id': 'D010024', 'term': 'Osteoporosis'}, {'id': 'D003863', 'term': 'Depression'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'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': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015444', 'term': 'Exercise'}, {'id': 'D004522', 'term': 'Educational Status'}], 'ancestors': [{'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}, {'id': 'D012959', 'term': 'Socioeconomic Factors'}, {'id': 'D011154', 'term': 'Population Characteristics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 406}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-06', 'completionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-06-24', 'studyFirstSubmitDate': '2008-07-16', 'studyFirstSubmitQcDate': '2008-07-17', 'lastUpdatePostDateStruct': {'date': '2015-06-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-07-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'improvement of frailty', 'timeFrame': 'baseline, 3, 6, and 12 months', 'description': 'Improvement of Cardiovascular Health Study Phenotypical Classification of Frailty (CHS\\_PCF) by at least one category (from pre-frail to robust, or from frail to pre-frail or robust) from baseline assessments.'}], 'secondaryOutcomes': [{'measure': 'Bone Mineral Density', 'timeFrame': 'baseline and 12 months', 'description': 'Dual-emission X-ray absorptiometry (DXA) of both Hip and spine'}, {'measure': 'quality of life assessment', 'timeFrame': 'pilot study: baseline, 3, 6, and 12 months, 2009 study: baseline, 6, and 12 months', 'description': 'EQ-5D index-Taiwan utility'}, {'measure': 'QUALEFFO_31', 'timeFrame': 'pilot study: baseline, 3, 6, and 12 months, 2009 study: baseline, 6, and 12 months', 'description': 'pain, physical function,mental function'}, {'measure': 'barthel index', 'timeFrame': 'pilot study: baseline, 3, 6, and 12 months, 2009 study: baseline and 12 months'}, {'measure': 'PRIME-MD (only measured in pilot study)', 'timeFrame': 'baseline, 3, 6, and 12 months', 'description': 'The Primary Care Evaluation of Mental Disorders'}, {'measure': 'BDI-II (only measured in 2009 study)', 'timeFrame': 'baseline, 6, and 12 months', 'description': 'Beck Depression Inventory Second Edition'}, {'measure': 'health-resource utilization', 'timeFrame': 'pilot study: baseline, 3, 6, and 12 months, 2009 study: baseline, 6, and 12 months'}, {'measure': 'Original Frailty Indicators', 'timeFrame': 'baseline, 3, 6, and 12 months', 'description': 'Weight loss, Exhaustion, Low level physical activity, Slow walking speed, Weak grip strength'}, {'measure': 'timed up and go', 'timeFrame': 'baseline, 3, 6, and 12 months'}, {'measure': 'one leg stand time', 'timeFrame': 'baseline, 3, 6, and 12 months'}, {'measure': 'dominant hand grip strength', 'timeFrame': 'baseline, 3, 6, and 12 months'}, {'measure': 'dominant knee extension power', 'timeFrame': 'baseline, 3, 6, and 12 months'}, {'measure': 'vitamin B12 in blood', 'timeFrame': 'pilot study: baseline and 12 month, 2009 study: baseline and 6 months'}, {'measure': 'vitamin D in blood', 'timeFrame': 'pilot study: baseline and 12 month, 2009 study: baseline and 6 months'}, {'measure': 'CRP in blood', 'timeFrame': 'pilot study: baseline and 12 month, 2009 study: baseline and 6 months'}, {'measure': 'testosterone in blood', 'timeFrame': 'pilot study: baseline and 12 month, 2009 study: baseline and 6 months'}, {'measure': 'IL-6 in blood', 'timeFrame': 'pilot study: baseline and 12 month, 2009 study: baseline and 6 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Frailty', 'Osteoporosis', 'Depression'], 'conditions': ['Frailty', 'Osteoporosis', 'Depression']}, 'referencesModule': {'references': [{'pmid': '23009149', 'type': 'DERIVED', 'citation': 'Chan DC, Tsou HH, Yang RS, Tsauo JY, Chen CY, Hsiung CA, Kuo KN. A pilot randomized controlled trial to improve geriatric frailty. BMC Geriatr. 2012 Sep 25;12:58. doi: 10.1186/1471-2318-12-58.'}]}, 'descriptionModule': {'briefSummary': 'Frailty, osteoporosis, and depression are three highly prevalent geriatric syndromes. Having these conditions are associated with adverse outcome in physical health, mental health, quality of life, and daily functioning. They are associated with higher mortality rates as well as increased health care cost. Risk factors, pathogenesis, clinical phenotypes, and interventions of these three geriatric syndromes are often related. Frailty is often defined as accumulations of multi-system deficiencies with increased vulnerability to multiple worse outcomes. Multifactorial, interdisciplinary integrated care models targeting frail older adults may have positive impacts on measurements associated with not only frailty, but also depression, or osteoporosis. The objective of this proposed study is to conduct a randomized control trial (RCT) to exam the effectiveness of integrated interventions on multiple outcomes among community-dwelling Taiwanese elders with high risks for frailty and/or osteoporosis, depression. We also plan to determine the differential effects of intervention between urban and rural area.', 'detailedDescription': "This is a three-year study. In the first year, we conducted a pilot study to test the feasibility of implementing integrated model on frailty, osteoporosis, depression, and other outcomes. Another objective is to determine optimal sample size for next level intervention in year 2 and 3 (2009 study).\n\nSubjects are community-dwelling Taiwanese elders (65-79 years of age) living in Toufen Town in Miaoli County, Taiwan. Subjects are first screened with telephone interviews with the Chinese Canadian Study of Health and Aging \\_Clinical Frailty Scale (CCSHA\\_CFS). Eligible subjects are invited to a community hospital to be screened with the Health Study Phenotypic Classification of Frailty (CHS\\_PCF). Subjects scored ≥ 1 on the CHS\\_PCF are enrolled. With a 2 by 2 factorial design, subjects are first randomized into exercise/nutrition integrated care (ENIC) group and usual care (UC) group with education. Within each group, subjects are further randomized into problem solving therapy (PST) and usual care (UC) group with education by study care managers with pre-specified protocol. UC group subject received a study educational booklet with telephone follow up on compliance of booklet reading and suggested diet and exercise programs. Besides the booklets, ENIC group subjects received structured exercise 3 times/week with nutrition consultation as needed at hospital for 3 months while PST group subjects received 6 sessions of PST at hospital in 3 months.\n\nSubjects were followed at 3, 6 and 12 months. Primary outcome is improvement of the CHS\\_PCF by at least one category (from pre-frail to robust, or from frail to pre-frail or robust) from baseline analysis. Secondary outcomes include the physical function and performance, cognition, depression, quality of life, healthcare resource utilizations and bone-mineral density (BMD). Intention-to-treat analysis was applied.\n\nThe pilot study enrolled 117 subjects, after analysis of the preliminary results, the study protocol for the second and third year (2009 study) is modified as follows:\n\n1. The study is conducted at one urban (Wanhua) and one rural (Toufen) site with roughly 150 participants at each site.\n2. Convenient samples referred from participant physicians' clinics instead of the population based samples in year 1 are used to decrease administration cost.\n3. Telephone based first stage screening instrument will be modified and validated for face to face interview.\n4. Longer intervention period (6-months) than year 1.\n5. Interventions provided in ENIC and PSTIC groups are combined into a single integrated care (IC) group. Interventions for IC group and UC group are minor changed, as described below.\n\nUC group: Inform the subjects about results of frailty, osteoporosis or depression assessment. The study educational booklet and CD-ROM on frailty, depression, osteoporosis, healthy diets, exercise protocols, and self-coping strategies will be given to participants. One 2-hour educational session is provided to participants to go through the booklet with demonstration of study exercise protocol. Subjects are encouraged to have balanced nutrition and regular exercises at home following the study protocol. Subjects were contacted bimonthly to check on how much they had read and watched the study material, and how well they had complied with the suggested diet and exercise protocols. However, it is at the subjects' discretion to discuss with their primary care physicians regarding the clinical interventions.\n\nIC group: Subjects will receive all interventions provided to the UC group. Furthermore, subjects will take exercise/rehabilitation courses at the participating hospitals twice a week for 24 weeks and 6 sessions of problem solving treatment (PST). If subjects do not improve on any of the 5 indicators from the (CHSPCF), comprehensive geriatric assessments (CGAs) are applied to identify more potential modifiable factors for frailty for individualized managements.\n\nActual number of subjects enrolled in pilot study and 2009 study are 117 and 289 respectively and the total number of subjects enrolled in pilot study and 2009 study is 406."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'maximumAge': '79 Years', 'minimumAge': '65 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Scored 3-6 with the "Canadian Study of Health and Aging Clinical Frailty Scale (CSHA- CFS) Chinese Telephone Interview Version" (Telephone Interview Version is replaced by In-Person Interview Version in 2009 study)\n* Frailty index ≥ 1\n\nExclusion criteria:\n\n* Nursing home residents\n* Cannot speak any of the following three dialogues: Mandarin, Taiwanese and Haga\n* Hearing impairment interfering with communication or daily activities\n* Visual impairment interfering with communication or daily activities.\n* Cannot complete the screening instrument with the CSHA-CFS Chinese Telephone/In-Person Interview Version\n* Scored 1, 2, or 7 with the CSHA-CFS Chinese Telephone/In-Person Interview Version\n* Cognitive impairment defined as 3-item recall ≤ 1\n* Functional Impairment defined as not able to walk for 5 meters without assistance\n* Suicidal Ideation defined as Suicide Subscale of The Mini-International Neuropsychiatric Interview (M.I.N.I.) ≥ 6\n* Alcohol abuse disorders active within the last year. (score ≥ 2 on the CAGE)\n* Organic mental disorders (Seizure, brain tumor, brain surgeries), History of schizophrenia or bipolar diagnosed from psychiatrist'}, 'identificationModule': {'nctId': 'NCT00718432', 'briefTitle': 'An Interventional Study of Geriatric Frailty, Osteoporosis, and Depression', 'organization': {'class': 'OTHER', 'fullName': 'National Health Research Institutes, Taiwan'}, 'officialTitle': 'Interventional Study of Geriatric Frailty, Osteoporosis, and Depression in a Community Based Randomized Trial.', 'orgStudyIdInfo': {'id': 'EC0970301'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'UC group', 'description': 'Usual care with education', 'interventionNames': ['Behavioral: Usual care with education']}, {'type': 'EXPERIMENTAL', 'label': 'ENIC group (IC group in 2009 study)', 'description': 'Exercise and nutritional integrated care', 'interventionNames': ['Behavioral: Exercise and nutritional integrated care']}, {'type': 'EXPERIMENTAL', 'label': 'PSTIC group (IC group in 2009 study)', 'description': 'Problem solving therapy integrated care', 'interventionNames': ['Behavioral: Problem solving therapy (PST) integrated care']}], 'interventions': [{'name': 'Exercise and nutritional integrated care', 'type': 'BEHAVIORAL', 'description': "Besides the information sharing and the educational booklets, the ENIC group subjects are invited to take a structured exercise course at the participating hospital 3 times a week for 3 months. (twice a week for 24 weeks in 2009 study) The exercise program included warm up; a range of motion, stretching, and postural-correction activities; aerobic strengthening; balance; and cool down. The research team also inquired about the subjects' dietary compliance and responded to their dietary questions during the exercise sessions.", 'armGroupLabels': ['ENIC group (IC group in 2009 study)']}, {'name': 'Usual care with education', 'type': 'BEHAVIORAL', 'description': 'The study educational booklet (plus CD-ROM in 2009 study) on frailty, depression, osteoporosis, healthy diets, exercise protocols, and coping strategies are given to the participants. UC group subjects will receive a 2-hour education based on the content of study booklet including 1-hour demonstration of study exercise program in 2009 study. Subjects are contacted monthly (bimonthly in 2009 study ) for frequencies of reading this booklet and the compliance on the suggested diet and exercise protocols. Subjects are also encouraged to follow with their primary care physicians for abnormal results identified from our assessments.', 'armGroupLabels': ['UC group']}, {'name': 'Problem solving therapy (PST) integrated care', 'type': 'BEHAVIORAL', 'description': "Besides the information sharing and the educational booklets, the PSTIC group subjects will receive 6 sessions of PST (within 12 weeks in pilot study, within 24 weeks in 2009 study) aiming at solving the 'here-and-now' problems contributing to their mood-related condition and helps increase their self-efficacy. If major depressions are found, subjects are referred to their primary care physicians for further medical managements.", 'armGroupLabels': ['PSTIC group (IC group in 2009 study)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Zhunan', 'country': 'Taiwan', 'facility': 'National Health Research Institutes', 'geoPoint': {'lat': 22.57358, 'lon': 120.54147}}], 'overallOfficials': [{'name': 'Ken N Kuo, M.D.', 'role': 'STUDY_CHAIR', 'affiliation': 'Natoinal Health Research Institutes'}, {'name': 'Ching-Yu Chen, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Natoinal Health Research Institutes'}, {'name': 'Rong-Sen Yang, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Natoinal Health Research Institutes'}, {'name': 'Keh-Ming Lin, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Natoinal Health Research Institutes'}, {'name': 'Chao Agnes Hsiung, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Natoinal Health Research Institutes'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Health Research Institutes, Taiwan', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Taiwan University Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}