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Sponsors and Collaborators: |
National Health Research Institutes, Taiwan National Taiwan University Hospital |
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Information provided by: | National Health Research Institutes, Taiwan |
ClinicalTrials.gov Identifier: | NCT00718432 |
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. Multifactorial, interdisciplinary integrated care models may benefit more to patients with the above 3 geriatric syndromes than single intervention targeting single condition. 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, osteoporosis, or depression.
Condition |
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Frailty Osteoporosis Depression |
Study Type: | Observational |
Study Design: | Case Control, Prospective |
Official Title: | Interventional Study of Geriatric Frailty, Osteoporosis, and Depression in a Community Based Randomized Trial.—a Pilot Study |
Estimated Enrollment: | 500 |
Study Start Date: | April 2008 |
Estimated Study Completion Date: | December 2009 |
Estimated Primary Completion Date: | April 2009 (Final data collection date for primary outcome measure) |
Groups/Cohorts |
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1
"Usual care- frailty and osteoporosis group": Educational materials on general knowledge of the two syndromes are provided. Subjects are encouraged to have balanced nutrition, regular exercises or rehabilitations when appropriate. It is at the subjects' discretions to decide the intensities of interventions.
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2
"Integrated care- frailty and osteoporosis group": The interdisciplinary geriatric care team (IGCT) will provide educational sessions on general knowledge of the two syndromes to subjects. The team will also assess nutritional needs, rehabilitation need, and exercise capacities of the subjects with personalized management strategies. Supervised rehabilitation/ exercise programs are also provided. If subjects do not improve on any of the 5 frailty indicators in 6 months, comprehensive geriatric assessments (CGA) are performed to look for other potential modifiable factors with appropriate interventions.
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3
"Usual care- depression group": Educational materials of late-life depression are provided. Again, it is at the subjects' discretions to determine the intensities of their interventions.
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4
"Integrated care- depression group": All subjects are referred to primary care physicians (PCPs). Treatment guidelines for the optimal management of late-life depression will be provided to the PCPs. Care managers in the IGCT will provide telephone counsellings, education sessions to subjects and their caregivers. Care mangers will also coordinate their care with the PCPs and follow on the treatment effects. Treatments typically include antidepressants in subjects with major depressive disorder and antidepressants or omega-3 PUFAs in cases with sub-threshold depressions.
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Subjects are community-dwelling Taiwanese elders older than 65 years of age, living in the catchment area of Tofun Twon in Maoli County, Taiwan. Subjects are first screened with telephone interviews. Potential enrollees are invited to community hospitals in the catchment areas for second stage interviews. Subjects meeting criteria of "prefrailty or frailty"- the frailty group, "osteopenia or osteoporosis"- the osteoporosis group, and "sub-threshold depression or major depression"- the depression group are enrolled. Subjects are randomised into the "usual care group" or the "integrated care group" by study care managers with prespecified protocol.
Interventions in the "usual care group" and the "integrated care group" among subjects with three geriatric syndromes are described below:
"Usual care- frailty and osteoporosis group": Educational materials on general knowledge of the two syndromes are provided. Subjects are encouraged to have balanced nutrition, regular exercises or rehabilitations when appropriate. It is at the subjects' discretions to decide the intensities of interventions.
"Integrated care- frailty and osteoporosis group": The interdisciplinary geriatric care team (IGCT) will provide educational sessions on general knowledge of the two syndromes to subjects. The team will also assess nutritional needs, rehabilitation need, and exercise capacities of the subjects with personalized management strategies. Supervised rehabilitation/ exercise programs are also provided. If subjects do not improve on any of the 5 frailty indicators in 6 months, comprehensive geriatric assessments (CGA) are performed to look for other potential modifiable factors with appropriate interventions.
"Usual care- depression group": Educational materials of late-life depression are provided. Again, it is at the subjects' discretions to determine the intensities of their interventions.
"Integrated care- depression group": All subjects are referred to primary care physicians (PCPs). Treatment guidelines for the optimal management of late-life depression will be provided to the PCPs. Care managers in the IGCT will provide telephone counseling, education sessions to subjects and their caregivers. Care mangers will also coordinate their care with the PCPs and follow on the treatment effects. Treatments typically include antidepressants in subjects with major depressive disorder and antidepressants or omega-3 PUFAs in cases with sub-threshold depressions.
Ages Eligible for Study: | 65 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Sampling Method: | Probability Sample |
Subjects are community-dwelling Taiwanese elders older than 65 years of age, living in the catchment area of Tofun Twon in Maoli County, Taiwan.
Inclusion Criteria:
Exclusion Criteria:
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Contact: Ken N. Kuo, M.D. | 886-37-246166 ext 36300 | Kennank@nhri.org.tw |
Taiwan | |
National Health Research Institutes | Recruiting |
Zhunan, Taiwan |
Study Chair: | Ken N Kuo, M.D. | Natoinal Health Research Institutes |
Principal Investigator: | Ching-Yu Chen, M.D. | Natoinal Health Research Institutes |
Principal Investigator: | Rong-Sen Yang, M.D. | Natoinal Health Research Institutes |
Principal Investigator: | Keh-Ming Lin, M.D. | Natoinal Health Research Institutes |
Principal Investigator: | Chao Agnes Hsiung, M.D. | Natoinal Health Research Institutes |
Responsible Party: | National Institute of Cancer Research ( National Health Research Instiutes, Taiwan ) |
Study ID Numbers: | EC0970301 |
Study First Received: | July 16, 2008 |
Last Updated: | July 17, 2008 |
ClinicalTrials.gov Identifier: | NCT00718432 |
Health Authority: | Taiwan: Department of Health |
Frailty Osteoporosis Depression |
Depression Musculoskeletal Diseases Mental Disorders Mood Disorders Osteoporosis |
Bone Diseases, Metabolic Depressive Disorder Bone Diseases Behavioral Symptoms |