A Interventional Study of Geriatric Frailty, Osteoporosis, and Depression
Recruitment status was Recruiting
| Tracking Information | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Received Date ICMJE | July 16, 2008 | ||||||||||||||||||||
| Last Updated Date | June 29, 2009 | ||||||||||||||||||||
| Start Date ICMJE | April 2008 | ||||||||||||||||||||
| Estimated Primary Completion Date | April 2009 (final data collection date for primary outcome measure) | ||||||||||||||||||||
| Current Primary Outcome Measures ICMJE |
Including physical health, mental health, social functioning, quality of life, daily functioning, and health care resource utilizations. Feasibility analysis is applied to assess the possibility for large scale disseminations of the proposed project. [ Time Frame: Center for Health Policy Research and Development ] [ Designated as safety issue: Yes ] | ||||||||||||||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||||||||||||||
| Change History | Complete list of historical versions of study NCT00718432 on ClinicalTrials.gov Archive Site | ||||||||||||||||||||
| Current Secondary Outcome Measures ICMJE |
The results of the proposed study will help shaping the geriatric healthcare policy toward the goal of "active aging" in Taiwanese community-dwelling elders. [ Time Frame: Center for Health Policy Research and Development ] [ Designated as safety issue: Yes ] | ||||||||||||||||||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||||||||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||||||||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||||||||||||||
| Descriptive Information | |||||||||||||||||||||
| Brief Title ICMJE | A Interventional Study of Geriatric Frailty, Osteoporosis, and Depression | ||||||||||||||||||||
| Official Title ICMJE | Interventional Study of Geriatric Frailty, Osteoporosis, and Depression in a Community Based Randomized Trial.—a Pilot Study | ||||||||||||||||||||
| Brief Summary | 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. |
||||||||||||||||||||
| Detailed Description | 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. |
||||||||||||||||||||
| Study Type ICMJE | Observational | ||||||||||||||||||||
| Study Design ICMJE | Observational Model: Case Control Time Perspective: Prospective |
||||||||||||||||||||
| Target Follow-Up Duration | Not Provided | ||||||||||||||||||||
| Biospecimen | Not Provided | ||||||||||||||||||||
| Sampling Method | Probability Sample | ||||||||||||||||||||
| Study Population | Subjects are community-dwelling Taiwanese elders older than 65 years of age, living in the catchment area of Tofun Twon in Maoli County, Taiwan. |
||||||||||||||||||||
| Condition ICMJE |
|
||||||||||||||||||||
| Intervention ICMJE | Not Provided | ||||||||||||||||||||
| Study Group/Cohort (s) |
|
||||||||||||||||||||
| Publications * | Not Provided | ||||||||||||||||||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||||||||||||||||||
| Recruitment Information | |||||||||||||||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||||||||||||||
| Estimated Enrollment ICMJE | 500 | ||||||||||||||||||||
| Estimated Completion Date | December 2009 | ||||||||||||||||||||
| Estimated Primary Completion Date | April 2009 (final data collection date for primary outcome measure) | ||||||||||||||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria: - |
||||||||||||||||||||
| Gender | Both | ||||||||||||||||||||
| Ages | 65 Years to 80 Years | ||||||||||||||||||||
| Accepts Healthy Volunteers | No | ||||||||||||||||||||
| Contacts ICMJE |
|
||||||||||||||||||||
| Location Countries ICMJE | Taiwan | ||||||||||||||||||||
| Administrative Information | |||||||||||||||||||||
| NCT Number ICMJE | NCT00718432 | ||||||||||||||||||||
| Other Study ID Numbers ICMJE | EC0970301 | ||||||||||||||||||||
| Has Data Monitoring Committee | Yes | ||||||||||||||||||||
| Responsible Party | National Health Research Instiutes, Taiwan, National Institute of Cancer Research | ||||||||||||||||||||
| Study Sponsor ICMJE | National Health Research Institutes, Taiwan | ||||||||||||||||||||
| Collaborators ICMJE | National Taiwan University Hospital | ||||||||||||||||||||
| Investigators ICMJE |
|
||||||||||||||||||||
| Information Provided By | National Health Research Institutes, Taiwan | ||||||||||||||||||||
| Verification Date | June 2009 | ||||||||||||||||||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||||||||||||||||||