Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

A Interventional Study of Geriatric Frailty, Osteoporosis, and Depression

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2009 by National Health Research Institutes, Taiwan.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
National Taiwan University Hospital
Information provided by:
National Health Research Institutes, Taiwan
ClinicalTrials.gov Identifier:
NCT00718432
First received: July 16, 2008
Last updated: June 29, 2009
Last verified: June 2009

July 16, 2008
June 29, 2009
April 2008
April 2009   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00718432 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
A Interventional Study of Geriatric Frailty, Osteoporosis, and Depression
Interventional Study of Geriatric Frailty, Osteoporosis, and Depression in a Community Based Randomized Trial.—a Pilot Study

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.

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.

Observational
Observational Model: Case Control
Time Perspective: Prospective
Not Provided
Not Provided
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.

  • Frailty
  • Osteoporosis
  • Depression
Not Provided
  • 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.
  • 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.
  • 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.
  • 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.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
500
December 2009
April 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 65 < Age < 80 years.
  • living in the catchment area of Tofun Twon in Maoli County, Taiwan
  • Patients with frailty
  • Patients with osteoporosis
  • Patients with depression

Exclusion Criteria:

-

Both
65 Years to 80 Years
No
Contact: Ken N. Kuo, M.D. 886-37-246166 ext 36300 Kennank@nhri.org.tw
Taiwan
 
NCT00718432
EC0970301
Yes
National Health Research Instiutes, Taiwan, National Institute of Cancer Research
National Health Research Institutes, Taiwan
National Taiwan University Hospital
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
National Health Research Institutes, Taiwan
June 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP