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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01350557
Other study ID # NHRI-EX98-9404PI
Secondary ID HMRPD180015
Status Completed
Phase N/A
First received May 6, 2011
Last updated February 2, 2017
Start date January 2005
Est. completion date July 2010

Study information

Verified date February 2017
Source Chang Gung Memorial Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Hip fracture in the elderly is associated with excess mortality of 5 to 20%, and mobility problems that usually results in costly hospital stays and lengthy rehabilitation procedures. The purpose of this study is to compare the costs and effectiveness of three care models- acute/sub-acute, comprehensive, and routine care models for hip fractured elders in Taiwan.


Description:

Hip fracture in the elderly is associated with excess mortality of 5 to 20%, and mobility problems that usually results in costly hospital stays and lengthy rehabilitation procedures. With this increase in the aging population, hip fracture represents a major and a fast growing health care problem in Taiwan. Currently, the incidence rate of hip fractures is 10 times of the incidence rate for the general population. Despite the use of advanced treatment, the one-year mortality rate (15.4%) remains significant, and many of the patients never recover completely in terms of activities of daily living functions. Many studies in the United States have proved that elderly patients with hip fracture can benefit from post-operative rehabilitation, early discharge planning programs, or transitional care programs. However, little is known about what intervention should be attempted for these patients and their families in Taiwan.

The purpose of this study is to compare the costs and effectiveness of three care models- acute/sub-acute, comprehensive, and routine care models for hip fractured elders in Taiwan.


Recruitment information / eligibility

Status Completed
Enrollment 299
Est. completion date July 2010
Est. primary completion date September 2005
Accepts healthy volunteers No
Gender All
Age group 60 Years and older
Eligibility Inclusion Criteria:

- Age 60 years or older

- Admitted to hospital for an accidental single-side hip fracture

- Receiving hip arthroplasty or internal fixation

- Able to perform full range of motion against gravity and against some or full resistance, and have a pre-fracture Chinese Barthel Index (CBI) score >70

- Living in northern Taiwan

Exclusion Criteria:

- Severely cognitively impaired and completely unable to follow orders (determined by a Chinese Mini-Mental State Examination [MMSE] score <10), or

- Terminally ill

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Comprehensive care
Comprehensive care consisted of subacute care plus health-maintenance interventions to manage depressive symptoms, manage malnutrition, and prevent falls.
Subacute care
Subacute care included geriatric consultation, continuous rehabilitation, and discharge planning.

Locations

Country Name City State
Taiwan Chang Gung Memorial Hospital Taoyuan

Sponsors (2)

Lead Sponsor Collaborator
Chang Gung Memorial Hospital National Health Research Institutes, Taiwan

Country where clinical trial is conducted

Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Primary Self-care ability Measured by the Chinese Barthel Index (CBI) as ability to perform activities of daily living (ADLs), with scores ranging from 0 to 100. 1, 3, 6, 12 months after hospital discharge
Secondary Depressive symptoms Depressive symptoms were assessed using the Chinese version of the Geriatric Depression Scale, short form (GDS-s). Patients with a score = 5 were categorized as at risk for clinical depression. 1, 3, 6, 12 months after hospital discharge
Secondary Nutritional status Nutritional status was assessed using the Mini Nutritional Assessment (MNA). MNA scores categorize each person as well-nourished (=24 points), at risk of malnutrition (17-23.5 points), and malnourished (<17 points). 1, 3, 6, 12 months after hospital discharge
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