Three Care Models for Elderly Patients With Hip Fracture
Primary Purpose
Hip Fracture
Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Comprehensive care
Subacute care
Sponsored by
About this trial
This is an interventional supportive care trial for Hip Fracture focused on measuring Elderly, Hip fracture, Intervention program
Eligibility Criteria
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
Sites / Locations
- Chang Gung Memorial Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
No Intervention
Other
Experimental
Arm Label
Control group
Subacute care group
Comprehensive care group
Arm Description
Patients receive only usual hospital care
Patients receive hospital usual care and subacute care. Subacute care consisted of geriatric consultation, a rehabilitation program, and early discharge planning.
Patients receive not only the subacute care (geriatric consultation, rehabilitation program, and discharge planning), but also health-maintenance interventions to prevent falls, consult on nutrition, and manage depression.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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).
Full Information
NCT ID
NCT01350557
First Posted
May 6, 2011
Last Updated
February 2, 2017
Sponsor
Chang Gung Memorial Hospital
Collaborators
National Health Research Institutes, Taiwan
1. Study Identification
Unique Protocol Identification Number
NCT01350557
Brief Title
Three Care Models for Elderly Patients With Hip Fracture
Official Title
Three Care Models for Elderly Patients With Hip Fracture
Study Type
Interventional
2. Study Status
Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
January 2005 (undefined)
Primary Completion Date
September 2005 (Actual)
Study Completion Date
July 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chang Gung Memorial Hospital
Collaborators
National Health Research Institutes, Taiwan
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hip Fracture
Keywords
Elderly, Hip fracture, Intervention program
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
299 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Patients receive only usual hospital care
Arm Title
Subacute care group
Arm Type
Other
Arm Description
Patients receive hospital usual care and subacute care. Subacute care consisted of geriatric consultation, a rehabilitation program, and early discharge planning.
Arm Title
Comprehensive care group
Arm Type
Experimental
Arm Description
Patients receive not only the subacute care (geriatric consultation, rehabilitation program, and discharge planning), but also health-maintenance interventions to prevent falls, consult on nutrition, and manage depression.
Intervention Type
Other
Intervention Name(s)
Comprehensive care
Intervention Description
Comprehensive care consisted of subacute care plus health-maintenance interventions to manage depressive symptoms, manage malnutrition, and prevent falls.
Intervention Type
Other
Intervention Name(s)
Subacute care
Intervention Description
Subacute care included geriatric consultation, continuous rehabilitation, and discharge planning.
Primary Outcome Measure Information:
Title
Self-care ability
Description
Measured by the Chinese Barthel Index (CBI) as ability to perform activities of daily living (ADLs), with scores ranging from 0 to 100.
Time Frame
1, 3, 6, 12 months after hospital discharge
Secondary Outcome Measure Information:
Title
Depressive symptoms
Description
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.
Time Frame
1, 3, 6, 12 months after hospital discharge
Title
Nutritional status
Description
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).
Time Frame
1, 3, 6, 12 months after hospital discharge
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yea-Ing L Shyu, PhD
Organizational Affiliation
Chang Gung University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chang Gung Memorial Hospital
City
Taoyuan
ZIP/Postal Code
333
Country
Taiwan
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
34766330
Citation
Handoll HH, Cameron ID, Mak JC, Panagoda CE, Finnegan TP. Multidisciplinary rehabilitation for older people with hip fractures. Cochrane Database Syst Rev. 2021 Nov 12;11(11):CD007125. doi: 10.1002/14651858.CD007125.pub3.
Results Reference
derived
PubMed Identifier
26936194
Citation
Tseng MY, Liang J, Shyu YI, Wu CC, Cheng HS, Chen CY, Yang SF. Effects of interventions on trajectories of health-related quality of life among older patients with hip fracture: a prospective randomized controlled trial. BMC Musculoskelet Disord. 2016 Mar 3;17:114. doi: 10.1186/s12891-016-0958-2.
Results Reference
derived
PubMed Identifier
22960477
Citation
Shyu YI, Liang J, Tseng MY, Li HJ, Wu CC, Cheng HS, Yang CT, Chou SW, Chen CY. Comprehensive care improves health outcomes among elderly Taiwanese patients with hip fracture. J Gerontol A Biol Sci Med Sci. 2013 Feb;68(2):188-97. doi: 10.1093/gerona/gls164. Epub 2012 Sep 7.
Results Reference
derived
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Three Care Models for Elderly Patients With Hip Fracture
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