Three Care Models for Elderly Patients With Hip Fracture

This study has been completed.
Sponsor:
Collaborator:
National Health Research Institutes, Taiwan
Information provided by (Responsible Party):
Yea-Ing Lotus Shyu, Chang Gung University
ClinicalTrials.gov Identifier:
NCT01350557
First received: May 6, 2011
Last updated: February 10, 2012
Last verified: February 2012
  Purpose

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.


Condition Intervention
Hip Fracture
Other: Comprehensive care
Other: Subacute care

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Supportive Care
Official Title: Three Care Models for Elderly Patients With Hip Fracture

Resource links provided by NLM:


Further study details as provided by Chang Gung Memorial Hospital:

Primary Outcome Measures:
  • Self-care ability [ Time Frame: 1, 3, 6, 12 months after hospital discharge ] [ Designated as safety issue: No ]
    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 [ Time Frame: 1, 3, 6, 12 months after hospital discharge ] [ Designated as safety issue: No ]
    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 [ Time Frame: 1, 3, 6, 12 months after hospital discharge ] [ Designated as safety issue: No ]
    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).


Enrollment: 299
Study Start Date: January 2005
Study Completion Date: July 2010
Primary Completion Date: September 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Control group
Patients receive only usual hospital care
Subacute care group
Patients receive hospital usual care and subacute care. Subacute care consisted of geriatric consultation, a rehabilitation program, and early discharge planning.
Other: Subacute care
Subacute care included geriatric consultation, continuous rehabilitation, and discharge planning.
Other Name: Subacute care
Experimental: Comprehensive care group
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.
Other: Comprehensive care
Comprehensive care consisted of subacute care plus health-maintenance interventions to manage depressive symptoms, manage malnutrition, and prevent falls.
Other Name: Comprehensive care

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.

  Eligibility

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01350557

Locations
Taiwan
Chang Gung Memorial Hospital
Taoyuan, Taiwan, 333
Sponsors and Collaborators
Chang Gung Memorial Hospital
National Health Research Institutes, Taiwan
Investigators
Principal Investigator: Yea-Ing L Shyu, PhD Chang Gung University
  More Information

No publications provided by Chang Gung Memorial Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Yea-Ing Lotus Shyu, Professor, Chang Gung University
ClinicalTrials.gov Identifier: NCT01350557     History of Changes
Other Study ID Numbers: NHRI-EX98-9404PI, HMRPD180015
Study First Received: May 6, 2011
Last Updated: February 10, 2012
Health Authority: Taiwan: Institutional Review Board

Keywords provided by Chang Gung Memorial Hospital:
Elderly
Hip fracture
Intervention program

Additional relevant MeSH terms:
Fractures, Bone
Hip Fractures
Wounds and Injuries
Femoral Fractures
Hip Injuries
Leg Injuries

ClinicalTrials.gov processed this record on July 29, 2014