Three Care Models for Elderly Patients With Hip Fracture

February 2, 2017 updated by: Yea-Ing Lotus Shyu, Chang Gung Memorial Hospital
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

299

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taoyuan, Taiwan, 333
        • Chang Gung Memorial Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control group
Patients receive only usual hospital care
Other: 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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Self-care ability
Time Frame: 1, 3, 6, 12 months after hospital discharge
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Depressive symptoms
Time Frame: 1, 3, 6, 12 months after hospital discharge
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
Nutritional status
Time Frame: 1, 3, 6, 12 months after hospital discharge
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chang Gung Memorial Hospital

Collaborators

National Health Research Institutes, Taiwan

Investigators

  • Principal Investigator: Yea-Ing L Shyu, PhD, Chang Gung University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2005

Primary Completion (Actual)

September 1, 2005

Study Completion (Actual)

July 1, 2010

Study Registration Dates

First Submitted

May 6, 2011

First Submitted That Met QC Criteria

May 9, 2011

First Posted (Estimate)

May 10, 2011

Study Record Updates

Last Update Posted (Estimate)

February 3, 2017

Last Update Submitted That Met QC Criteria

February 2, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NHRI-EX98-9404PI
  • HMRPD180015 (Other Identifier: Chang Gung Memorial Hospital)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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