NCT01350557

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
299

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2005

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2005

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2005

Completed
4.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2010

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

May 6, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 10, 2011

Completed
Last Updated

February 3, 2017

Status Verified

February 1, 2017

Enrollment Period

8 months

First QC Date

May 6, 2011

Last Update Submit

February 2, 2017

Conditions

Hip Fracture

Keywords

ElderlyHip fractureIntervention program

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Depressive symptoms

    1, 3, 6, 12 months after hospital discharge

  • Nutritional status

    1, 3, 6, 12 months after hospital discharge

Study Arms (3)

Control group

NO INTERVENTION

Patients receive only usual hospital care

Subacute care group

OTHER

Patients receive hospital usual care and subacute care. Subacute care consisted of geriatric consultation, a rehabilitation program, and early discharge planning.

Other: Subacute care

Comprehensive care group

EXPERIMENTAL

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

Interventions

Comprehensive careOTHER

Comprehensive care consisted of subacute care plus health-maintenance interventions to manage depressive symptoms, manage malnutrition, and prevent falls.

Comprehensive care group
Subacute careOTHER

Subacute care included geriatric consultation, continuous rehabilitation, and discharge planning.

Subacute care group

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chang Gung Memorial Hospital

Taoyuan District, 333, Taiwan

Location

Related Publications (3)

  • 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.

    PMID: 34766330DERIVED

  • 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.

    PMID: 26936194DERIVED

  • 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.

    PMID: 22960477DERIVED

MeSH Terms

Conditions

Hip Fractures

Interventions

Comprehensive Health CareSubacute Care

Condition Hierarchy (Ancestors)

Femoral FracturesFractures, BoneWounds and InjuriesHip InjuriesLeg Injuries

Intervention Hierarchy (Ancestors)

Patient Care ManagementHealth Services AdministrationPatient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Yea-Ing L Shyu, PhD

    Chang Gung University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 6, 2011

First Posted

May 10, 2011

Study Start

January 1, 2005

Primary Completion

September 1, 2005

Study Completion

July 1, 2010

Last Updated

February 3, 2017

Record last verified: 2017-02

Data Sharing

IPD Sharing
Will not share

Locations

TW(1)