NCT01052636

Brief Summary

Specific Aims The long-term objective of this study is to examine the effectiveness of an intervention program for older patients with hip fracture. First, an intervention program for elderly patients with hip fracture will be developed and implemented, then, the effectiveness of the intervention program will be examined. The specific aims are as follows:

  1. 1.To develop a well conceived and feasible protocol of hospital discharge and sub-acute care that involves the coordinated work of health care professionals (physicians, surgeons, nurses, and physical therapists) and the informal caregivers. The feasibility of implementing such a protocol within the context of an intervention study subject to the constraints of the clinical setting (i.e., CGMH) will be evaluated in a pilot study.
  2. 2.To conduct a randomized clinical trial to evaluate the outcomes and costs associated with the proposed hospital discharge/sub-acute care protocol for elderly patients with hip fracture. Both experimental and case study methods will be used. Information on outcome indicators including clinical outcomes, quality of life, self-care ability, family caregiving outcomes, patient and caregiver satisfaction, and services utilization will be collected and compared between the control group and the experimental group.
  3. 3.To conduct a validation clinical trial to verify the results of the primary randomized clinical trial and increase the generalization of the study findings.
  4. 4.To estimate the cost of this care model and its variations for individual patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
162

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2001

Typical duration 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, 2001

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2003

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2003

Completed
6.1 years until next milestone

First Submitted

Initial submission to the registry

January 17, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 20, 2010

Completed
Last Updated

February 3, 2017

Status Verified

February 1, 2017

Enrollment Period

2.9 years

First QC Date

January 17, 2010

Last Update Submit

February 2, 2017

Conditions

Hip Fracture

Keywords

Hip fractureIntervention programElderly

Outcome Measures

Primary Outcomes (1)

  • Quality of life

    1 year

Secondary Outcomes (6)

  • Clinical outcomes

    1 year

  • Self-care ability

    1 year

  • Family caregiving outcomes

    1 year

  • Patient and caregiver's satisfaction

    1 year

  • Service utilization

    1 year

  • +1 more secondary outcomes

Study Arms (2)

Control group

NO INTERVENTION

Patients receive only routine hospital care

Experimental group

EXPERIMENTAL

Patients receive regular hospital routine care and interdisciplinary intervention program

Other: Interdisciplinary intervention program

Interventions

Interdisciplinary intervention programOTHER

The intervention program developed for this study included three components: geriatric consultation service, rehabilitation program, and discharge-planning service.

Experimental 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 from emergency room due to hip fracture
  • Receiving hip arthroplasty or internal fixation
  • Living in northern Taiwan

You may not qualify if:

  • Severely cognitively impaired and completely unable to follow orders
  • Terminally ill

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chang Gung Memorial Hospital

Taoyuan District, 33305, Taiwan

Location

Related Publications (2)

  • 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

  • Shyu YI, Liang J, Wu CC, Cheng HS, Chen MC. An interdisciplinary intervention for older Taiwanese patients after surgery for hip fracture improves health-related quality of life. BMC Musculoskelet Disord. 2010 Sep 29;11:225. doi: 10.1186/1471-2474-11-225.

    PMID: 20920220DERIVED

MeSH Terms

Conditions

Hip Fractures

Condition Hierarchy (Ancestors)

Femoral FracturesFractures, BoneWounds and InjuriesHip InjuriesLeg Injuries

Study Officials

  • Yea-Ing L Shyu, Ph.D.

    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

January 17, 2010

First Posted

January 20, 2010

Study Start

January 1, 2001

Primary Completion

December 1, 2003

Study Completion

December 1, 2003

Last Updated

February 3, 2017

Record last verified: 2017-02

Data Sharing

IPD Sharing
Will not share

Locations

TW(1)