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Intervention Program for Elderly Patients With Hip Fracture

Primary Purpose

Hip Fracture

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Interdisciplinary intervention program
Sponsored by
Chang Gung Memorial Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Hip Fracture focused on measuring Hip fracture, Intervention program, Elderly

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age 60 years or older
  • Admitted from emergency room due to hip fracture
  • Receiving hip arthroplasty or internal fixation
  • Living in northern Taiwan

Exclusion Criteria:

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

Sites / Locations

  • Chang Gung Memorial Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control group

Experimental group

Arm Description

Patients receive only routine hospital care

Patients receive regular hospital routine care and interdisciplinary intervention program

Outcomes

Primary Outcome Measures

Quality of life

Secondary Outcome Measures

Clinical outcomes
Self-care ability
Family caregiving outcomes
Patient and caregiver's satisfaction
Service utilization
Cost of care

Full Information

First Posted
January 17, 2010
Last Updated
February 2, 2017
Sponsor
Chang Gung Memorial Hospital
Collaborators
National Health Research Institutes, Taiwan
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1. Study Identification

Unique Protocol Identification Number
NCT01052636
Brief Title
Intervention Program for Elderly Patients With Hip Fracture
Official Title
Intervention Program 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 2001 (undefined)
Primary Completion Date
December 2003 (Actual)
Study Completion Date
December 2003 (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
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: 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. 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. To conduct a validation clinical trial to verify the results of the primary randomized clinical trial and increase the generalization of the study findings. To estimate the cost of this care model and its variations for individual patients.
Detailed Description
The percentage of elderly persons in Taiwan has continually increased, from 2.5% in 1951 to 8.26% in 1998; the current number of elderly is 1,811,335. As in other countries with an increasing aging population, hip fracture represents a major and growing health care problem in Taiwan. Hip fractures resulted in 15,000 hospital admissions in 1997. It is estimated that the incidence rate (per 100, 000) for hip fracture in Taiwan was 211 for Taiwan's elderly population in 1993, 10 times the incidence rate for the general population. Despite advanced treatments, the one-year mortality rate for hip fracture remains significant (15.4%), and a majority of patients never recover completely in terms of activities of daily living. The economic costs of hip fractures among the elderly are huge and families suffer from caregiving burdens. Many studies in the United States have shown that elderly patients with hip fracture can benefit from post-operative rehabilitation, early discharge planning, and transitional care. However, little is known about what interventions should be attempted for these patients and their family caregivers in Taiwan. The purpose of this experimental study is therefore to explore the effectiveness of an intervention program for older patients with hip fracture. The cost of this care model will also be estimated. An intervention program will be developed in the first year. This program will be administered by a multidisciplinary health care team and will include a geriatric consultation service, an in-hospital and in-home rehabilitation program and a discharge planning component. During the first year, a pilot study consisting of 10 elderly patients with hip fracture and their caregivers in the experimental group and 10 in the control group will test the feasibility of the intervention program and establish a reference point for sample size modification. In the second and third years, a primary clinical trial will be conducted in Chang Gung Memorial Hospital in Lin Kuo. In this studies, 120 subjects who meet the sample criteria will be recruited and randomly assigned to the experimental and control group. Patients in the experimental group will receive regular hospital routine care and the intervention program. Patients in the control group will receive only routine hospital care. The outcome variables will include clinical outcomes, self-care ability, quality of life, family caregiving outcomes, patient and caregiver's satisfaction, and service utilization; data on those will be collected for one year after hospital discharge and compared between the experimental and control groups. Data on the cost of care will also be collected. A qualitative component will include in-depth interviews with five patients and their family caregivers from the experimental group, five from the control group and five health care providers, to explore the effects of the intervention program in detail. In the fourth and fifth years, a validation clinical trial will be conducted with 120 subjects. The intervention program will be implemented at a different medical center to validate the results of the primary clinical trial. The study results will provide suggestions for intervention protocols for elderly persons with hip fracture and guidelines for the development of intervention programs for other high-risk elderly persons in Taiwan. The findings also provide a reference for clinical and hospital administration decisions.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hip Fracture
Keywords
Hip fracture, Intervention program, Elderly

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
162 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control group
Arm Type
No Intervention
Arm Description
Patients receive only routine hospital care
Arm Title
Experimental group
Arm Type
Experimental
Arm Description
Patients receive regular hospital routine care and interdisciplinary intervention program
Intervention Type
Other
Intervention Name(s)
Interdisciplinary intervention program
Intervention Description
The intervention program developed for this study included three components: geriatric consultation service, rehabilitation program, and discharge-planning service.
Primary Outcome Measure Information:
Title
Quality of life
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Clinical outcomes
Time Frame
1 year
Title
Self-care ability
Time Frame
1 year
Title
Family caregiving outcomes
Time Frame
1 year
Title
Patient and caregiver's satisfaction
Time Frame
1 year
Title
Service utilization
Time Frame
1 year
Title
Cost of care
Time Frame
1year

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 from emergency room due to hip fracture Receiving hip arthroplasty or internal fixation Living in northern Taiwan Exclusion Criteria: Severely cognitively impaired and completely unable to follow orders Terminally ill
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yea-Ing L Shyu, Ph.D.
Organizational Affiliation
Chang Gung University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chang Gung Memorial Hospital
City
Taoyuan
ZIP/Postal Code
33305
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
20920220
Citation
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.
Results Reference
derived

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Intervention Program for Elderly Patients With Hip Fracture

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