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Hip FractureNCT01052636

Intervention Program for Elderly Patients With Hip Fracture

A study testing Interdisciplinary intervention program in people with Hip Fracture, run by Chang Gung Memorial Hospital at 1 site in Taiwan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 60 years and older
Conditions the study is for
Hip Fracture
What is being tested?
Interdisciplinary intervention program
Could I receive a placebo?
No, everyone receives an active treatment
How many people
162 participants
Where
1 siteTaiwan
Study dates
Jan 2001to Dec 2003
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 60 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Taiwan1 site
  • Chang Gung Memorial Hospital

    Taoyuan, 33305

Other trials in Taiwan

About this study

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. 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. 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. 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. To estimate the cost of this care model and its variations for individual patients.
Read the 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.

Conditions
Hip Fracture
Being tested
Interdisciplinary intervention program
Keywords
Hip fracture, Intervention program, Elderly
Medical subject headings
Hip Fractures

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Interdisciplinary intervention programOther

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

Study groups in NCT01052636
Study groupRoleWhat they receive
Control groupNo interventionPatients receive only routine hospital care
Experimental groupExperimentalPatients receive regular hospital routine care and interdisciplinary intervention program
Receives: Other: Interdisciplinary intervention program

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Quality of life

    Measured: 1 year

Secondary outcomes (6)
  1. Clinical outcomes

    Measured: 1 year

  2. Self-care ability

    Measured: 1 year

  3. Family caregiving outcomes

    Measured: 1 year

  4. Patient and caregiver's satisfaction

    Measured: 1 year

  5. Service utilization

    Measured: 1 year

  6. Cost of care

    Measured: 1year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Jan 2010 (estimated)
  2. Study startJan 2001
  3. Primary completionDec 2003
  4. Study completionDec 2003

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
162 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01052636
Sponsor's protocol ID
NHRI-EX90-9023PL
Other IDs
HMRPD9J10
Status last verified
Feb 2017
First submitted
17 Jan 2010
Last updated
3 Feb 2017
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Publications

  • 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.

    PubMed 34766330
  • 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.

    PubMed 20920220

Questions about this trial

What is this clinical trial studying?

A study testing Interdisciplinary intervention program in people with Hip Fracture, run by Chang Gung Memorial Hospital at 1 site in Taiwan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Quality of life (time frame: 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01052636, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2017.

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