Hip FractureNCT01350557
Three Care Models for Elderly Patients With Hip Fracture
A study testing Comprehensive care and Subacute care in people with Hip Fracture, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial 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. 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?
- Comprehensive care and Subacute care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 299 participants
- Where
- 1 siteTaiwan
- Study dates
- Jan 2005to Jul 2010
- 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 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
Who cannot join
- Severely cognitively impaired and completely unable to follow orders (determined by a Chinese Mini-Mental State Examination [MMSE] score <10), or
- Terminally ill
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Hip Fracture
- Being tested
- Comprehensive care, Subacute care
- Keywords
- Elderly, Hip fracture, Intervention program
- Medical subject headings
- Hip Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Comprehensive careOther
Comprehensive care consisted of subacute care plus health-maintenance interventions to manage depressive symptoms, manage malnutrition, and prevent falls.
Subacute careOther
Subacute care included geriatric consultation, continuous rehabilitation, and discharge planning.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Comprehensive care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1, 3, 6, 12 months after hospital discharge
Secondary outcomes (2)
Depressive symptoms
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.
Measured: 1, 3, 6, 12 months after hospital discharge
Nutritional status
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).
Measured: 1, 3, 6, 12 months after hospital discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2011 (estimated)
- Study startJan 2005
- Primary completionSep 2005
- Study completionJul 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Hip FractureStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 299 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Health Research Institutes, Taiwan
- Responsible party
- Principal investigator, Yea-Ing Lotus Shyu, Chang Gung University
- Investigators
- Yea-Ing L Shyu, PhD, Principal investigator, Chang Gung University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01350557
- Sponsor's protocol ID
- NHRI-EX98-9404PI
- Other IDs
- HMRPD180015
- Status last verified
- Feb 2017
- First submitted
- 6 May 2011
- 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 34766330Tseng 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.
PubMed 26936194Shyu 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.
PubMed 22960477
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Three Care Models for Elderly Patients With Hip Fracture
- ClinicalTrials.gov ID
- NCT01350557
- Acronym / sponsor ID
- NHRI-EX98-9404PI
- Conditions
- Hip Fracture
- Keywords
- Elderly, Hip fracture, Intervention program
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 299 participants (actual)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Collaborators
- National Health Research Institutes, Taiwan
- Study start
- Jan 2005
- Primary completion
- Sep 2005 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 10 May 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –Patients receive only usual hospital care |
| Subacute care group | Other | Other: Subacute carePatients receive hospital usual care and subacute care. Subacute care consisted of geriatric consultation, a rehabilitation program, and early discharge planning. |
| Comprehensive care group | Experimental | Other: Comprehensive carePatients 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. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- Severely cognitively impaired and completely unable to follow orders (determined by a Chinese Mini-Mental State Examination [MMSE] score <10), or
- Terminally ill
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Comprehensive careComprehensive care consisted of subacute care plus health-maintenance interventions to manage depressive symptoms, manage malnutrition, and prevent falls. | Other | Comprehensive care group |
| Subacute careSubacute care included geriatric consultation, continuous rehabilitation, and discharge planning. | Other | Subacute care group |
Primary outcome
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.
2 secondary outcomes
Depressive symptoms
Time frame: 1, 3, 6, 12 months after hospital discharge
Nutritional status
Time frame: 1, 3, 6, 12 months after hospital discharge
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2017.
- Derived from this study: PubMed 34766330Handoll 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.
- Derived from this study: PubMed 26936194Tseng 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.
- Derived from this study: PubMed 22960477Shyu 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yea-Ing L Shyu, PhD principal investigator
Chang Gung University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Comprehensive care and Subacute care 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 5 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?
Self-care ability (time frame: 1, 3, 6, 12 months after hospital discharge). 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 NCT01350557, which also lists 3 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.