- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT01350557
Three Care Models for Elderly Patients With Hip Fracture
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Einschreibung (Tatsächlich)
Phase
- Unzutreffend
Kontakte und Standorte
Studienorte
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-
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Taoyuan, Taiwan, 333
- Chang Gung Memorial Hospital
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-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
Inclusion Criteria:
- 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
Exclusion Criteria:
- Severely cognitively impaired and completely unable to follow orders (determined by a Chinese Mini-Mental State Examination [MMSE] score <10), or
- Terminally ill
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Unterstützende Pflege
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Single
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
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Kein Eingriff: Kontrollgruppe
Die Patienten erhalten nur die übliche Krankenhausversorgung
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Sonstiges: Subacute care group
Patients receive hospital usual care and subacute care.
Subacute care consisted of geriatric consultation, a rehabilitation program, and early discharge planning.
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Subacute care included geriatric consultation, continuous rehabilitation, and discharge planning.
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Experimental: Comprehensive care group
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.
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Comprehensive care consisted of subacute care plus health-maintenance interventions to manage depressive symptoms, manage malnutrition, and prevent falls.
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Self-care ability
Zeitfenster: 1, 3, 6, 12 months after hospital discharge
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Measured by the Chinese Barthel Index (CBI) as ability to perform activities of daily living (ADLs), with scores ranging from 0 to 100.
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1, 3, 6, 12 months after hospital discharge
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Depressive symptoms
Zeitfenster: 1, 3, 6, 12 months after hospital discharge
|
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.
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1, 3, 6, 12 months after hospital discharge
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Nutritional status
Zeitfenster: 1, 3, 6, 12 months after hospital discharge
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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).
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1, 3, 6, 12 months after hospital discharge
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Mitarbeiter und Ermittler
Sponsor
Mitarbeiter
Ermittler
- Hauptermittler: Yea-Ing L Shyu, PhD, Chang Gung University
Publikationen und hilfreiche Links
Allgemeine Veröffentlichungen
- 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.
- 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.
- 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.
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- NHRI-EX98-9404PI
- HMRPD180015 (Andere Kennung: Chang Gung Memorial Hospital)
Plan für individuelle Teilnehmerdaten (IPD)
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