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Clinical Trials/NCT01045330
NCT01045330
Completed
Not Applicable

Effect of the National Taiwan University Hospital Elder Life Program

National Taiwan University Hospital1 site in 1 country377 target enrollmentStarted: August 2009Last updated:

Overview

Phase
Not Applicable
Status
Completed
Enrollment
377
Locations
1
Primary Endpoint
Frailty rates and transition between frailty states

Overview

Brief Summary

The aim is to replicate, develop, and pilot test a model of care for the prevention and management of functional decline of older patients during hospitalization.

Detailed Description

to develop an intervention protocol that achieves clinical development objectives in a scientifically rigorous and time efficient manner.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Supportive Care
Masking
Triple (Participant, Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
65 Years to — (Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Age 65 year and older
  • Length of Stay is over 6 days
  • Able to communicate verbally or in writing

Exclusion Criteria

  • Mechanism ventilation
  • Aphasia, if communication ability is severely impaired
  • Terminal condition with comfort care only, death imminent
  • Combative or dangerous behavior
  • Severe psychotic disorder that prevents patient from participating in interventions
  • Severe dementia (e.g. unable to communicate; MMSE=0). For patients with severe impairment (e.g. MMSE\<10), decision to enroll will be made on a case-by-case basis depending on their ability to participate in intervention.
  • Respiratory isolation (e.g. tuberculosis). Patients on contact isolation (e.g. vancomycin-resistant enterococcus) or droplet precautions will be enrolled.
  • Discharge firmly anticipated within 6 days of admission. Enroll if discharge date unsure
  • Refusal by patient or family member.
  • Others. Reason to be well documented.

Outcomes

Primary Outcomes

Frailty rates and transition between frailty states

Time Frame: through study completion, an average of 3 months

Changes from Baseline Frailty rates at 6 weeks after discharge

Postoperative delirium incidence rate [Confusion Assessment Method (CAM)]

Time Frame: through study completion, an average of 3 months

Record the incidence of postoperative delirium developing during hospitalization after surgery

Functional status:Barthel Index.

Time Frame: through study completion, an average of 3 months

Changes from Baseline Barthel Index (BI) scores at 6 weeks after discharge

Mini-Nutritional Assessment scores (MNA)

Time Frame: through study completion, an average of 3 months

Changes from Baseline Mini-Nutritional Assessment (MNA) scores at 6 weeks after discharge

Mini Mental State Examination scores (MMSE)

Time Frame: through study completion, an average of 3 months

Changes from Baseline Mini Mental State Examination (MMSE) scores at 6 weeks after discharge

Postoperative bowel dysmotility

Time Frame: through study completion, an average of 3 months

Record the incidence of postoperative bowel dysmotility developing during hospitalization after surgery

Secondary Outcomes

  • Body weight(through study completion, an average of 3 months)
  • Grip strength(through study completion, an average of 3 months)
  • Length of Hospital Stay (LOS)(through study completion, an average of 3 months)
  • Oral health(through study completion, an average of 3 months)
  • Executive function(through study completion, an average of 3 months)
  • Geriatric Depressive Scale scores (GDS)(through study completion, an average of 3 months)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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