a Modified NTU-HELP Program

This study has been completed.
Sponsor:
Collaborators:
National Health Research Institutes, Taiwan
National Science Council, Taiwan
Information provided by (Responsible Party):
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT01045330
First received: January 8, 2010
Last updated: June 10, 2013
Last verified: May 2013
  Purpose

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.


Condition Intervention
Early Ambulation
Behavioral: a modified NTU-HELP

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Effect of the National Taiwan University Hospital Elder Life Program

Further study details as provided by National Taiwan University Hospital:

Primary Outcome Measures:
  • Functional status:Barthel Index. Nutrition Status:Mini-Nutritional Assessment, plaque index, Repetitive Saliva Swallowing Test. Cognitive Status:Chinese Mini-Mental State Examination (MMSE). Color Trails Test(CTT). [ Time Frame: admission (T0) to discharge (T1), two weeks (T2), four weeks (T3), and 6 weeks post surgery (T4) ] [ Designated as safety issue: No ]

Enrollment: 304
Study Start Date: August 2009
Study Completion Date: November 2012
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Usual Care Group
Usual care consists of standard hospital services provided by physicians, nurses, and support staff (e.g., physical therapist, dietitian) in the general surgery units.
Experimental: Experimental Group
The intervention consisted of a daily inpatient care protocol on three core intervention protocols on top of hospital routine care.
Behavioral: a modified NTU-HELP
The intervention consists of a daily inpatient care protocol on three core intervention protocols on top of hospital routine care.

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Coma
  • 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01045330

Locations
Taiwan
National Taiwan Unversity Hospital
Taipei, Taiwan, 110
Sponsors and Collaborators
National Taiwan University Hospital
National Health Research Institutes, Taiwan
National Science Council, Taiwan
Investigators
Principal Investigator: Cheryl Chai-Hui Chen, DNSc National Taiwan University
  More Information

No publications provided

Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT01045330     History of Changes
Other Study ID Numbers: 200803077R
Study First Received: January 8, 2010
Last Updated: June 10, 2013
Health Authority: Taiwan: Department of Health

ClinicalTrials.gov processed this record on April 16, 2014