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a Modified NTU-HELP Program

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01045330
First Posted: January 11, 2010
Last Update Posted: October 6, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
National Health Research Institutes, Taiwan
National Science Council, Taiwan
Information provided by (Responsible Party):
National Taiwan University Hospital
  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
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Effect of the National Taiwan University Hospital Elder Life Program

Resource links provided by NLM:


Further study details as provided by National Taiwan University Hospital:

Primary Outcome Measures:
  • 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

  • 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

  • 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 Outcome Measures:
  • Body weight [ Time Frame: through study completion, an average of 3 months ]
    Changes from Baseline Body weight at 6 weeks after discharge

  • Grip strength [ Time Frame: through study completion, an average of 3 months ]
    Changes from Baseline Grip strength at 6 weeks after discharge

  • Oral health [ Time Frame: through study completion, an average of 3 months ]
    i.e., plaque index, screens of swallowing function

  • Executive function [ Time Frame: through study completion, an average of 3 months ]
    ie.e, color trail test

  • Geriatric Depressive Scale scores (GDS) [ Time Frame: through study completion, an average of 3 months ]
    Changes from Baseline Geriatric Depressive Scale scores (GDS) at 6 weeks after discharge

  • Length of Hospital Stay (LOS) [ Time Frame: through study completion, an average of 3 months ]
    Record the length of hospital stay for abdominal surgery


Enrollment: 377
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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   65 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
  Study Documents (Full-Text)

Documents provided by National Taiwan University Hospital:
Statistical Analysis Plan  [PDF] October 2, 2017

  More Information

Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT01045330     History of Changes
Other Study ID Numbers: 200803077R
First Submitted: January 8, 2010
First Posted: January 11, 2010
Last Update Posted: October 6, 2017
Last Verified: May 2013