a Modified NTU-HELP Program

NCT ID: NCT01045330

Last Updated: 2017-10-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

377 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-08-31

Study Completion Date

2012-11-30

Brief Summary

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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

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

Conditions

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Early Ambulation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Experimental Group

The intervention consisted of a daily inpatient care protocol on three core intervention protocols on top of hospital routine care.

Group Type EXPERIMENTAL

a modified NTU-HELP

Intervention Type BEHAVIORAL

The intervention consists of a daily inpatient care protocol on three core intervention protocols on top of hospital routine care.

Interventions

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a modified NTU-HELP

The intervention consists of a daily inpatient care protocol on three core intervention protocols on top of hospital routine care.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Health Research Institutes, Taiwan

OTHER

Sponsor Role collaborator

National Science and Technology Council, Taiwan

OTHER_GOV

Sponsor Role collaborator

National Taiwan University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Cheryl Chai-Hui Chen, DNSc

Role: PRINCIPAL_INVESTIGATOR

National Taiwan University

Locations

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National Taiwan Unversity Hospital

Taipei, , Taiwan

Site Status

Countries

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Taiwan

References

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Chen CC, Li HC, Liang JT, Lai IR, Purnomo JDT, Yang YT, Lin BR, Huang J, Yang CY, Tien YW, Chen CN, Lin MT, Huang GH, Inouye SK. Effect of a Modified Hospital Elder Life Program on Delirium and Length of Hospital Stay in Patients Undergoing Abdominal Surgery: A Cluster Randomized Clinical Trial. JAMA Surg. 2017 Sep 1;152(9):827-834. doi: 10.1001/jamasurg.2017.1083.

Reference Type DERIVED
PMID: 28538964 (View on PubMed)

Provided Documents

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Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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200803077R

Identifier Type: -

Identifier Source: org_study_id