a Modified NTU-HELP Program

Effect of the National Taiwan University Hospital Elder Life Program

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.

Study Overview

• Status: Completed
• Conditions: Early Ambulation
• Intervention / Treatment: Behavioral: a modified NTU-HELP

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 377
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan, 110
    • National Taiwan Unversity Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Functional status:Barthel Index.	Changes from Baseline Barthel Index (BI) scores at 6 weeks after discharge	through study completion, an average of 3 months
Mini-Nutritional Assessment scores (MNA)	Changes from Baseline Mini-Nutritional Assessment (MNA) scores at 6 weeks after discharge	through study completion, an average of 3 months
Mini Mental State Examination scores (MMSE)	Changes from Baseline Mini Mental State Examination (MMSE) scores at 6 weeks after discharge	through study completion, an average of 3 months
Frailty rates and transition between frailty states	Changes from Baseline Frailty rates at 6 weeks after discharge	through study completion, an average of 3 months
Postoperative delirium incidence rate [Confusion Assessment Method (CAM)]	Record the incidence of postoperative delirium developing during hospitalization after surgery	through study completion, an average of 3 months
Postoperative bowel dysmotility	Record the incidence of postoperative bowel dysmotility developing during hospitalization after surgery	through study completion, an average of 3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Body weight	Changes from Baseline Body weight at 6 weeks after discharge	through study completion, an average of 3 months
Grip strength	Changes from Baseline Grip strength at 6 weeks after discharge	through study completion, an average of 3 months
Oral health	i.e., plaque index, screens of swallowing function	through study completion, an average of 3 months
Executive function	ie.e, color trail test	through study completion, an average of 3 months
Geriatric Depressive Scale scores (GDS)	Changes from Baseline Geriatric Depressive Scale scores (GDS) at 6 weeks after discharge	through study completion, an average of 3 months
Length of Hospital Stay (LOS)	Record the length of hospital stay for abdominal surgery	through study completion, an average of 3 months

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital
• Collaborators: National Science Council, Taiwan; National Health Research Institutes, Taiwan
• Investigators: Principal Investigator: Cheryl Chai-Hui Chen, DNSc, National Taiwan University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: August 1, 2009
• Primary Completion (Actual): November 1, 2012
• Study Completion (Actual): November 1, 2012

Study Registration Dates

• First Submitted: January 8, 2010
• First Submitted That Met QC Criteria: January 8, 2010
• First Posted (Estimate): January 11, 2010

Study Record Updates

• Last Update Posted (Actual): October 6, 2017
• Last Update Submitted That Met QC Criteria: October 4, 2017
• Last Verified: May 1, 2013

More Information

Terms related to this study

• Other Study ID Numbers: 200803077R