a Modified NTU-HELP Program

Early Ambulation Clinical Trial

Official title:

Effect of the National Taiwan University Hospital Elder Life Program

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01045330
• Other study ID #: 200803077R
• Status: Completed
• Phase: N/A
• First received: January 8, 2010
• Last updated: October 4, 2017
• Start date: August 2009
• Est. completion date: November 2012

Study information

• Verified date: May 2013
• Source: National Taiwan University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 377
• Est. completion date: November 2012
• Est. primary completion date: November 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Early Ambulation

Intervention

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.

Locations

Country	Name	City	State
Taiwan	National Taiwan Unversity Hospital	Taipei

Sponsors (3)

Lead Sponsor	Collaborator
National Taiwan University Hospital	National Health Research Institutes, Taiwan, National Science Council, Taiwan

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Functional status:Barthel Index.	Changes from Baseline Barthel Index (BI) scores at 6 weeks after discharge	through study completion, an average of 3 months
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Postoperative bowel dysmotility	Record the incidence of postoperative bowel dysmotility developing during hospitalization after surgery	through study completion, an average of 3 months
Secondary	Body weight	Changes from Baseline Body weight at 6 weeks after discharge	through study completion, an average of 3 months
Secondary	Grip strength	Changes from Baseline Grip strength at 6 weeks after discharge	through study completion, an average of 3 months
Secondary	Oral health	i.e., plaque index, screens of swallowing function	through study completion, an average of 3 months
Secondary	Executive function	ie.e, color trail test	through study completion, an average of 3 months
Secondary	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
Secondary	Length of Hospital Stay (LOS)	Record the length of hospital stay for abdominal surgery	through study completion, an average of 3 months