a Modified NTU-HELP Program

Not Applicable

Completed

• Conditions: Early Ambulation

• Registration Number: NCT01045330
• Lead Sponsor: National Taiwan University Hospital

Brief 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.

Detailed Description

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

Study Timeline

• Study Start: 2009-08
• Study First Submitted: 2010-01-08
• Study First Submitted QC: 2010-01-08
• Study First Posted: 2010-01-11
• Primary Completion: 2012-11
• Study Completion: 2012-11
• Status Verified: 2013-05
• Last Update Submitted: 2017-10-04
• Last Update Posted: 2017-10-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 377

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

National Taiwan Unversity Hospital; 🇨🇳 Taipei, Taiwan