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a Modified NTU-HELP Program

Effect of the National Taiwan University Hospital Elder Life Program

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01045330
Enrollment
377
Registered
2010-01-11
Start date
2009-08-31
Completion date
2012-11-30
Last updated
2017-10-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Early Ambulation

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.

Interventions

BEHAVIORALa modified NTU-HELP

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

Sponsors

National Health Research Institutes, Taiwan
CollaboratorOTHER
National Science and Technology Council, Taiwan
CollaboratorOTHER_GOV
National Taiwan University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

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

Secondary

MeasureTime frameDescription
Body weightthrough study completion, an average of 3 monthsChanges from Baseline Body weight at 6 weeks after discharge
Grip strengththrough study completion, an average of 3 monthsChanges from Baseline Grip strength at 6 weeks after discharge
Oral healththrough study completion, an average of 3 monthsi.e., plaque index, screens of swallowing function
Executive functionthrough study completion, an average of 3 monthsie.e, color trail test
Geriatric Depressive Scale scores (GDS)through study completion, an average of 3 monthsChanges from Baseline Geriatric Depressive Scale scores (GDS) at 6 weeks after discharge
Length of Hospital Stay (LOS)through study completion, an average of 3 monthsRecord the length of hospital stay for abdominal surgery

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 26, 2026