a Modified NTU-HELP Program

Study Overview
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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.

Official Title
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Effect of the National Taiwan University Hospital Elder Life Program

Conditions
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Early Ambulation

Intervention / Treatment
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* Behavioral: a modified NTU-HELP


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Usual Care Group<br>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<br>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<br>* The intervention consists of a daily inpatient care protocol on three core intervention protocols on top of hospital routine care.<br>|

What is the study measuring?
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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 |