Effect of the National Taiwan University Hospital Elder Life Program
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 377
- Locations
- 2
- Primary Endpoint
- Frailty rates and transition between frailty states
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 65 Years to — (Older Adult)
- Sex
- All
- Accepts 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
- •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.
Arms & Interventions
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 Group
The intervention consisted of a daily inpatient care protocol on three core intervention protocols on top of hospital routine care.
Intervention: a modified NTU-HELP (Behavioral)
Outcomes
Primary Outcomes
Frailty rates and transition between frailty states
Time Frame: through study completion, an average of 3 months
Changes from Baseline Frailty rates at 6 weeks after discharge
Postoperative delirium incidence rate [Confusion Assessment Method (CAM)]
Time Frame: through study completion, an average of 3 months
Record the incidence of postoperative delirium developing during hospitalization after surgery
Functional status:Barthel Index.
Time Frame: through study completion, an average of 3 months
Changes from Baseline Barthel Index (BI) scores at 6 weeks after discharge
Mini-Nutritional Assessment scores (MNA)
Time Frame: 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)
Time Frame: 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
Time Frame: through study completion, an average of 3 months
Record the incidence of postoperative bowel dysmotility developing during hospitalization after surgery
Secondary Outcomes
- Body weight(through study completion, an average of 3 months)
- Grip strength(through study completion, an average of 3 months)
- Length of Hospital Stay (LOS)(through study completion, an average of 3 months)
- Oral health(through study completion, an average of 3 months)
- Executive function(through study completion, an average of 3 months)
- Geriatric Depressive Scale scores (GDS)(through study completion, an average of 3 months)