Clinical trial NCT01045330: a Modified NTU-HELP Program
Official title: Effect of the National Taiwan University Hospital Elder Life Program
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Early Ambulation
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
Collaborators: name: National Health Research Institutes, Taiwan
name: National Science and Technology Council, Taiwan
First posted: 2010-01-11
Enrollment: 377
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Functional status:Barthel Index.
timeFrame: through study completion, an average of 3 months
measure: Mini-Nutritional Assessment scores (MNA)
timeFrame: through study completion, an average of 3 months
measure: Mini Mental State Examination scores (MMSE)
timeFrame: through study completion, an average of 3 months
measure: Frailty rates and transition between frailty states
timeFrame: through study completion, an average of 3 months
measure: Postoperative delirium incidence rate [Confusion Assessment Method (CAM)]
timeFrame: through study completion, an average of 3 months
measure: Postoperative bowel dysmotility
timeFrame: through study completion, an average of 3 months
Secondary outcomes:
measure: Body weight
timeFrame: through study completion, an average of 3 months
measure: Grip strength
timeFrame: through study completion, an average of 3 months
measure: Oral health
timeFrame: through study completion, an average of 3 months
measure: Executive function
timeFrame: through study completion, an average of 3 months
measure: Geriatric Depressive Scale scores (GDS)
timeFrame: through study completion, an average of 3 months
measure: Length of Hospital Stay (LOS)
timeFrame: through study completion, an average of 3 months
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan Unversity Hospital
Study officials:
affiliation: National Taiwan University
name: Cheryl Chai-Hui Chen, DNSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chen CC, Li HC, Liang JT, Lai IR, Purnomo JDT, Yang YT, Lin BR, Huang J, Yang CY, Tien YW, Chen CN, Lin MT, Huang GH, Inouye SK. Effect of a Modified Hospital Elder Life Program on Delirium and Length of Hospital Stay in Patients Undergoing Abdominal Surgery: A Cluster Randomized Clinical Trial. JAMA Surg. 2017 Sep 1;152(9):827-834. doi: 10.1001/jamasurg.2017.1083.