Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
377 participants
INTERVENTIONAL
2009-08-31
2012-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
TRIPLE
Study Groups
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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.
No interventions assigned to this group
Experimental Group
The intervention consisted of a daily inpatient care protocol on three core intervention protocols on top of hospital routine care.
a modified NTU-HELP
The intervention consists of a daily inpatient care protocol on three core intervention protocols on top of hospital routine care.
Interventions
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a modified NTU-HELP
The intervention consists of a daily inpatient care protocol on three core intervention protocols on top of hospital routine care.
Eligibility Criteria
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Inclusion Criteria
* 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.
65 Years
ALL
No
Sponsors
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National Health Research Institutes, Taiwan
OTHER
National Science and Technology Council, Taiwan
OTHER_GOV
National Taiwan University Hospital
OTHER
Responsible Party
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Principal Investigators
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Cheryl Chai-Hui Chen, DNSc
Role: PRINCIPAL_INVESTIGATOR
National Taiwan University
Locations
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National Taiwan Unversity Hospital
Taipei, , Taiwan
Countries
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References
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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.
Provided Documents
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Document Type: Statistical Analysis Plan
Other Identifiers
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200803077R
Identifier Type: -
Identifier Source: org_study_id