a Modified NTU-HELP Program
This study is currently recruiting participants.
Verified November 2012 by National Taiwan University Hospital
Sponsor:
National Taiwan University Hospital
Collaborators:
National Health Research Institutes, Taiwan
National Science Council, Taiwan
Information provided by (Responsible Party):
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT01045330
First received: January 8, 2010
Last updated: November 30, 2012
Last verified: November 2012
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Early Ambulation |
Behavioral: a modified NTU-HELP |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Supportive Care |
| Official Title: | Effect of the National Taiwan University Hospital Elder Life Program |
Further study details as provided by National Taiwan University Hospital:
Primary Outcome Measures:
- Functional status:Barthel Index. Nutrition Status:Mini-Nutritional Assessment, plaque index, Repetitive Saliva Swallowing Test. Cognitive Status:Chinese Mini-Mental State Examination (MMSE). Color Trails Test(CTT). [ Time Frame: admission (T0) to discharge (T1), two weeks (T2), four weeks (T3), and 6 weeks post surgery (T4) ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 301 |
| Study Start Date: | August 2009 |
| Estimated Study Completion Date: | November 2012 |
| Primary Completion Date: | November 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
No Intervention: 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: Experimental Group
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
The intervention consists of a daily inpatient care protocol on three core intervention protocols on top of hospital routine care.
|
Detailed Description:
to develop an intervention protocol that achieves clinical development objectives in a scientifically rigorous and time efficient manner.
Eligibility| Ages Eligible for Study: | 65 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01045330
Contacts
| Contact: Cheryl Chia-Hui Chen, DNSc | 886-2-23123456 ext 88438 | cherylchen@ntu.edu.tw |
Locations
| Taiwan | |
| National Taiwan Unversity Hospital | Recruiting |
| Taipei, Taiwan, 110 | |
| Contact: Cheryl Chia-Hui Chen, DNSc, Nursing, Yale University 886-2-2312-3456 ext 88438 cherylchen@ntu.edu.tw | |
| Principal Investigator: Cheryl Chia-Hui Chen, DNSc, Nursing, Yale University | |
Sponsors and Collaborators
National Taiwan University Hospital
National Health Research Institutes, Taiwan
National Science Council, Taiwan
Investigators
| Principal Investigator: | Cheryl Chai-Hui Chen, DNSc | National Taiwan University |
More Information
No publications provided
| Responsible Party: | National Taiwan University Hospital |
| ClinicalTrials.gov Identifier: | NCT01045330 History of Changes |
| Other Study ID Numbers: | 200803077R |
| Study First Received: | January 8, 2010 |
| Last Updated: | November 30, 2012 |
| Health Authority: | Taiwan: Department of Health |
ClinicalTrials.gov processed this record on May 19, 2013