NCT01045330

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
377

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2009

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2009

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

January 8, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 11, 2010

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2012

Completed
Last Updated

October 6, 2017

Status Verified

May 1, 2013

Enrollment Period

3.3 years

First QC Date

January 8, 2010

Last Update Submit

October 4, 2017

Conditions

Early Ambulation

Outcome Measures

Primary Outcomes (6)

  • 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 Outcomes (6)

  • Body weight

    through study completion, an average of 3 months

  • Grip strength

    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

  • +1 more secondary outcomes

Study Arms (2)

Usual Care Group

NO INTERVENTION

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

EXPERIMENTAL

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

Interventions

a modified NTU-HELPBEHAVIORAL

The intervention consists of a daily inpatient care protocol on three core intervention protocols on top of hospital routine care.

Experimental Group

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Age 65 year and older
  • Length of Stay is over 6 days
  • Able to communicate verbally or in writing

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan Unversity Hospital

Taipei, 110, Taiwan

Location

Related Publications (1)

  • 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.

    PMID: 28538964DERIVED

Study Officials

  • Cheryl Chai-Hui Chen, DNSc

    National Taiwan University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 8, 2010

First Posted

January 11, 2010

Study Start

August 1, 2009

Primary Completion

November 1, 2012

Study Completion

November 1, 2012

Last Updated

October 6, 2017

Record last verified: 2013-05

Locations

TW(1)